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
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
On August 24, 2015, the Patent Trial and Appeal Board (PTAB) declined institution of two petitions filed by Coalition For Affordable Drugs for Inter Partes Reviews (IPRs) of Acorda’s patents (U.S. Patent Nos: 8,007,826,...more
8/28/2015
/ Abuse of Process ,
Biotechnology ,
Generic Drugs ,
Hedge Funds ,
Information Disclosure Statement ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Owner Preliminary Response ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Real Party in Interest
In three petitions filed on the same day in 2013, styled Amneal v. Supernus, Amneal filed what appears to be the first challenge of Orange Book listed pharmaceutical patents that led to institution followed by a final...more
8/20/2015
/ Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Examiners ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Orange Book ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preponderance of the Evidence ,
Prior Art
Although Inter Partes Review (IPR) is limited to grounds of unpatentability based upon prior art references, it is nevertheless possible to raise issues of written description or enablement by applying intervening prior art...more
On May 28, 2015, the Federal Trade Commission (FTC) announced the settlement of its 2008 lawsuit against Cephalon, Inc. (now owned by Teva Pharmaceutical Industries, Ltd.), which alleged that Cephalon had made “reverse...more
6/2/2015
/ Abbreviated New Drug Application (ANDA) ,
Cephalon ,
Disgorgement ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Generic Drugs ,
Hatch-Waxman ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Settlement ,
Teva Pharmaceuticals
Some of the most commercially successful products to arise out of nanotechnology in terms of sheer size of revenues generated are nanotech drug formulations. This area continues to be hot in the wake of two recent deals, both...more
Though the first nanoparticulate drug formulation was approved by the U.S. FDA way back in 1995, a recent flurry of deals and product approvals have shown increasingly high valuations for nanomedicine companies....more