Bristol-Myers Squibb ($BMY) has won a court verdict to uphold its patent on Sprycel (dasatinib), fending off a challenge, for now, from India's BDR Pharmaceuticals, which sought a compulsory license to make the drug and sell it at a lower cost domestically. But other challenges abound, including one by little-known Lee Pharma for AstraZeneca's ($AZN) Onglyza.
|Delhi High Court Justice Manmohan|
BDR cited a provision in the Indian Patent Act that disallows so-called evergreening of drugs as the basis for its compulsory license application, but Justice Manmohan of the Delhi High Court rejected the claim, the Economic Times said.
India has been at the center of patent protection for drugs as its laws allow challenges under section 84 of India's Patent Act to seek a compulsory license if a local drugmaker can demonstrate it made sufficient efforts to seek a voluntary license from the innovator among other conditions.
The section jibes with a provision under the Trade Related Intellectual Property Rights agreement that allows local manufacture of patented drugs in cases where availability or other barriers exist.
On June 29, Hyderabad-based drugmaker Lee Pharma filed a compulsory license application in India for AstraZeneca's diabetes drug Onglyza (saxagliptin), stating the DPP-4 inhibitor did not satisfy pricing criteria, while listing Dr. Reddy's Laboratories, Teva Pharmaceutical Industries ($TEVA) and Zydus Cadila as potential customers, according to website SpicyIP.
A successful compulsory license case by Natco Pharma last year on Bayer's Nexavar (sorafenib) already had European companies upset. That was especially the case when the Indian Supreme Court upheld the Natco license earlier this year, citing the price. Natco began selling Nexavar for $170 a month, compared to Bayer's $5,000-a-month price.
Cipla, another Indian generics maker, jumped right in as well, offering it at $130 a month. The generics makers pay Bayer a small royalty.
Other companies have also seen patents breached. Pfizer ($PFE) suffered the loss of IP protection on cancer drug Sutent (sunitinib malate), and Roche's ($RHHBY) patent coverage on the hepatitis C treatment Pegasys (peginterferon alfa-2) has been revoked.
Novartis ($NVS) remains in the fight over a patent on blood cancer treatment Glivec/Gleevec, while reports suggest the Indian government has mulled a compulsory license on Roche's Herceptin (trastuzumab).
In the case of BDR, the aim was to sell dasatinib at about INR8,100 ($127.83) a month, compared to INR100,000 by BMS. The Indian Patent Office in 2013 had also rejected a compulsory license application by BDR, saying it failed to try the proper channels to obtain a voluntary license from the patent holder.
Another element in the legal tussle is Section 3(d) of the Indian Patent Act that can deny application if it is deemed the formulation lacked an inventive step.