Posts in Pharmaceutical


Distribution Agreement Considered a Commercial Offer and On-Sale Bar

The Federal Circuit reiterated that the on-sale bar does not exempt commercial agreements between a patentee and its supplier or distributor. It is the commercial character of …

A Fleeting Glimpse of Reason in the Drug Development Debate

Despite the difficulties, the private sector is far and away the best bet for developing the desperately needed medicines of the future. Government is a critical partner …
By Joseph Allen
26 days ago 2

Analyzing obviousness and anticipation challenges to claims directed to an isolated component of a prior art mixture

Based on the governing Federal Circuit case law, where the patent claim at issue is directed to a specific component (such as a specific enantiomer) of a …
By Theodore Chiacchio
1 month ago 1

Embrace IP That Works: Importance of Supplementary Protection Certificates (SPCs) in the European Union

The European Union suffers from an investment deficit relative to other industrialized nations. A recent report by the European Commission emphasizes this impact, “the EU needs to …
By Dr. Kristina Lybecker
1 month ago 0

When Post-Filing Evidence to Determine Written Description Support Is Admissible: Amgen v. Sanofi

May a court rely on post-priority-date evidence offered to show that a patent lacks written description support even though written description is judged based on the state …

Celgene’s New Revlimid® Lawsuits Shows Shifting Tactics From Earlier Natco Case

Celgene faces a new gang of generics moving in on its blockbuster Revlimid®.  Over the past year, a number of generics have filed ANDAs against Revlimid®, including …
By Zachary Silbersher
3 months ago 3

Did the Federal Circuit doom Amgen’s Enbrel® monopoly?

In the case, Amgen v. Sanofi, the Court vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor.  The Court’s decision turned …
By Zachary Silbersher
3 months ago 1

Avoiding drug development clinical trials from being an invalidating public use

The legal principles set out above, while seemingly straight-forward enough, leave ample room for case-specific interpretation and application when it comes to the question of whether the …
By Theodore Chiacchio
3 months ago 4

Novartis acquires French radiopharmaceutical firm for oncology drug after losing patent protection for Gleevec

Novartis has agreed to acquire French radiopharmaceutical firm Advanced Accelerator Applications (AAA) in a deal which values AAA at $3.9 billion USD. The deal, funded through short- and …
By Steve Brachmann
3 months ago 0

Double jeopardy at the PTAB forces Allergan and others to seek sovereign immunity defenses

The PTAB subjects all patent owners to double jeopardy, but the situation is particularly bad for pharmaceutical companies which already have to face a Congressionally-mandated validity review …
By Steve Brachmann
4 months ago 0

Pity the Patients if Exclusive Licensing is Undermined

We've learned from experience that just because a theory's off base doesn't mean it won't take root, particularly when it involves patents and medicine. "No Vaccines Before …
By Joseph Allen
4 months ago 1

Renegotiate NAFTA to Make it the Gold Standard in IP Protection

As President Trump embarks on the renegotiation of NAFTA, it is critical that we seize the opportunity to make it the gold standard in intellectual property rights …
By Dr. Kristina Lybecker
4 months ago 3

St. Regis Mohawks, BIO send letters to Senate Judiciary slamming the unfair playing field of IPRs at PTAB

On Thursday, October 12th, a pair of letters addressed to the bipartisan leadership of the Senate Judiciary Committee were delivered in an attempt to inform Senators on …
By Steve Brachmann
4 months ago 22

Eli Lilly patent covering Alimta lung cancer treatment upheld in final written decision from PTAB

On Thursday, October 5th, a final written decision issued by the Patent Trial and Appeal Board (PTAB) upheld a series of 22 claims from a patent owned by …
By Steve Brachmann
4 months ago 0

Patent settlement between AbbVie and Amgen delays Humira generic until 2023

On Thursday, September 28th, a judge in the District of Delaware entered an order stipulating dismissal in a patent infringement case brought by North Chicago-based pharmaceutical firm …
By Steve Brachmann
5 months ago 0