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Prior Art Abbreviated New Drug Application (ANDA) Patent Litigation

A&O Shearman

Federal Circuit Affirms Findings Of Non-Obviousness And Infringement Of Method Of Treatment Patent Claiming Dosing Regimen For...

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On March 28, 2025, the United States Court of Appeals for the Federal Circuit issued an opinion affirming the United States District Court for the District of New Jersey decision that Mylan Laboratories Ltd. (“Mylan”) induced...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd.

Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., Appeal No. 2023-1977 (Fed. Cir. Apr. 8, 2025) In our Case of the Week, the Federal Circuit affirmed that defendant Alkem’s proposed generic antibiotic did not...more

McDermott Will & Emery

ANDA Filing Alone Insufficient for Induced Infringement of Method Patent

The US Court of Appeals for the Federal Circuit upheld a district court’s findings of invalidity and noninfringement in a Hatch-Waxman case involving two sets of method patents directed to modulating dosages of pirfenidone, a...more

Robins Kaplan LLP

Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc.

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Case Name: Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc., Civ. No. 18-390 (MN), 2022 WL 3562555 (D. Del. Aug. 18, 2022) (Noreika, J.) Drug Product and Patent(s)-in-Suit: Velphoro® (sucroferric...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

McDermott Will & Emery

Long-Felt Need Not Felt Long Enough to Overcome Obviousness

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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

Robins Kaplan LLP

Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.

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Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 18-cv-734, 2021 WL 5323737 (D.N.J. Nov. 16, 2021) (Cecchi, J.)  Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patent No....more

Fitch, Even, Tabin & Flannery LLP

Expert Testimony May Establish Written Description Support for Negative Claim Limitation

On January 3, in Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., the Federal Circuit found written description support for a negative claim limitation, even though the negative claim limitation did not have...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

When does the absence of evidence turn into evidence of absence, and when does such absence amount to an adequate written description of the absence of a step of a method claim?  This is a question that comes readily to mind...more

McDonnell Boehnen Hulbert & Berghoff LLP

Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc. (Fed. Cir. 2021)

There are some cases where the Federal Circuit makes its decision based on the eternal verities of patent law (insofar as there are any eternal verities in patent law).  One such decision arose earlier this month when the...more

Robins Kaplan LLP

Auxilium Pharms., Inc. v. FCB I LLC

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Case Name: Auxilium Pharms., Inc. v. FCB I LLC, Civ. No. 20-16456, 2021 WL 2802537 (D.N.J. July 6, 2021) (Vazquez, J.) - Drug Product and Patent(s)-in-Suit: Testim® (testosterone gel); U.S. Patents Nos. 7,320,968 (“the ’968...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2021

University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) - In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to...more

McDonnell Boehnen Hulbert & Berghoff LLP

Belcher Pharmaceuticals, LLC v. Hospira, Inc. (Fed. Cir. 2021)

Imposition of liability under the equitable doctrine of inequitable conduct (as it has been variously defined) can result in a patent being held unenforceable; for this reason, former Chief Judge Rader called it the "atomic...more

McDonnell Boehnen Hulbert & Berghoff LLP

Takeda Pharmaceutical Co. v. Torrent Pharmaceuticals Ltd. (Fed. Cir. 2021)

In a terse, non-precedential opinion, the Federal Circuit affirmed a district court's judgment that Defendants Torrent Pharmaceuticals and Indoco Remedies Ltd. had failed to prove that the claims asserted by...more

McDonnell Boehnen Hulbert & Berghoff LLP

Bracco Diagnostics Inc. v. Maia Pharmaceuticals, Inc. (Fed. Cir. 2020)

Stipulating to infringement after a contrary claim construction is a conventional stratagem for a losing party to have a final judgment that can be challenged before the Federal Circuit.  The risk of course, is that if the...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

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

Robins Kaplan LLP

Bayer Intellectual Prop. GmbH v. Aurobindo Pharma Ltd.

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Case Name: Bayer Intellectual Prop. GmbH v. Aurobindo Pharma Ltd., No. 15-902, 2018 U.S. Dist. LEXIS 116931 (D. Del. July 13, 2018) (Stengel, C.J.)....more

Robins Kaplan LLP

Galderma Labs., L.P. v. Amneal Pharmaceuticals LLC

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Case Name: Galderma Labs., L.P. v. Amneal Pharmaceuticals LLC, No. 16-207-LPS, 2018 U.S. Dist. LEXIS 151037 (D. Del. Aug. 27, 2018) (Stark, C.J.)....more

Robins Kaplan LLP

Endo Pharms. Sols., Inc. v. Custopharm Inc.

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Case Name: Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 2018 U.S. App. LEXIS 19265 (Fed. Cir. July 13, 2018) (Circuit Judges Moore, Linn, and Chen presiding; Opinion by Chen, J.) (Appeal from D. Del., Robinson,...more

Jones Day

PTAB Upholds GILENYA™ Method of Treatment Patent, Prompting New ANDA Litigation

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In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not unpatentable on three separate grounds. Shortly thereafter, Novartis filed suit...more

Robins Kaplan LLP

Endo Pharms. Inc. v. Teva Pharms. USA, Inc.

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Case Name: Endo Pharms. Inc. v. Teva Pharms. USA, Inc., Fed. Cir. Nos. 2015-2021, -2022, -2023, -2024, -2025, -2026, -2028, -2031, -2033, -2034, -2035, -2041, -2042, -2046, -2047, -2049, -2059, -2060, 2016-1025, -1060, -1117,...more

Foley & Lardner LLP

Medical Treatment Patent Claims Held Patentable Subject Matter Under the Alice/Mayo Section 101 Test

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In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd, Slip Op. (Nos. 2016-2707, 2016-2708, April 13, 2018) the U.S. Court of Appeals for the Federal Circuit provided useful guidance for patentees seeking to...more

WilmerHale

Federal Circuit Patent Updates - April 2018

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01 Communique Laboratory, Inc. v. Citrix Online, LLC (No. 2017-1869, 4/26/18) (Newman, Mayer, Stoll) - Mayer J. Affirming plaintiff's motion for a new trial motion. The defendant did not improperly assert a “practicing...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Thoroughly Reverses District Court Findings of Velcade® Patent Obviousness

On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more

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