For years, India has refused rampant evergreening of patents of foreign pharmaceutical companies as per Section 3(d) of Indian law of The Patents Act, 1970. The evergreening of patents is a practice of tweaking of drugs in order to extend their patent term and thus their profitability. India, by prohibiting evergreening, is not only helping the growth of domestic generic drug makers but also helping millions of people who can hardly afford the high-priced modified drugs. [Explore our service: Patent Filing and Prosecution in India]
Every drug entering the marketplace has a long history, which starts from its initial stages of development to appearing on the countertop at our local pharmacist. The first step which these inventors and pharmaceutical corporations take, starts with seeking protection of the discovered drug in the form of a patent, referred to as a primary patent. Protection in the form of a patent spurs innovation by providing incentive to the inventors for the discovery along with granting a monopoly to the drug in the market for 20 years.
Evergreening or Secondary patenting Emergence
Expiration of 20 years of patents paves path for the entry of generic pharmaceutical drug that is equivalent to a branded drug in dosage, strength, route of administration, quality, performance, and intended use. However, it does not carry the brand name, hence are sold at cheaper prices. However, the entry of generics slows down the market for such big pharmaceutical companies.
The threat of this steep fall in profits that is driven by the sale of their blockbuster drugs urges pharmaceutical companies to find new ways to postpone their exclusivity. Over the past few decades, companies have used a process known as secondary patenting or evergreening to keep generic companies out of the market for longer so that they can reap the benefits of their drugs for a longer period than the stipulated 20 years. Secondary patenting or evergreening is achieved by seeking extra patents on modifications of the original drug: new forms of release, new dosages, new combinations or new forms. This strategy is most effective and lucrative when employed for protection of their blockbuster medicines, which reap handsome annual revenues. However, these secondary patents achieved after tweaking of the original patents meet very low thresholds of novelty and inventiveness and the improvement in the health outcomes are small or non-existent, as per critics.
These provisions of secondary patenting also extend to biologics (highly effective drugs produced within living micro-organisms, sold at higher costs) – the new big players in the therapeutics market. The complexity of biological molecules demands filing of many patents for one drug thus increasing the price at which it is available to the public. Thus, in order to help the big giants earn profits while maintaining the prices of the drugs. many countries like the U.S the patent laws play an important role in the emergence of practices like evergreening.
Also Read: The Rise of Biosimilars
India’s take on evergreening or secondary patenting
The U.S. IP law recognizes, accepts and promotes evergreening which has proved profitable for the big giants who have been extending exclusivity by bringing in variations of their already patentable drugs in the market. [Explore our service: Patentability Searches] India, however, does not allow evergreening. For example, AbbVie, a pharma giant has increased the price of Humira, world’s best-selling Biologic prescription drug in the U.S. by 100% by many of secondary patents. Humira costs $1,300 (Rs. 85,000) in the U.S.; the same treatment costs only $200 (Rs. 13,500) in India because of the rejection of secondary patents on Humira by the Indian Patent Office (IPO) and the consequent allowance of cheaper versions to enter the market.
Section 3(d) of The Patents Act, 1970 reads that “the mere discovery of a new form of a known substance or the discovery of any new property or new use for a known substance or of the use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant is not patentable”. So, Indian IP law can be regarded as an innovation in its own right, which deals specifically with such inventions. Indian IP laws are setting an example and leading the charge on curbing evergreening, thereby safeguarding its access of generic drugs to the general public for a bigger cause, i.e., public health.
-Harsha Agarwal and Editorial Team