Author: Samuel H. Megerditchian

Federal Circuit to PTAB: Explain Yourself

On January 22, 2016, the Federal Circuit vacated and remanded a decision by the United States Patent and Trademark Office, Patent Trial and Appeal Board (the “Board”) in an America Invents Act review, after ruling that the PTAB did not adequately describe its reasons for finding a Cutsforth Inc. brush holder patent invalid.

Supreme Court to Review Willful Infringement under 35 U.S.C. § 284

Last week, the U.S. Supreme Court granted certiorari to review the standard for willful infringement under 35 U.S.C. § 284. The Court was specifically asked to reject the rigid two-part test set forth by the Federal Circuit in In re Seagate, 497 F.3d 1360 (Fed. Cir. 2007), which requires the court to determine whether an alleged infringer: (1) acted despite an objectively high likelihood that its actions constituted infringement of a valid patent; and (2) this objectively-defined risk was either known or so obvious that it should have been known to the accused infringer.

Supreme Court Rejects Belief of Invalidity Defense for Inducement

A recent Supreme Court decision has held that an accused infringer’s good-faith belief that a patent is invalid is not a defense to inducement of infringement. In Commil USA, LLC v. Cisco Systems, Inc., Commil sued Cisco alleging infringement of its patent relating to a method of implementing short-range wireless networks. Commil alleged that Cisco had infringed Commil’s patent by making and using networking equipment and that Cisco induced others to infringe the patent by selling the infringement equipment for them to use.

Case Update: CryoLife Appeals Preliminary Injunction to Declaratory Judgment Defendant in Patent Case

CryoLife, Inc. has appealed the preliminary injunction recently issued against it in the United States District Court for the District of Delaware barring sales of its PerClot Topical blood-clotting powder product. CryoLife Inc. v. C.R. Bard Inc. et al., Dkt. Entry No. 121, Notice of Appeal. CryoLife has asked United States Court of Appeals for the Federal Circuit to review the district court’s grant of a preliminary injunction based on CryoLife’s failure to present (1) an alternative non-infringement argument based on Medafor, Inc.’s proposed claim construction and (2) expert analysis to support its invalidity contentions. As security, Medafor has agreed to pay CryoLife $100,000 if the injunction is overturned.

Heartburn Relief: AstraZeneca Wins Nexium Antitrust Trial

On December 5, 2014, an 11-person jury decided in favor of defendants AstraZeneca PLC and Ranbaxy Laboratories, Inc. in the first pay-for-delay class action trial since the United States Supreme Court in FTC v. Actavis, Inc. opened the door on antitrust suits based on patent settlements. Teva Pharmaceutical Industries, Ltd. was also defending the suit before reaching a settlement shortly before the trial ended. United States District Court Judge William Young of the District of Massachusetts last year permitted certification for the class members, including union health plans and insurance companies, based on an alleged injury of supracompetitive prices for AstraZeneca’s brand name heartburn drug, Nexium®.

Be Careful Identifying Your Licensed Patents and Products

On Friday, the Federal Circuit issued an opinion in Wi-LAN USA, Inc. v. Ericsson, Inc., which highlights the importance of using care when granting rights to or under patents. The interesting facts in this case resulted in two contradictory opinions from two district courts regarding the scope of an agreement pertaining to rights under certain patents. These opinions illustrate the potential dangers of unintended consequences that may arise from imprecise drafting in patent agreements.

The FDA Releases New Draft Guidance for Demonstrating Biosimilarity

On May 13, the Food and Drug Administration released a new draft guidance on the data needed to establish that a proposed therapeutic biological product is biosimilar to an approved reference product. This new guidance gives sponsors a roadmap, detailing the procedures needed to demonstrate biosimilarity between a proposed drug candidate and a reference product, and highlighting the types of data needed to support such a demonstration.

Market Growth of Fuel Cell Products Follow Patent Growth of Fuel Cell Technologies

Recently, Wal-Mart placed an order for 1,738 fuel cell powered forklifts that move products in Wal-Mart’s warehouses. This highly publicized order spotlights the emerging commercial markets, the technologies and patents that have made the production of energy through fuel cells more cost effective. The commercial use of fuel cells is certainly not new, however. Advancements in the technology have decreased costs associated with the production of energy from fuel cells and consequently there has been a rise in the commercial use of fuel cells. The Clean Energy Patent Growth Index shows that for the last decade fuel cell related patents outpaced all other clean energy technology patents until 2013 when solar patents for the first time surpassed fuel cell patents.