Federal Circuit

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The practice of serially filing continuation applications through a patent’s lifetime has come under increased pressure in recent years from newly implemented continuing application fees to expanded case law on non-statutory obviousness-type double patenting. A somewhat new interpretations of the doctrine of prosecution laches emerging from Sonos, Inc. v. Google, LLC in late 2023, however, that threatened an outright repudiation of the practice late into a patent’s 20-year term. In a post-trial motion, District Court Judge William H. Alsup set aside a $32.5M jury verdict that Google infringed Sono’s 10,469,966 and 10,848,885 patents, finding the patents unenforceable due to a 13-year delay from the priority date to the filing of the continuation applications that resulted in the patents at issue. Recently a Court of Appeals for the Federal Circuit (CAFC) panel of Chief District Judge Bumb and Judges Lourie and Prost reversed the finding of laches as unsupported by the evidence nonprecedential decision, stopping short of repudiating the possibility of finding laches for continuation applications filed late into a patent’s 20-year term.

The Federal Circuit’s decision in Eye Therapies, LLC v. Slayback Pharma, LLC  provides further insight into the tools available for patent claim construction. The Federal Circuit had previously held that a patent’s specification can evidence that the patentee intended for a term in the patent claims to have a different meaning than what is typical. Now, the Federal Circuit has held that the prosecution history—the exchanges between the U.S. Patent & Trademark Office and the patent applicant during the application process—can do the same.

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?