patent infringement

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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. 

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.

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 United States District Court for the District of Massachusetts recently denied a motion by Philips North America seeking leave of the Court to amend its claims of patent infringement against Fitbit to include several additional products finding Philips did not act diligently. This case serves as a reminder of the importance of timeliness in any litigation, but especially when a party’s diligence is a factor the court must consider.

The situation is familiar: an employee leaves one company to go work for another, or perhaps to found her own start-up.  She may be working on the same problems that she faced at her former workplace, and in the same technological space.

The employee’s work at her new company results in the issuance of a patent, and the new company takes the lead in the marketplace.  Based on the work done by the employee at the former employer, however, the former employer may believe that it has ownership rights in the new patent.

What rights might the former employer have?  A recent Federal Circuit decision, Bio-Rad v ITC – CAFC, sheds some light on how courts may resolve this kind of dispute—and how thorny the issues may be.  Key takeaways are summarized below.

In a significant recent decision, the Federal Circuit reversed a $66 million judgment against L’Oreal USA, Inc. for patent infringement and trade secret misappropriation asserted by Olaplex, Inc. The case arose as a result of L’Oreal and Olaplex entering into negotiations regarding a potential acquisition, pursuant to which Olaplex shared with L’Oreal its confidential information, including asserted trade secrets. L’Oreal subsequently walked away from the deal and launched competing products of its own. Though the parties’ negotiations were governed by a non-disclosure agreement, the Federal Circuit found Olaplex failed to prove that either its asserted trade secrets were actually trade secrets, or that L’Oreal had misappropriated them.

The United State Court of Appeals for the Federal Circuit recently affirmed a decision by the United States District Court for the Central District of California, setting aside a judgment and injunction in a patent infringement case due to material misrepresentations on the part of the prevailing party discovered after the final judgment was issued. This case serves as a reminder of the importance of making honest and factually accurate statements to a court and the severe consequences that can stem from failing to do so.