Life, in the world of pharmaceutical patents, is very complex. Conflicting interests, encouraging inventive genius, and enabling access to such inventions, lie at the core of the complexity. More often than not, competing goals, frequently filled with fanaticism and activism, tend to get ugly, questioning the founding principles of the patent system itself. Starting from individuals, the divide between opposing views, involving fights for supremacy of patents on one hand, and access to patented drugs on the other, extends to countries, and sometimes even groups of countries within a certain economic strata.
Promoting the progress of science and technology for public good is the primary goal of the patent system. It achieves the said objective through grant of exclusive rights to worthy inventions, which encourage inventors to invent and investors to invest in research and development. The incentives offered by the patent system play an important role in promoting inventive/innovative activity, especially in pharma industry, which is research and investment intensive. A 2010 study of the pharma benchmarking forum estimates a period of 13.5 years and an investment of 1.8 billion dollars to bring a new molecule to the market.
Given the sheer scale of investment, effort, and time, innovator pharmaceutical companies rely heavily on market exclusivity through patents for generating returns from their investments, making patents a crucial factor in their business. Taking advantage of the monopoly offered by the patent system, most companies price their drugs in line with timely recoupment plans. Such pricing, more often than not, falls outside the scope of affordability, especially in less developed countries like India, possibly obstructing access to healthcare. The issue obviously assumes greater significance, if the product or drug in question relates to a life threatening disease.
Recognizing the linkage between patent law and accessibility/affordability of pharmaceutical products, many countries, especially less developed countries have devised their patent laws in a manner they believe, facilitates accessibility and affordability of such products. Until the late 20th century, many developing nations like India and Brazil excluded product patent protection for pharmaceutical, chemical and food products. The categorical exclusion from the patent regime enabled the said countries make drugs patented in other countries, available through manufacturers of generic pharmaceutical products, commonly referred to as generic companies. This gave rise to an alternate pharma market with competitive pricing, which enabled these countries to provide access to drugs at an affordable price.
While debating innovation vs access to health, India, also referred to as the pharmacy of the world is a classic example that is discussed across the globe. As a member of WTO, India had to amend its patent law to bring it in conformity with the agreement on TRIPS. To fulfill the requirements under the said agreement, several amendments were made to the Indian Patent Act, first in 1999, followed by the 2002 amendment and finally, the 2005 amendment. Through the amendment in 2005, product patents were extended to all technologies including pharmaceutical inventions. While changing the law, the Indian government managed to incorporate, and retain certain provisions that favour generic companies, and by doing so, enable affordability and access to health care.
One such provision is the hotly debated Section 3d, which prohibits patents on new forms of known substances unless enhanced efficacy is shown. Though the statutory language of the provision gives scope for patenting new forms with enhanced efficacy, the narrow outlook of the courts towards efficacy, which has been held to not include reduced cost of manufacture, bioavailability, improved stability and the likes, makes the extent of patentability very narrow, thus opening the door for generic manufacturers, thereby facilitating access to health care. The recent Supreme Court decision in the Novartis case, which upheld the refusal to grant a patent on Gleevec, a cancer drug, subsequent to a rather long discussion about the importance of health care clearly elucidates the stand of Indian courts on the subject. Gleevec, which was being sold by Novartis at around 20 dollars per pill is now available for 2 dollars, a very affordable price.
Another provision India effectively used in favour of generic companies is the general compulsory licensing (CL) provision. As per the said provision, a licence can be granted by the patent office with respect to a patent, on completion of 3 years from its grant, if the subject matter of the patent fails to satisfy the reasonable requirements of the public, is not made available at a reasonably affordable price, or is not worked in India. Natco filed a CL application for an anti-cancer drug Sorafenib, whose patent is owned by Bayer, and which was being sold in India under the brand-name Nexavar for the treatment of advanced kidney and liver cancer. By showing that the drug was being catered to only one per cent of patients in need of it, and that the price of Rs. 2,80,000 (per month) was too high, Natco got a CL by proposing to sell the drug for around Rs. 8,880 per month (more than 30 times lesser than Bayer’s price). Although, several other countries such as Brazil and Thailand have issued compulsory licenses in the past in cases of national emergencies and public health crisis such as AIDS epidemic, India is the first nation to invoke the general compulsory license provisions based on requirements of the public and drug pricing.
Generic friendly approach of Indian courts extends to patent litigation as well. Innovator companies have not been able to acquire favourable preliminary decisions against generic companies, even in straight forward cases of patent infringement. For example, Cipla managed to prevent an injunction against selling a patented cancer drug on the grounds of health care, and public interest. In the said case, the Delhi High Court decided against Hoffman La Roche, permitting Cipla to sell the drug based on the logic that public interest in getting cancer treatment trumps the patent holder's right to prevent generic versions of the drug. Now, the drug is available to needy patients at four times lesser price than that of the patent holder from Cipla.
In another recent decision, the Delhi HC refused to grant interim relief to Merck with respect to infringement of its patents relating to sitagliptin. Sitagliptin is a DPP4 inhibitor patented by Merck and marketed as Januvia. Merck has also been marketing it in combination with metformin under the brand name Janumet. Despite the fact that Glenmark, a generic drug company launched sitagliptin and its combination with metformin in what seemed like a direct infringement of the patent, the court surprisingly denied an interim relief on its prima facie analysis of patentability, drawing on Section 3d, whose linkage with health care has been well established.
Rightly, India's patent, or rather anti-patent agenda is clearly in favour of access to affordable healthcare, and pharma patents are considered as stumbling blocks rather than as accolades for inventive activity. On perceiving the diametrically opposing objects, incentives for pharma innovation vs access to pharma products, one cannot help but wonder if at all, a balance can be struck between them. Many scholars have put their heads, and are exercising their valuable intellectual skills towards finding a model that enables pharmaceutical innovation without compromising on health care. Though they do not see eye to eye on the most appropriate model, most of them agree that the provision of an effective and efficient healthcare system in any country is a complex equation requiring a multifarious approach.
(Author is founding partner, Brain League IP Services)