Pharmacy of the World – Innovation and Drug Discovery in India – Part I

The Indian pharmaceutical industry, often referred to as the ‘pharmacy of the world’, is the third largest in volume and the thirteenth largest in value. However, there is some danger of losing the ‘pharmacy of the world’ tag as the Indian drug industry is increasingly becoming dependent on China for supply of bulk drugs and intermediaries. It is common knowledge that India is the largest provider of generic drugs globally, and the USA is its key market. In addition to having the second largest number of USFDA-approved manufacturing plants outside the USA, India also offers very low labour costs and cheaper cost of production in comparison to Western countries. It is predicted that the pharmaceutical sector is expected to grow to USD 100 billion by 2025. These figures indicate a prosperous path ahead for this sector in India. But, most of the current success is due to the generic manufacturers. India is not a pharmaceutical hub for discovery of new ‘medicines’, though we are now witnessing a slow and gradual shift towards innovation.

Indian Pharmaceutical Sector – Innovation

It would be unfair to say that there is a lack of innovation in the pharmaceutical sector. Indian companies have previously relied on its skilled workforce to innovate by way of ‘designing around’ patents, thus preventing infringement in the pre-TRIPS era. They manufactured cheaper generic medicines which were exported globally and earned India the ‘pharmacy of the world’ tag. Nonetheless, these companies have finally realized that future industrial growth would come only from new ‘drug discovery’ and are taking steps towards research and drug discovery.

The amount of R&D expenditure by Indian pharmaceutical companies has increased twofold from 4% to 8-10% over the years. Slowly and steadily, leading organizations like Dr. Reddy’s Laboratories, Cipla, Lupin Ltd., Biocon Ltd., and Sun Pharma are bringing about a change in the industry by moving into the ‘drug discovery’ business. Top Indian patent filers such as Cadila Healthcare, Dr. Reddy’s, Cipla, Sun Pharma, Wockhardt and Lupin are innovating as evident from their 100+ drugs in discovery phase and a sizeable drug pipeline.

Further, Indian pharmaceutical companies are extensively entering into collaborations for drug development and commercialization, and in 2016 alone, approximately 22 deals were signed. Additionally, they have collaborated with foreign pharmaceutical companies to enhance their R&D. The notable examples of these global collaborations include Sun Pharma-Able, Ranbaxy-GlaxoSmithKline, Torrent-AstraZeneca and Cipla-Roche. Moreover, the National Institutes for Pharmaceutical Education and Research (NIPERs), the national level institutes in pharmaceutical sciences have signed agreements with nearly 17 pharmaceutical companies in 2015 to accelerate and translate research into development and build up a culture of innovation within the country.

There are numerous other examples of Indian firms leading the way forward in innovation. Dr. Reddy’s is in the forefront of innovation, becoming the first Indian pharmaceutical company to launch New Chemical Entity (NCE) and has also enabled innovation in drugs for high blood pressure, diabetes and cancer. Also, a few companies have been in the forefront of vaccine innovation. R&D is already witnessing a major change among Indian companies with companies like Cipla, Dr. Reddy’s Labs, Wockhardt, Lupin, and Zydus Cadilla investing in pre-clinical development of small molecules with both novel targets and mechanism of action.

Further, the Indian government has unveiled the ‘Pharma Vision 2020’ initiative to strengthen India’s position as a major hub for end-to-end drug discovery and manufacture. In order to encourage innovation, the Indian government has allowed up to 100 percent Foreign Direct Investment in the pharmaceutical industry to foreign companies who can now avail the benefits of lower cost of highly skilled researchers as well as cost of production for better returns.

The Indian pharmaceutical industry has proven its capability to develop high-quality biosimilars for global markets and this has attracted many foreign organizations to set up small-molecule development and manufacturing establishments in India. This, alongside India’s highly skilled research community and a well-developed scientific base provides a fertile territory for drug research.

Despite so much promise of innovation in the pharmaceutical sector,  we still have a long way to go before India becomes a pharmaceutical hub for discovery of new ‘medicines’. In the next part of our series ‘Pharmacy of the World – Innovation and Drug Discovery in India’, we will discuss reasons for lack of world class innovation within our pharmaceutical industry and the factors that have limited the success of the industry to generics alone.

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भारत में मानवाधिकार के बिना बौद्धिक संपदा उत्पादन की आकांक्षा

बौद्धिक संपदा कानून भारत के लिए नई खोज नहीं हैं। 1947 में भारतीय स्वतंत्रता के बाद से पेटेंट और कॉपीराइट कानून अस्तित्व में रहें हैं। ये कानून हमें अंग्रेजों से विरासत में मिले थे। भारत ने आज़ादी के बाद भी एक कमज़ोर पेटेंट कानून अपनाया क्यूंकि भारत ज्यादातर टेक्नोलॉजी विकसित देशों से आयात करता रहा है। पेटेंट के विपरीत, भारत ने 1947 में स्वतंत्रता के बाद अंतरराष्ट्रीय घटनाक्रम के अनुरूप अपने कॉपीराइट कानून में निरंतर परिवर्तन किए।

1994 में ट्रिप्स समझौते को अपनाने के बाद भारत को अपने पेटेंट कानून में महत्वपूर्ण बदलाव करना पड़ा। यह कोई आश्चर्य की बात नहीं है कि भारत को ट्रिप्स समझौते के तहत अपना दायित्व को पूरा करने के लिए अपने कॉपीराइट कानून में बहुत कम बदलाव करना पड़ा था। हालांकि आज तक कॉपीराइट उद्योग यूनाइटेड किंगडम और संयुक्त राज्य अमेरिका की तरह विकसित नहीं हो पाया है।

और आश्चर्य की बात है की भारत में पिछले १० साल से एक विकसित पेटेंट कानून लागू है, पर हम लोग अभी भी भारत से एक बड़ी खोज या आविष्कार की प्रतीक्षा कर रहे हैं|

भारत में बौद्धिक संपदा के उत्पादन की कमी के कारणों में से एक ख़राब शिक्षा प्रणाली को जिम्मेदार ठहराया जा सकता है जिसमे की रट के याद रखने पर ज्यादा जोर दिया जाता है और गहन सोच को ज्यादा महत्व नहीं दिया जाता है। हालांकि, ख़राब शिक्षा प्रणाली की तुलना में अधिक महत्वपूर्ण कारण यह तथ्य है कि आज भी भारत में वास्तविक और प्रभावी मानवाधिकार नहीं हैं। भाषण और अभिव्यक्ति की किसी भी वास्तविक स्वतंत्रता के बिना हमारे दिमाग से कुछ भी पैदा करना लगभग असंभव है। यदि मन सोचने और अभिव्यक्त करने के लिए स्वतंत्र नहीं है तो हम भारत में किसी भी बौद्धिक संपदा को कैसे बनाने की उम्मीद करते हैं। आख़िरकार, बौद्धिक संपदा हमारे मन की रचनाएँ हैं।

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भारत में बौद्धिक संपदा बनाने के लिए आवश्यक तत्व क्या हैं?

1994 में ट्रिप्स समझौते को अपनाने के बाद से इस बात पर जोर दिया गया है कि एक मजबूत बौद्धिक संपदा कानूनों के परिणामस्वरूप भारत में अधिक बौद्धिक संपदा का निर्माण होगा। हालांकि, मजबूत बौद्धिक संपदा कानूनों के अपनाने से भारत में अधिक बौद्धिक संपदा का निर्माण नहीं हुआ है। इसका मुख्य कारण यह है कि बौद्धिक संपदा बनाने के लिए बौद्धिक संपदा कानूनों के अलावा और भी तत्वों की जरूरत होती है।

आविष्कारों और नवाचारों की रक्षा के लिए एवं बौद्धिक संपदा बनाने के लिए प्रोत्साहन प्रदान करने में बौद्धिक संपदा कानून बहुत महत्वपूर्ण हैं। हालांकि, एक आविष्कारक या एक नवप्रवर्तक के लिए बौद्धिक संपदा कानून उनकी बौद्धिक कृतियों की रक्षा के लिए केवल एक कानूनी साधन है जो की ‘राज्य’ द्वारा प्रदान किया गया जाता है। इसलिए, यदि बौद्धिक संपदा कानून हमारे दिमाग से बनाने के लिए एक प्रोत्साहन हैं, तो स्पष्ट सवाल यह है कि हमारे मन से बौद्धिक संपदा बनाने के लिए क्या आवश्यक तत्व हैं?

बौद्धिक संपदा बनाने के लिए निम्नलिखित आवश्यक तत्व हैं:

1. गहन सोच और बोलने की स्वतंत्रता।

यदि आप सोच नहीं सकते हैं, तो आप कभी भी अपने दिमाग से कुछ भी नहीं बना सकते हैं. सबसे जरूरी है की सोच गहन हो। गहन सोच से हम दायरे से बहार और कुछ हट कर सोच सकते हैं. गहन सोच से हम वो कल्पनाये कर सकते हैं जो और लोग कल्पना करने में चूक जाते हैं. यह बाजार में समस्याओं और अंतराल की पहचान करने और अप्रत्याशित स्थानों या चीजों में मौका ढूंढने में हमे सक्षम भी करती है।

बोलने और अभिव्यक्ति की स्वतंत्रता भी उतना ही महत्वपूर्ण है क्योंकि यदि आपको एक अलग दृष्टिकोण या राय व्यक्त करने की अनुमति नहीं है, तो कुछ नया बनाने की संभावना लगभग शून्य है।

2. सहानुभूति

सहानुभूति की क्षमता एक आविष्कारक या एक नवप्रवर्तक को बाजार की जरूरतों और आवश्यकताओं को समझने की क्षमता प्रदान करता है इससे पहले कि बाज़ार को अपनी ज़रूतों का एहसास हो।

3. जोखिम और विफलता

आपने मन से एक नया उत्पाद या सेवा बनाने की कोशिश बहुत ज्यादा जोखिम का काम है, और ज्यादातर इसमें विफलता ही प्राप्त होती है। यदि हम विफलता से डरते हैं, तो इस बात की संभावना ज्यादा है की हम कोई कोशिश नहीं करेंगे और अपने दिमाग से कुछ नया नहीं बना पायेंगे।

4. दृढ़ता, धैर्य और विश्वास

एक क्षण में आविष्कार या नवाचार का उत्पादन नहीं होता है। एक विचार को अवधारणा से लेकर अंत तक एक उत्पाद या सेवा बनाने में बहुत लंबा समय लगता है। प्रकाश बल्ब या हवाई जहाज रातोंरात नहीं बनाया गया था। इसके अलावा व्यक्ति को अपने ऊपर सम्पूर्ण विश्वास होना चाहिए की उसकी कड़ी मेहनत और श्रम अपेक्षित परिणाम देगी।

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Why do we fail to innovate in India?

It is no secret that Indian startup ecosystem has been lacking innovation. The successful Indian startups Flipkart, OYO Rooms, Ola and Gaana have emulated successful ideas of Amazon, Airbnb, Uber and Spotify, respectively. Lack of innovation has been found to be one the most common reason for failure of Indian startups according to a recent study, “Entrepreneurial India,” by the IBM Institute for Business Value and Oxford Economics. However, it would be unfair to single out startups for lacking innovation, especially when the present Indian companies themselves have failed to innovate world-class products or services. Indian companies have a dismal record in filing patents. Let the numbers for the International Patents filed in 2017 speak for themselves:

Country-wise International Patents Filed, 2017 (Source- WIPO) Numbers of International Patent Filed
US 56,319
China 48,875
Japan 48,206
Republic of Korea 15,745
India 1,583

In fact, there are only a handful of Indian companies that invest substantially in R&D. In the last three years, the Government of India through the Department of Industrial Policy and Promotion has made tremendous effort to promote innovation in India. Unfortunately, none of the measures have made any significant impact on innovation from Indian entities or individuals. Definitely, it is not the intellect of the Indians because these same individuals have made serious contribution to innovation in other developed countries. So, what are the reasons for lack of world-class innovation in India?

Colonial past & social system

To begin with, Indian history and social system contribute a lot to lack of innovation. The colonial policies of the British prior to our independence in 1947 prevented development of Indian industries. The British colonial powers never wanted India to be self-reliant in industrial production, but merely a supplier of raw materials. Post-independence, we have been relying on technology from outside to develop our industries. Not that we are an exception in this case. After World War II, most of the developing countries imported technology. Even countries like China, Japan and South Korea imported technologies, but eventually they build upon the borrowed technology to innovate and invent. Add, to this the Indian feudal system that even after 70 years of independence is deeply entrenched in our institutions and relationships. The problem with the feudal mindset is that it does not allow us to question and change the status quo.

Education system- Marks rather than critical thinking

India inherited a colonial education system that was based on a rote learning system. Unfortunately, we have made very little change in our education system. Till the age of around 17 years, our students in schools are trained to memorise information. The students in school are examined and evaluated on their capacity to retain and reproduce the information on examination papers. There is no emphasis on critical thinking or hands-on learning in our education system. Our higher education in professional colleges is no different. Students are expected to do the same. Memorise and reproduce. We teach our students that there is only one possible way of doing things throughout their education journey and formative years, and then we expect them to think differently and innovate, when they become start-off their careers.

Cultural mind-set

Are we risk-averse and scared of failure? The answer is in affirmative. Ask our students, who are always under tremendous pressure to excel. However, when we try to do something new, initially, chances of failure are higher. Therefore, with limited opportunities of employment in the government and the private sector, the focus is to confirm to the status quo rather than try something new.

Frugal innovation is not real innovation

In recent past there has been a glorification of ‘frugal innovation’. It’s true that Indians have been able to come up with unique products using minimalist resources in adverse conditions. However, none of these ‘frugal innovation’ have translated into world-class products. More than the ability to innovate, ‘frugal innovation’ represents our strong desire to innovate even with limited resources. One of the limitations of ‘frugal innovation’ is that it seeks immediate quick solution to a problem rather than a long-term effective and sustainable solution.

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Lecture on Discoveries and Inventions- Abraham Lincoln

On April 6, 1858, Abraham Lincoln gave his first lecture on “Discoveries and Inventions” before the Young Men’s Association of Bloomington, Illinois.

All creation is a mine, and every man, a miner.

The whole earth, and all within it, upon it, and round about it, including himself, in his physical, moral, and intellectual nature, and his susceptabilities, are the infinitely various “leads” from which, man, from the first, was to dig out his destiny.

In the beginning, the mine was unopened, and the miner stood naked, and knowledgeless, upon it.

Fishes, birds, beasts, and creeping things, are not miners, but feeders and lodgers, merely. Beavers build houses; but they build them in nowise differently, or better now, than they did, five thousand years ago. Ants, and honey-bees, provide food for winter; but just in the same way they did, when Solomon refered the sluggard to them as patterns of prudence.

Man is not the only animal who labors; but he is the only one who improves his workmanship. This improvement, he effects by Discoveries, and Inventions. His first important discovery was the fact that he was naked; and his first invention was the fig-leaf-apron. This simple article — the apron — made of leaves, seems to have been the origin of clothing — the one thing for which nearly half of the toil and care of the human race has ever since been expended. The most important improvement ever made in connection with clothing, was the invention of spinning and weaving. The spinning jenny, and power-loom, invented in modern times, though great improvements, do not, as inventions, rank with the ancient arts of spinning and weaving. Spinning and weaving brought into the department of clothing such abundance and variety of material. Wool, the hair of several species of animals, hemp, flax, cotten, silk, and perhaps other articles, were all suited to it, affording garments not only adapted to wet and dry, heat and cold, but also susceptable of high degrees of ornamental finish. Exactly when, or where, spinning and weaving originated is not known. At the first interview of the Almighty with Adam and Eve, after the fall, He made “coats of skins, and clothed them” Gen: 3-21.

The Bible makes no other alusion to clothing, before the flood. Soon after the deluge Noah’s two sons covered him with a garment; but of what material the garment was made is not mentioned. Gen. 9-23.

Abraham mentions “thread” in such connection as to indicate that spinning and weaving were in use in his day — Gen. 14.23 — and soon after, reference to the art is frequently made. “Linen breeches, [“] are mentioned, — Exod. 28.42 — and it is said “all the women that were wise hearted, did spin with their hands” (35-25) and, “all the women whose hearts stirred them up in wisdom, spun goat’s hair” (35-26). The work of the “weaver” is mentioned — (35-35). In the book of Job, a very old book, date not exactly known, the “weavers shuttle” is mentioned.

The above mention of “thread” by Abraham is the oldest recorded alusion to spinning and weaving; and it was made about two thousand years after the creation of man, and now, near four thousand years ago. Profane authors think these arts originated in Egypt; and this is not contradicted, or made improbable, by any thing in the Bible; for the alusion of Abraham, mentioned, was not made until after he had sojourned in Egypt.

The discovery of the properties of iron, and the making of iron tools, must have been among the earliest of important discoveries and inventions. We can scarcely conceive the possibility of making much of anything else, without the use of iron tools. Indeed, an iron hammer must have been very much needed to make the first iron hammer with. A stone probably served as a substitute. How could the “gopher wood” for the Ark, have been gotten out without an axe? It seems to me an axe, or a miracle, was indispensable. Corresponding with the prime necessity for iron, we find at least one very early notice of it. Tubal-cain was “an instructer of every artificer in brass and iron[“] — Gen: 4-22. Tubal-cain was the seventh in decent from Adam; and his birth was about one thousand years before the flood. After the flood, frequent mention is made of iron, and instruments made of iron. Thus “instrument of iron” at Num: 35-16; “bed-stead of iron” at Deut. 3-11 — “the iron furnace [“] at 4-20 — and “iron tool” at 27-5. At 19-5 — very distinct mention of “the ax to cut down the tree” is made; and also at 8-9, the promised land is described as “a land whose stones are iron, and out of whose hills thou mayest dig brass.” From the somewhat frequent mention of brass in connection with iron, it is not improbable that brass — perhaps what we now call copper — was used by the ancients for some of the same purposes as iron.

Transportation — the removal of person, and goods — from place to place — would be an early object, if not a necessity, with man. By his natural powers of locomotion, and without much assistance from Discovery and invention, he could move himself about with considerable facility; and even, could carry small burthens with him. But very soon he would wish to lessen the labor, while he might, at the same time, extend, and expedite the business. For this object, wheel-carriages, and water-crafts — wagons and boats — are the most important inventions. The use of the wheel & axle, has been so long known, that it is difficult, without reflection, to estimate it at it’s true value.

The oldest recorded allusion to the wheel and axle is the mention of a “chariot” Gen: 41-43. This was in Egypt, upon the occasion of Joseph being made Governor by Pharaoh. It was about twentyfive hundred years after the creation of Adam. That the chariot then mentioned was a wheel-carriage drawn by animals, is sufficiently evidenced by the mention of chariot-wheels, at Exod. 14-25, and the mention of chariots in connection with horses, in the same chapter, verses 9 & 23. So much, at present, for land-transportation.

Now, as to transportation by water, I have concluded, without sufficient authority perhaps, to use the term “boat” as a general name for all water-craft. The boat is indispensable to navigation. It is not probable that the philosophical principle upon which the use of the boat primarily depends — towit, the principle, that any thing will float, which can not sink without displacing more than it’s own weight of water — was known, or even thought of, before the first boats were made. The sight of a crow standing on a piece of drift-wood floating down the swolen current of a creek or river, might well enough suggest the specific idea to a savage, that he could himself get upon a log, or on two logs tied together, and somehow work his way to the opposite shore of the same stream. Such a suggestion, so taken, would be the birth of navigation; and such, not improbably, it really was. The leading idea was thus caught; and whatever came afterwards, were but improvements upon, and auxiliaries to, it.

As man is a land animal, it might be expected he would learn to travel by land somewhat earlier than he would by water. Still the crossing of streams, somewhat too deep for wading, would be an early necessity with him. If we pass by the Ark, which may be regarded as belonging rather to the miracalous, than to human invention the first notice we have of water-craft, is the mention of “ships” by Jacob — Gen: 49-13. It is not till we reach the book of Isaiah that we meet with the mention of “oars” and “sails.”

As mans food — his first necessity — was to be derived from the vegitation of the earth, it was natural that his first care should be directed to the assistance of that vegitation. And accordingly we find that, even before the fall, the man was put into the garden of Eden “to dress it, and to keep it.” And when afterwards, in consequence of the first transgression, labor was imposed on the race, as a penalty — a curse — we find the first born man — the first heir of the curse — was “a tiller of the ground.” This was the beginning of agriculture; and although, both in point of time, and of importance, it stands at the head of all branches of human industry, it has derived less direct advantage from Discovery and Invention, than almost any other. The plow, of very early origin; and reaping, and threshing, machines, of modern invention are, at this day, the principle improvements in agriculture. And even the oldest of these, the plow, could not have been conceived of, until a precedent conception had been caught, and put into practice — I mean the conception, or idea, of substituting other forces in nature, for man’s own muscular power. These other forces, as now used, are principally, the strength of animals, and the power of the wind, of running streams, and of steam.

Climbing upon the back of an animal, and making it carry us, might not, occur very readily. I think the back of the camel would never have suggested it. It was, however, a matter of vast importance.

The earliest instance of it mentioned, is when “Abraham rose up early in the morning, and saddled his ass,[“] Gen. 22-3 preparatory to sacraficing Isaac as a burnt-offering; but the allusion to the saddle indicates that riding had been in use some time; for it is quite probable they rode bare-backed awhile, at least, before they invented saddles.

The idea, being once conceived, of riding one species of animals, would soon be extended to others. Accordingly we find that when the servant of Abraham went in search of a wife for Isaac, he took ten camels with him; and, on his return trip, “Rebekah arose, and her damsels, and they rode upon the camels, and followed the man” Gen 24-61[.]

The horse, too, as a riding animal, is mentioned early. The Red-sea being safely passed, Moses and the children of Israel sang to the Lord “the horse, and his rider hath he thrown into the sea.” Exo. 15-1

Seeing that animals could bear man upon their backs, it would soon occur that they could also bear other burthens. Accordingly we find that Joseph’s bretheren, on their first visit to Egypt, “laded their asses with the corn, and departed thence” Gen. 42-26.

Also it would occur that animals could be made to draw burthens after them, as well as to bear them upon their backs; and hence plows and chariots came into use early enough to be often mentioned in the books of Moses — Deut. 22-10. Gen. 41-43. Gen. 46-29. Exo. 14-25[.]

Of all the forces of nature, I should think the wind contains the largest amount of motive power — that is, power to move things. Take any given space of the earth’s surface — for instance, Illinois –; and all the power exerted by all the men, and beasts, and running-water, and steam, over and upon it, shall not equal the one hundredth part of what is exerted by the blowing of the wind over and upon the same space. And yet it has not, so far in the world’s history, become proportionably valuable as a motive power. It is applied extensively, and advantageously, to sail-vessels in navigation. Add to this a few wind-mills, and pumps, and you have about all. That, as yet, no very successful mode of controlling, and directing the wind, has been discovered; and that, naturally, it moves by fits and starts — now so gently as to scarcely stir a leaf, and now so roughly as to level a forest — doubtless have been the insurmountable difficulties. As yet, the wind is an untamed, and unharnessed force; and quite possibly one of the greatest discoveries hereafter to be made, will be the taming, and harnessing of the wind. That the difficulties of controlling this power are very great is quite evident by the fact that they have already been perceived, and struggled with more than three thousand years; for that power was applied to sail-vessels, at least as early as the time of the prophet Isaiah.

In speaking of running streams, as a motive power, I mean it’s application to mills and other machinery by means of the “water wheel” — a thing now well known, and extensively used; but, of which, no mention is made in the bible, though it is thought to have been in use among the romans — (Am. Ency. tit—Mill) [.] The language of the Saviour “Two women shall be grinding at the mill &c” indicates that, even in the populous city of Jerusalem, at that day, mills were operated by hand — having, as yet had no other than human power applied to them.

The advantageous use of Steam-power is, unquestionably, a modern discovery. And yet, as much as two thousand years ago the power of steam was not only observed, but an ingenius toy was actually made and put in motion by it, at Alexandria in Egypt. What appears strange is, that neither the inventor of the toy, nor any one else, for so long a time afterwards, should perceive that steam would move useful machinery as well as a toy.

We have all heard of Young America. He is the most current youth of the age. Some think him conceited, and arrogant; but has he not reason to entertain a rather extensive opinion of himself? Is he not the inventor and owner of the present, and sole hope of the future? Men, and things, everywhere, are ministering unto him. Look at his apparel, and you shall see cotten fabrics from Manchester and Lowell; flax-linen from Ireland; wool-cloth from [Spain;] silk from France; furs from the Arctic regions, with a buffalo-robe from the Rocky Mountains, as a general out-sider. At his table, besides plain bread and meat made at home, are sugar from Louisiana; coffee and fruits from the tropics; salt from Turk’s Island; fish from New-foundland; tea from China, and spices from the Indies. The whale of the Pacific furnishes his candle-light; he has a diamond-ring from Brazil; a gold-watch from California, and a spanish cigar from Havanna. He not only has a present supply of all these, and much more; but thousands of hands are engaged in producing fresh supplies, and other thousands, in bringing them to him. The iron horse is panting, and impatient, to carry him everywhere, in no time; and the lightening stands ready harnessed to take and bring his tidings in a trifle less than no time. He owns a large part of the world, by right of possessing it; and all the rest by right of wanting it, and intending to have it. As Plato had for the immortality of the soul, so Young America has “a pleasing hope — a fond desire — a longing after” teritory. He has a great passion — a perfect rage — for the “new”; particularly new men for office, and the new earth mentioned in the revelations, in which, being no more sea, there must be about three times as much land as in the present. He is a great friend of humanity; and his desire for land is not selfish, but merely an impulse to extend the area of freedom. He is very anxious to fight for the liberation of enslaved nations and colonies, provided, always, they have land, and have not any liking for his interference. As to those who have no land, and would be glad of help from any quarter, he considers they can afford to wait a few hundred years longer. In knowledge he is particularly rich. He knows all that can possibly be known; inclines to believe in spiritual rappings, and is the unquestioned inventor of “Manifest Destiny.” His horror is for all that is old, particularly “Old Fogy”; and if there be any thing old which he can endure, it is only old whiskey and old tobacco.

If the said Young America really is, as he claims to be, the owner of all present, it must be admitted that he has considerable advantage of Old Fogy. Take, for instance, the first of all fogies, father Adam. There he stood, a very perfect physical man, as poets and painters inform us; but he must have been very ignorant, and simple in his habits. He had had no sufficient time to learn much by observation; and he had no near neighbors to teach him anything. No part of his breakfast had been brought from the other side of the world; and it is quite probable, he had no conception of the world having any other side. In all of these things, it is very plain, he was no equal of Young America; the most that can be said is, that according to his chance he may have been quite as much of a man as his very self-complaisant descendant. Little as was what he knew, let the Youngster discard all he has learned from others, and then show, if he can, any advantage on his side. In the way of land, and live stock, Adam was quite in the ascendant. He had dominion over all the earth, and all the living things upon, and round about it. The land has been sadly divided out since; but never fret, Young America will re-annex it.

The great difference between Young America and Old Fogy, is the result of Discoveries, Inventions, and Improvements. These, in turn, are the result of observation, reflection and experiment. For instance, it is quite certain that ever since water has been boiled in covered vessels, men have seen the lids of the vessels rise and fall a little, with a sort of fluttering motion, by force of the steam; but so long as this was not specially observed, and reflected and experimented upon, it came to nothing. At length however, after many thousand years, some man observes this long-known effect of hot water lifting a pot-lid, and begins a train of reflection upon it. He says “Why, to be sure, the force that lifts the pot-lid, will lift any thing else, which is no heavier than the pot-lid.” “And, as man has much hard lifting to do, can not this hot-water power be made to help him?” He has become a little excited on the subject, and he fancies he hears a voice answering “Try me”   He does try it; and the observation, reflection, and trial gives to the world the control of that tremendous, and now well known agent, called steam-power. This is not the actual history in detail, but the general principle.

But was this first inventor of the application of steam, wiser or more ingenious than those who had gone before him? Not at all. Had he not learned much of them, he never would have succeeded — probably, never would have thought of making the attempt. To be fruitful in invention, it is indispensable to have a habit of observation and reflection; and this habit, our steam friend acquired, no doubt, from those who, to him, were old fogies. But for the difference in habit of observation, why did yankees, almost instantly, discover gold in California, which had been trodden upon, and over-looked by indians and Mexican greasers, for centuries? Gold-mines are not the only mines overlooked in the same way. There are more mines above the Earth’s surface than below it. All nature — the whole world, material, moral, and intellectual, — is a mine; and, in Adam’s day, it was a wholly unexplored mine. Now, it was the destined work of Adam’s race to develop, by discoveries, inventions, and improvements, the hidden treasures of this mine. But Adam had nothing to turn his attention to the work. If he should do anything in the way of invention, he had first to invent the art of invention — the instance at least, if not the habit of observation and reflection. As might be expected he seems not to have been a very observing man at first; for it appears he went about naked a considerable length of time, before he even noticed that obvious fact. But when he did observe it, the observation was not lost upon him; for it immediately led to the first of all inventions, of which we have any direct account — the fig-leaf apron.

The inclination to exchange thoughts with one another is probably an original impulse of our nature. If I be in pain I wish to let you know it, and to ask your sympathy and assistance; and my pleasurable emotions also; I wish to communicate to, and share with you. But to carry on such communication, some instrumentality is indispensable. Accordingly speech — articulate sounds rattled off from the tongue — was used by our first parents, and even by Adam, before the creation of Eve. He gave names to the animals while she was still a bone in his side; and he broke out quite volubly when she first stood before him, the best present of his maker. From this it would appear that speech was not an invention of man, but rather the direct gift of his Creator. But whether Divine gift, or invention, it is still plain that if a mode of communication had been left to invention, speech must have been the first, from the superior adaptation to the end, of the organs of speech, over every other means within the whole range of nature. Of the organs of speech the tongue is the principal; and if we shall test it, we shall find the capacities of the tongue, in the utterance of articulate sounds, absolutely wonderful. You can count from one to one hundred, quite distinctly in about forty seconds. In doing this two hundred and eighty three distinct sounds or syllables are uttered, being seven to each second; and yet there shall be enough difference between every two, to be easily recognized by the ear of the hearer. What other signs to represent things could possibly be produced so rapidly? or, even, if ready made, could be arranged so rapidly to express the sense? Motions with the hands, are no adequate substitute. Marks for the recognition of the eye — writing — although a wonderful auxiliary for speech, is no worthy substitute for it. In addition to the more slow and laborious process of getting up a communication in writing, the materials — pen, ink, and paper — are not always at hand. But one always has his tongue with him, and the breath of his life is the ever-ready material with which it works. Speech, then, by enabling different individuals to interchange thoughts, and thereby to combine their powers of observation and reflection, greatly facilitates useful discoveries and inventions. What one observes, and would himself infer nothing from, he tells to another, and that other at once sees a valuable hint in it. A result is thus reached which neither alone would have arrived at.

And this reminds me of what I passed unnoticed before, that the very first invention was a joint operation. Eve having shared with Adam in the getting up of the apron. And, indeed, judging from the fact that sewing has come down to our times as “woman’s work” it is very probable she took the leading part; he, perhaps, doing no more than to stand by and thread the needle. That proceeding may be reckoned as the mother of all “Sewing societies”; and the first and most perfect “world’s fair” all inventions and all inventors then in the world, being on the spot.

But speech alone, valuable as it ever has been, and is, has not advanced the condition of the world much. This is abundantly evident when we look at the degraded condition of all those tribes of human creatures who have no considerable additional means of communicating thoughts. Writing — the art of communicating thoughts to the mind, through the eye — is the great invention of the world. Great in the astonishing range of analysis and combination which necessarily underlies the most crude and general conception of it — great, very great in enabling us to converse with the dead, the absent, and the unborn, at all distances of time and of space; and great, not only in its direct benefits, but greatest help, to all other inventions. Suppose the art, with all conception of it, were this day lost to the world, how long, think you, would it be, before even Young America could get up the letter A. with any adequate notion of using it to advantage? The precise period at which writing was invented, is not known; but it certainly was as early as the time of Moses; from which we may safely infer that it’s inventors were very old fogies.

Webster, at the time of writing his Dictionary, speaks of the English Language as then consisting of seventy or eighty thousand words. If so, the language in which the five books of Moses were written must, at that time, now thirtythree or four hundred years ago, have consisted of at least one quarter as many, or, twenty thousand. When we remember that words are sounds merely, we shall conclude that the idea of representing those sounds by marks, so that whoever should at any time after see the marks, would understand what sounds they meant, was a bold and ingenius conception, not likely to occur to one man of a million, in the run of a thousand years. And, when it did occur, a distinct mark for each word, giving twenty thousand different marks first to be learned, and afterwards remembered, would follow as the second thought, and would present such a difficulty as would lead to the conclusion that the whole thing was impracticable. But the necessity still would exist; and we may readily suppose that the idea was conceived, and lost, and reproduced, and dropped, and taken up again and again, until at last, the thought of dividing sounds into parts, and making a mark, not to represent a whole sound, but only a part of one, and then of combining these marks, not very many in number, upon the principles of permutation, so as to represent any and all of the whole twenty thousand words, and even any additional number was somehow conceived and pushed into practice. This was the invention of phoenetic writing, as distinguished from the clumsy picture writing of some of the nations. That it was difficult of conception and execution, is apparent, as well by the foregoing reflections, as by the fact that so many tribes of men have come down from Adam’s time to ours without ever having possessed it. It’s utility may be conceived, by the reflection that, to it we owe everything which distinguishes us from savages. Take it from us, and the Bible, all history, all science, all government, all commerce, and nearly all social intercourse go with it.

The great activity of the tongue, in articulating sounds, has already been mentioned; and it may be of some passing interest to notice the wonderful powers of the eye, in conveying ideas to the mind from writing. Take the same example of the numbers from one to one hundred, written down, and you can run your eye over the list, and be assured that every number is in it, in about one half the time it would require to pronounce the words with the voice; and not only so, but you can, in the same short time, determine whether every word is spelled correctly, by which it is evident that every separate letter, amounting to eight hundred and sixty four, has been recognized, and reported to the mind, within the incredibly short space of twenty seconds, or one third of a minute.

I have already intimated my opinion that in the world’s history, certain inventions and discoveries occurred, of peculiar value, on account of their great efficiency in facilitating all other inventions and discoveries. Of these were the arts of writing and of printing — the discovery of America, and the introduction of Patent-laws. The date of the first, as already stated, is unknown; but it certainly was as much as fifteen hundred years before the Christian era; the second — printing — came in 1436, or nearly three thousand years after the first. The others followed more rapidly — the discovery of America in 1492, and the first patent laws in 1624. Though not apposite to my present purpose, it is but justice to the fruitfulness of that period, to mention two other important events — the Lutheran Reformation in 1517, and, still earlier, the invention of negroes, or, of the present mode of using them, in 1434. But, to return to the consideration of printing, it is plain that it is but the other half — and in real utility, the better half — of writing; and that both together are but the assistants of speech in the communication of thoughts between man and man. When man was possessed of speech alone, the chances of invention, discovery, and improvement, were very limited; but by the introduction of each of these, they were greatly multiplied. When writing was invented, any important observation, likely to lead to a discovery, had at least a chance of being written down, and consequently, a better chance of never been forgotten; and of being seen, and reflected upon, by a much greater number of persons; and thereby the chances of a valuable hint being caught, proportionably augmented. By this means the observation of a single individual might lead to an important invention, years, and even centuries after he was dead. In one word, by means of writing, the seeds of invention were more permanently preserved, and more widely sown. And yet, for the three thousand years during which printing remained undiscovered after writing was in use, it was only a small portion of the people who could write, or read writing; and consequently the field of invention, though much extended, still continued very limited. At length printing came. It gave ten thousand copies of any written matter, quite as cheaply as then were given before; and consequently a thousand minds were brought into the field where there was but one before. This was a great gain; and history shows a great change corresponding to it, in point of time. I will venture to consider it, the true termination of that period called “the dark ages.” Discoveries, inventions, and improvements followed rapidly, and have been increasing their rapidity ever since. The effects could not come, all at once. It required time to bring them out; and they are still coming. The capacity to read, could not be multiplied as fast as the means of reading. Spelling-books just began to go into the hands of the children; but the teachers were not very numerous, or very competent; so that it is safe to infer they did not advance so speedily as they do now-a-days. It is very probable — almost certain — that the great mass of men, at that time, were utterly unconscious, that their conditions, or their minds were capable of improvement. They not only looked upon the educated few as superior beings; but they supposed themselves to be naturally incapable of rising to equality. To immancipate the mind from this false and under estimate of itself, is the great task which printing came into the world to perform. It is difficult for us, now and here, to conceive how strong this slavery of the mind was; and how long it did, of necessity, take, to break it’s shackles, and to get a habit of freedom of thought, established. It is, in this connection, a curious fact that a new country is most favorable — almost necessary — to the immancipation of thought, and the consequent advancement of civilization and the arts. The human family originated as is thought, somewhere in Asia, and have worked their way princip[al]ly Westward. Just now, in civilization, and the arts, the people of Asia are entirely behind those of Europe; those of the East of Europe behind those of the West of it; while we, here in America, think we discover, and invent, and improve, faster than any of them. They may think this is arrogance; but they can not deny that Russia has called on us to show her how to build steam-boats and railroads — while in the older parts of Asia, they scarcely know that such things as S.Bs & RR.s. exist. In anciently inhabited countries, the dust of ages — a real downright old-fogyism — seems to settle upon, and smother the intellects and energies of man. It is in this view that I have mentioned the discovery of America as an event greatly favoring and facilitating useful discoveries and inventions.

Next came the Patent laws. These began in England in 1624; and, in this country, with the adoption of our constitution. Before then [these?], any man might instantly use what another had invented; so that the inventor had no special advantage from his own invention. The patent system changed this; secured to the inventor, for a limited time, the exclusive use of his invention; and thereby added the fuel of interest to the fire of genius, in the discovery and production of new and useful things.

 

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Understanding the Value Chain of Innovation

Innovation has become a buzzword, used extensively to convey different perspectives with social, economic and political underpinnings. This creates confusion in the mind of the people as to the nature and purpose of innovation and its relation with intellectual property rights. However, the expectations from innovation carry one commonality i.e. bringing something new to the respective field or providing effective/new solution to the existing problems comprising new technologies, new products, new services and whole new industries. Innovation is a necessity for economic growth as industries as well as products get matured in due course of time while the market demands new products and services. Innovation ensures creation and transformation of new knowledge into new products, processes or services according to market demands stimulating higher standards of living. In addition to this, innovation also carries surprises creating new demands and providing competitive advantage to companies.

The value chain of innovation runs through creating business, new jobs, and personal income with an ultimate aim of human progression. However, the term innovation is used in a very limited sense in present time as many people restrict the meaning of innovation as to the creation of new products through advanced technologies such as software, biotechnology, robotics so on and so forth having tremendous impact on economy. Moreover, there is a regional asymmetry as to the places too; places having industrial hub get prominence as compared to those, which are not that developed. This neglects the diversity of innovation that is rooted in society in different forms catering the local demands. Jonathan Aberman has in the Washington Post blog entitled “It’s time to broaden our definition of innovation” aptly maintained we need to stop unicorn hunting, and reset why innovation matters. We must give “innovation” back its broader meaning.” Many activities taking place in small places may provide viable solution to a given problem.

“Innovation improving life” was one of the ultimate goals of innovation reflected in the theme of the World IP Day 2017. The theme aimed at using innovation as a tool to bring positive changes in human lives and exploring how it is making human lives, healthier, safer and more comfortable, changing problems into progress. In effectuating such sort of innovation the drivers supporting innovative processes needs to be strengthened. Intellectual property is seen as such a strong driver in promoting innovative process in the present knowledge economy. However it needs a viable ecosystem in which it functions supported by basic infrastructure, robust R&D system and progressive business environment. Intellectual property supported by proper research and business ecosystem attracts investors and promotes innovation. The supporting mechanism for intellectual property may consist of basic infrastructure, an effective implementation machinery, and viable court system backed by a coherent policy framework.

In the value chain of innovation, one of the pertinent question is who can become an innovator and for whose benefit it is persuaded? Going for an inclusive innovation, one of the policy objectives should be making people realize that they can act as innovator to participate and contribute in economic progress and bring a change because of them and not without them. The other policy objective should be an equitable distribution of benefits of innovation among various stakeholders and public at large. Different fields need a different model of innovation e.g. information and technology, biotechnology and medical technology in healthcare needs a collaborative model of innovation. In the present age, individual efforts cannot result in meaningful innovation unless combined through a collaborative model in certain sectors. This opens the gateway for open and collaborative research. The proper understanding of all the integers of innovation value chain and a holistic approach to innovation may yield results improving life. Emphasizing on the relevance of innovation as a game changer Francis Gurry stated:

“With this year’s World IP Day campaign (2017) we are celebrating innovation and how it improves our lives. We are also celebrating all the risk takers, all those who have dared to bring about positive change through innovation”.

In India the definition of innovation varies from one sector to another and the context in hand. Many analysts now agree that macro-indicators such as ‘R&D, patents filed in a year, number of research papers and number of PhDs in science and engineering’ are inadequate to capture the realities of India’s innovation system. In India, financial structures that support innovation are fragile and disconnected and majority of publications from reputed institutions of science and technology are not routed to provide solutions. There is little follow up by the groups of institutions involved even if they try to provide solutions. Most patents are not commercially valuable but still maintained by various organizations due to lack of proper IP audit. Problems persist at the idea stage itself as the user’s needs, market demands and potential obstacles in bringing the idea to the market is usually not properly understood. Moreover, the bureaucratic hurdles, poor urban and rural infrastructure, weak industry-academia linkage and less innovative Micro Small and Medium Enterprises (MSMEs) are few other challenges before India’s innovation ecosystem. However, to make India a truly innovative country the fundamental challenges are: how to bring innovation to the grass root level?; how to recognize the potential of small inventors and innovators? and how to achieve the social purpose of innovation?

Despite these challenges, there are few sectors in which India has made great strides such as pharmaceuticals and automobiles. Indian pharmaceutical industries are providing low cost affordable medicines and innovative pharmaceutical products in major markets. Globally India ranked third in manufacturing pharmaceutical products by volumes. India has been the world’s second fastest growing car market since 2010. However, the average technology value added in manufactured products by Indian Industry is very low as India focuses ‘more on assembling and sales than on design and development, making the process very shallow.’ Whereas, MSMEs which are the backbone of Indian economy are facing great challenges and many of them have been shut down due to ‘financial non-availability, obsolete technology, infrastructural constraints, inadequate and delayed credit and managerial deficiencies.’

However, the Government of India has made tremendous efforts to encourage innovation in India through various policy initiatives. Many reforms are taking place in Indian legal and administrative system relating to intellectual property and innovation. The Government schemes are focusing on inventors, MSMEs and startups with all the support including financial support, rebates in patent filing, expedited examination process, incubation and intellectual property facilitation centers. However, the Government has to make a practical assessment of these initiatives so that its popular slogans such as “Make in India”, “Startup India” and “Digital India” should touch base with people’s life. This is only possible, if we connect all the dots of value chain of innovation with an inclusive and integrated approach. As an important constituent of innovation, intellectual property should be respected and valued by developing an intellectual property culture in India.

Dr. Kshitij Kumar Singh is Chief Editor of iprpolicy.com and is Assistant Professor at Amity Institute of Advanced Legal Studies where he teaches intellectual property.

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What are the essential elements for creating intellectual property in India?

Since the adoption of TRIPS agreement in 1994, it has been emphasized that a stronger intellectual property laws will result in creation of more intellectual property in India. However, mere adoption of stronger intellectual property laws has not resulted in creation of more intellectual property in the country. The main reason being that it takes more than just intellectual property laws to create intellectual property.

Intellectual property laws are very important for protecting inventions & innovations and in providing an incentive to create intellectual property. However, for an inventor or an innovator, intellectual property laws are just a legal means provided by the state to protect their intellectual creations. Therefore, if intellectual property laws are an incentive to create from our minds, then the obvious question is what are the essential elements for creating from our minds?

The following are the essential elements for creating intellectual property:

1. Critical thinking and freedom of speech

If you cannot think, you can never create anything from your mind. Above all, the process of thinking has to be critical. Critical thinking allows one to think ‘out of the box’. It allows one to see and imagine what others have missed and have not imagined yet. It also enables a person to identify problems and gaps in the market and find opportunity in unexpected places or things. Freedom of speech and expression is equally important because if you are not allowed to express a different viewpoint or opinion, the possibility of creating anything new is almost zero.

2. Empathy

The ability to empathize allows an inventor or an innovator to understand the needs & requirements of the market even before the market realizes what it needs.

3. Risk & Failure

Trying to create a new product or service from our mind always entails a very high risk and more often than not, in the initial stages, it leads to failure. If individuals are afraid of failure, then it is quite unlikely that they will take a chance and try to create anything new from their mind.

4. Persistence, patience & faith

Moment of genius does not produce invention or innovation. It takes a long time, from conceptualizing the idea to finally making a product or service. Light bulb or aeroplanes were not created overnight. Above all, one needs a very high level of faith that all the hard work and labor will produce desired results.

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Novel experiments must begin with oneself that leads to a quicker discovery of truth- M.K. Gandhi

This and other experiments enhanced my faith in such household remedies, and I now proceeded with them with more self-confidence. I widened the sphere of their application, trying the earth and water and fasting treatment in cases of wounds, fevers, dyspepsia, jaundice and other complaints, with success on most occasions. But, nowadays I have not the confidence I had in South Africa, and experience has even shown that these experiments involve obvious risks.

The reference here, therefore, to these experiments is not meant to demonstrate their success. I cannot claim complete success for any experiment. Even medical men can make no such claim for their experiments. My object is only to show that he who would go in for novel experiments must begin with himself. That leads to a quicker discovery of truth, and God always protects the honest experimenter.  

(Excerpt from the book My Experiments with Truth, An Autobiography, M.K. Gandhi, Chapter “Who God Protects”)

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‘Open Markets’ & Counterfeiting in India

‘Open markets’ are ubiquitous in India. The term ‘open market’ refers to non-motor & brick establishments that have mushroomed in and around public spaces across the country. They have emerged as an additional market space surrounding motor & brick shops in well-established markets in India. The following pictures of an ‘open market’ located in Nehru Place (a well known financial district and computer market in the heart of New Delhi) provide the general characteristics of an ‘open market’:

The most common articles of trade in these ‘open markets’ consist of clothing, shoes, bags and electronics. Most of the goods, if not all of them are usually counterfeit in these ‘open markets’. Counterfeits of international brands like Nike, Reebok, Adidas, and other international brands are a common eye sore to brand owners.

Unfortunately, the brand owners have been unable to prevent the omnipresent counterfeiting in these ‘open markets’ even though India has a well-developed and evolved trademark law, which came in affect on Sep 15, 2003. This law is extensively used by the brand owners to prevent counterfeiting in India. And, the Indian judiciary has further strengthened the new trademark law by regularly issuing Anton Pillar and John Doe orders in an ex parte interlocutory injunction to prevent counterfeiting. But, it is very rare for a brand owner to pursue an anti-counterfeiting action in these ‘open markets’.

Absence of anti-counterfeiting action in ‘open markets’:

There are numerous reasons why brand owners have not taken stern anti-counterfeiting measures against ‘open markets’ in India. The most important reason is that these ‘open markets’ are at the bottom of the food chain. So far brand owners have focused on manufacturing units rather than the last transaction in the chain of counterfeiting. However, merely focusing on the manufacturing units have not produced desired effect of choking supply to these ‘open markets’ because small-scale operators rather than large manufacturing units manufacture most of the counterfeits in India. Therefore, even after a successful anti-counterfeiting action in form of a civil or criminal raid, it’s easier for the counterfeiter to relocate and continue the production of counterfeit product from a different location.

Additionally, there are enormous logistical difficulties in conducting anti-counterfeiting in these ‘open markets’. Usually, these ‘open markets’ are a tightly knit community. If there is even a whiff of a possible anti-counterfeiting raid in the market, the vendors move the counterfeit goods in no time. The other problem is the fact that the vendors in these ‘open markets’ trade in different kinds of the counterfeit products. So even if one brand owner pursued an anti-counterfeiting action in one of these ‘open markets’ replete with all kinds of counterfeit products, the actual rate of return of one particular brand is too low. This deters a single brand owner to pursue an expensive anti-counterfeiting action. And, since these ‘open markets’ are spread all over the country it is a colossal task for a brand owner to pursue an anti-counterfeiting action in all the markets simultaneously.

So it seems that in the present state of affairs unless brand owners follow a different strategy, the trade in counterfeiting will continue unabated in these ‘open markets’ in India.

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Computer Related Inventions – Indian IPO Guidelines and its Impact

The Indian Intellectual Property Office has issued fresh guidelines for examination of Computer Related Inventions (CRIs) on 19th February 2016. The guidelines had been kept in abeyance since 14th December 2015 by an official order of the Indian IPO. The aim of the guidelines is to foster uniformity and consistency in the examination of patent applications relating to CRIs, especially since Section 3(k) of the Indian Patents Act provides an explicit exclusion of a mathematical or business method or a computer programme per se or algorithms from the subject matter of patentability.

The guidelines serve the purpose of providing a holistic framework of the procedure to be adopted by the Indian Patent Office while examining CRIs. According to the guidelines CRIs are inventions, which involve the use of computers, computer networks or other programmable apparatus and include such inventions having one or more features of which are realized wholly or partially by means of a computer programme or programmes. The guidelines have provided definitions of various legal terminologies relevant for examination of CRIs along with the present jurisprudence in India and numerous case laws relating to CRIs. The Indian Patent Office has clarified that these guidelines do not constitute rule making. And, in case of any conflict between the guidelines and the Indian Patents Act or Rules, the latter would prevail. The Indian IPO will revise the guidelines in future, if required, based on interpretations by Courts of law, statutory amendments and valuable inputs from the stakeholders.

Challenges for Startups and Tech Companies

In substance, the guidelines have confirmed the exclusion of software programmes provided under Section 3(k) of the Indian Patents Act. On the other hand, the Indian Patent Office has categorically reaffirmed that if the substance of a patent claims relating to CRIs, taken as a whole do not fall into any of the excluded categories then CRIs will not be denied a patent. This is a setback to tech giants like Google, Facebook, Twitter and other US companies, which rely on software patents for competitive edge in a market economy.

Absence of software patents will provide an incentive to Indian companies and developers to innovate and develop new software and technologies without fear of any patent litigation. Ironically, the incentive that allows creation of software programme in the first instance, takes away the benefit of crucial legal protection to protect their software, which seems to be fair because if you can copy others then all sense of proportion would imply that it is fair that others are allowed to copy your creation. Of course, the software companies and developers can fall back on copyright to protect their intellectual creation. However, copyright law does not provide a strong legal protection as compared to patent law. Copyright law protects only the expression not the idea.

The only possible way of extending patent protection to software programmes in India is through a statutory amendment in the Indian Patents Act because Section 3(k) explicitly excludes a mathematical or business method or a computer programme per se or algorithms from the subject matter of patentability. It is unconceivable that Indian judiciary will override the express prohibition provided under the Indian Patents Act.

Thus, it is good news for Indian startups to innovate and develop new software without any threat of potential patent infringement suits. But, it puts them in a quandary as to how to protect and leverage their ideas in an open market without patent protection. Indian startups and tech companies will have to be very diligent in protecting their confidential information. This can be achieved by an effective non-disclosure agreement. However, the biggest challenge a startup would face in absence of a patent protection is at the stage when they pitch for funds to an investor. It is very rare that an investor would agree to sign a non-disclosure agreement to make an early stage investment.

The official order of the Indian IPO (link) and the guidelines (link) are available online.

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Indian IPR Policy- Review 2015

2015 started with the controversial ‘first draft’ of the ‘National IPR Policy’ of India. It was prepared by a government panel and was issued for public circulation in November 2014. There was much hope and optimism that for the first time the Government of India will lay down a path which will not only help in resolving the IPR policy issues that have plagued the Indian market but also quell international pressures. Neither objective has been achieved by the ‘first draft’; various stakeholders (both domestic and foreign) have in fact criticised it. Most of the IPR policy issues, like compulsory licensing, efficient prosecution of patent applications, photocopying of academic books and effective functioning of copyright collecting societies are yet being shaped. Additionally, there has been no traction in geographical indications and traditional knowledge. India continues to be a low producer of IP. The only definitive policy decision that can be extrapolated from the ‘first draft’ is the fact that India has refused to accept TRIPS plus obligations. Therefore, the contentious provision of section 3(d) of the Indian Patents Act is here to stay along with a strong compulsory licensing regime. In fact, the government has affirmed that India comply with international standards.

‘First draft’ – National IPR Policy

The ‘first draft’ provides in detail various measures to improve the IP culture and production in India. Emphasis is on promoting IP through educational programmes. The intent is to include IP education as part of our education system at all levels and incorporate IP culture within our industry. There is no conclusive evidence that merely transmitting IP education will make India and Indians producers of IP, as we require more than just IP education for making Indians producers of IP. There is also a long list of targeted programs to encourage large pools of scientific and technological talent of India to produce IP. With respect to legal framework of IP the ‘first draft’ categorically states that IP laws will be reviewed to remove anomalies and inconsistencies based on an objective and analytical studies. To meet the constant request of foreign IP owners, the government has also detailed measures to make Intellectual Property Offices (IPOs) more efficient. There is also a promise to set up an IP Promotion & Development Council (IPPDC) as a nodal organization for the promotion, creation and commercialization of IP assets and establishment of a national level Institute of Excellence to provide leadership in IP. For combating IP violations there are suggestions for strengthening the enforcement and adjudicatory mechanism.

Unfortunately, it’s been over one year since the ‘first draft’ was published and very little has been put into action. In fact, after flak from various stakeholders, the Department of Industrial Policy & Promotion in April 2015 had informed a leading newspaper that the final version of the policy had been finalised but is yet to be approved by the Cabinet. The year 2015 is long gone and we are still waiting for a reformulated IPR policy from the Government of India.

Future of IPR Policy of India-

The Government of India had announced in August 2015 that they will be coming out with a new IPR policy in about two months. We are in January 2016 and are still waiting for the new policy document. Therefore, it is very difficult to predict when the government will issue the new IPR policy document in the public domain. Without a clear IPR policy, there will be very few changes in the present IPR culture and regime of India.

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Why care about Intellectual Property?

“The answer is simple. The new drivers of wealth in our society are knowledge, not hard asset, based. Generally, we manage what we measure. Knowledge assets are new drivers of wealth production must be managed. If they can’t be measured well, how do we know we’re managing them well? If they can’t be measured well, how do we know how many resources to allocate to them.”

By Steven M. H. Wallman, Foreword (In pursuit of intellectual capital), Hidden Value, Profiting from the intellectual property economy, Edited by Bruce Berman.

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Will a stronger IPR metamorphose Indians into Inventors & Innovators?

It’s been almost one year since the song, ‘India needs a stronger IPR law and policy’ was first published after the grand Indian election of 2014. It has remained the number one song even in 2015 and there is no sign of its fading away in the near future. Till date there have been several versions of the song, ‘India needs a stronger IPR law and policy’. All the versions claim that a stronger IPR regime will benefit India in 3 possible ways:

  1. A stronger IPR law & policy will make India an attractive destination for investment.
  2. A stronger IPR law & policy will lead to greater R&D investment both by foreign as well Indian firms and therefore create more intellectual property in India.
  3. A stronger IPR law & policy will metamorphose Indians (people & firms) into inventors & innovators.

If benefits are so obvious then why hasn’t India adopted a stronger IPR law and policy? It would seem a win-win situation to everyone.

The obvious reason might be that India already has a stronger intellectual property regime. India has incorporated all the obligations under the TRIPS Agreement (Agreement on Trade Related Aspects of Intellectual Property Rights, 1994) that provides for global ‘minimum standards’ for every form of intellectual property. ‘Minimum standards’ should not be read as a weak IPR regime because for countries alien to these standards before 1994, they almost qualify as ‘maximum standards’.

Back to the benefits that India will supposedly gain by adopting a stronger IPR law and policy.

  1. A stronger IPR law & policy will make India an attractive destination for investment.

It’s true that an IP intensive firm investing in India would feel safe if they were sure that their IP would be protected in a time-bound legal system. In January 2005, India adopted all the mandatory IP norms under the TRIPS agreement but still there has been no surge of investments in India by IP intensive firms.

The problem, therefore, lies more in the enforcement of IP laws, which can be attributed to an extremely slow legal process and lack of understanding of IP nuances. The temporary injunction cases can easily last up to a couple of years and rarely do we find any finality to IP cases.

Imagine the horror of a technological firm protecting IP in an Indian court; by the time the temporary injunction is settled, the technology would become obsolete and useless in some cases. One solution often recommended is the establishment of fast track IP courts with specialized judges.

Therefore, the biggest problem is the absence of an effective and time-bound legal resolution. Delay in legal resolution results in an ineffective enforcement of IP rights. Unfortunately such delays are, however, a bigger Indian problem and not just limited to IP laws. If a stronger IPR law and policy could change India’s legal system then we should not wait another day to adopt them.

  1. A stronger IPR law & policy will lead to greater R&D investment by foreign and Indian firms and therefore create more intellectual property in India.

Again, if IP intensive firms feel safe that their legal rights are protected in a secured time, then even with the present IPR laws there should have been more IP investment in India since January 2005. However, the change did not see a surge in investment by IP intensive firms. What it did manage to do is lead to market and social problems and the resultant increase in number of IP litigation in India.

Absence of an efficient time-bound judicial system is one of the biggest issue for investors looking to invest in India. Uncertainty and long legal delays have never attracted investors. When you add bureaucratic red tape for getting approvals from the government, it certainly deters them further. And, finally the relationship based business practices confuse investors so much that they start looking at other countries in Asia. Therefore, it appears that a change in IPR law and policy will not cause any real change unless we address other challenges in India.

Additionally, a change in IPR law and policy will not result in any substantial increase in R&D by Indian firms either. Few big Indian firms have substantially raised their R&D expenditure in last decade but majority do not invest in R&D. This has more to do with the absence of spirit of inventiveness and capacity to take risk both at the level of the firm and the individual. The absence of spirit of inventiveness and capacity to take risk will explain that stronger IPR alone will not metamorphose Indians (people and firms) into inventors & innovators.

  1. A stronger IPR law & policy will metamorphose Indians into inventors & innovators.  

Mere change in the law will not metamorphose Indians (people & firms) into inventors or innovators. There is no doubt that Indians are creative and intelligent but we have failed in last seventy years to come up with a path breaking invention or innovation in the country. However, Indians have contributed significantly in inventions and innovations outside India. Have we ever wondered what is the reason that Indians become inventors and innovators outside India? Is it merely the presence of a stronger IPR law and policy?

No. It’s much more than just having stronger IPR law and policy. It has to do with the spirit of inventiveness and risk taking capacity of the individuals within the society. The spirit of inventiveness requires an education that promotes critical thinking and allows challenging the old norms. It can only spring in a society that has basic human right of free speech and expression. The basic human rights are quintessential for invention or innovation because they allow everyone to participate in an entrepreneurial activity and try a new idea.

Even after the existence of an inventive spirit and capacity to take risk, it is essential to have an ecosystem, which supports the transformation of ideas into finished products and services. And, this is not possible without proper state support and a system based on meritocracy rather than personal relationships and social status.

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‘I lay no claim to originality’- M.K. Gandhi

“I have written twenty chapters on the subject of Indian Home Rule which I venture to place before the readers of Indian Opinion. I have read much, I have pondered much. During the stay for four months in London of the Transvaal Indian deputation I discussed things with as many of my countrymen as I could. I met, too, as many Englishmen as it was possible for me to meet. I consider it my duty now to place before the readers of Indian Opinion the conclusions, which appear to me to be final. The Gujarati subscribers of Indian Opinion number about 800. I am aware that, for every subscriber, there are at least ten persons who read the paper with zest. Those who cannot read Gujarati have the paper read to them. Such persons have often questioned me about the conditions of India. Similar questions were addressed to me in London. I felt, therefore, that it might not be improper for me to ventilate publicly the views expressed by me in private.

These views are mine, and yet not mine. They are mine because I hope to act according to them. They are almost a part of my being. But, yet, they are not mine, because I lay no claim to originality. They have been formed after reading several books. That which I dimly felt received support from these books.”

(Excerpt from the Foreword of the book Hind Swaraj, M.K. Gandhi).

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Indian Patent Policy- Issues & Challenge

Indian Patent Policy- Issues & Challenge

It’s been over two decades since India adopted an evolved patent system under the TRIPS Agreement. However, there is no consistent patent and public health policy framework even when there are obvious social and market problems in the country. Numerous cases involving issue of compulsory licensing have been litigated. At present there is no long-term policy framework to deal with social and market problems, which scuttles innovation and economic growth in India. The patent and public health policy issues are complicated because of the public health challenges that the country is facing with its large population.

Issues

(i)     Compulsory License

The issue of compulsory license is the most controversial issue in India and is still unresolved even after the ruling of Supreme Court of India on 13 December 2014. The Supreme Court ruled against Bayer, which in a last ditch attempt tried to block the sale of a cheap generic version of its cancer drug Nexavar in India. The Supreme Court dismissed Bayer’s claim that no compulsory license should be issued, however, the court did not rule on any questions of law and have left all questions of law open. Compulsory license has been used regularly in India to meet public health demands of cheap medicines. However, excessive licensing hampers growth and development. It impacts not only the foreign direct investment (FDI) but provides little incentive to Indian pharmaceutical companies to spend considerable energy in drug discovery research.

(ii)    Section 3 (d) of the Indian Patent Act

India has incorporated Section 3 (d) in the Indian Patent Act, which prevents firms from extending patents on their products by making slight changes to a compound, a practice known as “evergreening”. In 2013, the Supreme Court of India upheld the rejection of patent application for Glivec (Novartis) on the grounds that it is not a new medicine, but an amended version of a known compound. Indian courts have in recent years also revoked patents granted to other international drugmakers, including Pfizer, Roche and Merck.  Experts are concerned that this provision prevents pharmaceutical companies from supporting continued research and development of new medicines.

(iii)    Access to Medicine

Access to medicines is one of the biggest challenge and by far the most important issue in India. In last few months, the Government of India has put hundreds of medicines under price control to make medicines more affordable for its citizens. A long-term patent policy framework has to take into account the public health interest of India and balance it with the interest of patent owners.

(iv)    Patent Litigation

Continuous patent litigation on the issues of life saving drugs is a result of absence of any policy framework to deal with the issue of life saving drugs. In absence of any clear policy framework, patent disputes are used as a tool to provide solution to the public health challenges because there is no consistent policy to address the issue of life saving drugs.

Challenge

Since the time an evolved patent system was superimposed on the Indian legal system, the policy issues have perplexed policy experts. Most of the policy issues have being litigated in Indian courts. The unresolved policy issues have long-term implications on the market economy, the deadweight loss to the society and economic growth & innovation. It is imperative that India should address these policy issues with an objective framework based on an empirical socio-economic analysis.

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