Federal Circuit

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The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. § 271(e)(1). The Federal Circuit’s ruling, and the subsequent denial of Edwards’s petition for rehearing en banc, underscores the breadth of the safe harbor, putting to bed the question of whether “solely” means “only” in the context of the safe harbor.

Litigators in the life sciences field are no doubt familiar with the so-called “artificial” act of infringement established by 35 U.S.C. § 271(e)(2)(A)-(B): namely, that a party can be sued for patent infringement by merely filing an Abbreviated New Drug Application (“ANDA”) for a generic drug or a Biologics License Application (“BLA”) for a biosimilar drug. The filing of such an action can allow for, among other things, the resolution of patent infringement disputes before the generic (or biosimilar) drug enters the market. 

Recently, in Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc., the Federal Circuit held for the first time that the Patent Trial and Appeal Board (“the Board”) has the authority to issue a Final Written Decision even after the statutory deadline has passed.

Congress introduced post grant review (“PGR”) and inter partes review (“IPR”) in 2011 as part of the America Invents Act (AIA). Parties can use these processes to ask the Board to review the patentability of a patent’s claims. Under the AIA, the Board must provide a Final Written Decision within one year of instituting the PGR or IPR; this can be extended for good cause for an additional six months.

Cell therapy products in the U.S. are estimated to be worth approximately $4.5 billion currently and expected to grow to over $30 billion in the next ten years. As market value increases litigation is bound to heat up.

Recently, Fate Therapeutics and the Whitehead Institute sued Shoreline Biosciences in the Southern District of California for allegedly infringing six patents directed to composition and methods relating to induced pluripotent stem cells (iPSCs) directly under 35 U.S.C. §§ 271(a) and (g), and for inducing infringement. Fate’s infringement theories included both literal infringement and infringement under the Doctrine of Equivalents. The court granted summary judgment of noninfringement to Shoreline for all asserted claims.

The Court of Appeals for the Federal Circuit recently addressed the issue of “analogous prior art,” a patent law doctrine fundamental to the legal determination of whether a patent is invalid as obvious over the prior art. The decision illustrates the importance of carefully considering whether asserted prior art is analogous to the challenged patent, as the use of non-analogous art can result in dismissal of any obviousness argument based on that art.

The concept of corporate legal separateness has long been a fortress protecting affiliated business entities such as parents, subsidiaries, and sister companies from various kinds of liability and litigation. However, how much protection does such legal separateness offer the information that corporations gather and store when faced with vehicles of written discovery such as interrogatory requests or requests for production? In other words, if an opposing party requests information or documents from a party that requires that party to seek information or documents from an affiliated non-party entity, is the party then required to seek the requested information or documents from its affiliated non-party entities?

Recently, in Google LLC v. Ikongoro Tech. LLC, the Patent Trial and Appeal Board (“the Board” or “PTAB”) instituted inter partes review after it had previously denied the institution of such a review due to the pendency of related district court litigation in the Western District of Texas—a case which was subsequently transferred to the Northern District of California by the Federal Circuit granting mandamus relief.  The Board’s decision casts light on the interplay between the PTAB’s discretion to deny institution of inter partes review and the increased focus on transfers out of the Western District of Texas.

The Federal Circuit’s recent ruling in MaxPower Semiconductor Inc. et al v. Rohm Semiconductor USA, LLC highlights the interplay between the liberal federal policy favoring arbitration agreements and the Patent Trial and Appeal Board’s (“PTAB”) authority as an agency tribunal having a broad role to protect the public interest in…