IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
In Janssen Pharmaceuticals, Inc. v. Mylan Laboratories., the United States Court of Appeals for the Federal Circuit affirmed a district court ruling that a pharmaceutical dosing claim limitation was nonobvious despite prior...more
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
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
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
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
On February 10, in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed a district court’s holding that Adapt’s methods of treatment of opioid overdose is invalid as obvious. The...more
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
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
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
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
In a terse, non-precedential opinion, the Federal Circuit affirmed a district court's judgment that Defendants Torrent Pharmaceuticals and Indoco Remedies Ltd.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
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
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
The Federal Circuit recently reversed a lower court’s ruling of validity under the § 112 written description requirement effectively opening the door for a number of generic drug manufacturers to enter the market with a...more
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
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
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
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
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
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
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
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
After a bench trial, the US District Court for the District of Delaware found several Hospira patents covering a diluted, “ready-to-use” composition of dexmedetomidine obvious in view of the concentrated prior art product—but...more
Addressing the issue of whether a topical gel with an increased concentration of active ingredient would have been obvious over a prior art liquid product, the US District Court for the District of New Jersey concluded that...more
Case Name: Acorda Therapeutics Inc. v. Roxane Labs., Inc., 14-882-LPS, 2016 U.S. Dist. LEXIS 48479 (D. Del. Mar. 31, 2017) (Stark, J.)....more