After hearings on a pre-grant opposition filed by the domestic drug maker USV Ltd that lasted a year, the Kolkata patent office has rejected US drug giant Eli Lilly & Co.’s patent application for Forteo, its osteoporosis drug. Forteo is a biotechnology-based drug that generates $600 million in annual sales for Lilly. The company had already launched this product in India anticipating a patent protection.
The decision, which was delivered on Monday, noted that the application has been rejected on grounds of prior knowledge, incremental innovation and failure to establish enhancement of known efficacy.
Forteo is the only biotechnology drug available in India for osteoporosis. It is a synthetic form of parathyroid hormone (PTH), which is naturally found in the body. This hormone is to be given by injection for the treatment of osteoporosis in men and post-menopausal women who are at high risk for a fracture.
It is also supplied in a disposable pen device that can be used for up to 28 days to in once-a-day, self-administered injections. However, at least two companies, including USV, are now expected to launch the generic version of this drug in the local market soon.
Indian patent law does not permit patent protection for drugs if it is patented elsewhere before 1995, and its claims of innovation are only incremental, under the provisions of Section 25(1)(b) and Section 3(e). The drug also cannot be patented if its efficacy is not significantly superior to the already known molecule under Section 3(d) of the law.
Last year, the Chennai patent office rejected a patent application of Swiss drug maker Novartis AG for its blood cancer drug Glivec on the same grounds. A legal challenge filed by Novartis questioning this law was also rejected by Madras high court early this month.
A senior official from USV, who did not want to be quoted, said the company had raised three issues: that Lilly had filed a patent for this product in Europe before 1995; its claims on the innovation were only marginal; and there was no substantial efficacy level compared with the known drug.
An Eli Lilly & Co India Ltd spokesman would only say that “all patent applications of Eli Lilly & Co are handled by a team based in New York. Any queries regarding patents can only be answered by the team that is responsible for filings.”
In India, the osteoporosis market is currently estimated at Rs400 crore with a patient population of more than 180 million. The market is growing at 25-30% annually as this disease, more common among women and older people, is most prevalent in India.
All the currently available osteoporosis drugs in the Indian market are chemical-based and leading brands include Fosamax of Merck & Co. Inc., Actonel of Procter & Gamble Co., and Boniva of Roche Scientific India Ltd.
Jeetha D’Silva contributed to this story