The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product (active pharmaceutical...more
The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more
Since the inception of inter partes reviews (IPRs) and post grant reviews (PGRs) under the America Invents Act, the option for a patent owner to file a motion to amend its claims was always present, but motions to amend were...more
In Biogen International GmbH v. Banner Life Sciences LLC, a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) held that the scope of a patent term restoration under 35 U.S.C. §156 only includes the active...more
In an effort to help independent inventors and small businesses bring “important and possibly life-saving treatments” to market more quickly, the United States Patent and Trademark Office (USPTO) is implementing the COVID-19...more
To wrap up 2019 and usher in 2020 for practitioners who handle Patent Trial and Appeal Board (PTAB) matters, Foley partners Jeanne Gills, Steve Maebius, and George Quillin discussed 2019’s major developments in a webinar on...more
1/23/2020
/ America Invents Act ,
Constitutional Challenges ,
Covered Business Method Proceedings ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Post-Grant Review ,
PTAB Precedential Opinion Panel (POP) ,
Real Party in Interest ,
USPTO
One area of estoppel arising from an unsuccessful AIA petition that remains poorly understood relates to prior art that is described both in a printed publication or patent and also was in use by others, such as to create...more
The Court of Appeals for the Federal Circuit is poised to decide a case which may create new estoppel concerns for AIA petitioners under 35 USC § 315(e)(2). The appeal resulted from a Hatch-Waxman litigation in BTG v. Amneal,...more
The Patent Trial and Appeal Board (“PTAB”) issued its initial Trial Practice Guide in August 2012, shortly before America Invents Act (“AIA”) post-grant proceedings became available. That Guide had not been supplemented or...more
On July 20, 2018, the Federal Circuit held in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals that tribal sovereign immunity does not prevent IPR on a patent assigned to a tribe asserting such immunity. The court expressly...more
On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on...more
6/18/2018
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Proposed Legislation ,
Tribal Governments
Today in Oil States v. Greene’s Energy, the Supreme Court upheld the constitutionality of IPR proceedings, finding that they are a permissible second review of patents conducted by the administrative agency that issues them...more
4/27/2018
/ Administrative Proceedings ,
America Invents Act ,
Article III ,
Constitutional Challenges ,
Inter Partes Review (IPR) Proceeding ,
Oil States Energy Services v Greene's Energy Group ,
Patents ,
Post-Grant Review ,
Public Rights Doctrine ,
SCOTUS ,
Seventh Amendment ,
USPTO
In a case of first impression, an expanded PTAB panel (including Chief APJ Ruschke) found that a parallel enforcement action by a patent owner waives its sovereign immunity defense against under the 11th Amendment an AIA...more
In Mylan v. Allergan (IPR2016-00127, Paper No. 73), the PTAB granted a rare request for discovery filed be Petitioner in response to summaries of data presented in a Patent Owner Response used to rebut obviousness. In...more
Today in Aqua Products, Inc. v. Matal, a fractured Court of Appeals for the Federal Circuit (CAFC) sitting en banc decided to flip the burden of persuasion onto petitioners in IPR proceedings to show that an amendment is not...more
10/6/2017
/ Appeals ,
Burden of Persuasion ,
Burden of Production ,
Claim Amendments ,
Inter Partes Review (IPR) Proceeding ,
Motion to Amend ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Remand ,
Reversal ,
USPTO
As we have previously reported, sovereign immunity of state universities (who are instruments of state government) has been used to avoid IPRs under the immunity clause of the US Constitution (“Sovereign Immunity of State...more
We reviewed a sub-group of two hundred and four (204) IPRs filed by generic drug companies against pharmaceutical patents to assess PTAB outcomes and key trends in dealing with this technology field. The survey captured IPR...more
We have previously noted that the increasing rate of pre-institution settlement may in part be responsible for the declining institution rate in IPR proceedings because stronger petitions may drive earlier settlements,...more
March 31st marked the mid-point of the PTAB’s fiscal year and the release of mid-year statistics on AIA proceedings...
...One interesting trend is a continued increase in overall number of IPR petitions (mid-year there are...more
In what is becoming a familiar basis for reversal of PTAB decisions, the Federal Circuit yet again reversed the PTAB for its failure to adequately explain the basis for combining multiple prior art references in support of...more
On January 9, 2017, in Phigenix, Inc. v. Immunogen, Inc., the Federal Circuit held that petitioner Phigenix lacked standing to appeal an adverse final written decision in an IPR. While acknowledging that the AIA permits a...more
1/18/2017
/ Administrative Proceedings ,
America Invents Act ,
Appeals ,
Article III ,
Burden of Production ,
Injury-in-Fact ,
Inter Partes Review (IPR) Proceeding ,
Judicial Review ,
Patent Trial and Appeal Board ,
Patents ,
Standing
In what appears to be a case of first impression, the PTAB is poised to rule on the question of whether state sovereign immunity prevents an IPR challenge from being maintained against a University of Florida (“UF”) patent...more
In a case that appears to be a case of first impression, the PTAB found in its decision denying institution in IPR2016-00781 that a final written decision in an earlier IPR created estoppel under 35 U.S.C. § 315(e)(1),...more
CRISPR is a gene editing technique that promises to revolutionize genetic engineering, but already is raising ethical, business, and legal issues. This is the first in a monthly series of articles on CRISPR. ...more
On July 25, 2016, the Court of Appeals for the Federal Circuit (CAFC) held in In re Magnum Oil Tools International (Newman, O’Malley & Chen) that the burden of production to show unobviousness does not shift to a patent owner...more
8/1/2016
/ Burden of Proof ,
Burden-Shifting ,
CAFC ,
Corporate Counsel ,
Cuozzo Speed Technologies v Lee ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Petition For Rehearing ,
Prior Art ,
USPTO