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Patent Invalidity Appeals Pharmaceutical Patents

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2024 #3

Allergan USA, Inc. v. MSN Laboratories Private Ltd., Appeal No. 2024-1061 (Fed. Cir. August 13, 2024) In this week’s Case of the Week, the Federal Circuit clarifies rules relating to when an applicant’s patent can be...more

White & Case LLP

Federal Circuit Limits the Application of Obviousness-Type Double Patenting for Patents in the Same Family

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On August 13, 2024, a three-judge panel of the Court of Appeals for the Federal Circuit issued a decision, authored by Judge Lourie, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061, which limits the...more

Bradley Arant Boult Cummings LLP

Preliminary Injunction Halts Sales of Tumor-Informed Cancer Screening Test

Late last week in Natera, Inc. v. NeoGenomics Laboratories, Inc. (24-1324), the Federal Circuit affirmed a preliminary injunction ruling from the lower court that mostly prohibits NeoGenomics from selling its oncology test...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

Smart & Biggar

PM(NOC) Regulations: Six-year anniversary of major amendments

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September 21, 2023, marked the sixth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the sixth year...more

Fish & Richardson

Federal Circuit Evaluates Enablement for Antibody Claims for the First Time Since Amgen v. Sanofi in Baxalta Inc. et al. v....

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On May 18, 2023, the Supreme Court in Amgen Inc. v. Sanofi unanimously affirmed the Federal Circuit’s holding that U.S. Patent Nos. 8,829,165 and 8,859,741 did not enable certain functional genus claims describing a class of...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2022 #4

Mosaic Brands, Inc. v. Ridge Wallet LLC, Appeal Nos. 2022-1001, -1002 (Fed. Cir. Dec. 20, 2022) - In our Case of the Week, the Federal Circuit discussed the corroboration requirement concerning the amount of evidence...more

Smart & Biggar

Federal Court of Appeal upholds invalidity of fampridine patent

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The Federal Court of Appeal (FCA) dismissed an appeal by Biogen and a cross-appeal by Taro from a decision of the Federal Court... dismissing two actions by Biogen under the Patented Medicines (Notice of Compliance)...more

Knobbe Martens

Silence Is No Support for Negative Claim Limitation

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NOVARTIS PHARMACEUTICALS CORP. V. HEC PHARM CO., LTD. Before Moore, Hughes, and Linn (dissenting). Appeal from the United States District Court for the District of Delaware. Summary:  Silence regarding the presence or...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - April 2022 #3

Niazi Licensing Corporation v. St. Jude Medical SC, Inc., Appeal No. 2021-1864 (Fed. Cir. Apr. 11, 2022) - The Federal Circuit’s only precedential patent decision this week comes on appeal from a district court decision...more

McDermott Will & Emery

Long-Felt Need Not Felt Long Enough to Overcome Obviousness

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit upheld a finding that patents covering Narcan, a naloxone-based intranasal opioid overdose treatment, were obvious despite evidence of long-felt need. Adapt Pharma Operations...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions: Mylan Labs. Ltd v. Janssen Pharmaceutica, N.V.,...

Mylan appealed from a Patent Trial and Appeal Board (Board) discretionary denial of institution of an inter partes review (IPR) proceeding. The Board declined to institute Mylan’s IPR under NHK-Fintiv, a multi-factor analysis...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court - February 2022 #2

Adapt Pharma Operations Limited v. Teva Pharmaceuticals USA, Inc., Appeal No. 2020-2106 (Fed. Cir. Feb. 10, 2022) - In our Case of the Week, the Court of Appeals for the Federal Circuit, in both the majority opinion and...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2021 #5

MLC Intellectual Property, LLC v. Micron Technology, Inc., Appeal No. 2020-1413 (Fed. Cir. Aug. 26, 2021) - For those interested in an important Section 112 written description case, we recommend reading the Juno...more

Smart & Biggar

Federal Court of Appeal upholds decision finding Seedlings' LifeCard patent invalid and not infringed by Pfizer’s EpiPen

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On July 28, 2021, the Federal Court of Appeal (FCA) dismissed Seedling’s appeal from the Federal Court decision of Justice Grammond (2020 FC 1, previously reported), which concluded that certain claims of Seedlings' LifeCard...more

Smart & Biggar

Federal Court dismisses Roche’s PMNOC Regulations actions against Sandoz re: pirfenidone

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By judgment dated May 12, 2021, the Federal Court dismissed patent infringement actions related to Sandoz’s pirfenidone capsules and tablets for the treatment of idiopathic pulmonary fibrosis (IPF) (Roche’s ESBRIET):...more

Goodwin

Sanofi Files Opposition to Amgen’s Petition for Federal Circuit to Reconsider Decision Invalidating Praluent Patents

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As we previously reported, in April 2021, Amgen petitioned for the full Federal Circuit to reconsider the decision of a three-judge panel that two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165 patent”) and...more

WilmerHale

CAFC Patent Cases - May 2021 #2

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Precedential Federal Circuit Opinions - CAP EXPORT, LLC v. ZINUS, INC. [OPINION]  (2020-2087, 5/5/21) (Dyk, Bryson, Hughes) - Dyk, J. Affirming decision to set aside judgment and injunction pursuant to Federal Rule of...more

Smart & Biggar

Federal Court of Appeal affirms prohibition order against Apotex regarding abiraterone

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As previously reported, in the final decision released under the pre-amended Patented Medicines (Notice of Compliance) Regulations (Regulations), the Federal Court granted a prohibition order relating to Canadian Patent No....more

McDonnell Boehnen Hulbert & Berghoff LLP

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2020)

On September 3rd, the Federal Circuit affirmed under Rule 36 the decision by the District Court of Nevada (Du, J.) in March that the claims asserted by Amarin Pharma against West-Ward Pharmaceuticals International Ltd., Hikma...more

McDonnell Boehnen Hulbert & Berghoff LLP

IBSA Institut Biochimique, S.A. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)

The Federal Circuit has spent the past few years applying the Supreme Court's most recent precedent, Nautilus, Inc. v. Biosig Instruments, Inc., on the indefiniteness standards in the patent statute.  35 U.S.C. § 112(b).  The...more

Morrison & Foerster LLP - Federal Circuitry

Last Week in the Federal Circuit (July 27-31): Gambling on an APA Challenge

It was a moderately eventful week at the Federal Circuit as the judges geared up for their August argument session and perhaps returned from their summer vacations. The Court issued 13 opinions and 2 orders on petitions for a...more

Smart & Biggar

First decision under amended PMNOC Regulations: Federal Court finds Amgen’s filgrastim patent obvious

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UPDATE: On November 3, 2020, the Federal Court of Appeal dismissed Amgen’s appeal. See our article here. On April 16, 2020, Justice Southcott of the Federal Court issued the first decision under the amended Patented...more

McDonnell Boehnen Hulbert & Berghoff LLP

Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

Last month, in Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit reversed a decision by the U.S. District Court for the District of New Jersey finding certain claims of U.S. Patent...more

McDonnell Boehnen Hulbert & Berghoff LLP

Kaken Pharmaceutical Co. v. Iancu (Fed. Cir. 2020)

Ever since the Supreme Court's decision in Dickinson v. Zurko, patent applicants (and with the advent of inter partes review proceedings before the Patent Trial and Appeal Board, patentees) have found it difficult to overcome...more

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