Federal Circuit Invalidates Myriad Primer And Method Claims As Lacking Subject Matter Eligibility

In a case styled as In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (also known as Myriad v. Ambry), the Federal Circuit held four of Myriad’s “primer” claims and two of Myriad’s detection method claims invalid for lack of subject matter eligibility under 35 USC § 101. The timing of this decision–coming two days after the USPTO’s Interim Guidance on subject matter eligibility which led many of us to believe that biotechnology inventions could be patented once again–makes it tempting to refer to the Federal Circuit as the Grinch Who Stole Christmas. But while the Grinch changed his mind just in time, it may take Congressional action before diagnostic and personalized medicine innovators have reason to celebrate.

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USPTO Finally Issues New Guidance On Patent Subject Matter Eligibility

The USPTO has issued new “Interim Guidance” for determining whether claims are eligible for patenting under 35 USC § 101. Although the new guidance technically applies to all technologies and all types of claims, Applicants with claims involving natural products will find the most to like about the USPTO’s revised position on subject matter eligibility. The Interim Guidance supersedes the March 4, 2014 guidance issued under the Supreme Court decisions in Myriad and Mayo, and  supplements the June 25, 2014 preliminary guidance issued after the Supreme Court decision in Alice Corp. v. CLS Bank. Continue reading this entry

Sequenom Deal May Avoid Federal Circuit Decision

Less than a month after their case was argued at the Federal Circuit, Illumina Inc. and Sequenom Inc. have announced a deal to settle their patent infringement litigation. While I haven’t seen an order dismissing the case, that is a likely next step.  Continue reading this entry

Federal Circuit Says Secret Prior Art Is Prior Art For All Purposes

In Tyco Healthcare Group LP v. Ethicon Endo-Surgery, Inc., the Federal Circuit agreed with the district court that Ethicon’s prototype constituted prior art under 35 USC § 102(g) based on its earlier date of conception, but reversed the district court’s decision that it could not be used for obviousness purposes because of its later reduction to practice. This case highlights the problem of “secret prior art” that will be ameliorated–but not eliminated–by the first-to-file provisions of the America Invents Act. Continue reading this entry

Federal Circuit Finds No Biosimilars Application Means No Case Or Controversy For Sandoz

In Sandoz Inc. v. Amgen Inc., the Federal Circuit upheld the district court decision dismissing Sandoz’s declaratory judgment action for lack of jurisdiction. Although this may be the first Federal Circuit decision relating to a possible “biosimilar” product, the court was careful to steer clear of the biosimilars statute. Apparently the judges aren’t the only ones trying to avoid the patent provisions of the Biologics Price Competition and Innovation Act. Continue reading this entry