02/26/2015 On February 26, 2015, RMMS submitted an amicus brief on behalf of the Generic Pharmaceutical Association in Commil USA, LLC v. Cisco Systems, Inc., No. 13-896.
In this case, scheduled for oral argument in March 2015, the Supreme Court will decide Commil’s challenge to the Federal Circuit’s decision recognizing a defendant’s good-faith belief of invalidity as a defense to induced infringement. The GPhA brief supports the Federal Circuit opinion, and argues against the effort by Commil and its allies (including PHrMA, BIO and brand pharmaceutical companies) to eliminate the specific-intent-to-infringe standard for inducement liability and substitute a mere knowledge-of-the-patent-and-infringement-allegation standard. The mere knowledge standard would no doubt greatly expand induced infringement liability. Given the requirements of the Hatch-Waxman Act and FDA regulations, that standard could arguably make generic ANDA filers automatically liable for induced infringement whenever a doctor or patient uses their product to infringe a patent. A mere knowledge standard would also threaten the generics’ ability to use ‘Section (viii)’ statements to carve out patented indications from the generic label to avoid potential liability.
The GPhA brief argues that the specific intent requirement for inducement liability is consistent with the language and common law origins of the Patent Statute, and is set forth in Supreme Court precedent and twenty-five years of Federal Circuit precedent not challenged below. Moreover, parties to our patent system have relied upon this specific intent standard in their businesses and IP strategies for many years, and the Court should not upset these settled expectations. The GPhA brief also argued that the alternatives proposed by Commil and its brand pharmaceutical supporters would disrupt settled pharmaceutical industry expectations, are ripe for brand abuse, and abandon the fundamental premise that inducement liability requires culpable wrongdoing.
William A. Rakoczy, Deanne M. Mazzochi and Jeffrey A. Marx are listed on the GPhA brief.
A full copy of the brief is available here .