The Supreme Court handed down its opinion in Impression Products v. Lexmark, reversing the Court of Appeals for the Federal Circuit regarding the scope of the patent exhaustion doctrine. The Court held that patent rights are...more
The U.S. Supreme Court handed down its decision today in Impression Products, Inc. v. Lexmark International, Inc., unsurprisingly reversing the Federal Circuit regarding the metes and bounds of the patent exhaustion doctrine....more
The Federal Circuit's decision on Friday, in Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc., illustrates the risks a litigant can take when agreeing to stipulation in an effort at least to reduce litigation...more
On April 26, 2017, the Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc. from Sandoz counsel (Deanne E. Maynard), Amgen counsel (Seth P. Waxman), and presenting the opinion of the United States, an Assistant to...more
4/28/2017
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Sandoz ,
Sandoz v Amgen
On Wednesday, April 26, the Supreme Court will hear oral arguments in Sandoz Inc. v. Amgen Inc, involving interpretation for the first time of the Biologics Price Competition and Innovation Act ("BPCIA"), which was enacted...more
4/26/2017
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Oral Argument ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
The Federal Circuit returned to its consideration of the outcome in the District Court of The Medicines Company's ANDA litigation against Mylan and Bioniche Pharma over a proposed generic version of Medicines' bivalirudin...more
The U.S. Supreme Court overturned another Federal Circuit decision today (this one having been decided en banc by the appellate court), in SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC. The outcome was...more
The Federal Circuit handed down two related opinions last week, Los Angeles Biomedical Research Institute v. Eli Lilly & Co. and Eli Lilly & Co. v. Los Angeles Biomedical Research Institute, one of which raised the question...more
In an opinion by Justice Sotomayor, the Supreme Court today reversed the Federal Circuit's decision in Life Tech. Corp. v. Promega Corp. involving the proper scope of infringement under 35 U.S.C. § 271(f)(1). This provision...more
The Federal Circuit, in its third opinion involving ANDA litigation between these parties over Shire's LIALDA® (mesalamine) product, has apparently brought this case to a close in generic drug maker Watson's favor, in a...more
The Federal Circuit had the opportunity to provide guidance on a question now in its twilight: what is the standard for determining who is the true inventor under pre-AIA 35 U.S.C. § 102(f), in Cumberland Pharmaceuticals...more
From the nadir of the Supreme Court's allegations that the Federal Circuit "fundamentally misunderstood" the law of inducing infringement in Limelight Networks, Inc. v. Akamai Technologies, Inc., the nation's specialized...more
The Federal Circuit's decision in Amgen v. Sandoz, regarding litigation "under" (or at least based upon) the Biologics Price Control and Innovation Act (BPCIA), interpreted for the first time two provisions of the law. The...more
12/13/2016
/ Amgen ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Sandoz ,
Sandoz v Amgen
The patent prosecutor's art requires exquisite foresight, if not prescience, in balancing the requirements for specificity needed to satisfy the disclosure requirements of § 112 while anticipating efforts to design around the...more
The Federal Circuit recently affirmed a district court's claim construction and determination that claim terms were not indefinite in Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc....more
One of the aspects of inter partes review that differed from other post-grant review proceedings before the Board of Patent Appeals and Interferences (succeeded by the Patent Trial and Appeal Board) is a requirement for...more
The Supreme Court denied certiorari today in Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., thereby leaving intact the Federal Circuit's fractured precedent on the question of whether post-approval...more
The complexities that can be attendant on defending against an infringement allegation, and the possibility that a straightforward path to non-infringement can be complicated by claim construction even for terms construed...more
In parallel decisions regarding litigation over the same patent, the Federal Circuit affirmed a District Court decision that the claims were invalid for indefiniteness under 35 U.S.C. § 112(b). This decision, expressly...more
The past decade or so of U.S. patent law has been characterized by a consistent theme between Federal Circuit decisions and the Supreme Court's invalidation of them (and sometimes can be discerned even in those rare instances...more
Arcane aspects of the law are frequently analogized as constituting "traps for the unwary," and patent law seems to have more than its share of minutiae that fall within that characterization. The equitable principle of...more
On June 13, 2016, the Supreme Court ruled unanimously, in an opinion by Chief Justice Roberts, that an award of enhanced damages pursuant to 35 U.S.C. § 284 should be within the sound discretion of a district court, albeit...more
6/14/2016
/ 35 U.S.C. § 284 ,
Abuse of Discretion ,
Appeals ,
Enhanced Damages ,
Halo v Pulse ,
Highmark ,
Octane Fitness v. ICON ,
Patent Infringement ,
Patents ,
SCOTUS ,
Standard of Proof ,
Standard of Review ,
Stryker v Zimmer ,
Totality of Circumstances Test ,
Willful Infringement
The aphorism that "[t]he race is not always to the swift nor the battle to the strong, but that's the way to bet," variously attributed to Damon Runyon, Franklin P. Adams, and Hugh Keough, could readily be updated to include...more
6/14/2016
/ 35 U.S.C. § 284 ,
Abuse of Discretion ,
Enhanced Damages ,
Halo v Pulse ,
Highmark ,
Octane Fitness v. ICON ,
Patent Infringement ,
Patents ,
SCOTUS ,
Standard of Proof ,
Standard of Review ,
Stryker v Zimmer ,
Totality of Circumstances Test ,
Willful Infringement
The Federal Circuit and the Supreme Court spent an inordinate amount of time wrestling with each of their conceptions of the scope and application of the doctrine of equivalents a dozen years ago, coming to an accommodation...more
In a recent book entitled Imbeciles: The Supreme Court, American Eugenics, and the Sterilization of Carrie Buck, author Adam Cohen examines the case of Buck v. Bell, where Justice Oliver Wendell Holmes wrote that "[t]hree...more