A PTAB panel recently granted a Petitioner’s motion to submit a second expert declaration that directly addressed deficiencies identified by the PTAB’s Institution Decision. While a “close” case, the panel concluded that...more
Biofrontera AG (“Petitioner”) filed an unopposed motion to dismiss the petition during the preliminary phase of the proceedings. Here, DUSA Pharmaceuticals, Inc. (“Patent Owner”) had not yet filed a Preliminary Response, and...more
The PTAB and District Courts do not always see eye to eye when it comes to prior art. On August 21, 2020, the Board issued a trio of final written decisions refusing to invalidate the claims of three patents, two of which...more
In Amneal Pharmaceuticals LLC v. Almirall, LLC, the Federal Circuit recently found 35 U.S.C. § 285 did not authorize the Court awarding attorney’s fees for conduct occurring at the PTAB. No. 2020-1106, 2020 WL 2961939, at *2...more
6/22/2020
/ 35 U.S.C. § 285 ,
Abbreviated New Drug Application (ANDA) ,
American Rule ,
Attorney's Fees ,
Fee-Shifting ,
Generic Drugs ,
Inter Partes Review (IPR) Proceeding ,
Litigation Fees & Costs ,
Orange Book ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Voluntary Dismissals
Last year, this blog discussed various strategic considerations for litigants seeking declarations of invalidity in district court actions to avoid being precluded from also seeking inter partes or other post-grant review...more
10/14/2019
/ Counterclaims ,
Declaratory Judgments ,
Inter Partes Review (IPR) Proceeding ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Patents ,
Post-Grant Review ,
Real Party in Interest ,
Time-Barred Claims
Mylan Pharmaceuticals, Inc. petitioned for inter partes review (IPR) of U.S. Patent No. 6,858,650 (the “‘650 Patent”), which is owned by UCB Pharma GmbH (“UCB”) and is directed to chemical derivatives of a drug for treating...more
2/1/2019
/ Abbreviated New Drug Application (ANDA) ,
Article III ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Standing
The America Invents Act (“AIA”), also called the Patent Reform Act of 2011, was enacted to overhaul the U.S. patent system and harmonize the domestic patent laws with those in the rest of the world. The AIA also created new...more
1/29/2019
/ America Invents Act ,
Appeals ,
Assignment of Inventions ,
Confidentiality Agreements ,
Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc ,
Inventions ,
On-Sale Bar ,
Patent Applications ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Use ,
Reaffirmation ,
Reversal ,
SCOTUS ,
Section 102 ,
Third-Party Relationships
In Microsoft Corp. v. Saint Regis Mohawk Tribe, the PTAB refused to stay ten IPRs filed by Microsoft while Patent Owner St. Regis appeals a Federal Circuit decision that tribal sovereign immunity cannot be asserted in an IPR...more
Sen. Orrin Hatch has introduced a bill that would augment the Hatch-Waxman Act, limiting challengers ability to proceed with patent challenges both in court and at the PTAB. Following is the introduction of the “Hatch-Waxman...more
12/26/2018
/ America Invents Act ,
Biosimilars ,
BPCIA ,
Generic Drugs ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Market Manipulation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review
Among the many differences from a patent litigation in a district court, the expedited nature of an inter partes review (IPR) brings with it an obligation for the petitioner to have a full-fledged legal theory of its case...more
As we reported in our July 2, 2018 article Hatch Bill: Restore Hatch-Waxman Balance; Limit Generics’ Access to PTAB, Senator Orrin Hatch (R-Utah), the namesake and coauthor of the Hatch-Waxman Act, proposed (but has not yet...more
Senator Orrin Hatch (R-Utah), the namesake and coauthor of the Hatch-Waxman Act, proposed (but has not yet introduced) an amendment titled the “Hatch-Waxman Integrity Act of 2018” during the Senate Judiciary Committee held on...more
In September 2017, Saint Regis Mohawk Tribe moved to dismiss six instituted trials on petitions filed by Mylan Pharmaceuticals Inc. Those petitions challenged six patents that, at the time the petitions were filed, belonged...more