Welcome to the first issue of the BakerHostetler Life Sciences Newsletter! Within it you will find an overview of noteworthy developments in the life sciences space and at BakerHostetler. ...more
Does a claim that merely recites an inherent property of an otherwise obvious claim require an additional analysis to demonstrate that a person of ordinary skill in the art would have had a reasonable expectation of success...more
Novartis markets and sells a combination therapy of valsartan and sacubitril under the brand name Entresto® for the treatment of various forms of heart failure. MSN submitted an Abbreviated New Drug Application seeking...more
3/11/2025
/ Abbreviated New Drug Application (ANDA) ,
Claim Construction ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Intellectual Property Protection ,
Novartis ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular
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
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 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 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
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
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
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
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
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
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
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
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 (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
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
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
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
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
“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
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
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
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
4/14/2016
/ AMP v Myriad ,
Biotechnology ,
Diagnostic Method ,
DNA ,
Life Sciences ,
Mayo v. Prometheus ,
Patent-Eligible Subject Matter ,
Patents ,
Petition for Writ of Certiorari ,
SCOTUS ,
Section 101 ,
Sequenom
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