Apixaban Patent: Natco gets HC relief for its upcoming medicine Apigat

NEW DELHI: Days after ending a patent row over its cancer drug Regonat with Bayer, drugmaker, Natco Pharma is reported to have now been embroiled in a fresh dispute with Bristol-Myers Squibb (BMS) over copyright infringement of its anticoagulant formulation. Granting interim relief to Natco Pharma, the Delhi High court has recently dismissed an interim injunction plea filed by BMS, seeking to protect its drug Apixaban against Natco's Apigat.

The matter originated when BMS received information that Natco Pharma is planning to launch a generic version of Apixaban under the probable brand name-Apigat and has "already distributed sample packs to many cardiologists in the country.

BMS opposed the same stating that BMS is the rightful owner of the patent for its formulation Apixaban, the term of which will expire on 17th September 2022. It further stated that the patent was granted for the said product in 2011.

Apixaban is used in the prevention and treatment of thromboembolic diseases.

Also Read: Cancer Drug Patent Issues: Delhi HC junks Bayer plea to block Natco Pharma Regonat

BMS had filed its claims for patent infringement at the Delhi high court, asserting its patents, and had secured an injunction on 5 July. However, Natco challenged the ruling and got the injunction lifted on 16 July by a division bench comprising Judges S. Muralidhar and Talwant Singh.

Natco had reportedly 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 current 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," a patent expert requesting anonymity told Live Mint.

The firm also filed a petition with 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," one person aware of the matter told the daily.

Commenting on the issue, a BMS spokesperson in an email response told Live Mint, "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."

The matter has been sent back to the single judge bench directing it to pass a fresh verdict on the issue.