Mumbai: US drug multinational Eli Lilly & Co. has voluntarily withdrawn its application at the Kolkata patent office for a crystal form of its osteoporosis drug, sold under the Forteo brand.
Lilly, which lost an earlier patent claim for another form of the same drug following a pre-grant opposition from a local rival drug maker USV Ltd in August, had filed three patent applications in India for different forms of this biotech drug. Another form of the molecule, which the firm has applied a patent for, is not revealed.
Forteo, a new generation drug for osteoporosis, generates about $600 million (Rs2,364 crore) in annual sales for Eli Lilly.
Eli Lilly’s application for a crystalline form of the drug teriparatide has been withdrawn by the applicant under section 11B (4) of the Indian Patent Act last fortnight, according the patent office. Teriparatide is the generic name of Forteo. The company has already launched this product in India anticipating patent protection.
An Eli Lilly and Co. (India) Pvt. Ltd spokesman said he couldn’t immediately comment.
In August, after hearings on a pre-grant opposition filed by USV that lasted a year, the Kolkata patent office had rejected Eli Lilly’s first patent application, on grounds of prior knowledge, incremental innovation and failure to establish enhancement of known efficacy.
Forteo is the only biotech drug—medicines that are developed from living forms—available in India for osteoporosis treatment. It is a synthetic form of parathyroid hormone, 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 risk fractures as their bones become brittle due to loss of calcium.
It is also supplied in a disposable pen device that can be used for up to 28 days 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.
Eli Lilly’s decision to withdraw its patent application in India follows a similar move by other two multinational giants Novartis AG and GlaxoSmithKline Plc. (GSK) in India early this year.
While GSK had withdrawn its Indian patent applications for two of its antiretroviral combination drugs, combivir and trizivir, used to combat HIV/AIDS, Novartis’ filing for patenting its HIV/AIDS drug atazanavir in India lapsed earlier this year as the company did not pursue the application.
India is likely to see many such patent withdrawals amid fierce opposition for local companies and some patient activist groups.
Patient groups and generic drug companies have been aggressively opposing patent claims, especially after successfully opposing a patent filing by Novartis on its cancer drug Glivec at the Chennai patent office early last year.
Indian patent rules do not permit patent protection for drugs here if it has been patented elsewhere before 1995, and its claims of innovation are only incremental, under the provisions of Section 25(1)(b) and Section 3(e) of the Indian Patents Act.
The drug also cannot be patented if its efficacy is not significantly superior to an already known molecule under Section 3(d) of the law.
Novartis’ appeal against Section 3(d) was rejected by the Madras high court in August this year, but an appellate panel is separately hearing an appeal, which is being closely watched by the global pharmaceuticals industry, against the patent rejection by the Chennai patent office.
Because decisions at India’s four patent offices–at Chennai, Kolkata, Mumbai and New Delhi—are independent of one another, drug patent applicants often make more than one filing at two or more of such offices in the hope that one of them will approve the application even if it is rejected elsewhere.
“Since these offices operate without a coordinated single system to process these applications, many such patent applications on incremental innovations have already been granted patents,” said Anand Grower, a senior lawyer with Lawyers Collective, a Mumbai-based non-governmental organization that deals with issues related to health care and access to medicine.