ROLE OF INTELLECTUAL PROPERTY RIGHTS IN DEVELOPING COUNTRIES -ASHWINI SANDU.

Size: px

Start display at page:

Download "ROLE OF INTELLECTUAL PROPERTY RIGHTS IN DEVELOPING COUNTRIES -ASHWINI SANDU."

Brittney Hill
5 years ago
Views:

1 ROLE OF INTELLECTUAL PROPERTY RIGHTS IN DEVELOPING COUNTRIES -ASHWINI SANDU.

2 Can you guess?

7 How does one protect their brand? Most brands are distinct and being distinctive is the way potential users will decide whom to do business with. Protecting these brands from counterfeiters essential for good business How does one protect ones brand and product?

8 IPR Promotes innovation Brands (trademarks ) as well as products that the brands represent are part of Intellectual Property. Since its inception in the 15 th century, Intellectual Property Rights (IPR) have evolved with a view to promote innovation and thus economic development. What are the various types of Intellectual Properties?

9 Various types of IPRs Patents Copyrights Trademarks Geographical Indicators Integrated Circuits

10 Intellectual property rights are monopoly rights granted to the innovator or pioneer by the government. Stronger IP laws are known to be keystones to economic development, but may not be the best policy for all countries. Adoption of various aspects to suit their needs seems to be the policy adopted by most developing countries. How does Intellectual Property lead to economic development?

11 Kautilya on Government Policy

12 The innovation cycle Proceeds

13 From Innovation to Revenue Generation Successful protection of products and services leads to revenue generation in the form of taxes for the nation. Revenue generation for commercial organizations lead to investments into other industries and markets. Stronger IP laws Create an environment that foster innovation. Build innovator confidence. Increased transfer of knowledge into the country. Increased FDI specifically in knowledge based industry such as pharmaceuticals, agrochemicals, IT, electronics etc.

14 Development of knowledge, innovation and technology has always made way for economic growth through idea selection, development and commercialization. Countries have always encouraged protection of commercially viable products Adoption of various aspects to suit their needs seems to be the policy adopted by most developing countries. Case studies

15 India s Pharma Success Story By 2012, India s Pharmaceutical market is estimated to grow by an impressive US$17.8 billion, an increase from the current figure of US$12.2bn. The Indian pharmaceutical industry is responsible for around 8% of world pharmaceutical production How was this achieved?

16 India s Pharma Success Story The Indian Patents Act (1972) abolished product patents in chemicals, food and medicine. Process patents were allowed. This policy was adopted in view of the economic situation in India. Most of India s population could not afford expensive medicines sold by the innovator companies.

17 India s Pharma Success Story Generic Indian pharmaceutical companies were able to manufacture innovator drugs sold in India. This would not have been possible had there been product patents for drugs. Process patents helped in innovating newer, better and more cost effective methods to manufacture drugs.

18 India s Pharma Success Story From 2,237 licensed drug manufacturers in grew to 16,000 by Production of drugs grew at an average rate of 14.4% per year from 1980 to India became a net exporter of pharmaceutical products, and the market share of foreign multinational corporations (MNCs) dropped from 80-90% to 40% In 1995, six of the top ten pharmaceutical firms in India were domestic, and employment in the sector had reached half a million people. In 1995, India signed the TRIPS Agreement (Trade Related Aspects of Intellectual Property Rights) which led to the introduction of the product patent for pharmaceuticals as well as chemicals.

19 How did the product patent help? Indian pharmaceutical companies rose up to the challenge. R&D investments increased. Pre-product patent -R&D spending focused on improved process. Post product patent-increased R&D spending in formulations, new product development, and new drug delivery systems.

20 Patent Protection: Policy Trends Become part of the Global Patent Regime Meet International Obligations. Safeguardthe Rights of Patent Holders as also Protect Public Interest. Modernise the Patent Administration. Create Awareness regarding Patents.

21 Case study: Lupin pharmaceuticals Servier a French innovator pharmaceutical company owned the patent rights to Coversyl-(Perindopril) which is used to treat high blood pressure, heart failure or stable coronary artery disease. The Perindopril patent portfolio was slated to expire in 2003 in the European Union. Servier had many secondary patents, claiming (for example) various crystalline forms of Perindopril and processes for their manufacture. This kept the generic manufactures at bay.

22 Case study: Lupin pharmaceuticals Lupinhad groups of synthetic process patents on a polymorph of Perindopril and many related applications in many countries in the European Union. In 2007, Lupinagreed to sell its Perindopril patent application and other Intellectual Property to Servierfor multiple countries in EU The total consideration was Euro 20mn

Case Study: Ranbaxy Bayer was the innovator of Ciprofloxacin in 1983 with the grant of EP0049355. Ciprofloxacin is a synthetic antibiotic.

23 Case Study: Ranbaxy Bayer was the innovator of Ciprofloxacin in 1983 with the grant of EP Ciprofloxacin is a synthetic antibiotic. The antibiotic was an instant hit and sales during the Anthrax scare in the US reached $1.04 billion. Bayer's formulation was required to be taken twice a day, a dosage of 500mg tablets

24 Case Study: Ranbaxy The large dosage was major problem. Ranbaxy developed a novel drug delivery system for ciprofloxacin. Ranbaxy came up with a simple yet innovative solution a once a day formulation (1000mg tablet) that releases the active ingredient from two layers while the first releases ciprofloxacin into the blood within hours, it is followed up by a second extended release of the active ingredient to sustain the impact over 24 hours.

25 Case Study: Ranbaxy Bayer being the innovator of the ciprofloxacin approached Ranbaxy for a $65 million licensing deal to manufacture and market its once-a-day formulation worldwide except in India and China.

26 Case Study: Glenmark Glenmark Pharmaceuticals : most successful generic manufacturers Glenmark has now entered into new drug discovery which was hitherto an uncharted territory for most Indian pharmaceuticals Glenmark has been developing GBR 500 which is the first biologic (biotechnology drug) to be out-licensed by an Indian company. The molecule belongs to the technology platform of monoclonal antibodies whose market was worth $48 billion in 2010 and is estimated to cross $80 billion by 2015 when the overall biologics market is estimated to be at $239 billion. (source Forbes)

27 Case Study: Glenmark Sanofipaid $50 million to Glenmark in July as an upfront payment in a $613 million outlicensing deal for GBR 500 The rest of the money will come in milestone payments if and when the molecule GBR 500 crosses various clinical stages. The first phase of clinical trials for the molecule has been completed.

28 Case Study: Glenmark Promising new drugs being developed by Glenmark: Source: Forbes

29 India s Pharma Success Story

30 India s Pharma Success Story India s pharmaceutical success story continues today with different policies in place. Compulsory licensing of patents. Compulsory working of patents. Careful price cap on innovator drugs etc. All this has led to India one of the only two countries where western MNCs do not dominate (the other is Japan) India is a net exporter and self sufficient in drugs Drug prices among the lowest in the world Source of good quality cheap drugs for the rest of the world.

31 India s efforts towards innovation The Department of Science and Technology (DST) has established the National Innovation Foundation (NIF) ( Its main goals are to provide institutional support in scouting, spawning, sustaining and scaling up grassroots green innovations and helping their transition to self supporting activities (such as start ups) The NIF website is a portal for licensing information for patents as well as other related services.

32 Case Study: China China started the Open Door policy in the 1970 s by inviting foreign businesses. As China s economy grew software manufacturers and vendors also introduced their wares into the Chinese market. If China wanted these investors and manufacturers to stay it would have to strengthen its IP laws. How did it go about?

33 Case Study: China China has three basic IP laws: Patent law Trademark law Copyright law But software counterfeiting was a major problem Enforcement of IPR was a major issue. 79% of Chinese use unlicensed software. Economic losses incurred by IP rights holders - Up to RMB 100,000 (approximately US$ 15,000)

34 Case Study: China roadmap to better IP enforcement. Source- Ernst and Young

35 Case Study: China Problems with non-enforcement: Increased sale of counterfeit software Impact on the software industry devaluation of software products Job loss many including Google had threatened to pull out of China due to lack of IP protection. Stifling of creativity and innovation Potential security threat.

36 Case Study: China In order to enforce stronger IP rights, the Chinese Government increased the penalty for software infringement. The penalty is the highest in Asia -Up to seven years imprisonment for unlicensed usage This has led to increased investment in software and related industries in China. Major players such as Microsoft, Autodesk, Google etcwho had threatened to pull out of Chinese markets have started reinvesting.

37 Case Study: Japan Japan is one of the most technologically advanced countries in the world. Post world war II Japan began rebuilding its economy. It built its economy by manufacturing products inexpensively. In the 90 s there was a downturn in Japan s economy as more companies shut down and unemployment rose.

38 Case Study: Japan Japan looked towards University research Small and Medium enterprises (SME s) Individual inventors Pooling their creativity to come up with new idea s and new products. As a part of it plan to promote a more knowledge based economy, Japan enacted a Science and Technology basic law, which promoted subsidized help to universities and SME s who file patents in Japan and abroad.

39 Case Study: Japan The aim was to start the creativity cycle

40 Case Study: Japan Japan also introduced Technical Licensing Organization (TLO) Laws in 2005 Which led to the foundation of a patent court, and procedural and litigation changes in the courts. The TOLs were solely for universities and to commercialize the patents obtained by the universities. Today TOL s in Japan are not just centers for techtransfer but have become centers that assist university start-ups and obtain patents. The number of start ups have increased since the introduction of such innovator friendly laws.

41 Conclusion: Stronger IP laws are the best way towards economic development. Promotion of innovation leads to increased industrial development. Innovation should not be just from commercial organizations but also from individual innovators, universities and start ups. Encouraging innovation at the grass root level pays potential dividends in the form of start ups and technology transfers which further boost the economy.

42 Seeing is believing IPOs BEFORE AND AFTER

43 Facade Before Now

44 Application Receiving Section Before Now

45 Working Area Before Now

46 Multipurpose area Before Now

47 Storage space Before Now

48 Thank You.

Patenting trends in Indian pharmaceutical industry

Annals of Library and Information Studies Vol. 64, December 2017, pp. 260-267 Patenting trends in Indian pharmaceutical industry Pratibha Gokhale a and Sudha Kannan b a Former Head, Department of Library