In one of its first precedential opinions of the new year, the US Court of Appeals for the Federal Circuit held that a claim using “comprising” as a transition phrase followed by a limitation requiring a component that...more
The US Court of Appeals for the Federal Circuit recently upheld the district court’s denial of a judgment as a matter of law (JMOL) or, alternatively, motion for a new trial, reinforcing the fine line that exists between...more
Welcome to the third issue of the Morgan Lewis Pharma Review, which summarizes key recent cases from the Federal Circuit and district courts that impact the pharma space, including Federal Circuit and district court decisions...more
As of 2019, post-grant proceedings have been in use for seven years. Designed as an alternative to district court litigation, post-grant proceedings have offered litigants a faster and more cost-effective forum for resolving...more
Quarterly Post-Grant and Patent Litigation Update -
Welcome to our ongoing updates relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. We hope you find...more
A split Federal Circuit panel recently upheld the district court’s judgment of invalidity and noninfringement because the phrase “consisting essentially of” rendered the asserted claims indefinite and the proposed ANDA label...more
There have been two interpretations of the “acts of infringement” language in the patent venue statute regarding ANDA submissions in Hatch-Waxman litigation....more
12/8/2017
/ Abbreviated New Drug Application (ANDA) ,
Bristol-Myers Squibb ,
Hatch-Waxman ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patents ,
Principal Place of Business ,
TC Heartland LLC v Kraft Foods ,
Teva Pharmaceuticals ,
Venue
AbbVie’s arguments raised in a prior IPR were key to the PTAB’s finding of no commercial success.
The Patent Trial and Appeal Board (PTAB) found all of the claims of three AbbVie Biotechnology Ltd. (AbbVie) patents...more
FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products.
This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance)....more
Apotex—Biosimilars Must Provide 180-Day Marketing Notice after FDA Approval July 06, 2016 According to the Federal Circuit, post-licensure notice 180 days before commercial marketing is mandatory for biosimilars....more
7/6/2016
/ Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
In a Section 101 analysis under Alice Corp. Pty. Ltd. v. CLS Bank Intl., “[a]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces”—even if individual claim...more
7/6/2016
/ Abstract Ideas ,
Appeals ,
AT&T Mobility ,
CLS Bank v Alice Corp ,
Inventions ,
Patent Infringement ,
Patent Validity ,
Patent-Eligible Subject Matter ,
Patents ,
Prior Art ,
Reversal ,
Section 101