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Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry. Patterson Belknap represents biotechnology, pharmaceutical and healthcare companies in a broad range of patent litigation matters, including patent infringement cases, PTO trial proceedings, patent licensing and other contractual disputes. Our team includes highly experienced trial attorneys with extensive technical knowledge, many of whom have advanced scientific degrees and industry experience in fields such as molecular biology, biochemistry, chemistry, statistics and nuclear engineering.

All-or-Nothing Damages Strategy Leaves Promega with Nothing

The Federal Circuit’s recent decision in Promega Corp. v. Life Technologies Corp. is a cautionary tale that failure to present evidence of damages closely tied to each alternative basis of liability may result in a hollow victory – infringement with no corresponding damages.  The Federal Circuit, on remand from the Supreme Court, affirmed the district court’s rulings in a patent suit against Life Technologies that both overturned the jury’s $52 million infringement verdict in favor of Promega, and denied Promega’s motion for a new trial on damages and infringement. The Federal Circuit held that Promega was not entitled to any damages under the narrow “all-or-nothing” damages strategy that Promega had pursued throughout the litigation, and that Promega had waived any alternative damages arguments.

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A New Strain Of Inequitable Conduct Litigation

In July, a split panel of the Federal Circuit upheld the district court’s use of an adverse inference from litigation misconduct to hold a patent unenforceable for inequitable conduct. The Federal Circuit’s decision in the case, Regeneron Pharmaceuticals Inc. v. Merus NV, raises interesting questions about the relationship between attorney misconduct during litigation (which is not supposed to affect the enforceability of a patent) and misconduct during prosecution of the patent (which can). Because the court’s opinion gives no clear answer to these questions, it opens new tactical opportunities for defendants asserting inequitable conduct defenses in patent cases and may incrementally expand the use of a doctrine that the Federal Circuit has famously referred to as a “plague” and repeatedly tried to rein in.

To continue reading Aron Fischer and Rachel Schwartz's article from Law360, please click here.

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Supreme Court Reverses § 271(f)(1) Ruling in Biotech Case

In Life Technologies Corp. v. Promega, the Supreme Court reversed the Federal Circuit’s interpretation of 35 U.S.C. § 271(f)(1), and held that a single component does not constitute a “substantial portion of the components of a patented invention” under the statute. The Court, however, declined to address how many components are needed to trigger liability.

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Federal Circuit’s Application of Mayo Revives Biotech Patent

In Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc., the Federal Circuit reversed a ruling of patent invalidity under Section 101, reviving a biotech patent to a method of preserving hepatocytes, liver cells, for medical use.  The Federal Circuit reversed the district court at both steps of the Supreme Court’s framework for patent eligibility set out in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).  In the wake of the Supreme Court’s recent denial of certiorari in Sequenom Inc., v. Ariosa Inc., where Sequenom sought guidance on the proper application of the Mayo two-step test, the Federal Circuit’s decision provides important guidance for how to determine patent eligibility for biotech inventions that build on natural discoveries.  It also may help stem what many, including several Federal Circuit judges, have described as a crisis in medical innovation due to how courts and the Patent Office have applied Mayo.  

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