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Stages of Patent Invalidation Proceedings
Before Lourie, Prost, and Reyna. Appeal from the U.S. District Court for the District of Delaware. Summary: A patent was not invalid for lack of written description for failing to describe the specific infringing embodiment...more
Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., et al., Nos. 2023-2218, -2220, -2221 (Fed. Cir. (D. Del.) Jan. 10, 2025). Opinion by Lourie, joined by Prost and Reyna. The FDA approved a New Drug Application from...more
Not surprisingly, the Federal Circuit visited upon Plaintiff/Appellant PureCircle two of the Four Horsemen of the Biotech Patent Apocalypse* in a decision affirming the District Court's invalidation of the claims asserted...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s holding that the asserted method of treatment patent was valid and infringed because safety and efficacy are not patent concerns. The Federal Circuit...more
As part of the recovery from the global COVID-19 pandemic, the U.S. Court of Appeals for the Federal Circuit took steps to return to normal operations. It began requiring live oral arguments in August 2022 and, by November,...more
Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more
[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more
On December 8, 2021, the Federal Circuit in AztraZeneca AB v. Mylan Pharms. Inc. held that the claim construction of a percentage term should “‘most naturally align[] with the patent’s description of the invention,’ as...more
The Federal Circuit invalidated Juno Therapeutics, Inc.’s T cell therapy patent for cancer treatment and erased a billion dollar judgment in Juno’s favor. The court held that the jury verdict regarding the patent’s written...more
On Aug. 26, 2021, the Federal Circuit held the asserted claims of Sloan Kettering’s CAR-T patent invalid for lack of written description, reversing the final judgment of a California district court awarding Sloan Kettering...more
Dominating the entering gallery of the Impressionists exhibit at the Art Institute of Chicago is Georges Seurat's A Sunday on La Grande Jatte (see below). Painted in the pointillist style, the work comprises millions of...more
The PTAB Strategies and Insights newsletter provides timely updates and insights into how best to handle proceedings at the USPTO. It is designed to increase return on investment for all stakeholders looking at the entire...more
On April 20, in Sebela Ireland v. Prinston Pharmaceutical, the Federal Circuit held that Sebela’s appeal challenged only contingent patent invalidity findings and dismissed the appeal for lack of constitutional standing. In...more
A Maddening Habit - Biotechnology is an unpredictable science. When its practitioners wish to enforce their patents, they often run into a serious problem. Unlike chemists or pharmacologists, who for a century or so have...more
The District Court for the Northern District of West Virginia recently found method of treatment claims directed to treating a specific disease at a specific dose invalid for lack of written description based on the context...more
In a case relating to compounds for the treatment of the Hepatitis C virus (HCV), the US Court of Appeals for the Federal Circuit upheld a district court’s grant of judgment as a matter of law (JMOL) for lack of enablement...more
The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more
Mere Potential for Future Appeal Does Not Prevent Triggering Estoppel of Inter Partes Reexamination When Party Fails to Seek Relief in the First Instance - In Virnetx Inc. v. Apple Inc., Appeal Nos. 2017-1591, -1592,...more
In an opinion addressing the definiteness of a term of degree, the US Court of Appeals for the Federal Circuit affirmed a final determination of the US International Trade Commission (ITC), concluding that an asserted claim...more
GUANGDONG ALISON HI-TECH CO. V. ITC - Before Wallach, Hughes, and Stoll. Appeal from United States International Trade Commission. Summary: A term of degree is not indefinite so long as the written description provides...more
Broad Claim Language and Unpredictability in the Art Lead to Non-Enablement - In Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., Appeal Nos. 2017-2498, -2499, -2545, -2546, broad patent claims were invalid as...more
PATENT CASE OF THE WEEK - Forum US, Inc. v. Flow Valve, LLC, Appeal No. 2018-1765 (Fed. Cir. June 17, 2019) - Our case of the week features a rarely visited rule concerning reissue patents—the “original patent...more
Addressing a decision granting summary judgment of invalidity due to lack of sufficient written description and noninfringement, the US Court of Appeals for the Federal Circuit explained that a patent holder’s contentions...more
Federal Circuit Summary - Before Reyna, Taranto, and Chen. Appeal from the United States District Court for the District of Delaware. Summary: Where the complexity and predictability of a claimed embodiment were...more
D Three Enterprises, LLC v. SunModo Corporation, Appeal Nos. 2017-1909, -1910 (Fed. Cir. May 21, 2018) - The Court affirmed a grant of summary judgment of invalidity in favor of patent infringement defendants, based on a...more