Posts Tagged: "glaxosmithkline"

Kava Plant May Prevent Cigarette Smoke-induced Lung Cancer *** Conditional Approval for Treatment of T-cell Lymphoma in Dogs *** All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1 *** Favorable Markman Ruling for Dopomed in GRALISE® Patent Litigation *** More FDA Woes for Ranbaxy *** Inovio Develops DNA-based Immune Booster to Enhance T-cell Responses *** Fish & Richardson Wins Hatch-Waxman Litigation for Allergan *** FDA approves Mekinist with Tafinlar for Advanced Melanoma

What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of December 2013. Fitch Puts Negative Outlook on Bristol-Myers. AstraZeneca Loses at the Federal Circuit on Omeprazole. Merck and GlaxoSmithKline Collaborate on Regimen for Advanced Renal Cell Carcinoma. Teva and Pfizer Settle Viagra® Patent Dispute. FTC Settles with Mylan over Agila Acquisition. FDA Fast Tracks Savara Pharmaceuticals Antibiotic AeroVanc to treat MRSA. Fitch Gives Johnson & Johnson AAA Rating. Sales of Antiretroviral Drugs for HIV Predicted to Decrease.

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.

Once again, a plethora of interesting events has occurred since the last time we stopped by. What was the biggest headline? That decision may be up for grabs, but certainly, the $500 million penalty paid by Ranbaxy Laboratories is high on the list. In other news, yet another Johnson & Johnson manufacturing scandal has erupted, this time in South Korea, where the authorities plan to bring criminal charges against its Janssen unit and ban production of five products – notably, a type of Children’s Tylenol. A non-profit group put Bayer on notice that a lawsuit will be filed charging the drugmaker with making “unsubstantiated and illegal claims” about the ability of its One-A-Day vitamin to prevent various disease, such as breast cancer, bolster physical energy and improve immunity, among other things.

The FDA decided not to pursue a re-hearing before a federal appeals court that recently ruled the federal government could not prosecute a sales rep who promoted off-label uses of a medicine because his speech was not false and misleading. Meanwhile, Congress delayed Medicare price restraints on a group of medications that will benefit Amgen while costing taxpayers up to $500 million over two years. Still further, after a federal court judge decided that the Bristol-Myers patent on the Baraclude hepatitis B treatment was invalid, some analysts are saying the ruling may prompt greater scrutiny of so-called composition of matter patents.

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.

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.

Recently I received an e-mail with a link alerting me to something posted on the 271 blog relating to Bilski. The video (viewable on the 271 blog) is taken from a movie about World War II that focuses at least in part on Adolph Hitler. The video posted is from a scene that appears to be taking place in Hitler’s…

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…

In the much anticipated decision from the Eastern District of Virginia the claims and continuation rules enjoined on October 31, 2007, were unceremoniously thrown out!  Judge Cacheris concluded: Because the USPTO’s rulemaking authority under 35 U.S.C. § 2(b)(2) does not extend to substantive rules, and because the Final Rules are substantive in nature, the Court finds that the Final Rules…