Posts Tagged: "pharmaceuticals"

Trade partners negotiating the Tans-Pacific Partnership trade deal have reached an agreement. The agreement details have not been released, and likely will not be submitted to Congress for a mandatory review for at least a month, perhaps longer… Presently the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement reportedly knocks that term of protection down to 5 years. While the term of data exclusivity is not one in the same with reducing the term of market exclusivity, there is little doubt that more limited data exclusivity would likely lead to significant negative consequences for the bio-pharma industry.

The first bit of good news for Bass came with respect to his IPR petition against Celgene Corporation. Celgene Corporation filed a motion for sanctions against the Coalition for Affordable Drugs on July 28, 2015. On September 25, 2015, the PTAB, in a decision authored by Administrative Patent Judge Michael Tierney, explained that the purpose of the America Invents Act (AIA) was to “encourage the filing of meritorious patentability challenges, by any person who is not the patent owner, in an effort to improve patent quality.” Given that Bass and the Coalition for Affordable Drugs did not own the patent in question the law allows these types of challenges. The PTAB also shot down the argument that financial motivation is at all relevant, explaining on some level financial motivation is what drives all IPR challenges.

Although not a prolific filer of U.S. patent applications, Gilead does currently holds 2,131 active patent grants according to data collected by Innography… Despite all of the recent focus on Gilead’s anti-viral medications, we noted a trio of patents issued to the company recently by the USPTO to address issues in patient cardiac health. U.S. Patent No. 9056108, issued under the title Method of Treating Atrial Fibrillation, claims a kit containing a first composition which includes dronedarone or a pharmaceutically acceptable salt thereof, and then a second composition which includes ranolazine. This innovation was found to improve the anti-arrhythmic efficacy of dronedarone, which can be used to treat atrial fibrillation but is poorly tolerated by patients in higher doses.

On August 10th, the rights to sell Daraprim were bought from Impax Laboratories Inc. (NASDAQ:IPXL) of Hayward, CA, by Turing Pharmaceuticals, a privately held company with headquarters in New York City and Switzerland. Shortly after acquiring Daraprim, Turing CEO Martin Shkreli raised its price by more than 5,000 percent, from $13.50 per pill up to $750 per pill for a medication that’s not usually prescribed by itself; it’s typically part of a larger regimen for AIDS and cancer patients. As the result of public outcry, Shkreli announced several days ago that the price would drop from $750 a pill to some unspecified level. He pointed out that at $13.50 a pill the drug was not profitable to sell. Still, the damage has been done to an industry everyone loves to hate because drug prices in the U.S. are perceived to be outrageously high already.

The stark reality of how government operates leaves us with a patent system that will be perpetually on the brink. Giant corporations have become effectively insulated from any consequences associated with stealing patented innovations, yet they continually want more and more help from Congress, which they dress up and roll out as “reform.” Even if they fail this time these companies will return, with more lobbyists and special interest groups demagoguing innovators as inherently evil, Satan practically. Rather than recognize the critical role patents play in the innovation ecosystem and in the U.S. economy, Congress is poised to flush the patent system down the drain because there are a handful of giant tech corporations that believe they would benefit.

According to Celgene, the Kyle Bass strategy of shorting a stock and filing an inter partes review challenge is an abuse of the process and not what post grant procedures were designed to accomplish. In a filing seeking sanctions filed with the Patent Trial and Appeal Board (PTAB) at the United States Patent and Trademark Office (USPTO), Celgene argues that the financial motivation for the IPR filing makes the filings by Bass’ Coalition for Affordable Drugs sanctionable. Bass calls this theory “curious,” pointing out that “at the heart of nearly every patent and nearly every IPR, the motivation is profit.”

In what can only be characterized as a bizarre, rambling, and intellectually dishonest article, ‘The Economist’ has inexplicably taken the position that patents are not necessary for innovation. The complexity of innovation today and the required investment necessary to innovate, as well as the highly speculative nature of innovation, seems lost on the author. It is surprising, and disappointing, that a publication like The Economist would turn a blind-eye to the underlying financial realities of innovation. Truthfully, The Economist owes its readers a sincere apology for this entire article. Some could, and probably should, call into question the motivations for building an anti-patent argument upon such a rotten foundation.

Hybrigenics (ALHYG), a French bio-pharmaceutical company with a focus on research and development of new treatments against proliferative diseases, has announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to inecalcitol for the treatment of acute myeloid leukemia (AML) in the United States. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation allows the company receiving the designation to leverage a wide range of financial and regulatory benefits, including government and institutional grants, and waiver of FDA user fees for the potential submission of a New Drug Application.

The controversy swirling around the Trans-Pacific Partnership (TPP) Trade Agreement sheds light on two critically important but divisive issues: international trade and intellectual property protection for pharmaceuticals. One of the most significant sticking points in the negotiations is the issue of intellectual property protection for pharmaceuticals, specifically data exclusivity. Data exclusivity is a means of correcting a free-riding market failure, providing the innovative firms with a limited period of time in which data from clinical trials and other required testing cannot be used by competing firms to secure market access.

During the last hearing of the House Judiciary Committee there was an attempt to insert language via amendment that would make it impossible for Kyle Bass and others to challenge pharmaceutical patents via post grant challenge at the Patent Office. Judiciary Chair Congressman Bob Goodlatte (R-VA) vociferously objected saying that if the amendment to prevent post grant challenges to pharmaceutical patents passed it would create a so-called scoring problem with the Congressional Budget Office (CBO). What an admission by Goodlatte! No legislative help is coming for pharma’s post grant challenge problem because the federal government likes the idea of some patents on important drugs being invalidated, which will save Medicare money.

Global innovation continued to climb during 2014 but at the slowest pace seen since the global economic recession hit in 2009. The Reuters report didn’t draw any specific conclusions as to why the innovation slowdown had occurred but did draw a correlation between published scientific literature and patenting activities, noting that the former typically precedes the latter by three to five years. As graphs published in the Reuters study clearly show, scientific literature publications in 12 industries increased between 2008 and 2009 at a slower rate than prior years, mirroring the patenting slowdown experienced this year. Troublingly, a steep drop in published scientific literature was experienced in 2010, so if this model holds we may see a reduction in global patenting activity when the annual Reuters innovation study comes out next year.

To listen to the critics, one would believe that the Trans-Pacific Partnership (TPP) Trade Agreement marks the end of the world for global health, especially for the poor. They are, in a word, wrong. Admittedly, the TPP Agreement is extremely contentious, but the TPP Agreement contains important provisions regarding intellectual property (IP) rights, especially the standards of protection for pharmaceuticals. If the global community is to truly benefit from the promise of medical progress, we must stop the attack on the IP protections that incentivize innovation and turn our attention to the issues that genuinely inhibit access to medicines.

HHS is suing a defendant that merely wants to market a generic version of a drug that is used to treat patients with human immunodeficiency virus (HIV). Not only is the United States government a patent troll, but the government is also trying to deprive patients who need live saving HIV drugs an affordable generic version. Egad!

There’s been a lot of positive activity in recent months for Bristol-Myers Squibb of New York City. In early March, the U.S. Food and Drug Administration approved the use of BMS’s immunotherapy drug Opvido for the treatment of lung cancer. The approval came ahead of schedule after a clinical trial of the drug was ended due to a significant improval in survival rates. In the early days of April, the company announced a partnership with Dutch-based pharmaceutical developer uniQure that will see BMS pay uniQure $254 million for the successful development of a genetic therapy for congestive heart failure. Also in early April, BMS finalized the acquisition of Flexus Biosciences, a California firm focused on developing anti-cancer therapeutics.

The early months of 2015 have been interesting ones for the pharmaceutical industry, an incredibly valuable industry sector that comes under our focus from time to time here at IPWatchdog. The first quarter of this calendar year has seen a number of mergers and acquisitions which are showing us that the patent market for pharmaceuticals is quite active right now.…