Posts Tagged: "drug development"

How will our patent system treat this wonderful new discovery? How long will it take before its curative benefits can be deployed ? We can only hope that DC’s meddlers in our innovation ecosystem read the Ms. Sun’s article. Because however fervently the medical and scientific communities respond to this growing superbug crisis, IP’s DC government legal eagles are either unaware or unconcerned. The USPTO is regularly rejecting microbial patent applications in blind servitude to Alice-Mayo’s confusing eligibility formula. We can hope, but cannot be assured, the Federal Circuit will make sense some day of Alice-Mayo’s two-step test. But when? Worse, it appears that SCOTUS is infected by the anti-patent poison infesting our Capitol. How refreshing it would be to have our Congress and the nation’s highest Court be as concerned with superbugs as they seem to be with PR-created patent trolls.

The pending report of the UN Secretary General’s High Level Panel on Access to Medicines not only attacks the patent system as predicted, but proposes giving the organization oversight of drug development. If you think United Nation functionaries would be more effective than entrepreneurs, you’ll be delighted. If you live in the real world where bureaucracy is the enemy of innovation, you don’t know whether to laugh or cry.

Biopharmaceutical innovation is difficult, expensive, time-consuming, and risky. More so now than ever. A 2014 study by Tufts University’s Center for the Study of Drug Development calculated that a mere one in eight (11.8%) of all drugs that enter clinical trials are ultimately approved by the U.S. Food and Drug Administration. The drug development gamble appears to be getting riskier. A report released on May 25th by the Biotechnology Innovation Organization (BIO), the biotechnology industry’s national trade group, finds that fewer than one in ten (9.6%) of drugs that enter clinical trials will gain approval by the U.S. Food and Drug Administration.

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.

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.

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.

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.

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.