Posts Tagged: "drugs"

While patents protect innovations that are novel, nonobvious and useful, data exclusivity protects the extensive preclinical and clinical trial data required to establish new therapies as safe and effective. Regulatory data protection safeguards this data for a limited period of time, preventing competing firms from free-riding on the data that was generated at great expense. Specifically, biosimilar firms seeking regulatory approval are required to produce their own preclinical and clinical trial data to establish safety and efficacy, or wait the set period of time after which they are able to utilize the innovator’s prior approval in an abbreviated regulatory approval, eliminating the need for independently generated data.

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.

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.

On June 26, the Third Circuit held that payment includes more than just cash transfers. Judge Scirica, in a unanimous decision, wrote that Glaxo’s promise to Teva not to introduce an authorized generic version of epilepsy-and-bipolar-disorder-treating Lamictal was an “unusual, unexplained reverse transfer of considerable value.” And the court held that this transfer could “give rise to the inference that it is a payment to eliminate the risk of competition.”

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.

This year the pharmaceutical world has already seen some incredible mergers and acquisitions. This rapid pace of activity represents the highest level of pharmaceutical and biotech takeovers since 2009, according to Bloomberg Business. The week of March 30th started with the announcement of four major pharma or biotech mergers which totaled greater than $17 billion in costs, including the $3.5 billion Teva acquisition of Auspex. One particular deal, the purchase of benefits management company Catamaran Corp. by health insurer UnitedHealth Group Inc., will exceed $12 billion on its own.

Unfortunately, the high cost of pharmaceutical medications is why about 50 million adults between the ages of 19 and 64 do not fill out a prescription every year. Medications purchased over the Internet can cost up to 90 percent less than the same medication purchased in a brick-and-mortar pharmacy. It is also easy to understand those cost savings given the ingredients found in online pharmaceuticals. Consumers obviously need better protections to make sure that the medication they’re purchasing is the medication are ordering and not drywall or rat poison.

How tragic if the United States of America turns its patent system into a tool that rich and powerful companies use to suppress innovation that challenges their comfortable status quo. But Just because there are sharks doesn’t mean you stay out of the ocean. We need to get ahead of the curve and aggressively publicize what we’re doing to protect the public interest. That means showing how Bayh-Dole and the patent system advance human well-being and wealth creation not just here but around the world.

Cystic fibrosis creates a thick, sticky mucus that builds up in the airways, causing infections, and making it difficult to breathe. Chronic pain is a common problem for patients, which increases dramatically during the last 6 months of life. Those fortunate enough to survive childhood can only expect to live to be 37 years old. Despite this, some are criticizing the Cystic Fibrosis Foundation for spending $150 million to find a cure.