This post was first published on 18th February, 2011.
Public Interest today is a potent weapon of generic companies to safeguard their interests in the changing patent landscape in India. India’s membership to WTO required implementation of the product patent regime for drugs by 2005 and implementation of the obligation was opposed by generic companies in the name of public interest. It was argued that the introduction of such a regime would impede access to medicines and health care. The public consciousness and media’s highlighting of the importance of access to AIDS and cancer drugs pushed the contention of Innovator companies regarding new drug development and return of investment to the bottom. The final emergence of product patent regime as India did not have any other option required generic companies to deal with the fact rather than work against it.
Despite the critical change from process to product patent regime for drugs, Indian patent law still favours the generic companies in many respects when compared to US or European Patent Law. Public interest can be quoted as the primary reason for the same. The value given to public interest by the government can be elucidated through legislative, administrative and judicial actions.
Though product patents are now available for drugs, the Indian Patents Act has a strong exclusion that narrows the scope of products that can be patented. By prohibiting patents on new forms, new properties and new uses of known substances, the Act narrows the scope of drug patents by at least fifty percent. The high standards laid down by the patent office and courts in the Novartis case[1] makes it all the more difficult for Innovator companies. The drug in the Novartis case was a salt form of a substance used for cancer treatment and public interest though not explicitly cited by the patent office or the court was an important influencing factor.
Public interest was also very effective for CIPLA, a generic company, in its litigation with Hofman La Roche[2]. In the case, Cipla managed to prevent an injunction against it through the use of public interest. The case once again related to a drug called ‘Erlotinib Hydrochloride’ for treatment of cancer. The court in this case denied an injunction to Hofman La Roche based on the reasoning that public interest in getting cancer treatment trumps the patent holder’s right to prevent generic versions of the drug.
Another example of public interest favouring generic companies is the lack of patent linkages with respect to drug approval. The recent Bayer case[3] pointed out the fact that patent and drug approval process are two independent mechanisms. The focus of the public debate with respect to the topic revolved around the fact that such a linkage would be fatal to generic companies, which would in turn have a negative impact on access to medicines. Many legislative provisions such as research exemptions, parallel import exemption, bolar exemption and so on have been framed in a manner that favours generic companies rather than Innovator based on the perception that legislating otherwise would be against public interest.
The recent rejection of Abbott’s HIV drug[4] by the patent office indicates the extent to which public interest may overshadow patents. In the case, Abbott’s application with respect to Lopinavir/ritonavir was rejected on the grounds of lack of novelty and inventive step. However, it was reported in the media that by rejecting the patent application, the Indian Patent Office has favoured the interests of patients and their access to medicines.
Many patent wars ranging from opposition of patents to interpretation of patent provisions revolve around public interest. The interest of the public has largely been interpreted in India to mean safeguarding interests of generic companies. In other words, Public Interest is safe-guarded if Generic versions of drugs are available at affordable prices. Public interest is not perceived by many to be the goal of Innovator companies.
Innovator’s role in developing new drugs that can provide treatment for diseases, which are today not treatable, is not considered as an important aspect in the public interest equation. The importance of investment in research on treatment for diseases specific to India is generally not counted as an important public interest factor. The focus is primarily on treating Innovators as money makers and not as companies developing treatments for new drugs and looking to re-coup investments for investing in research.
The focus on public interest in India must change from generic favoured public interest to public interest that balances the role of both Innovator and generic companies. Both are important for furthering public interest and Indian government, patent office and courts must open their eyes to a public interest that balances that interest of the public in the short and also long term.
Authored by Mr. Ajay V.
[1] MANU/TN/1263/2007 and MANU/IC/0008/2009
[2] Decided on 19th March 2009, Delhi High Court.
[3] Decided in February 2010, Delhi High Court.
[4] Decided in January 2011.
