Since February 2015, hedge fund manager Kyle Bass has filed more than 30 petitions seeking Inter Partes review of U.S. patents covering approved pharmaceutical products. Kyle Bass even formed a special entity for this purpose–the Coalition for Affordable Drugs–with a stated goal of targeting patents that “have little value other than to drive up prescription…

In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the U.S. Court of Appeals for the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that favors biosimilar applicants in one respect while favoring reference product sponsors (e.g., owners…

The Federal Circuit has issued its long-awaited decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., but the decision is not good news for those seeking to obtain or enforce U.S. patents on diagnostic methods. The appeals court affirmed the district court’s finding that Sequenom’s claims are invalid under 35 USC § 101, applying the analytical framework set forth…

The U.S. Court of Appeals for the Federal Circuit issued its remand decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., and this time affirmed the district court decision that Limelight was not liable for infringement of Akamai’s patents because Limelight had not performed each step of the method claims and was not responsible for…

Under U.S. patent laws, the 20-year term of a patent can be extended if the USPTO fails to meet certain timeliness benchmarks during the patent examination process. The statute provides for Patent Term Adjustment (PTA) equal to the number of days of USPTO delay, less the number of days of applicant delay. The statute defines…

Last week, in In Re Roslin Institute, the U.S. Court of Appeals for the Federal Circuit held that cloned cattle, sheep, pigs and goats are non-patent eligible subject matter under 35 USC § 101. While the result that these cloned animals cannot be patented may not be surprising, the basis for the court’s finding–that the claimed subject matter…

Pursuant to a U.S. White House initiative aimed at addressing the “challenges from Patent Assertion Entities (PAEs)” and stemming the economic drain of meritless patent litigation, the USPTO has issued propose rules to require patent applicants and patent owners to disclose patent ownership information during and after patent prosecution and during any Patent Trial and Appeal Board…

The USPTO has issued new Guidance For Determining Subject Matter Eligibility to help examiners apply the principles of Myriad and Prometheus to any claim “reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products.” The guidelines focus on a “signficantly different” test, and include lists of factors that weigh towards and against patent eligibility. The guidelines also include several…

Last week, the Patent Trial and Appeal Board of the U.S. Patent Office (PTAB) issued eight decisions in Inter Partes review and Covered Business Method proceedings, in each case invalidating at least some of the challenged claims of the patent at issue. That brings to 15 the total number of patents invalidated in an Inter Partes review…