An independent patent expert, requesting anonymity, said Natco contended that Apixaban, which is used in the prevention and treatment of blood clots, was already disclosed in an earlier patent filing by BMS and, hence, the new patent claim was not valid for protection.
Natco had also filed a lawsuit in a Hyderabad court earlier, seeking clarification. “Apixaban with patent (IN243917 expiring December 2019) covers a large number of molecules and also disclosed Apixaban. Another patent IN247381 which expires in September 2022 also claims Apixaban," said the patent expert.
It also filed a petition before the Intellectual Property Appellate Board seeking revocation of the suit patent. “Natco initiated declaratory suits in a Hyderabad court due to the unique nature of multiple patents covering the single molecule," said one person aware of the matter, also requesting anonymity.
An email sent to the Indian patent office did not elicit any response till press time.
BMS had filed its claims for patent infringement at the Delhi high court, asserting its patents, and had secured an injunction on 5 July. Natco appealed against the ruling and got the injunction lifted on 16 July by a division bench comprising judges S. Muralidhar and Talwant Singh.
The two-judge bench sent back the matter to the single judge bench asking it to pass a fresh verdict. The case is likely to come up for hearing on 23 July.
“BMS had been granted an interim injunction against Natco for infringement of the Apixaban patent. BMS had filed legal proceedings before the Delhi high court against Natco challenging this infringement on which the proceedings are currently pending determination by the Court. Intellectual Property (IP) protection is crucial for fostering innovation in our industry and BMS is committed to the appropriate enforcement of its IP when infringed. IP provides a period of exclusivity to justify the significant risk, expense and time required to bring a new therapy to patients," said a BMS spokesperson in an email response.
Legal tussles over patents are not new. On 14 July, in a similar case, the division bench of the Delhi high court dismissed an injunction petition filed by German drug maker Bayer to protect its cancer drug Regorafenib sold under brands Stivarga, Nublexa and Resihance against Natco Pharma. Regorafenib is used to treat colorectal cancer, the sixth most common cancer in India.
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