Posts Tagged: "FDA"

It will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review. It will also increase FDA’s access to external expertise to improve the drug review process. FDASIA will foster timely interactive communication with sponsors during the drug development phase as a core Agency activity to facilitate the conduct of efficient and effective drug development programs and help make safe and effective drugs available to the American public in a timely manner.

Last week, on Friday, June 15, 2012, Merck (NYSE: MRK) announced the U.S. District Court for the District of New Jersey (Judge Peter G. Sheridan) ruled against the company on the issue of patent infringement in its suit against Apotex Inc. According to Merck, global sales of Nasonex® in 2010 topped $1.2 billion. See Merck News. A variety of Internet sources place the Nasonex® market share of the inhaled steroid market at 47%. Therefore, this patent loss some 6 years before the Nasonex® patent expires is a big deal.

The mantra of the anti-patent community is nearly in unison on the issue of patented drugs. Of course, everyone wants drugs to be developed, but no one wants to pay the exorbitant prices charged for blockbuster, patented drugs. You can add me to that list of individuals who doesn’t like the prices, but at least there is a benefit. Without appropriate financial incentives in place drugs would not be patented, but then again they wouldn’t be developed either. But what is the justification for scarcity and exorbitant prices of old drugs that are off patent?

The inclusion of an enhanced Accelerated Approval pathway, crafted by Senator Kay Hagan (D-NC), will help expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases while preserving the FDA’s robust standards for safety and effectiveness. Senator Hagan is to be congratulated for her hard work and leadership on this very important provision.

Erik Iverson is Associate General Counsel with the Bill & Melinda Gates Foundation, working exclusively with Foundation’s Global Health initiate. Mr. Iverson works with grantees in the development of intellectual property management plans, collaboration agreements and global access strategies with respect to the health solutions being funded by the Foundation. During our conversation Iverson and I talked about how the Gates Foundation seeks to incentivize innovators, as well as foster and respect intellectual property rights while at the same time engaging in what by its very nature is a humanitarian effort.

One of the most debated issues in patent and antitrust law today involves pharmaceutical patent settlements. Brand-name drug manufacturers pay generic firms to settle patent litigation and delay entering the market. How should the antitrust laws respond? The Cipro case presents an ideal vehicle for Supreme Court review. It involves a simple, undisputed payment from brand to generic to delay entering the market.

Contrary to the FDA, the European Medicines Agency confirmed that the benefits of Avastin® in combination with paclitaxel outweigh the risks, further determining that the combination of Avastin® and paclitaxel remains a valuable treatment option for patients suffering from metastatic breast cancer. If the FDA is successful in removing the breast cancer indication from Avastin® Genentech (a member of the Roche Group and the maker of Avastin®) could lose $1 billion of its $6 billion in annual sales of Avastin® due to the lost sales associated with use to treat breast cancer.

On Monday, September 22, 2010, the United States Patent and Trademark Office announced via Federal Register Notice that the Office is considering pro-business strategies for incentivizing the development and widespread distribution of technologies that address humanitarian needs. One proposal being considered is a fast-track ex parte reexamination voucher pilot program to create incentives for technologies and licensing behavior that address humanitarian needs. Under the proposed pilot program, patent holders who make their technology available for humanitarian purposes would be eligible for a voucher entitling them to an accelerated re-examination of a patent. Given that patents under reexamination are often the most commercially significant patents, it is believed that a fast-track reexamination, which would allow patent owners to more readily and less expensively affirm the validity of their patents, could provide a valuable incentive for entities to pursue humanitarian technologies or licensing.

I am skeptical about the prospects for invalidating patents on drugs, particularly important or blockbuster drugs. I also question whether anti-patent do-gooders in the biotech and pharma space are really causing more harm than good through attempts to bust patents on blockbuster drugs. According to their own press release, PUBPAT acknowledges that the tablet is heat stable and does not need to be refrigerated like prior versions of the drug. They seemingly make the argument, although not directly, that because this makes it much more convenient for patients it is unfair to charge prices sufficient to recoup R&D and a premium to make the speculative R&D reasonably profitable for investors. Of course, the fact that the drug in question is extremely convenient for patients is not a reason to invalid the claims, and in fact is likely a compelling reason why in this instance the patent claims cover a truly novel and nonobvious innovation.

Those who are opposed to exclusive rights because it prevents innovation and provides no benefit to the public really should do their homework. They run about throwing this study from an agenda driven economist or that study from a disgruntled economist as if these fictitious mental exercises that ignore reality are evidence of some kind. At the same time they ridicule and pick apart the Studies that reach a contrary conclusion, and simply ignore facts. In this space we really don’t need to be doing any Studies. We just need to observe history. The numbers simply do not lie. Granting exclusive rights has resulted in 13 times the number of drugs to treat rare disease.

Did you know that while a total of 4,849 ex parte and inter partes patent reexamination requests were filed from 1999 to 2009, only 55 are reexaminations of patents associated with FDA approved products and listed in the FDA’s Orange Book? This is just one of the most surprising and interesting facts that emerged from our first of its kind…

Some may recall my “dissertation” on the case of Amgen Inc. v. F. Hoffman-La Roche Ltd. See CAFC: A Divisional By Any Other Name Is Not a Divisional .  In Amgen, the Federal Circuit made it clear that you had better characterize an application as a “divisional” if you wanted the benefit of the “safe harbor” provided by 35 U.S.C…

For many months we have been hearing about the government attempts to “reform” health care in the United States, and this weekend the United States Senate is actually working, yes Senators working on a weekend, as the contentious debate continues. Even a relatively rare Presidential visit to Capitol Hill is scheduled for later this afternoon, presumably so President Obama can…

Teva Pharmaceutical Industries Ltd. issued a press release last week discussing the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the…

On Thursday morning, August 13, 2009, CNBC aired a segment titled Fixing America’s Health Care System on Squawk Box, which is CNBC’s longest running program.  Appearing on the program were Dr. Scott Gottlieb, who is a former FDA deputy commissioner, Tommy Thompson, former Health & Human Services Secretary and Wisconsin Governor and Jim Greenwood, a former Republican Congressman who is…