Methods Exploiting Junk DNA May Be Useful But Lack Patent Eligibility

Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35 USC § 101. Although Judge Dyk found the claims at issue to be similar to claims held invalid in other Federal Circuit decisions, the finding in Genetic Technologies Ltd. v. Merial LLC seems to go one step further down the road of ineligibility. Continue reading this entry

Amgen Hedges Its Bets With Cross-Petition For Certiorari Of Biosimilar Decision

Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a “Conditional Cross-Petition” for certiorari. Amgen urges the Court to deny Sandoz’s petition for certiorari, but asks the Court to grant its Conditional Cross-Petition if the Court decides to grant Sandoz’s petition. The gist of Amgen’s position seems to be that the 180-day pre-marketing notice issue raised by Sandoz is not ripe for review, but if the Court decides to review that aspect of the Federal Circuit decision, it should consider it in the context of the statutory framework as a whole, including the “requirement” that the biosimilar applicant provide a copy of its application to the reference product sponsor, and review the Federal Circuit’s decision that that “requirement” is optional. Continue reading this entry

Will the Federal Circuit Invalidate 13,500 Continuation Patents?

The Federal Circuit is set to hear oral arguments in Immersion Corp. v. HTC Corp. on May 6, 2016. According to the amicus brief filed on behalf of the United States, if the court affirms the district court decision “over 13,500” continuation patents could be invalidated. According to the amicus brief filed by the Intellectual Property Owners Association, the ripple effects of such a decision could reach over 30,000 patents. Indeed, this could be the one case where all stakeholders (except maybe HTC) hope that the court upholds the USPTO’s interpretation of a statute. Continue reading this entry

The USPTO Patent Quality Checklist

In furtherance of its efforts to improve patent quality, the USPTO has issued a request for comments on new patent quality metrics being developed for implementation in 2017. As set forth in the March 25, 2016 Federal Register Notice, the new metrics will focus on the correctness and clarity of Office Actions, and will be implemented using a “Master Review Form” questionnaire. The USPTO has asked that written comments be sent to QualityMetrics2017@uspto.gov by May 27, 2016.  Continue reading this entry

Second Time Is The Charm For Kyle Bass Challenges Of Ampyra Patents

The USPTO Patent Trial and Appeal Board (PTAB) has decided to institute inter partes review (IPR) proceedings against the Ampyra patents based on the second set of petitions filed by Kyle Bass and the Coalition for Affordable Drugs. This decision shows that even patent owners who successfully avoid institution of one IPR may face a subsequent IPR by the same party as long as it is based on different prior art.  Continue reading this entry