Indian pharmaceutical industry is moving towards a maturity level. This is more so regarding the generic pharmaceutical industry of India. Good news for generic pharmaceutical industry of India is that the patent rights of many world renowned drugs and medicines are set to expire till 2017. This would give a free hand to generic drugs companies to produce and sale generic medicine in India and world wide.
United States lawmakers are formulating a legislation that would create new punishments for companies from China and elsewhere that use trade secrets stolen by crackers and cyber criminals. The bill in this regard would likely include visa restrictions for entities using cracked and stolen intellectual property.
The idea is to make cracking activities for stealing US intellectual property and trade secrets punishable in a more stringent manner. US intend to make the deterrent consequences of online stealing of its IP more significant than the gains.
It would mean people could not travel to industry conferences or conduct research collaborations and for universities it could mean its students might have difficulties studying in the US.
In another related development, the new funding law signed this week by President Barack Obama contained an amendment which limits the purchase of China-made electronic products by a small group of government departments and agencies. The amendment says that the agencies must consult with law enforcement before purchasing equipment made by companies “owned, directed or subsidised” by China.
The patent law of India is incorporate as the Indian Patents Act, 1970. As on date, we do not provide any utility models protection in India. A utility model protection provides a protection akin to patent but the duration of such protection is lesser as compared to a regular patent.
Similarly, the prerequisites for acquiring a utility model are less stringent as compared to patents. In utility models although the requirement of novelty must be duly met yet the burden to prove inventive step and non-obviousness can be easily discharged.
This practically means that the protection for utility models is generally sought for innovations of incremental character which may not meet the patentability criteria. This also means that cosmetic improvements of already existing and publically known inventions would not be protected by granting a patent.
When it comes to pharmaceuticals there are many more complexities involved. From Doha Declaration to compulsory licenses, pharmaceutical patents are subject to many tests. The pharmaceutical giant Bayer AG’s is also facing threes challenges in India.
The Intellectual Property Appellate Board has already rejected Bayer AG’s plea to stop Natco Pharma from producing a cheaper generic version of its patented cancer drug Glivec. The matter finally reached the Supreme Court of India and it is going to pronounce its judgment on 1st April, 2013.
The concerned patent case before Supreme Court would decide the fate of patent protection of the Glivec drug in India. It would also clarify what drug is patentable in India and many more definitional and other issues.
The patent office of India has refused patent protection for Glivec on the grounds that it is not a new medicine but an amended version of a known compound – a decision consistent with domestic patent law which sets tight restrictions on multiple patents for a drug.
India last year also allowed local drug maker Natco Pharma to sell cheaper copies of Bayer AG’s cancer drug Nexavar through the mechanism of compulsory licensing. Also last year, India revoked patents granted to Pfizer Inc’s cancer drug Sutent, Roche Holding AG’s hepatitis C drug Pegasys, and Merck & Co’s asthma treatment aerosol suspension formulation. They were all revoked on grounds that included lack of innovation.
We at Perry4Lawbelieve that the decision of Supreme Court should definitely consider the aspects of Doha Declaration, TRIPS Agreement, Public Health and Public Interest, Compulsory License Requirements, etc. We would cover the decision of Supreme Court once it is given.
Nothing can improve the reach of the generic medicines manufacturers of India than utilising the e-commerce platforms. However, these e-commerce platforms and websites must comply with Indian laws to fully encash the benefits of e-commerce.
The legal formalities required for starting e-commerce business in Indiamust be duly complied with to escape various civil and criminal liabilities. This is more so regarding pharmaceutical industry where the risks and stakes are really high.
Legal issues of e-commerce in India vary as per different business models. For instance, electronic trading of medical drugs in India requires more stringent e-commerce and legal compliances as compared to other e-commerce activities. Digital communication channels for drugs and healthcare products in Indiaare scrutinised more aggressively than other e-commerce activities. In fact, regulatory and legislative measures to check online pharmacies trading in banned drugs in India are already in pipeline.
As per the latest reports, the patent expiry of several major well known drugs, coupled with other factors, will fuel growth of global generic pharmaceuticals market by 2017. If this scenario is supported by suitable health policies and equitable distribution of medicines, India can be a hub for global generic medicines production.
In fact, leading global generic pharmaceutical manufacturers are already entering into contractual agreements with well known pharmaceutical companies for marketing rights and exclusivity in producing generic versions of their medicines. E-commerce can provide a viable platform to sell these generic medicines across the world.