Posts Tagged: "gsk"

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.

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.

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.

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.

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 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.

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…

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…

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…