Astellas & Pfizer Settle Their Lawsuit Against Sun Pharma

As per findings pertaining to court filings, Astellas Pharma Inc. and Pfizer Inc. have gone on to reach a settlement in their lawsuit against Sun Pharmaceutical Industries Ltd. with regards to the production of a generic variant of the highly valuable prostate cancer medication, Xtandi.

According to the proposed dismissal order, which was filed on October 20 in the US District Court for the District of New Jersey, the co-plaintiffs as well as Sun have agreed to quit every claim related to US Patent No. 7,709,517. However, they have also left the prospect open when it comes to reviving their respective allegations in the future.

That said, notably, the deal has not yet been approved. Magistrate Judge Jessica S. Allen recently granted the parties’ demand to release their joint status update filed on September 29. The outcome was reflected in a letter order that was docketed on October 24. After providing Judge Allen with an update on the progress of tasks regarding the claim construction and fact discovery, both parties asked for a two-week postponement of the status conference for more negotiations when it comes to the settlement talks.

Last December, Astellas, Pfizer’s Medivation unit, as well as the University of California filed a lawsuit against Sun, which claimed that the latter’s proposed generic versions of Xtandi’s 40- and 80-milligram tablets went on to violate the ‘517 patent. This patent focuses on the active ingredient of the drug, enzalutamide, as well as its other pharmaceutical compositions.

According to the lawsuit, Enzalutamide was created by the university that currently holds the patent. The university has licenced the patent to both Medivation and Medivation Prostate Therapeutics. Pfizer exclusively sublicenses the patent to Astellas. Enzalutamide is marketed in the US through a joint effort between Medivation and Astellas, and outside of the US, Astellas is solely responsible for marketing the product.

Apparently, there is a division among pharmaceutical industry experts regarding whether Xtandi will still happen to be a target for efforts to lower drug prices, given that it was not included in the list of drugs under Medicare negotiations by the Biden administration.

Critics, which also include lawmakers, argue that the drug industry’s behaviour is difficult, specifically regarding the high price of drugs in the US. Without insurance, the retail price can exceed $13,000 per month, as reported by Bloomberg LP. These critics believe that the government should intervene and, at the same time, take measures to align the cost with what patients pay in other nations. It is noted that the University of California researchers’ development of innovations when it comes to several patents on the drug was funded by grants provided by the US government.

According to a Bloomberg’s analyst note dated October 20, it is anticipated that Xtandi will be added to a future list of drugs that will face Medicare price reductions starting January 1, 2027. This could potentially lead to administrative action that may be legally challenged, causing undesirable holdups.

The ‘517 patent is one of three patents listed for Xtandi in the US Food and Drug Administration’s registry of approved drugs, referred to as the Orange Book. The expiration in August 2027 is the most recent among the three.

According to Bloomberg data, Astellas reported that Xtandi had sales of $2.5 billion in the 12 months ending on March 31, which accounted for 29.5% of the total revenue.

According to Bloomberg data, Pfizer reported that the US revenue from the Xtandi alliance was $1.2 billion in 2022, which accounts for 1.2% of the overall revenue.