Posts Tagged: "Drug"

The dilemma for developing countries is primarily a function of two things: lack of access to existing medicines and absence of innovation on the treatments and cures that are needed. Admittedly each of these can be linked to intellectual property rights, but poverty is at the heart of both issues. Fundamentally, drugs are not available because there is no market for them and the necessary market incentives are absent. To facilitate innovation, especially on ‘diseases of poverty’ the UN and member states need to commit to cultivating market incentives and removing obstacles.

Twitter’s popularity has not only benefited the legitimate side of the pharmaceutical industry. A study released in December, supported by both the Global Health Policy Institute and the Alliance for Safe Online Pharmacies, found an empirical link between all Twitter content and content aimed at the illicit drug sales. A survey of two week’s worth of posts shared on Twitter, involving the analysis of more than two million tweets, turned up 45,000 tweets which encouraged drug abuse. The survey found that more than three-quarters of tweets both pertaining to the non-medical use of prescription medications and including a hyperlink to a sales affiliate related to the anti-anxiety drug Valium.

The new year was hardly underway before Representative Lloyd Doggett (D-TX) and 50 of his House colleagues sent a letter to Health and Human Services Secretary Sylvia Burwell and NIH Director Francis Collins urging them to “march in” under the Bayh-Dole Act to control prices for drugs developed under the law. While the high cost of drugs is a legitimate concern, attempts to address the problem through technology transfer statutes would only guarantee that we will have fewer new drugs, not that they will be cheaper. The march-in provision is intended for instances when a licensee is not making good faith efforts to bring an invention to market or when national emergencies require that more product is needed than a licensee is capable of making, not to fix drug prices.

The number of these potentially anticompetitive deals has fallen significantly following the Supreme Court’s landmark antitrust decision in FTC v. Actavis in 2013. The total number of such deals filed with the FTC has dropped to 21 in FY 2014 from 29 in FY 2013, and 40 in FY 2012 prior to the Actavis ruling. The FTC staff report for FY 2014 represents the first annual snapshot of such deals following the Actavis decision.

Drugs for the treatment of late-stage cancers are less expensive to develop, in part because late-stage drugs extend patients’ lives for a shorter period of time such that clinical trials are concluded more quickly. This means that such drugs require less time to research, develop, test and bring to market than drugs that treat earlier stage cancers, providing the innovator with a longer effective patent life. In essence, less research and development investment is directed toward drugs that treat patient groups requiring lengthy clinical trials, those with longer commercialization lags… It’s worthwhile to ask whether a ‘one-size-fits-all’ patent policy is optimal. How we can think creatively about patent protection in an effort to incentivize the innovation we want and push the frontiers of modern medicine.

The idea of reducing drug prices through more government control is always simmering on the backburner and doesn’t require much to bring it to a full boil. Two recent actions turned up the heat to full blast. The response is often calls for more regulation, but ever increasing regulation benefits established players, which while inconvenienced, can afford to play the game. Start-ups can’t survive in endless oceans of red-tape that increase their costs while restricting market entry. Before rushing to impose more federal control, it might be wise to ask if government regulations inadvertently contribute to the problem.

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.

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.

The United States District Court for the Southern District of Indiana ruled in favor of Eli Lilly (NASDAQ: LLY), issuing a final judgment in the Hatch-Waxman infringement litigation relating to U.S. Patent No. 7,772,209. This matter arose as the result of the defendants’ filing of Abbreviated New Drug Applications (ANDAs) with the Food and Drug Administration (FDA). The ‘209 patent, covering a method of use, protects the co-administration of pemetrexed disodium with two nutrients – folic acid and vitamin B12, which protects against the side effects of the drug Alimta®. The district court found direct infringement by administering physicians under § 271(a), and thus inducement of infringement by Defendants under § 271(b).

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.

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.