Tuesday, November 13, 2012

Indian Product Patent for Medicines & TRIPS (Hindu News Analysis -1)

Recently the Intellectual Property Appellate Board (IPAB) in a landmark decision, revoked "product patent" held by Roche A.G, a Swiss Drug Manufacturer, on a drug named pegylated interferon alfa2a (Brand Name: Pegasys), used by Hepatisis C and HIV+ patients

This was the first "product patent" given to any medicine under the new TRIPS mandated product patent regime.
[Note: This is the first product patent for medicine. There may have been other patents for other products.]

Read the complete news here(4th Nov, The Hindu).  

Important lines in italicized blue colour.
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News Analysis
1. Indian Pharmaceutical Industry is leader among developing countries having demonstrated strong innovation capabilities, strength in developing cost-efficient processes and significant capacity in setting up manufacturing plants for drugs satisfying international quality norms, earning worldwide recognition as the ‘pharmacy of the developing world

Basic features of Indian Pharmaceuticals Market
Taking advantage of the freedom countries had before the creation of the WTO, India abolished product patent protection in pharmaceuticals in 1972. This operated as a pull mechanism, enabling domestic pharma players to build technical expertise in reverse engineering of existing medicines by modifying the manufacturing process. Apart from that, a push was given in form of public investments in manufacturing and in R&D, Indian pharmaceutical companies made enormous progress and enabled them to make their own generic versions of medicines.

[Note: 
  • India is member of WTO since 1st Jan'1995, same day when WTO officially came into being; erstwhile it was called GATT
  • Pull - By having no product patent for medicines; Push - public investment in manufacturing and R&D; Both these push-pull factors led to Indian success story in generic drugs]  
Generic Drug Success Story: 
A generic drug is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. Hence a generic drug must contain the same active ingredients as the original formulation.
Best success story of India's generic drug production has been in the case of antiretrovirals (ARVs) for the treatment of HIV/AIDS. 
  • Competition between Indian generic producers has resulted in reductions in the prices of AIDS medicines from as much as Rs 8 lacs (@Rs54/$) to as little as Rs 3000 per person per year. 
  • Lack of product patents on each separate drug allowed Indian generic manufacturers to combine three different AIDS medicines in one single pill. The availability of these generic fixed-dose combinations has dramatically simplified AIDS treatment in resource-limited settings and has resulted in government treatment programmes across the developing world. Over 6.6 million people living with HIV are now on treatment in developing countries, the majority on Indian-made generic ARVs.
Future of Generic Drug
  • In the near-term, the generic opportunity will continue to lure more companies and with increased competition, generic drugs will see greater price erosion.
  • Long term future for Generic Drugs
    • R&D productivity of large global pharmaceutical players(innovators) has slowed down over the past few years  - which means average cost of developing a new drug has increased a lot and after spending several years, only a handful of molecule has been developed. This would mean generic drug opportunity would also be lowered.
    • Hence to sustain growth Indian Pharma Cos. should look at other avenues such as
      • Joint R&D with big MNC Pharma Cos. 
      • Expanding bio-pharmaceuticals beyond vaccines
      • Expanding geographical distribution of drugs
      • Contract Research & Clinical Trials -  low cost of manufacturing in India makes it an ideal place for contract research. Doing research for outside companies in India. Apart from this, availability of a large patient pool also helps clinical trials, which contributes the most, in terms of revenue, to the contract research segment. An increased presence in contract research will also help Indian Pharma Cos. build expertise to move up the value chain and engage in new drug discovery.
      • New Drug Discovery - only handful of Indian Pharma Cos. do it currently - Sun Pharma, Piramal, Glenmark
2. TRIPS Agreement & India 
To comply with WTO's TRIPS Agreement, India amended its patent laws and re-introduced product patent protection in pharmaceuticals from 1st Jan 2005. TRIPS required India to start granting 20-year product patents on medicines

Product patents gives patent holders exclusive rights over the manufacture, sale, use, offer for sale and import of the patented medicine. This allows them to exclude competitors or generic companies from producing the medicine and because of lack of competition results in high prices and restricted availability.

While debating the impact of complying with these requirements of the TRIPS Agreement, the Indian Parliament recognised that the WTO rules could pose a significant barrier to generic production and access to medicines. Hence they turned to the 2001 Doha Declaration on the TRIPS Agreement and Public Health signed by all WTO members that states categorically that TRIPS 'can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all'.

The Indian Parliament thus included multiple health safeguards in the amendments to India's patent law inter-alia a provision restricting 'ever-greening', i.e. the practice of pharmaceutical companies extending their exclusive rights on a medicine by making minor or obvious changes to the medicine and applying for additional patents. Section 3(d) of India's patent law accordingly prohibits patents on new forms of existing medicines unless the patent applicant can show a significant increase in efficacy. The law also allows health groups to challenge patent applications, and people living with HIV, cancer and hepatitis C have used these provisions to ensure that frivolous patents are not granted on key medicines in India(This is what happened in the Roche's case, leading to revoking of its patent).

TRIPS Agreement
Trade-Related Aspects of Intellectual Property Rights (TRIPS) is a WTO agreement negotiated during the Uruguay Round(GATT 1986-94) of WTO. TRIPS agreement introduced Intellectual Property Rights (IPRs) for the first time in the multilateral trading systems.

  • It recognizes IPRs as private rights.
  • It is based on the basic principles of the other WTO Agreements, like non-discrimination clauses - National Treatment and Most Favoured Nation Treatment.
  • It promotes “technological innovation” and “transfer and dissemination” of technology.
  • It establishes standards of protection for IPRs, which each WTO member countries should follow. India is a signatory to this agreement. 
TRIPS is by far the most comprehensive international instrument on IPRs, dealing with all types of IPRs, with the sole exception of breeders’ rights



IPRs covered under the TRIPS agreement are:  


  • Trademark is a distinctive sign which identifies certain goods or services as those produced or provided by a specific person or enterprise. e.g. 
Observe ® symbol signifying Trademark Registered.

  • Patent is an exclusive right granted by a country to the inventor to make, use, manufacture and market the invention that satisfies the conditions of novelty, innovativeness and usefulness. Remember, patent is country specific, and patent in one country is not applicable for other country. e.g. Product patent which was granted to Roche for Pegasys medicine, which was revoked recently. 
  • Industrial Designs refer to creative activity, which result in the ornamental or formal appearance of a product. 
  • Trade Secret is any information that has been intentionally treated as secret and is capable of commercial application. It protects information that confers a competitive advantage to those who possess such information.
  • Geographical Indication - It is an indication used to identify agricultural, natural or manufactured goods and originates from a definite geographical territory. So, it provides economic prosperity to community of the concerned territorial region. This would mean, one can't grow tea in Shimla and call it Darjeeling Tea and claim protection of its IPR. It has to be produced from Darjeeling to be treated so. 
         

Various Acts passed by Parliament to protect IPRs
Beyond TRIPS: The EU-India FTA negotiations
Several of the health safeguards included by the Indian Parliament in the Indian patent law may be at risk of being overturned or undermined by the TRIPS-plus demands of the European Commission - the executive arm which negotiates on behalf of the EU - in the EU-India FTA negotiations. There are areas of concern in the ongoing negotiations that could adversely impact India's generic drug production capacity and hence the ability of patients in India and across the developing world to access safe, effective and affordable generic medicines from India. 

The three major areas of concerns in the proposed TRIPS-plus agreement are: 

  • Intellectual Property - In this area of concern, EU has demanded from India inter alia following main things:
    • Longer patent term (existing is 20 yrs) - Longer term, so longer monopoly period for patent holder and hence delay in generic medicine entry in market.
    • Data Exclusivity - Generic manufacturers to compulsorily conduct clinical trials to get marketing approvals for introduction of medicine in market or else wait for 5-10 yrs of exclusivity period. 
    • Enforcement measures - Patent holders like MNC pharma companies can use public resources, money and authorities to enforce their private rights. The impact of such aggressive IP enforcement measures has been seen in 2008 and 2009 when generic medicines on their way from India to Africa and Latin America were seized at European ports. Indian Govt. had taken strong objection to it. Read here 
  • Investments - This area contains provisions designed to protect the interests of European investors in India and can be used to prevent governments from adopting pro-public-interest regulations related to health, environment, development, etc.
  • Regulatory StandardsThe area of concern here is that EU demands that India should harmonise its drug regulatory standards with those of the EU. These standard have been designed in such a way that only well-resourced companies could adhere and in long run would squeeze generic drug making companies out of production. 
Seeing apprehensions raised by various quarters, PMO office in April 2011 had issued a press release stating that nothing in the EU-India FTA would go beyond TRIPS or India's domestic law. Read here

3. Intellectual Property Appellate Board (IPAB)
Intellectual Property Appellate Board has been constituted on 15th Sept 2003 under Department of Industrial Policy and Promotion, Ministry of Commerce and Industry to  hear appeals against the decisions of the Patent Controller in Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) also called Intellectual Property Office (IPO).  

Please note that IPAB will take only those appeals against Patent Controller decisions, which are given under various acts of Patents, Trademarks and Geographical Indications(See above table for list of acts). Hence, Industrial Designs IPR are out of limits for IPAB.  

In the news item that we are discussing, Roche's product patent on Pegasys medicine was challenged by Sankalp Rehabilitation Trust in IPAB against the ruling of Patent Controller(whom they approached earlier) under The Patents Act 1970. IPAB ruled against Roche and revoked its patent.  

4. Hepatitis C Disease
  • Hepatitis C(Hep C) is a viral disease
  • 10-12 Million people in India infected with Hep C, mostly in Injecting Drug Users (IDUs) and among them, majority in North East India.
  • Hep C can lead to liver cirrhosis, liver cancer and liver failure.
  • Hep C treatment is not available in Govt hospitals due to high cost of treatment.


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