Friday, December 28, 2012

Stanford India Biodesign: Commercialization is the next Frontier

Stanford India Biodesign (SIB), the ambitious alliance between the Design School at Stanford, AIIMS and IIT Delhi to train a new generation of medical device innovators, is making steady progress. I attended the 6th Medtech Summit held at Delhi on December 21, and was impressed to see SIB on the verge of moving to Phase 2. I wrote about last year’s summit in an earlier blogpost, and it was good to see the visible progress over the last year.


SIB’s Achievements so far




First, the overall statistics. SIB has so far trained 24 fellows. Fellows visited Stanford for 6 months to learn about the design process, and then returned to India to the SIB design studio at AIIMS to put what they learnt into practice. Fellows come from a variety of backgrounds including medicine, engineering and design. In addition, 28 interns have worked on projects at SIB in India, and imbibed much of their learning from the fellows and the SIB India faculty.

The programme has resulted in the development of 12 devices so far. 20 provisional patents have been granted to cover these devices, and 5 PCT applications have been filed. 5 products are in various stages of trials. 2 companies have been formed, and one product has been licensed for sale and manufacture by Hindustan Latex Limited to the Ministry of Health.


Future Plans

SIB Associate Director Raj Doshi mentioned that when SIB was started in 2007 the approach was to start one centre, show some success, and then expand. SIB is proceeding smoothly along this trajectory. More institutions now plan to replicate the SIB model locally. 2 biodesign centres, at IIT Madras and the Indian Institute of Science, will be funded by the Department of Biotechnology. To facilitate transfer of the Biodesign approach and curriculum, a set of Biodesign Training Modules has been created by the faculty involved in SIB. These modules were released at the Medtech Summit. Two new cross-institutional networks are being formed: the National Biodesign Alliance, and an Indian Biodesign Consortium.

Going forward, there will be a focus on innovation in two areas: Devices & implants; and Invitro diagnostics. A Translational Health Science & Technology Centre is also coming up. The SIB programme itself has been extended for another 5 years. The three prongs going forward will be research for affordable innovation, interconnecting research competencies and resources, and creating a regulatory framework for devices.

Innovations by SIB Fellows

As is the practice at the Medtech Summit, the fellows presented a quick overview of their work.


This year’s team output was showcased by Jonathan. All SIB teams follow the Stanford methodology of Identify + Invent + Implement. On return from Stanford, the team immersed itself in clinical practice to identify unmet needs that would become the focus of their innovation efforts. Clinical immersion spans the three levels of healthcare that exist in India: a community health centre, a district hospital, and the All India Institute of Medical Sciences, India’s premier reference hospital.

This year’s team focused on gastrointestinal disease, the most common cause of hospitalization in India. Their clinical immersion revealed as many as 176 needs which were successively scaled down to 43, 10 and 3 needs respectively based on a variety of criteria including impact, market, technical feasibility, personal preferences, and inputs from the SIB advisors.

All three short-listed needs have high potential impact: (1) a better way to do liver biopsies could help solve a major health problem. 10% of Indians are likely to have suffered from a liver-related disease during their lifetime. Alcohol-caused liver disease results in 40% of liver cirrhosis deaths. The burden of liver failure could exceed Rs. 100 crore every year. There is a potential demand of 4.8 crore liver biopsies every year. (2) Upper Gastrointestinal Variceal bleeding is another serious gastrointestinal health condition. If it can be stopped, 1.8 crore patients could benefit. While it is treatable through endoscopy, a typical patient has to wait upto 8 hours till he can access endoscopic treatment. (3) Abdominal paracentesis affects 3.6 crore patients every year.

Finding it difficult to prioritise between these three significant clinical needs, the team decided to address all three! They showcased Bioscoop, a low-cost device that helps perform a percutaneous liver biopsy; Variseal, a device to help stabilized patients suffering from variceal bleeding till they can be taken for an endoscopy; and Parasafe, a safe and standardized way to do paracentesis. All three devices are low cost and can be used with a high degree of accuracy by relatively less-skilled medical and paramedical staff. For good measure, the team also invented a handheld device for removing foreign bodies from the nose, a boon to pediatric ENT practice.

Innovations by SIB 2011 Fellows




The Medtech Summit was also graduation time for the 2011 fellows who completed their formal association with the programme. Ayesha Chaudhary showcased NeoBreathe, the device the 2011 fellows created to overcome neonatal asphyxia. While asphyxia can be overcome by resuscitation, existing resuscitation methods are too complex and can be used effectively only by the most skilled and dexterous individuals. NeoBreathe de-skills the process by making it much easier: a well-designed resuscitation bay takes care of neck positioning; a foot-powered suction device allows the device to be used even when there is no electricity. The device has a clear indicator that gives feedback on whether the condition is being addressed. The 2011 fellows have co-founded Windmill Health Technologies to commercialise this device. Other devices demonstrated included Uthishtami, a device to help the elderly get up from their chairs, and a device designed to reduce hospital acquired infections – it’s a smart and interactive device worn around the waist that dispenses disinfectant to the wearer. It indicates how long it is since the doctor or nurse last cleaned her hands.

Panel on Training Needs

I was part of a panel consisting of industry folks (Ravi Kaushik of GE, Sandy Sudhir of Invent India), educationists (Suresh Devasahayam from CMC Vellore, Amaresh Chakrabarti from IISc) and Dr. Sujay Shad from Gangaram Hospital. Biten Kathrani of J&J and Anurag Mairal of SIB moderated the discussion. All of us agreed that we need to scale up SIB-like efforts by going well beyond the confines of elite institutions; that innovation needs to be a more cross-functional process; and that with time the emphasis will shift from needs and ideas to commercialization and market impact. Reflecting these last two points, there will be a need for more generalists and entrepreneurs who can integrate all these together.

My contribution to the panel was a plea to extend the scope of the SIB training to include business model innovation. Understanding the motivations of Indian buyers of medical products, and their purchase processes combined with exposure to channel structures and distribution issues would help these smart inventors get the end-to-end business perspective that would help their creatively designed products reach the market.

Takeaways

Thanks to the pioneering efforts of Dr Bhan at the DBT, Dr Balram Bhargava at AIIMS, and all those involved in the SIB programme, the seeds for medical device innovation in India have been sown. As more institutions get involved, this orientation will get diffused with greater benefit to all.

Given regulatory requirements and the fact that human lives are involved, medical devices have to be robust and clinically tested. While devices can use simple concepts, and be focused on ease-of-use and low cost, one thing is clear – this is not a realm for Jugaad thinking. In fact, SIB’s greatest strength is its emphasis on a systematic innovation process. Systematic innovation doesn’t mean high technology nor does it mean high cost – it refers to a process that allows the results of creative thinking to be validated through careful experiments and trials.

The SIB format is well suited to devices of low to moderate complexity. That is what a team can work on and complete within the SIB timeframe. In his remarks, Dr. Deka, Director of AIIMS, called for taking on more complex and sophisticated products, but it’s not clear how that will happen in the present format. Hopefully, fellows will move on to such devices as they progress in their careers.



And, though SIB has done very well so far in creating capable inventors who understand the design process, the next challenge will be commercializing some of the devices. Commercialization has been India’s Achilles heel in the past. Will we be able to overcome it now?

Friday, December 21, 2012

Building Innovative Products Out of India: Lessons from Bell Labs India, CDOT, Cisco, Concept2Silicon and Ittiam

What will it take to build an Apple or Google out of India? This is a question we often ask, and you might recall that I gave one perspective on this in my Outlook Business column some months ago.




Sanjay Nayak of Tejas Networks has devoted the last decade to building high tech telecom products out of India. He is passionate about building a supportive product ecosystem in Bangalore/India. So, when he invited me to moderate a panel discussion on “Fostering an Innovation Economy in India: Issues, Challenges & Recommendations” at the IEEE ANTS 2012 conference at Bangalore last week, I jumped at the opportunity.


We had great participants - Vishy Poosala of Bell Labs, VVR Sastry of CDOT (former CMD of Bharat Electronics), Srini Rajam of Ittiam, Satya Gupta of concept2silicon (and present chair of the Indian Semiconductor Association), and Ishwar Parulkar of Cisco, I had requested each participant to start with a short account of a successful innovation project they had been associated with in India, and what made it work. Since we hear so much about the obstacles to innovation in India, I thought some bright spots may offer ways around these.


And, a real treat followed as we got some insightful examples from all the speakers.


Vishy Poosala – Alcatel Lucent (Bell Labs)


Vishy started by describing an interesting phenomenon his team noticed. Rather than download songs legally available through mobile service providers, mobile owners preferred to buy songs from a corner store. The obvious reason was cost – it’s much more expensive to buy songs "legally." Why do downloaded songs cost more? His team found out that the reason for this was that the service providers had congested networks, and therefore did not want to promote downloads that would congest their networks further. Bell Labs India proposed a solution to this problem - a "Mango Box" which could push content to users at off peak times when there was no congestion, and hence songs (or other content) could be sold cheaper. While they managed to commercialise this product in India, revenues were never big enough to excite AT&T. Ultimately, "Mango" got traction when it was deployed in the US for use on AT&T's iphone network. The lessons? Address local problems, but look out for global problems where the same solution can be applied. Vishy mentioned that AL ventures, an internal venturing arm of Alcatel Lucent played a key role in making this cross-fertilization happen.

Srini Rajam - Ittiam




Srini went next. Ittiam has completed a successful decade of a focused IP play. It earns all its revenues from licensing IP it has created. In 2009, Ittiam identified that the then smartphones did not have the capability to play HD video. Creating that capability was non-trivial because it involved change in the software architecture and working with both handset and silicon players. There was a window of opportunity open, and Ittiam sought to address this by quickly creating the IP, filing a patent and then working with the players to implement it. Not only were 10 million phones incorporating this IP sold in the first year, one of Ittiam's major clients highlighted the HD video playback in its product marketing collateral. Based on this experience, Srini stressed the importance of innovation as a process - the spark (idea), followed by implementation, and then business impact. Clearly, as in the Alcatel Lucent case, choice of the product is key as well.

VVR Sastry - CDOT


After CDOT's pioneering efforts on switching for rural exchanges in the 1980s, CDOT disappeared from public imagination. While it has continued to be involved in strategic projects, it’s no longer "visible." Sastry of CDOT gave one example of how CDOT is trying to change that. Mobile base stations are power guzzlers and are already being targeted by environmentalists for their high carbon footprint. At the same time, rural call rates are not always high, and rural cellular infrastructure is under-utilized. CDOT is trying to solve this problem through shared GSM radio. With the regulators possibly allowing spectrum sharing, this could be a way for better utilization of rural cellular infrastructure. While admittedly a late life cycle product with an emerging market focus, this has the potential to lower costs yet provide multi-operator service in rural locations. Sastry stressed "right product at the right time", providing a “total product concept" and keeping up the motivation of engineers.


Satya Gupta – Concept2Silicon




Satya Gupta's company Concept2Silicon is just 3 years old. He encourages innovation through Friday brainstorming sessions. He stressed the importance of aligning new product ideas with needs and timing. In particular, he underlined the importance of aligning products to local conditions and price points. He outlined one important opportunity. Education is rapidly shifting from the traditional classroom to electronic media. But the electronic media used in the classroom are not interactive and don't allow the teacher to adapt/change content or modify / add comments easily. Interactive whiteboards are available, but they are imported and too expensive. This is an area where Concept2Silicon sees product innovation opportunities.


Ishwar Parulkar - Cisco




Ishwar is the CTO of Cisco's Provider Access Business Unit in Bangalore. He shared the highlights of the ASR 901 router, the first product developed end-to-end by Cisco in India (see my earlier post on this project for more details). Defining what product to build in India was critical - they chose a router for access providers (= mobile service providers) not only because this was a relevant market in India but also because this was not a core segment addressed by Cisco's existing products. Scale, reliability and monetization were 3 key criteria for Cisco. To build the product in Bangalore, Ishwar's team had to persuade vendors to enhance their local capabilities. They also had to transfer knowledge in certain areas like certification. Thus product development efforts involved building a local ecosystem. The third element was creating an appropriate organizational and operational model - there were 3 stages: an incubation stage (under the radar) till a concept could be proved, a stage of scale up with "borrowed resources," and a third stage of mainstreaming with more funding.Today, ASR 901 has a market not only in India, but across the world.

Fostering an Innovation Economy

In the discussion that followed, several interesting questions came up which addressed the larger theme that Sanjay had identified for the session:

1. Will India be restricted to “late in the life cycle” or niche products, or will we be able to come out with genuinely new products?

2. What needs to be done to improve the innovation ecosystem?

3. How does India compare to China on the innovation front?

4. How can we improve collaboration between academia and industry?

5. How can we enhance the economic dividend to India of innovation activities here?

Most of the comments in response to the first question identified the usual obstacles to creating really innovative products from India: hierarchy in Indian society (vs. the questioning attitude required to do genuine innovation); fear of failure; the education system; and inadequate private sector investment in R&D. There was agreement that many of these things are changing, and the future looks optimistic. But the slow growth of private sector R&D investment continues to be an issue of concern.

Satya Gupta had some very specific and relevant suggestions on improving product innovation. His own experience in his company has been that even the components required for product innovation are not easily available, and often need to be imported with delays of upto 3-4 weeks. This slows down the innovation process, and also demotivates the innovator. He called for the setting up of resource centres – he called them ESDM innovation centres – that are fully equipped and ready-to-use for experimentation. This will help start-up entrepreneurs quickly try out new ideas.

There was broad agreement that China has been able to do several things on a scale that India is unable to even dream of – these include development of infrastructure, education in science and technology, funding for start-ups etc. China has a strong desire to dominate telecom and has therefore supported the creation of large corporations like Huawei and ZTE. In contrast, India lacks a strategic orientation, is unable to spend the R&D money committed because of cumbersome bureaucratic processes, and is no longer even the source of the largest number of graduate students abroad.

Regarding academia-industry collaboration, speakers pointed to the incentive systems in Indian academia that appear to favour academic research resulting in papers and do not give importance to industrial R&D. A specific example was given of a person with considerable international corporate R&D experience who was denied a job in one of the IITs because she did not have adequate research output (=papers in journals).

The fifth question – economic dividend for india – prompted an interesting discussion around value capture in the innovation process. Sanjay Nayak wondered aloud whether Indian companies need to invest more in marketing and branding if India is to capture more value. There was a broad agreement that collaboration was key to improving the economic returns to India – and that even multinational subsidiaries in India may gain from collaborating with each other rather than trying to “sell” their innovations to reluctant managements in the developed world.

Does innovation have to be a struggle? Or can it be the mainstream of a company’s activities? Many speakers pointed out that innovation involves change, and most human beings don’t like change. Hence innovation will always involve overcoming obstacles. Ishwar pointed out that even in Apple, ideas are hard fought. But I felt that companies like 3M, Google, and our own Titan have shown that innovation can become a more routine activity of the company.

Conclusion

I see confidence in our abilities to innovate from India growing, and that’s a good thing. There is a new generation of innovation evangelists returning to India (people like Vishy and Ishwar) who are determined to make things happen here. At the same time, we have people like Srini and Sanjay who have shown that good innovation can come out of India and that it’s possible to run innovative companies here. Of course, it’s not easy, but I see the formation of a critical mass of people who know how to make innovation work. Let’s hope a lot more people get inspired by their examples in the days to come.

Saturday, December 15, 2012

Eureka Forbes: Making Open Innovation Work


According to water.org, 128 million people in India lack access to safe drinking water. I suspect that’s an underestimate because the World Bank estimates that 21% of communicable diseases in India are due to unsafe drinking water. Water in India is often contaminated by pollution, or poor sanitation. India’s local governments in cities, towns and villages struggle to meet the drinking water needs of their citizens. Even when water is available, its quality is often in question. No wonder that several companies from the Tatas to Unilever have identified water purification as an important product category to be in.

About Eureka Forbes – a Pioneer in Retail Appliances for Water Purification


Eureka Forbes has been one of the pioneers in the water filtration/purification business in India. The company made its name as the pioneer of large-scale direct selling in India through the sale of vacuum cleaners. Few people in urban India would have escaped the attention of a Eureka Forbes salesman – it has an 8,000-strong direct sales force across 550 cities/towns Their meticulous training system for direct sales has made them the preferred source of direct sales people in the country.

Though Eureka Forbes has a formidable presence in the country through its flagship Aquaguard product, the company continues to search for new and better ways of providing clean drinking water to its consumers. Recently, Dr. Raman Venkatesh the CTO of Eureka Forbes spoke to a group of IIMB executive education participants about how his company manages its innovation activity.


Eureka Forbes’ Innovation Strategy

Eureka Forbes has some distinctive advantages in the appliance market. It has strong name/brand recognition, and distribution muscle through its direct sales force, presence in retail outlets (about 15,000 dealers across 1800 towns) and strong service network  (1100 service centres across India).  Yet, as a medium-sized company (Eureka Forbes is not listed, but it is estimated to be a Rs. 1,500 crore company), it does not have the luxury of huge resources to spend on R&D. Besides, there are important developments in water purification technology happening across the world. In these circumstances, Eureka Forbes has adopted open innovation as its innovation approach. Though it doesn’t have a structured scanning process at present, it keeps its eyes and ears open for new technologies from anywhere in the world. It encourages its employees to bring in such ideas to the company.

One important mechanism it uses is the Euro Senate – a group of 8-12 employees, cutting across functions, elected by all employees of the company every year. These eurosenators play the role of a product council to solicit and pilot new product ideas. While many of these ideas come from the field through interactions with customers, one big idea came through the sister of a Eurosenator who alerted the company to an important new technological development in water purification reported in the media in the US.

Reflecting the company’s ability to translate knowledge into innovation and operational excellence, Eureka Forbes has been a winner of the “Most Admired Knowledge Enterprise” Award four times. Other important Eureka Forbes knowledge management initiatives include an intranet portal, Euroshare, where employees submit and share their knowledge and expertise, and a knowledge helpline that employees can access to give immediate answers to customer queries.

Of course, given the company’s strong competitive position in one of the world’s biggest markets for water purification, Eureka Forbes is an obvious target for research institutions and companies trying to license out new technologies. Eureka Forbes has taken special care to build a reputation as a good partner so as to encourage more such enquiries to come their way. They have an open invitation for technology partnerships on their website!

Though Eureka Forbes takes different forms of formal intellectual property protection to improve appropriability, the company believes in frequent product introductions as a way of staying ahead (see my previous post on how effective innovators combine legal protection with product-market actions – Eureka Forbes is a good example of this). Their target is to achieve 20% of their revenues from products launched within the last 5 years, but they are currently achieving a “new product vitality index” of more than double that with 3 – 5 new product introductions every year in the last 5 years.

A Recent Breakthrough Innovation


One of the challenges Eureka Forbes faces is translating its innovations into a language that customers can understand. One of their recent products, AquaSure, is based on Amrit ®, an integrated multi-stage technology that the company sourced from Argonide Corporation, a company based in Florida. This disruptive technology based on a Nanoceram filter allows the transformation of even contaminated water into water as clean as bottled water without the use of chemicals. The filter attracts viruses and other biological micro-organisms “like a magnet,” thus providing “sabse surakshit paani.” See video of interview with Raman Venkatesh and Fred Tepper from Argonide Corporation USA to understand more about the technology. The technology is cost-effective as well with Eureka Forbes estimating a water filtration cost of 20 paise per litre.

As is often the case with successful innovations, innovation has to enter the marketing and advertising domain as well. The technology may be highly sophisticated but technology doesn’t sell unless consumers can relate to it – hence Eureka Forbes came up with the kitanu magnet campaign, a memorable advertising approach that communicated the almost miraculous power of the technology in a way the consumer can understand. (See the video which likens the process through which Aqua Sure acts like a magnet, pulling out all contaminants, to the way the police catches criminals).



Tailpiece

Of course, while open innovation may be an optimal strategy for Eureka Forbes, the challenge of putting the country on a trajectory of technology development remains. Availability of clean water continues to be a challenge in India, and several CSIR labs and other research institutions have been working on water purification methods for decades. Some of these, like the Reverse Osmosis method, have been commercialized, but it appears that we have not been able to keep pace with technological developments outside the country that allow even higher degree of purity, and safety against biological organisms. Let’s hope that we can put our scientific talent and industrial capabilities together to create distinctive technological capabilities of our own.

Saturday, December 8, 2012

Does India provide a supportive environment for getting value out of innovation?

When we talk about supporting innovation in India, the first things that come to mind are the availability of capital and people with the right skills. But, the efforts and risks involved in innovation don’t make sense unless inventors and firms can get value out of their innovative activity.


When will innovation make money for inventors? That depends on issues like: Are users willing to try out new products and services? Do the capital markets place a premium on companies that are more innovative? Can an inventor protect his innovation from being copied by others, i.e., can he be sure that he (and he alone) will be able to capture the value from the innovation he creates? The right hand side of the framework below captures these “demand-side” factors.


In this article, I will focus on the last question – the issue of value appropriation - and ask a broad question: Does India provide a supportive environment for appropriating value from Innovation?

Appropriating Value from Innovation

To answer this question, I will investigate whether the Indian system for protecting intellectual property provides an effective mechanism for protecting inventor rights. Please remember that there is an exchange relationship at the bottom of the intellectual property system: the State gives an inventor a limited time monopoly to exploit her idea in return for the inventor sharing her knowledge or idea with society. So, a good intellectual property system has to balance the needs of both inventors and society at large.

Of course, I must add that from a firm-strategy perspective, appropriating value does not depend on intellectual property alone. As the graphic below (adapted from VK Narayanan’s book Managing Technology and Innovation for Competitive Advantage) shows, a firm’s ability to appropriate value from innovation also depends on its product market actions as well as its ability to innovate continuously and stay ahead of competitors. But, the intellectual property environment, and IP strategies followed by the firm form an important third prong, and these are the focus of this post.


A Historical Perspective

Independent India started off with a fairly strong intellectual property protection system. This should not surprise us because this was intended to protect the rights of British inventors under the colonial regime. However, there was growing disquiet about this system in the first two decades after independence, particularly in the area of pharmaceuticals where strong patent protection was seen as enabling multinational drug companies to extract monopoly profits from a poor country. As is well known, this culminated in our making important amendments to the Patents Act including removal of provisions to patent new molecules, and providing relatively short periods of patent protection in all cases. The new legislation – the Indian Patents Act of 1970 - is commonly credited with the growth of India’s generic pharmaceutical industry (based on an ability to create new processes for known drugs and scale them up effectively) and some of the lowest priced drugs in the world.

By the 1990s, many things had changed. Globalization was the order of the day, and India had climbed on the globalization bandwagon. International talks were on to provide a supportive environment for global trade. These talks expanded in scope to incorporate intellectual property protection. In 1995, India signed up for the GATT treaty and promised to put in place stronger intellectual property laws by January 1, 2005. India kept its promise, though not everyone is happy about this! But, the timing was right – by 2005, many Indian companies were taking innovation more seriously, and were therefore looking for stronger intellectual property protection for their inventions.

Where do we stand today?

Information

While the law changed, the procedural aspects of patenting have taken time to catch up. One of the important characteristics of a good patent system is easy availability of information about what patents have been issued. For several years this was a major bottleneck in India with such information not available online, and available only through a set of CDs compiled by TIFAC in Delhi. Even now, though there is an online database, it is nowhere as powerful or as comprehensive as the US PTO’s website. I would have thought that with all our software and IT prowess we should have been able to build something better than what the US PTO offers but…

Procedures and Process

Another important procedural issue is the speed with which the Patent Office considers applications, and the quality of the examination process. The importance of this dimension was recognized some years ago and a drive to hire and train patent examiners was launched. But, I saw a recent advertisement of the Controller General of Patents, Designs & Trademarks calling for applications for trademark examiner positions in which they are offering a consolidated salary of Rs. 25,000 per month to people with a degree in law and 3 years experience. I am sure it will be a challenge to get well qualified people at that level of compensation.

In an alternate effort to speed up the process, there was a proposal to involve the CSIR in preliminary screening and evaluation. But this was objected to by many as the CSIR itself is an active player in the intellectual property space and is, in fact, the Indian entity with the largest number of US patents.

While it’s difficult to judge the quality of patent examination, what we do know is that after an initial spurt in the speed of examination and grants, the process has slowed down again at a time when the number of applications is on the increase. Mint newspaper carried a useful graphic recently summarizing the challenge:



The Law Itself

As far as I can make out, there has been reasonably widespread acceptance of the amendments to the Patents Act made in 2004, 2005 and 2006 except for a couple of issues. The first issue is the now infamous Section 3 (d) that seeks to prevent evergreening by pharmaceutical companies by requiring a major inventive step as reflected in enhanced therapeutic value for a molecule to be awarded a patent. This has been a contentious issue almost since Day 1 of the new patents legislation, and a series of refused / cancelled patents to big name pharmaceutical companies has shown that the law has bite.

The second issue has been the issue of compulsory licensing. On March 9, 2012, the Controller General of Patents issued the first post – 2005 compulsory licence to Natco Pharma to manufacture its equivalent of Bayer’s Nexavar, a drug for treatment of kidney cancer. This has raised a hornet’s nest, as it has raised contentious issues like (1) what is a reasonable price for a drug? (2) what constitutes “working” a patent? and (3) what is the appropriate royalty to be paid to the inventor company in the event of compulsory licensing?

It’s fascinating to note that most of the controversies regarding the new patent law in India have centered around the pharmaceutical space. Globally, the big debates on intellectual property in recent times have been in the smart phone space involving companies like Apple, Samsung, and Google (Motorola Mobility). It’s almost as though we live on two separate planets! I suppose the reason for this is that India is still not a big market for high end smartphones and therefore the patent and design wars of this industry have not spilt over into India. But this is also another indication that India has failed to find a place at the high table of the most active innovation domains (see my earlier post on the areas in which India has the most active researchers).

In our obsession with the healthcare domain, we might be missing out on developments in other sectors that call for changes in our intellectual property protection laws. A new generation of software product companies is emerging from India (see my recent article in Outlook Business), and large companies like TCS and Infosys are embracing products and platforms in their quest for “non-linear” growth. But we continue to deny software products patent protection and limit their intellectual property protection to the Copyrights Act.

Awards & Enforcement

Consistent with their position in other matters, Indian courts tend to be conservative in penalties and awards for intellectual property violations unlike the multi-million dollar (or even multi-billion dollar) awards of American courts. In a way that’s good because it prevents intellectual property from becoming a separate game of corporate strategy. But the flip side of this is that there is the distinct possibility that an inventor may not receive adequate compensation for infringement of his intellectual property rights.

This become particularly critical in the case of the small inventor who anyway fights a David vs Goliath battle if the infringer is a large company with the ability to exploit all the procedural opportunities for delay available in the Indian legal system. In fact, if I were an inventor in India that would be my main fear – I may be able to obtain a patent and other forms of intellectual property protection, but will I be able to enforce my patent rights in a meaningful and timely way? Even in the US, the inventor of the intermittent windshield wiper, Robert Kearns had to struggle for years in his battle with large US auto companies (see the graphic below); I shudder to think what would happen to an equivalent inventor in India!


As we go forward, there will also be a need to ensure greater consistency in judicial decisions in the intellectual property domain. Without any disrespect meant to our honourable judges, I can see that in some of the recent judgements they have struggled to cope with the technicalities involved. Not too far in the future, when we have a critical mass of intellectual property cases, it will help to have a single court at the appellate level as has been done in the US.

Conclusion

In the 1950s and 1960s, we saw companies like Xerox and Pilkington Glass that established monopolies in their respective industries based on technologies which had strong patent protection. Today, the pace of innovation in most industries has hastened to the extent that companies need to innovate continually to derive maximum benefit from their innovations. But, intellectual property rights continue to provide the first-level protection for innovator companies.

As India develops a modern industrial economy, and more companies depend on innovation for their competitive advantage, our need to provide an appropriate level of legal support to enable innovative companies to capture the benefit of their innovations will grow. In this, our priority should be on improving IPR-related information flows, better processes and procedures, and enforceability, and on shifting our attention beyond the healthcare industry.



Monday, December 3, 2012

The Power of Longitudinal Research

Some of the oldest and most contentious debates on human beings centre around the relative influence of heredity (genetics), environment and individual voluntary action on growth and development. These include whether mental illness has genetic origins, what factors determine “success” in life, and whether adults continue to “develop” as they grow older (or whether all development happens before a certain age). These questions cross disciplinary boundaries as they involve concepts from psychology, psychiatry, sociology, and genetics.

Great thinkers like Freud and Erikson made significant contributions to these debates, but many of their contributions were based on intuitive theorizing rather than rigorous empirical evidence. With time and careful research, some of their theories have been upheld, and others disproved! The studies that have made the most impact are longitudinal studies in which a carefully chosen cohort of respondents was tracked periodically over an extended period of time.
The Harvard Grant Study
One of the most well known of these studies is the Havard Grant study which commenced in the late 1930s and early 1940s and continues till this day. The survivors of the cohort (who were Harvard sophomores when they were recruited) have now entered their 90s, and the data collected therefore allows several inferences to be drawn on adult development.

  
George F. Vaillant was the director of the Harvard Grant Study for over two decades. His latest book, The Triumphs of Experience, presents the latest findings. I found it a fascinating read as it not only uncovers new insights, but also questions some of the conclusions reached at earlier stages of the study. The Harvard Grant Study draws its conclusions from rigorous multivariate analysis, but Vaillant presents the findings with a distinctive and rare combination of statistical rigour and empathy for his subjects – in addition to tables containing the statistical results, there are profiles (disguised, of course) of different respondents of the study, and these give the reader a sense of being part of the study team.
The original design and subsequent evolution of the study show how much our models of adult development have changed over time. At the time the study started, physical constitution and mental health indicators were expected to be important predictors of subsequent progress of the study. Parental/family relationships and childhood upbringing were thought to be unimportant. Yet, the latest Harvard Grant Study findings show that loving relationships during childhood are important for longevity and success in life.
Findings of the Harvard Grant Study

Some of the important findings of this study reported in The Triumphs of Experience:

  • Individuals develop through their adult lives as well, not only upto the stage of adolescence.


  • The impact of childhood trauma decreases over time; more importantly, the positive experiences of a loving childhood have enduring impact.

  • Being well integrated and self-driving while young helps people live longer.

  • Divorce led to happier marriages than the bottom third of sustaining marriages.

  • Alcoholism had bigger negative impacts than measured by most previous studies. It accounted for more than half of the divorces in the Grant Study. The study shows that it is unlikely that alcoholics can return safely to social drinking, thereby upholding the methodologies followed by organizations like Alcoholics Anonymous.

  • The involuntary coping styles predicted by Freud exist, and they are important for human effectiveness

Phases of Adult Maturation


I particularly liked the chapter on maturation where Vaillant extends Erikson’s work to identify six phases of adult maturation (or what he prefers to call “development tasks”). These are shown in the graphic below. These phases form an excellent blueprint for adult evolution. What struck me was how many of us get bogged down in the tasks of identity and career consolidation when there are more fulfilling tasks ahead of us. While it’s true that many people in India do get involved in generative and guardian-like tasks, these are often restricted to the family context. Though we often discuss India’s demographic dividend, remember that India has a large and growing number of older people as well, and it would be a shame if we don’t take advantage of their wisdom.



 Important Lessons for Management of Long-term Research Programs
The Harvard Grant Study is interesting from a research management perspective as well. Over its 70+ year lifespan so far, the study has transcended several research directors and team members, but the integrity of the study has not been compromised. George Vaillant estimates that about $ 20 million has been spent on the study over time, with an average cost of $10,000 per research paper published. The study has had different sponsors at different times, and while the study had to adapt itself to the priorities of these sponsors (such as a major retailer, cigarette company and a program against alcoholism), it still managed to sustain the collection of data related to its core research questions.
With its emphasis on the choice of appropriate control variables and other related issues of study design, this book is a great primer on how to design and adapt longitudinal research studies for maximum research impact. In India, we need to build a tradition of undertaking sustained, long-term research programs, and this book that describes the approach taken by the Grant study will be invaluable in this endeavour.
[See David Brooks’ nice piece on this study in the New York Times for another perspective]