News & Analysis as of

Obviousness Prior Art Abbreviated New Drug Application (ANDA)

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

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

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

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

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

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

McDonnell Boehnen Hulbert & Berghoff LLP

Horizon Medicines LLC v. Alkem Laboratories Ltd. (Fed. Cir. 2021)

Joint inventorship has been called "one of the muddiest concepts in the muddy metaphysics of patent law" because the "exact parameters of what constitutes joint inventorship are quite difficult to define." Mueller Brass Co....more

Robins Kaplan LLP

Auxilium Pharms., Inc. v. FCB I LLC

Robins Kaplan LLP on

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

Kilpatrick

Federal Circuit Reaffirms That There Is No ‘Reasonable Expectation Of Success’ In Trying To Invalidate A Chemical Compound Claim...

Kilpatrick on

The Federal Circuit (in an unpublished opinion) recently reaffirmed the difficulty generic challengers face when trying to establish chemical structural obviousness to invalidate a drug compound patent claim. This recent...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

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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2020

PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more

McDonnell Boehnen Hulbert & Berghoff LLP

Nuvo Pharmaceuticals (Ireland) Designated Activity Co. v. Dr. Reddy's Laboratories Inc. (Fed. Cir. 2019)

There are provisions and interpretations of U.S. patent law that can be in tension depending on the circumstances under which they are argued, whether before an Examiner or during litigation.  One of these is the dichotomy...more

McDonnell Boehnen Hulbert & Berghoff LLP

Orexo AB v. Actavis Elizabeth LLC (Fed. Cir. 2018)

The varying appellate fortunes of patentees regarding the question of obviousness is illustrated nicely in the Federal Circuit decision in Orexo AB v. Actavis Elizabeth LLC handed down earlier this month. The statute, 35...more

McDermott Will & Emery

Prior Art May Teach Away From a Formulation despite Reference to It

Deferring to the district courts findings of fact regarding a prior art reference “teaching away”, the US Court of Appeals for the Federal Circuit upheld a decision finding patents directed toward intranasal formulations for...more

Jones Day

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

Jones Day on

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

Foley & Lardner LLP

Federal Circuit Emphasizes Need For Reasonable Expectation Of Success

Foley & Lardner LLP on

In Genzyme Corp. v. Dr. Reddy’s Labs. Ltd., the Federal Circuit affirmed the district court decision upholding Genzyme’s Orange Book listed patent for the cancer drug Mozobil® against an obviousness challenge, because the...more

Knobbe Martens

Federal Circuit Review - November 2017

Knobbe Martens on

Fractured Federal Circuit Holds Patent Owner Does Not Bear Burden of Persuasion in IPR Motions to Amend - In Aqua Products, Inc. v. Matal, Appeal No. 2015-1177, the Federal Circuit, sitting en banc, held that a patent...more

McDermott Will & Emery

Secondary Considerations Transformed into Rebuttal Evidence

McDermott Will & Emery on

Addressing the issue of prima facie obviousness, the US Court of Appeals for the Federal Circuit affirmed a district court’s ruling that evidence of secondary considerations failed to overcome a strong showing of obviousness....more

Knobbe Martens

Federal Circuit upholds Millennium’s Patent on Velcade®

Knobbe Martens on

MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC - (Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) - This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA...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

McDermott Will & Emery

ANDA Update - March 2017 Volume 3, Number 1

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Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

McDermott Will & Emery

No Approval for Generic Product for Treatment of Rosacea **WEB ONLY**

Addressing infringement under the doctrine of equivalents and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling barring approval of a generic version of Finacea® gel...more

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