News & Analysis as of

Patents Prior Art Food and Drug Administration (FDA)

Foley & Lardner LLP

Cancer Drugs: Strategies For Patenting Antibody-Drug Conjugate Inventions

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Antibody-drug conjugate (ADC) is a promising class of cancer treatments with accelerating U.S. Food and Drug Administration (FDA) approval and rapidly growing market size as discussed in previous articles in this series. This...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms Obviousness of Rifaximin Polymorph Patents and Denial of Motion to Modify Judgment After Post-Trial...

In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for...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

Venable LLP

EYLEA® IPR Appeals Filed

Venable LLP on

On March 13, 2024, Regeneron appealed the PTAB Board’s (“the Board”) recent Final Written Decisions (“FWDs”) that found claims of two Regeneron patents related to EYLEA® (aflibercept) unpatentable....more

Foley & Lardner LLP

Federal Circuit Considers Patentability of Overlapping Ranges

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In UCB Inc. v. Actavis Laboratories UT Inc., the Federal Circuit affirmed the district court’s judgement of invalidity on obviousness grounds but reversed the finding of anticipation. In reaching its decision on anticipation,...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

A&O Shearman

PTAB Decision Invalidating Claims Finding Lack of Written Description and Later Priority Date Upheld by Federal Circuit

A&O Shearman on

Procedural History - Regents of the University of Minnesota v. Gilead Sciences, Inc., Case No. 2021-2168 (Fed. Cir. Mar. 6, 2023) is an appeal by the Regents of the University of Minnesota (“Minnesota”) from a final...more

Robins Kaplan LLP

Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc. Narcan® (Naloxone)

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Case Name: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., Case No. 2020-2106, 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022) (Circuit Judges Newman, Prost, and Stoll presiding; Opinion by Stoll, J.; Dissenting Opinion by...more

McDonnell Boehnen Hulbert & Berghoff LLP

Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2022)

In a crowded pharmaceutical art, the deficiencies thereof being so patent that the FDA encouraged industry to address and correct them, concerning a formulation developed to address the opioid crisis raging earlier in this...more

Knobbe Martens

Federal Circuit Review - September 2021

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Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more

McDermott Will & Emery

Material Information Submitted to FDA but Withheld from PTO Gives Rise to Inequitable Conduct

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The US Court of Appeals for the Federal Circuit found prior art submitted to the US Food and Drug Administration (FDA), yet withheld from the US Patent & Trademark Office (PTO) during prosecution of an asserted patent,...more

Troutman Pepper

Federal Circuit Review - Issue 282

Troutman Pepper on

282-1 Federal Circuit Opines on Printed Matter Doctrine and Reverses District Court Decision Holding Medical Device Patent Invalid and Noninfringed - The United States Court of Appeals for the Federal Circuit recently...more

Robins Kaplan LLP

Valeant Pharms Int’l, Inc. v. Mylan Pharms Inc.

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BECAUSE THE PRIOR ART TAUGHT OVERLAPPING PH RANGES AND STRUCTURALLY SIMILAR COMPOUNDS AS THOSE CLAIMED IN THE PATENT-IN-SUIT, THE FEDERAL CIRCUIT REVERSED SUMMARY JUDGMENT OF NON-OBVIOUSNESS. Case Name: Valeant Pharms...more

Robins Kaplan LLP

Onyx Therapeutics, Inc. v. Cipla Ltd.

Robins Kaplan LLP on

BECAUSE A POSA WOULD NOT HAVE SELECTED THE PRIOR-ART COMPOUND AS A “LEAD COMPOUND,” AND THERE WAS EVIDENCE THAT THE INVENTION MET AN UNMET NEED AND OVERCAME INDUSTRY SKEPTICISM, DEFENDANT FAILED TO PROVE THAT THE...more

Knobbe Martens

Federal Circuit Review - December 2019

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Specification’s Narrow Description of the Invention Results in Disavowal of Claim Scope - In Techtronic Industries Co. Ltd. v. ITC., Appeal No. 18-2191, the consistent description in the specification of a particular...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2019 #4

PATENT CASE OF THE WEEK - Persion Pharms. LLC v. Alvogen Malta Operations Ltd., Appeal No. 2018-2361 (Fed. Cir. Dec. 27, 2019) - In this week’s Case of the Week, the Federal Circuit affirmed a district court judgment...more

Knobbe Martens

Completion of Phase I Safety Trials for FDA Approval May Not Be Sufficient to Show Reasonable Expectation of Success

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OSI PHARMACEUTICALS, LLC v. APOTEX INC - Before Stoll, Newman, and Taranto. Appeal from the Patent Trial and Appeal Board. Summary: A pharmaceutical company’s statement touting the completion of Phase I safety trials...more

Goodwin

An Interview with Prof. Arti Rai about the Role of “Patent Thickets” in U.S. Biosimilar Market Entry

Goodwin on

Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the...more

McDermott Will & Emery

Merely Articulating a Goal Does Not Provide Reasonable Expectation of Success

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court non-obviousness decision, finding that a prior art reference that articulates a goal without explaining how that goal is achieved does not provide a...more

McDermott Will & Emery

Skepticism Does Not Need to Be Based on Impossibility

Addressing secondary considerations of non-obviousness, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) obviousness decision, finding that skepticism does not need to be...more

Jones Day

Confidential FDA Communications as Prior Art in Hatch-Waxman Litigation

Jones Day on

The Situation: In a Hatch-Waxman litigation, the claims recite oxymorphone with less than 0.001% of an impurity called 14-hydroxymorphinone. The prior art includes confidential communications from the FDA to oxymorphone...more

Knobbe Martens

Prior Art Regulatory Guidelines That Recite a Goal Without Teaching How That Goal Can Be Achieved Are of Limited Value as an...

Knobbe Martens on

ENDO PHARM, INC., v. ACTAVIS LLC - Before Wallach, Clevenger, and Stoll. Appeal from the United States District Court for the District of Delaware....more

Knobbe Martens

Secondary Consideration of Skepticism Supports Non-Obviousness at PTAB

Knobbe Martens on

Before Moore, Wallach, and Hughes. Appeal from the Patent Trial and Appeal Board - Summary: Industry skepticism is a question of fact that weighs in favor of non-obviousness and can range on a scale, with the most weight...more

Robins Kaplan LLP

Tris Pharma Inc. v. Actavis Labs. Fl, Inc.

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Case Name: Tris Pharma Inc. v. Actavis Labs. Fl, Inc., Fed. Cir. Nos. 2017-2557, -2559, -2560, 2018 U.S. App. LEXIS 32774 (Fed. Cir. Nov. 20, 2018) (Circuit Judges Newman, O’Malley, and Chen presiding; Opinion by Chen, J.)...more

Husch Blackwell LLP

Unique Issues With Cannabis-Related Patents And Their Enforcement

Husch Blackwell LLP on

Chapter 1 – The Double-Edged Nature of the FDA Approval Process 2018 proved to be a very busy (and frankly dizzying) year for the cannabis industry as three more states, including Missouri, passed laws legalizing some form...more

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