News & Analysis as of

Prior Art Pharmaceutical Patents

Rothwell, Figg, Ernst & Manbeck, P.C.

Threading the Needle: Navigating the Matrix Created by the U.S. Supreme Court and Unified Patent Court   

As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. We recently reviewed the Unified...more

Goodwin

Eight on AI: Quick Considerations on Patenting Drug Discovery Therapeutics using Artificial Intelligence (AI) and Life...

Goodwin on

Many life science companies are using AI/ML to identify new disease targets and new therapeutics, predict the efficacy and toxicity of potential clinical therapeutic candidates, design clinical trials and dosing or treatment...more

Goodwin

Moderna Litigation Against BioNTech and Pfizer Stayed Pending IPR

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We previously reported on the litigation brought by ModernaTX, Inc. and Moderna US, Inc. (collectively, “Moderna”) against BioNTech SE, BioNTech Manufacturing GmbH, BioNTech US Inc. (collectively, “BioNTech”), and Pfizer Inc....more

McDonnell Boehnen Hulbert & Berghoff LLP

Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc. (Fed. Cir. 2024)

The Federal Circuit handed down an opinion last week that invalidated several asserted claims and found infringement under 35 U.S.C. § 271(e)(2) of the claims, while refusing to modify its judgment on infringement after...more

Sheppard Mullin Richter & Hampton LLP

2023 Federal Circuit Case Summaries - Intellectual Property: Year End Report

We are pleased to share Sheppard Mullin’s inaugural “Year in Review” report that collects and reports on most key patent law-related Federal Circuit decisions for 2023. This is a follow up to the quarterly report we...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - April 2024 #2

Janssen Pharms., Inc. et al. v. Teva Pharm. USA, Inc. et al., Appeal Nos. 2022-1258, -1307 (Fed. Cir. April 1, 2024) In this week’s Case of the Week, the Federal Circuit vacated-in-part a district court’s bench trial...more

McDonnell Boehnen Hulbert & Berghoff LLP

Medtronic, Inc. v. Teleflex Life Sciences Ltd. (Fed. Cir. 2024)

Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings.  This post concerns the decision in Medtronic, Inc....more

Axinn, Veltrop & Harkrider LLP

Going Global on Polymorphs

We were so pleased to have the opportunity to address InformaMarkets’ 13th Annual Pharma IPR Conference in Mumbai on legal challenges to polymorph patents. Patents covering one or more crystalline forms of a drug substance at...more

McDonnell Boehnen Hulbert & Berghoff LLP

Pfizer Inc. v. Sanofi Pasteur Inc. (Fed. Cir. 2024)

Last week, the Federal Circuit handed down its opinion in Pfizer Inc. v. Sanofi Pasteur Inc., affirming the Patent Trial and Appeal Board's (PTAB) determination that all claims of U.S. Patent No. 9,492,559 challenged in...more

Venable LLP

Merck Files Four IPRs Challenging The Johns Hopkins University Pembrolizumab Patents

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On March 4, 2024, Merck Sharp & Dohme, LLC (“Merck”) filed four IPRs challenging The Johns Hopkins University (“JHU”) patents covering methods of treatment using pembrolizumab, which Merck sells under the trade name...more

Goodwin

PTAB Issues Final Written Decisions Finding Claims of Aflibercept-related Patents Invalid

Goodwin on

On January 9, 2024, the PTAB issued final written decisions in IPR2022-01225 and IPR2022-01226, filed by Mylan on two Regeneron patents directed to dosing of aflibercept — U.S. Patent Nos. 10,130,681 and 10,888,601. The PTAB...more

Sheppard Mullin Richter & Hampton LLP

Anticipation and Obviousness in Patent Law: An Analysis of Recent IPR Decisions

In Incept v. Palette Life Sciences 21-2063, 21-2065 (Fed. Cir. Aug. 16, 2023), the case addresses the Board’s anticipation and obviousness determinations in two IPRs (IPR2020-00002 and IPR2020-00004), where the Board held the...more

AEON Law

Patent Poetry: Federal Circuit: Only Implicit Expectation of Success Required

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The Federal Circuit has affirmed a decision by the Patent Trial and Appeal Board (PTAB or Board) finding that a combination of prior art references requires only an implicit indication of a reasonable expectation of success. ...more

Akin Gump Strauss Hauer & Feld LLP

Patentee’s Own Clinical Trial Renders Unpatentable Patent Claims Directed to Antibody Treatment

In a final written decision of an inter partes review proceeding, the Patent Trial and Appeal Board found all 12 claims of a challenged patent unpatentable as either anticipated or obvious. Each ground of unpatentability...more

Jones Day

PTAB Rejects Double-Dose of Prior Art

Jones Day on

In Sandoz Inc. v. Acerta Pharma B.V. (IPR2023-00478), a Patent Trial and Appeal Board (“PTAB”) panel denied IPR institution where the asserted prior art was cumulative of that considered during prosecution. This denial...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

In those (in retrospect) halcyon days more than a decade ago (before Mayo, Myriad, Alice, and the subject matter eligibility quagmire arose), perhaps the most significant Supreme Court decision was KSR Int'l Co. v. Teleflex...more

Sheppard Mullin Richter & Hampton LLP

Amgen Inc. v. Sandoz Inc, No. 2022-1147 (Fed. Cir. Apr. 19, 2023)

This case is an appellate review of the district court’s findings regarding patent obviousness and priority date. Background Amgen produces and markets apremilast, a medication for the treatment of certain types of psoriasis...more

Axinn, Veltrop & Harkrider LLP

Axinn IP Update: Federal Circuit Applies Lead Compound Analysis and Confirms Obviousness of Deuterated Derivatives of Ruxolitinib

On August 22, 2023, the Federal Circuit affirmed an IPR Final Written Decision holding claims to deuterated derivatives of ruxolitinib unpatentable as obvious and rejected the patentee’s argument that a skilled artisan would...more

Linda Liu & Partners

How to reduce the risk of pharmaceutical patent application in China?

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As a large pharmaceutical consumer market, China's position in the layout of pharmaceutical patents has been valued. Inventions such as medical use, drug crystalline form and the like, have been paid more attention in the...more

Sheppard Mullin Richter & Hampton LLP

Sanofi-Aventis Deutschlan GMBH v. Mylan Pharmaceuticals Inc.

The Federal Circuit reversed a Patent Trial and Appeal Board (“Board”) decision finding the challenged claims of Sanofi-Aventis’ ’614 patent unpatentable as obvious....more

Sheppard Mullin Richter & Hampton LLP

In re Couvaras, No. 2022-1489 (Fed. Cir. June 14, 2023)

This case addresses obviousness under 35 U.S.C. § 103 in relation to a method of increasing prostacyclin release to reduce hypertension in a patient. In particular, this case discusses issues relating to motivation to...more

MoFo Life Sciences

Obviousness In Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms Of Action

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Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. The Supreme Court emphasized “the need...more

Knobbe Martens

Federal Circuit Review - June 2023

Knobbe Martens on

Objective Evidence in Determining Obviousness - In Medtronic, Inc. v. Teleflex Innovations, Appeal No. 21-2357, the Federal Circuit held that a close prima facie case of obviousness can be overcome by strong evidence of...more

A&O Shearman

When is the composition of a product on the market prior art?

A&O Shearman on

G1/23 – EPO Enlarged Board of Appeals of the EPO “available” (referral from T 0438/19) - Under which circumstances can the public prior use of a product constitute prior art for novelty or inventive step[s], specifically...more

Haug Partners LLP

In re Couvaras: Limitations of Unexpected Results for Non-Obviousness of Claimed Mechanisms of Action

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On June 14, 2023, the Federal Circuit affirmed the decision of the Patent Trial and Appeal Board upholding an Examiner’s rejection of all pending claims in U.S. Patent Application 15/131,442 (’442 application). The Federal...more

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