In a joint appeal of two adverse decisions from the District Court, the Federal Circuit on procedural grounds rejected an appeal from the Wisconsin Alumni Research Foundation ("WARF") in Wisconsin Alumni Research Foundation...more
In Natera Inc. v. NeoGenomics Laboratories, Inc. the Federal Circuit affirmed the District Court's grant of a preliminary injunction against NeoGenomics in patent infringement litigation involving Natera's U.S. Patent Nos....more
The Federal Circuit once again had an opportunity to opine on the extent of behavior by a generic drugmaker who opts to accept a "section viii carve-out" in its FDA approval (resulting in a so-called "skinny label) on...more
U.S. Senator Chris Coons (D-DE), along with Sen. Thom Tillis (R-NC), have been the motivating force for patent reform for almost a decade, primarily in their efforts to roll back legislative efforts and judicial decisions...more
The Federal Circuit handed down an opinion last week that invalidated several asserted claims and found infringement under 35 U.S.C. § 271(e)(2) of the claims, while refusing to modify its judgment on infringement after...more
In its recent decision in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. the Federal Circuit reminds us that most verities in patent law are not eternal and frequently subject to case-by-case interpretation,...more
A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...more
One of the characteristics of patent infringement litigation in the aftermath of the Supreme Court's decision in Markman v. Westview Instruments, Inc. (holding that claim construction was a matter of law to be reviewed de...more
Not surprisingly, the Federal Circuit visited upon Plaintiff/Appellant PureCircle two of the Four Horsemen of the Biotech Patent Apocalypse* in a decision affirming the District Court's invalidation of the claims asserted...more
The provisions of U.S. regulatory law regarding FDA approval for less than all the indications for which an innovator drug was approved under 21 U.S.C. § 355(j)(2)(A)(viii) (the so-called "skinny label) has in the recent past...more
The Federal Circuit dismissed an appeal from an unsuccessful challenger in an inter partes review (IPR) proceeding based on failure to satisfy the standing requirements for appeal in Allgenesis Biotherapeutics Inc. v....more
The Federal Circuit reviewed the latest decision from the Patent Trial and Appeal Board (PTAB) in an inter partes review that claims 3-6 and 10 of U.S. Patent No. 6,548,019 are obvious, in Rembrandt Diagnostics LP v. Alere,...more
The Patent Trial and Appeal Board (PTAB) has benefited, particularly after enactment of the Leahy-Smith America Invents Act, from the deference to its factual findings mandated by the Supreme Court's interpretation in...more
Today, the Supreme Court again disregarded the views of the Federal government regarding whether to grant certiorari, here in Teva Pharmaceuticals USA v. GlaxoSmithKline LLC, and in some ways the only positive outcome is that...more
"Hope springs eternal [in the human breast]" (Alexander Pope) and "Insanity is doing the same thing over and over and expecting different results" (the latter attributed variably to Albert Einstein and Werner Erhart) are two...more
An appellant's burden on appeal is never easy but it is particularly difficult when the questions at issue are based on factual evidence. The appellate judiciary is loathe (generally) to second guess a district court judge...more
In perhaps one of his most infelicitous lyrics* Bob Dylan inserted the adage that it is unwise to change horses in midstream. This lesson comes to mind with regard to the Federal Circuit's decision late last year regarding...more
High Court Will Tackle Proper Enablement Standard -
Constituting something of a surprise, the Supreme Court on Friday, November 3rd granted Amgen's petition for certiorari on the second of the Questions Presented in its...more
11/7/2022
/ Amgen ,
Biotechnology ,
Certiorari ,
Doctrine of Equivalents ,
Enablement Inquiries ,
Life Sciences ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Sanofi ,
SCOTUS
On Friday, August 26th, Moderna Tx, Inc. and Moderna US, Inc. filed a complaint for patent infringement in Federal district court for the District of Massachusetts against Pfizer, Inc., BioNTech SE, BioNTech Manufacturing...more
For most of the past decade, the Supreme Court has been marking out the metes and bounds of the Patent Trial and Appeal Board's execution of the post-grant review provisions of the Leahy-Smith America Invents Act,...more
The consequences of expressly recited claim limitations and how patentees can be held to these limitations was illustrated in the Federal Circuit's recent decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc. ...more
Last year, the Supreme Court declined an invitation to abrogate the doctrine of assignor estoppel by an assignor sued for patent infringement in Minerva Surgical v. Hologic. Nevertheless, the Court followed its proclivities...more
The Federal Circuit today affirmed a decision by the District Court denying defendant Thales DIS AIS Deutschland USA's motion for preliminary injunction to prevent patentee plaintiff Koninklijke Philips N.V. from obtaining an...more
The consequences of joint development agreements, particularly under circumstances where later development is pursued independently by the parties, can create, inter alia, allegations of improper ownership and infringement if...more
Personal jurisdiction is one of those basic concepts in civil procedure that evokes strong memories in most lawyers, of their first year in law school, cases like International Shoe, Burger King, Helicopteros, and World-Wide...more