Pfizer fights approval of generic Ibrance
Pfizer is seeking to block a generic version of its cancer drug Ibrance (palbociclib) from entering the market until the patent covering the drug expires in May 2036.
The US pharmaceutical company filed its lawsuit against Indian multinational Natco Pharma at the US District Court for the District of Delaware on Tuesday, October 19.
Pfizer’s Ibrance is protected by US patent number 11,065,250 (the ‘250 patent), which was granted in July 2021. The drug is approved for the treatment of certain forms of cancer including metastatic breast cancer.
Natco notified Pfizer on September 21 that it had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA), seeking to engage in the manufacture and sale of generic palbociclib tablets ahead of the ‘250 patent’s expiry.
Within the letter, Natco “knowingly and deliberately challenged Pfizer’s patent rights” but did not actually contest the validity of any of the claims of the ‘250 patent, Pfizer said.
Should Natco’s ANDA be approved before the ‘250 patent expires, Natco’s activities in respect of producing generic palbociclib tablets would constitute infringement of the ‘250 patent, according to the complaint.
Pfizer said that the products covered by the ANDA “contain palbociclib in an amount that satisfies literally and/or by equivalents the palbociclib limitation of claim of 1 of the ’250 patent”.
The US pharmaceutical company added that it would be substantially and irreparably damaged by this infringement.
Pfizer asked the court to declare that the commercial manufacture, use, sale, offer for sale, or importation of Natco’s generic Ibrance product (or any other Natco drug which is covered by the ‘250 patent) will both infringe and induce infringement of the ‘250 patent.
Pfizer is requesting judgment to confirm that the patent-in-suit has been infringed by virtue of Natco’s ANDA and that the effective date of any FDA approval given should not be earlier than the expiration of the ‘250 patent, to include any extensions or further periods of exclusivity.
Finally, Pfizer is seeking a preliminary and permanent injunction to prevent Natco from infringing the ‘250 patent ahead of its expiry, as well as costs and attorneys’ fees.
In July 2021, Pfizer and Natco resolved a dispute in Delaware centring on three Ibrance patents. The resolution brought an end to litigation that started when Pfizer filed a patent infringement lawsuit in 2019.
Since resolving that complaint, Pfizer has filed multiple lawsuits in the same state relating to Natco’s ANDAs for generic versions of Ibrance.
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