Ron Kern

U.S. Electronic Patent Grants and the Effect on the Timing of Filing Continuation and Divisional Patent Applications

By Ron Kern on March 10, 2023 Posted in Patents, USPTO

On April 18, 2023, the U.S. Patent and Trademark Office (PTO) will begin moving away from issuing paper patents and will begin issuing patents electronically as electronic patent grants (eGrants). In addition to reducing paper waste, the PTO states that eGrants will “benefit[] stakeholders by reducing pendency and streamlining the process.”[1] According to the PTO, … Continue Reading

The Supreme Court Again Declines to Address the Written Description Standard

By Ron Kern on January 11, 2023 Posted in Patent

Without any comments, the Supreme Court has denied Juno Therapeutics’ Petition for Rehearing, which requested that the Court hold the case in abeyance pending the resolution of Amgen Inc. v. Sanofi, Aventisub LLC. Juno filed its petition after the Federal Circuit held that Juno’s claims were invalid because the patent at issue “does not disclose … Continue Reading

Juno Therapeutics Requests That the Supreme Court Wait to Make a Decision on Its Written Description Question Until Amgen’s Enablement Case Is Resolved

By Ron Kern on November 30, 2022 Posted in Patent

Juno Therapeutics (Juno) has filed a Petition for Rehearing with the Supreme Court, requesting that the Court vacate its previous order denying Juno’s petition for certiorari and hold the case in abeyance pending the resolution of Amgen Inc. v. Sanofi, Aventisub LLC. Just days after agreeing to review the scope of the enablement requirement in … Continue Reading

Supreme Court Denies Review of the Written Description Requirement

By Ron Kern on November 16, 2022 Posted in Patent

Just days after agreeing to review the scope of the enablement requirement in Amgen Inc. v. Sanofi, Aventisub LLC, the Supreme Court denied Juno Therapeutics, Inc.’s (Juno) request to review the scope of the written description requirement. Interestingly, both cases involved similar questions – whether the respective portion of 35 U.S.C. §112(a) is governed by … Continue Reading

Supreme Court to Address What it Means to Have an Enabling Disclosure

By Ron Kern on November 8, 2022 Posted in Patent

The Supreme Court has granted Amgen’s Petition for a Writ of Certiorari, agreeing to address what it means to provide an enabling disclosure. In particular, Amgen asked the Court to address: Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, … Continue Reading

Characterization of Claim Elements as “Conventional” Results in Section 101 Subject Matter Ineligibility

By Ron Kern on July 25, 2022 Posted in Patents

In an attempt to broaden a patent’s disclosure and provide Section 112 support for features that are not explicitly disclosed within the patent’s specification (such as reagents, assays, techniques, etc.), patent applications are often drafted with boilerplate language to indicate that other “conventional,” “well-known” or “routine” features may be used. But acknowledging that features of … Continue Reading

Federal Circuit Holds That Claims Directed to Methods of Treating Pain in a Renally Impaired Patient Are Patent-Eligible Under Section 101

By Ron Kern on March 29, 2019 Posted in Patent

For the second time in as many weeks, the Federal Circuit has reversed a district court’s finding of patent ineligibility under Section 101 in the life science space, this time concluding that claims directed to methods of treating pain in renally impaired patients are patent-eligible. In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the … Continue Reading

The Federal Circuit Opens the Door Wider for the Subject Matter Eligibility of Methods of Treatment, Compositions and Methods of Manufacturing

By Ron Kern on March 18, 2019 Posted in Patent

“We live in a natural world, and all inventions are constrained by the laws of nature . . . we must be careful not to overly abstract claims when performing the Alice analysis.”[1] These are the promising words from the Federal Circuit in its recent decision in Natural Alternatives v. Creative Compounds, in which the … Continue Reading

Federal Circuit holds that claims directed to diagnosing neurotransmission or developmental disorders are invalid for failing to recite patent eligible subject matter

By Ron Kern on February 11, 2019 Posted in Patent

In Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC,[1] the Federal Circuit affirmed the district court’s ruling that claims covering methods for diagnosing neurological disorders by detecting autoantibodies are directed to a natural law together with conventional steps, and are therefore invalid under 35 U.S.C. § 101. Although the claims at issue were said to … Continue Reading

Supreme Court Denies Sequenom’s Petition for Certiorari

By Ron Kern on June 28, 2016 Posted in Uncategorized

On June 27, 2016, the U.S. Supreme Court, without comment, denied Sequenom’s petition for certiorari, leaving in place the Court’s previous rulings prohibiting the patenting of laws of nature and natural phenomenon. Sequenom filed its writ of certiorari with the U.S. Supreme Court on March 21, 2016, asking the Court to provide clarification regarding the … Continue Reading

Sequenom Asks the Supreme Court to Clarify the Limits on Section 101

By Ron Kern on March 25, 2016 Posted in Patent

On March 21, 2016, Sequenom filed a writ of certiorari with the U.S. Supreme Court, asking the Court to provide clarification regarding the limits of 35 U.S.C §101 as it relates to patent eligibility of diagnostic tests. Sequenom’s petition presents the following question: Whether a novel method is patent-eligible where: (1) a researcher is the … Continue Reading

Sandoz Requests Supreme Court Review of the Federal Circuit’s Interpretation of Biosimilar Law

By Ron Kern on February 18, 2016 Posted in Uncategorized

On February 16, 2016, Sandoz Inc. filed a petition for a writ of certiorari with the U.S. Supreme Court, asking the Court to review the Federal Circuit’s interpretation of the Biologics Price Competition and Innovation Act (BPCIA). The petition presents the following questions to the Court: Whether notice of commercial marketing given before FDA approval … Continue Reading

Federal Circuit denies en banc review of Ariosa v. Sequenom

By Ron Kern on December 8, 2015 Posted in Uncategorized

On December 2, 2015, an almost unanimous Federal Circuit decision was issued denying the en banc rehearing of Ariosa v. Sequenom, a case having significant consequences for diagnostic patents and Section 101 case law in general.[1] The concurrences and dissent in the Ariosa case offer insight into how the various judges perceive the existing Section … Continue Reading

Methods of treating a subset of patients are likely nonobvious if the subset exhibits unexpected results

By Ron Kern on November 17, 2015 Posted in Uncategorized

In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc.,[1] a recent decision involving methods of treating a specific subset of patients, the Court of Appeals for the Federal Circuit (“Federal Circuit”) ruled that, although the claims of the patent at issue were invalid as obvious, singling out a particular subset of patients for treatment can still … Continue Reading

A Split Decision Remains Split; No en banc Review of Amgen v. Sandoz

By Ron Kern on October 20, 2015 Posted in Uncategorized

On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation Act (BPCIA) and rights and obligations of patent owners and biosimilar applicants under the Act. For now, the public is … Continue Reading