Which parties to an IPR proceeding have standing to either appeal or participate in an appeal from an adverse final written decision by the Board? The Federal Circuit had previously held that a petitioner that did not...more
On Monday, January 8, 2018, the en banc Federal Circuit held in Wi-Fi One, LLC v. Broadcom Corp. that PTAB time-bar determinations under 35 U.S.C. § 315(b) are appealable because they do not fall within the scope of the...more
On Friday, August 13, 2016, the Federal Circuit granted a petition for rehearing en banc filed in the In re Aqua Products, Inc. case to consider two questions related to the PTAB's treatment of Motions to Amend in IPR...more
8/16/2016
/ America Invents Act ,
Appeals ,
Burden of Persuasion ,
Burden of Production ,
Burden-Shifting ,
Inter Partes Review (IPR) Proceeding ,
Intervenors ,
Motion to Amend ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Petition For Rehearing ,
Preponderance of the Evidence ,
Prior Art ,
Standard of Review ,
Substantial Evidence Standard ,
USPTO
Last year, the Federal Circuit described the Biologics Price Competition and Innovation Act ("BPCIA") as "a riddle wrapped in a mystery inside of an enigma" in the Amgen v. Sandoz case. Nevertheless, one of the provisions of...more
7/12/2016
/ aBLA ,
Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz v Amgen
The saga of the first-filed IPR petition (IPR2012-00001) came to a close today when the Supreme Court decided the Cuozzo Speed Technologies, LLC v. Lee case. We have been following this case ever since the PTAB issued its...more
6/21/2016
/ Appeals ,
Arbitrary and Capricious ,
Covered Business Method Proceedings ,
Cuozzo Speed Technologies v Lee ,
Due Process ,
Inter Partes Review (IPR) Proceeding ,
Judicial Review ,
Patent Trial and Appeal Board ,
SCOTUS ,
Statutory Authority ,
USPTO
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
Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar -
The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more
6/7/2016
/ aBLA ,
Amended Regulation ,
America Invents Act ,
Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Community Trademark ,
Declaratory Judgments ,
EU ,
Filing Fees ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Inventions ,
Notice Requirements ,
On-Sale Bar ,
Patent Dance ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Popular ,
Preliminary Injunctions ,
Prior Art ,
Public Use ,
Renewal Fees ,
Sandoz ,
Sandoz v Amgen ,
Trademark Registration ,
Uniform Commercial Code (UCC) ,
USPTO
In March 2015, the FDA approved the first biosimilar application, which was for a follow-on biologic drug of Amgen’s reference product NEUPOGEN® (filgrastim). Yet, before the applicant, Sandoz, could launch its biosimilar...more
6/3/2016
/ aBLA ,
Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen
On March 4, the Supreme Court announced that the Cuozzo Speed Technologies, LLC v. Lee appeal would be argued on April 25, 2016 (the last week of oral hearings for the October Term 2015). As we reported previously, the...more
February 4, 2016, marked the one-year anniversary of the initial In re Cuozzo Speed Technologies, LLC[1] Federal Circuit decision – the first opinion stemming from the first appeal of the first final written decision of the...more
The PTAB at the Federal Circuit -- Supplemental Evidence Edition -
On New Year's Eve, the Federal Circuit affirmed the PTAB's denial of a motion to submit supplemental evidence pursuant to 37 C.F.R. § 42.123(a),...more
As we reported earlier, the Federal Circuit recently affirmed the PTAB's Final Written Decision in the Versata Development Group v. SAP America, Inc. case -- the first appeal under the covered business method ("CBM") patent...more
7/17/2015
/ America Invents Act ,
Appeals ,
Covered Business Method Patents ,
Covered Business Method Proceedings ,
Cuozzo Speed Technologies ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review
Earlier this week, the Federal Circuit issued an order denying a petition for rehearing en banc in the In re Cuozzo Speed Technologies, LLC case. As we have previously reported, this case was the first appeal of the first...more
7/10/2015
/ America Invents Act ,
Amicus Briefs ,
Appeals ,
Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Intellectual Property Owners Association ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Petition For Rehearing ,
PHRMA ,
Post-Grant Review ,
SCOTUS ,
Teva v Sandoz ,
USPTO
On March 19, 2015, U.S. District Judge Seeborg of the Northern District of California denied a motion for a preliminary injunction filed by Amgen to prevent the imminent launch by Sandoz of a biosimilar version of NEUPOGEN®...more
Federal Circuit Sides with Patent Office in First IPR Final Written Decision Review -
Earlier today, the Federal Circuit decided the first appeal from the Patent Trial and Appeal Board ("PTAB" or "Board") related to an...more
Last week, the Federal Circuit heard the first oral argument for the first appeal of an inter partes review ("IPR") final written decision for the first IPR ever filed (IPR2012-00001). ...more