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Revisiting FDA’s Original Guidance on Orange Book Listability in Light of Heightened FTC Scrutiny

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

Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

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

Pharma Patents Assigned to Indian Tribe to Thwart Inter Partes Review

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

Key Trends In Pharmaceutical IPRs Filed By Generic Petitioners

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

Is The Real IPR Institution Rate Higher When Petitioner Errors & Pre-Institution Settlements Are Considered?

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

Survey of Pharmaceutical IPRs Filed By Generic Drug Company Petitioners

We have reviewed a sub-group of 111 IPRs filed by generic drug companies against pharmaceutical patents to assess outcomes and trends. While our survey was not intended to capture every IPR filed by a generic drug company, it...more

PTAB Institutes Kyle Bass IPR Against Pharmaceutical Patent Based On SEC Document

Kyle Bass has filed numerous prior IPR petitions against pharmaceutical patents, some of which have been denied due to use of prior art references that were not sufficiently proven to be “publicly accessible” (see “Clinical...more

Federal Circuit Affirms PTAB's IPR Decision Invalidating A Pharmaceutical Patent

On December 17, 2015, in Merck v. Gnosis, the Federal Circuit affirmed the PTAB’s IPR Decision finding a pharmaceutical patent invalid for obviousness. Justice Newman vigorously dissented from the majority’s view (Justices...more

PTAB Requests Additional Briefing on Hedge Fund IPR Questions: A Decision May Be Near

On Sept. 1, 2015, the PTAB issued an order in Coalition for Affordable Drugs (CFAD) v. NPS Pharmaceuticals for the parties to brief the following questions in 7 business days...more

Kyle Bass Loses Round 1 of IPR Attack Against Pharma/Biotech Patents

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

Lessons Learned From the 1st Successful Pharmaceutical IPR Defense of Orange Book Listed Patents

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

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