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The Obviousness-Type Double Patenting Saga Continues!

A later-filed, later-issued, earlier-expiring child patent cannot be used as an obviousness-type double patenting (ODP) reference against its first-filed, first-issued, later-expiring parent patent having a common priority...more

[Podcast] Biotechnology, Chemical and Pharmaceutical: Supreme Showdown

In 2023, a lawsuit that had wound its way through the judicial system for nearly 10 years finally had its day in the U.S. Supreme Court – and made waves in the biotechnology, chemical and pharmaceutical communities. Our...more

In the Wake of the Amgen Decision, the USPTO Will Continue To Use the Wands Factors when Evaluating Enablement

In the wake of the U.S. Supreme Court’s decision in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) (Amgen), in which the Court addressed whether Amgen’s functional antibody genus claims satisfy the enablement requirement, the U.S....more

The Supreme Court Again Declines To Reevaluate Subject Matter Eligibility of Diagnostic Claims

The Supreme Court seemed, at least to a small degree, interested in evaluating the subject matter eligibility of diagnostic claims when it requested that the respondents (Natera Inc. and Eurofins Viracor Inc.) respond to a...more

Federal Circuit Affirms Lack of Enablement of Functional Antibody Claims

In its recent decision in Baxalta Inc. v. Genentech, Inc., No. 2022-1461, 2023 WL 6135930 (Fed. Cir. Sept. 20, 2023), the Federal Circuit applied the Supreme Court’s decision in Amgen Inc. v. Sanofi to affirm the District of...more

Method of Treatment Claims Are Not Invalid for Lacking Written Description or Enablement Simply Because the Treatment Is Not Safe...

The Federal Circuit’s recent decision in United Therapeutics Corp. v. Liquidia Techs., Inc., No. 2022-2217, 2023 WL 4695903 (Fed. Cir. July 24, 2023), provides an interesting discussion on the written description and...more

Congress Seeks to Eliminate the Judicial Exceptions to Patent Eligibility

On June 22, Senator Thom Tillis (R – NC) and Senator Chris Coons (D – DE) introduced the Patent Eligibility Restoration Act of 2023, which seeks to eliminate all judicial exceptions to patent eligibility. The bill proposes...more

Will the Supreme Court Reevaluate the Subject Matter Eligibility of Diagnostic Claims?

Since the Supreme Court’s decisions in Mayo Collaborative Servs. v. Prometheus Lab’ys, Inc., 566 U.S. 66 (2012), and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014), “diagnostic” patent claims have repeatedly...more

Now What? The Supreme Court Addresses Enablement

What do telegraphic communications, incandescent lamps, wood veneering glues, and antibodies have in common? Nothing. That is of course, until May 18, 2023, when the Supreme Court ruled that Amgen’s antibody claims, like...more

Incorporated References Can Be Used in an Anticipation Rejection

A claim is said to be anticipated when a single prior art reference discloses, either expressly or inherently, each and every limitation of the claim. But what happens when a prior art reference discloses some aspects of the...more

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

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...more

The Supreme Court Again Declines to Address the Written Description Standard

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....more

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

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...more

Supreme Court Denies Review of the Written Description Requirement

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...more

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

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...more

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

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...more

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

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...more

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

“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.”...more

Federal Circuit Holds That Claims Directed to Diagnosing Neurotransmission or Developmental Disorders Are Invalid for Failing to...

In Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, the Federal Circuit affirmed the district court’s ruling that claims covering methods for diagnosing neurological disorders by detecting autoantibodies are...more

Supreme Court Denies Sequenom’s Petition for Certiorari

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...more

Supreme Court Asked to Clarify Limits on Diagnostic Method Patents

Arguing that the current state of the law weakens the patent system and poses a danger to life science innovators, biotechnology company, Sequenom, Inc., has filed a writ of certiorari with the U.S. Supreme Court, asking the...more

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

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....more

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

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...more

Federal Circuit denies en banc review of Ariosa v. Sequenom

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...more

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

In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc., a recent decision involving methods of treating a specific subset of patients, the Court of Appeals for the Federal Circuit (“Federal Circuit”) ruled that,...more

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