Timing the filing of an inter partes review for companies in the early stage of developing a biosimilar product should be carefully considered based on the recent Federal Circuit case, Momenta Pharmaceuticals, Inc. v Bristol-Myers Squibb Co., Appeal No. 2017-1694 (February 7, 2019). Momenta filed an IPR before the PTAB to challenge the validity
Now Available! Seyfarth Shaw’s BioLoquitur Bulletin: Drugs Available in 2018 for Generic Competition
Seyfarth Shaw is pleased to announce The BioLoquitur Bulletin: Drugs Available in 2018 for Generic Competition, published by the Life Sciences team. The BioLoquitur Bulletin provides a brief overview of selected New Chemical Entities (NCE) that were approved by the FDA in the year 2014. While not every NCE will be a target for
“Rigged” Pricing, Contracting and Rebate “Schemes,” and Drug Pricing “Shell Games:” FDA Commissioner Scott Gottlieb Lets Loose on the U.S. Biosimilar Market While Offering Peek at New Policies
In a few short days, the United States will mark the eight-year anniversary of the Biologics Price Competition and Innovation Act (“BPCIA”). Signed into law on March 23, 2010, the BPCIA creates a regulatory pathway for the approval of biosimilar drugs in the United States and a mechanism, albeit voluntary, for resolving patent right disputes relating to the innovator biologic products.
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Innovation in Hatch-Waxman and ANDA Litigation
The Hatch-Waxman Act was enacted in 1984 to address two main congressional goals: (1) to encourage innovation in pharmaceutical research and development; and (2) to help generic drugs reach the market more quickly. Through amendments to both the patent and the food and drug laws, the Act established several practices intended to provide brand-name firms
FDA Issues New Guidance for IND Sponsors
In late December the FDA issued a new guidance, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The purpose of the guidance is to “describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in
Sandoz v. Amgen: The Latest in Biosimilar “Dances”
Finding against the Federal Circuit once again on a patent case, the Supreme Court issued a unanimous decision in Sandoz v. Amgen relating to the interpretation of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) in its first decision on the Act. The Supreme Court’s decision firmly establishes the availability of a third
Draft FDA Guidance On Demonstrating Interchangeable Biosimilar Proteins
The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) amended Section 351(k) of the Public Health Service Act (42 U.S.C. § 262(k)) in providing ways to obtain licenses for certain biological products via abbreviated applications from the Food and Drug Administration (“FDA”) in order to market biosimilar products or interchangeable products for therapeutic uses.
Will Formal Opinions Act as a Shield Against Charges of Induced Infringement?
In Commil v. Cisco Systems, the Federal Circuit held that “evidence of an accused inducer’s good-faith belief of invalidity may negate the requisite intent for induced infringement.”i The court’s opinion did not describe the kind of proof needed to show good faith, but it is reasonable to expect that a competent opinion of counsel may meet this requirement. This holding potentially underscores the value of invalidity opinions, particularly in the context of method of treatment claims. In fact, in Commil, the court reiterated that opinions of counsel regarding non-infringement are admissible to show the defendant’s state of mind and its bearing on indirect infringement.ii The Federal Circuit has now further opened the door to allow the existence of an invalidity opinion to negate the intent required to demonstrate inducement of infringement. The Supreme Court granted certiori and heard oral arguments in this case on March 31, 2015.
For Indirect Infringement, Will Opinions of Counsel Regarding Invalidity Become More Relevant? If so, Invalidity Where?
In Commil v. Cisco Systems, the Federal Circuit held that “evidence of an accused inducer’s good-faith belief of invalidity may negate the requisite intent for induced infringement.” CITE. The court’s opinion did not explore the proof needed to show good faith, but it is reasonable to expect that a competent opinion of counsel may meet this requirement, potentially resurrecting the importance of invalidity opinions.
Federal Circuit Reluctant to Relinquish Control of Claim Construction
Judge Newman’s dissent in Enzo Biochem, Inc. v. Applera Corp., 780 F.3d 1149 (Fed. Cir. 2015), demonstrates that the Federal Circuit is struggling with how much deference it is supposed to give in the review of claim construction in view of the Supreme Court’s ruling in Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831 (2015).