Posts Tagged: "Sandoz"

CAFC Affirms Ruling that Blocks Generic Version of Amgen’s Psoriasis Drug Until 2028

Yesterday, in a precedential decision, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed a district court ruling that upheld the validity of several claims in two Amgen patents and barred Sandoz and Zydus from producing generic versions of Amgen’s psoriasis drug Otezla until 2028. The CAFC ruling also upheld the district court’s ruling that three claims in Amgen’s U.S. Patent 10,092,541 were invalid. However, that did not stop Amgen from declaring victory in the case in a press release.

Patent Filings Roundup: Robot Vacuum Wars, PTAB Filings Dip, Pharma Litigation Abounds

This week’s District Court filings were robust, with a dip in Patent Trial and Appeal Board (PTAB) filings–a big chunk of which were related to a dispute over robot vacuum cleaners. A few new (or renewed) assertion campaigns, a few small inter-company disputes, and a number of pharmaceutical disputes led the charge. I say Robot, you say vacuum:  Call it the great robot vacuum wars of 2020: industry leader iRobot sued SharkNinja for infringement of three patents (as well as false advertising)—seeking a preliminary injunction of a competing product right before the lucrative holiday season.  iRobot contended that SharkNinja had “brazenly ripped off” their Roomba robotic vacuum cleaners with their much less expensive IQ Robot competitor product.  That bid failed, and the case continued; now SharkNinja has filed multiple IPRs seeking to invalidate the asserted patents.

CAFC sides with Sandoz, Amgen’s state claims preempted by BPCIA

Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. State law claims are preempted by the BPCIA on both field and conflict grounds, which means only remedy available against biosimilar applicants refusing to engage in the patent dance is filing for a declaration of infringement, validity, or enforceability of a patent that claims the biological product or its use. Notably, this must be done before receiving manufacturing information from the biosimilar company. Patent lawsuits are notoriously costly so, in the short term, the decision will have the greatest impact on innovator start-ups with limited financial resources. In the long term, relying on costly litigations to keep biosimilar drugs off the market will likely increase the consumer price for any biologic drug.

SCOTUS says OK to give notice of commercial marketing before FDA license under Biologics Price Competition and Innovation Act

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(l) has two notification requirements that are important to this case… The second question addressed by the Court was whether the applicant must provide notice after the FDA licenses its biosimilar, or if it may provide notice before the FDA licenses its biosimilar. The Court concluded that an applicant might, but does not have to, provide notice to the manufacturer of the biologic before obtaining a license from the FDA.

Industry Reaction to SCOTUS decision in Sandoz v. Amgen

The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry of biosimilar products. In holding that a biosimilar applicant cannot be compelled through federal law to engage in the patent dance, the Court effectively gave biosimilar applicants a license to hide the ball. Given the complexity of biologics and biosimilars, it can be very difficult for an innovator company to reasonably determine which of its patents might be infringed by the biosimilar. Now, potentially meritorious patent infringement questions could be kicked far down the road. This could lead to delayed launch of the biosimilar product, possibly through a decision not to launch at risk or possibly by way of injunctive relief outside the BPCIA.