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Posts Tagged: "gsk"

CAFC Again Says Teva Induced Infringement on Carvedilol, Assures Holding Narrowly Applies

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Thursday underscored its October 2020 ruling that generic company, Teva Pharmaceuticals, was liable for induced infringement of GlaxoSmithKline’s (GSK’s) patent directed to a method of treating Congestive Heart Failure (CHF) using carvedilol. The court clarified, however, that its ruling should apply only narrowly to the facts of this particular case. Judge Prost again dissented.

Federal Circuit Says Teva Induced Infringement of GSK Patent on Congestive Heart Failure Drug

In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the United States Court of Appeals for the Federal Circuit (CAFC) on Friday reversed a district court’s motion for judgment as a matter of law (JMOL) for Teva, finding that Teva was liable for induced infringement of GlaxoSmithKline’s (GSK’s) patent directed to a method of treating Congestive Heart Failure (CHF) using carvedilol….. Chief Judge Prost authored a dissenting opinion, wherein she expressed the majority’s opinion undermined a critical balance between patent protection and public access once a patent expires “by allowing a drug marketed for unpatented uses to give rise to liability for inducement and by permitting an award of patent damages where causation has not been shown.”

Why NIH/Industry Partnerships Matter: Ask an HIV patient

Those who believe that patents aren’t important or that companies would undertake the rigors of commercial development with only non-exclusive licenses don’t understand the realities facing innovators like Inovio… Unfortunately, there’s good reason for anxiety. If they are successful their patents could be subjected to years of post-grant reviews by competitors and those who believe life science patents harm the public interest. Even if their IP holds up, they may face howls from critics and politicians demanding that the government step in to issue compulsory licenses so others here and abroad can copy the vaccine. For the 35 million living with HIV, the scientific barriers aren’t the only ones standing in the way of effective treatments.

Pharma Scandals: Bribery, Insider Trading and Paula Deen

The summer may be in full swing, but the torrent pace of news and interesting developments has not subsided at all. Hot days simply yield hot stories. Unarguably, the most sensational item over the past few weeks has been the GlaxoSmithKline bribery scandal unfolding in China. As of mid-July, four Glaxo executives, all of whom are Chinese nationals, were detained and authorities hinted that other drugmakers may be examined as they review records held by travel agencies implicated in the drama.

Pharma Law and Business – A Monthly Roundup for January 2013

Not surprisingly, 2013 began with a predictable rush of interesting news. So here are some of the most recent highlights, from court rulings and medical study findings to FDA doings and steps taken to developed new parameters for prescribing and clinical trials in various places. The Obama administration again missed a deadline for releasing much-anticipated Sunshine guidelines for industry transparency. The year also began with the usual anticipation surrounding the annual JP Morgan Healthcare conference. Meanwhile, a research letter in JAMA Internal Medicine caused a stir after finding that 43 percent of doctors in practice more than 30 years acknowledged they sometimes or often acquiesce to patients who pester them for – or even demand – brand-name drugs.

Tafas v. Dudas/Doll – 5 Years Later But Still Very Pertinent

Although such Final Rules were widely criticized by most companies in the United States, a sole individual, Dr. Triantafyllos Tafas, a co-inventor of a computerized automated microscope, stood alone against the Rules package for nearly three months against the might of the USPTO. Dr. Tafas filed suit because he truly believed the U.S. patent system was being manipulated by a few large entities to the significant detriment of research-intensive entities such as emerging companies, universities, and research institutes, particularly those in the chemical, bioengineering, pharmaceutical, and biotech fields. Dr. Tafas’ beliefs grew from his experience attempting to start his company in Europe where he found few investors willing to invest in small companies whose only major asset was a patent portfolio. However, he found investors in the U.S. to be much more respectful of U.S. patents and willing to invest in companies with a good patent portfolio, irrespective of whether they were owned by a large multinational or the new kid on the block. This cemented Dr. Tafas’ belief in the importance of the U.S. patent system.

Patent Business: Deals, Acquisitions & Licenses July 2012

This deal will give GSK exclusive rights to BENLYSTA, which is a human monoclonal antibody that inhibits B-cell activating factor (BAFF) approved for treatment of systemic lupus erythematosus. It is believed that BENLYSTA has blockbuster potential. According to Human Genome Sciences, the principle patents covering BENLYSTA will generally expire between 2016 and 2023 in the United States and between 2016 and 2021 in the rest of the world. For 2011 sales of BENYLYSTA were approximately $52 million, but there is great optimism that the drug will become a blockbuster as it continues to gain market share and as it may ultimately be approved for treatment of other autoimmune diseases.

Licensing Executives Society Announces 2010 Deals of Distinction™ Awards

In May 2009, Genzyme Corporation acquired the worldwide rights to a potential breakthrough treatment for Multiple Sclerosis (MS) along with three marketed oncology products from Bayer Healthcare Pharmaceuticals. In February, the University of Pennsylvania (Penn) and AstraZeneca forged a new collaborative research agreement, featuring a significant licensing component, that makes use of their respective talents and resources to generate new Alzheimer’s Disease (AD) drug candidates for the clinical development pipeline.

Tafas and GlaxoSmithKline Awarded Jefferson Medal by NJIPLA

Tafas and GSK were recognized with this prestigious award for their successful legal challenge to the claims and continuations rules made final in 2007 by the United States Patent and Trademark Office. Dr. Tafas was first to file his complaint against the USPTO, which was filed the day after the final rules were announced in August 2007. The rules were not to go into effect until November 1, 2007, and for some time it seemed as if Dr. Tafas alone would take on the Patent Office. In October 2007, after previously promising to challenge the rules, GSK filed its complaint. Armed with the benefit of the Patent Office response to the Tafas complaint, GSK was able to assault the rules from another flank and with full knowledge of how the Patent Office postured itself to defend against Tafas. By challenging immediately Dr. Tafas and his attorneys (Steven Moore and James Nealon of Kelly Drye) did an enormous service for the industry and took the fight to the Patent Office. They exposed the Patent Office and in tandem with GSK were able to keep the USPTO on their heels throughout the proceedings.

JUST IN: Federal Circuit Denies Vacatur in USPTO Rules Case

Earlier today the Chief Judge Paul Michel of the United States Court of Appeals for the Federal Circuit issued an Order declaring the pending appeal of Dr. Tafas and GlaxoSmithKline moot due to the fact that USPTO Director David Kappos has withdrawn the rules. The Federal Circuit per Judge Michel, however, denied the motion of the USPTO and GlaxoSmithKline to…

Tafas Objects to Vacatur in Claims and Continuations Appeal

Late this evening attorneys representing Dr. Triantafyllos Tafas filed a Reply to Motion for Dismissal of Appeal and Request for Remand. In this filing Tafas points out that the decision made by USPTO Director David Kappos to withdraw the claims and continuations rules does moot the appeal, there is a difference between mooting an appeal and vacating an underlying district…

USPTO Agrees to Withdraw Claims & Continuations Rules

PRESS RELEASE: GlaxoSmithKline (NYSE: GSK) today announced that it has reached agreement with the United States Patent and Trademark Office (USPTO) to join the USPTO’s motion to dismiss its litigation over Final Regulations published in August 2007 (Triantafyllos Tafas and SmithKline Beecham Corporation, SmithKline Beecham PLC and Glaxo Group Limited vs. David J. Kappos and the United States Patent and…

Federal Circuit to Rehear Tafas and GSK v. Doll

On Monday, July 6, 2009, the United States Court of Appeals for the Federal Circuit (minus Judge Lourie who did not participate in the poll of judges) decided to rehear the claims and continuations rule challenge of Tafas and GlaxoSmithKline en banc.  Additionally, the CAFC has vacated the panel decision that awarded a victory to the USPTO.  The date of…

Tafas Requests Rehearing of Claims & Continuations Ruling

As soon as I learned that the date for requesting rehearing or en banc consideration of the Federal Circuit ruling in the GSK and Tafas appeal of the claims and continuations rules was pushed back to June 3, 2009, I said to myself, of course!  Important things always seem to pop up while I am on the road teaching the…

Federal Circuit Grants USPTO, GSK and Tafas More Time

Last Thursday I wrote regarding the USPTO, GlaxoSmithKline and Dr. Tafas jointly requesting an extension of time within which to either request reconsideration or rehearing en banc of the Federal Circuit’s decision in the claims and continuations saga.  This morning I learned that the Federal Circuit has granted the requested extension of time, so the parties have until the end…