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

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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shutterstock_96589270The 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.

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.


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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.


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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).


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