Is Patent Law Hampering Your R&D? Lessons from the Biomedical Field

Wednesday, October 26, 2016

Patent law should promote innovation, but as recent research has uncovered, there can be unintended consequences to these regulations that stymie creation. The biomedical field is rife with examples of the conflict between the two, and can serve as a lesson to other industries.

Biomedical researchers have an incentive to patent their discoveries as soon as possible. Early filing can establish their claim to patent protection and dissuade others from competitive behavior. A patentable idea, however, is not necessarily a commercially viable one. In some cases, time between discovery and market—known as the commercialization lag—combined with a focus on short-term returns divert investment away from ideas with long-term value.

Take cancer therapies. Like all drugs, these must go through multiple phases of study as dictated by the FDA. Some treatments, however, such as late-stage therapies, have relatively short clinical trial phases, allowing these drugs to reach market faster. Recent research suggests that these treatments receive priority in terms of investment.

For example, one study found that in a five-year period, eight drugs were approved for late-stage lung cancer treatment. In one case, a drug was approved even though it only extended the life expectancy of patients by two months. During the same period, no drugs were approved for lung cancer prevention, and only six drugs were approved for other types of cancer prevention.

Beyond investment discrepancies, patent law may hamper follow-on innovation by creating barriers to inventions related to a patented idea. Such obstacles include the threat of infringement when a new product is developed based on patented IP.

The human genome provides an example. The entire genome was sequenced by two research initiatives, the publicly funded Human Genome Project, which released its findings to the public, and the private firm Celera, which used IP controls and licensing to protect the use of its gene discoveries. A recent study found that genes protected by Celera's IP experienced a 20%-30% reduction in follow-on research and development compared to non-protected genes.

In another instance, Mayo Collaborative Services v. Prometheus Laboratories, Inc., the U.S. Supreme Court invalidated a patent related to drug dosing based on genetic variation arguing that “patent law not inhibit further discovery by improperly tying up the future of laws of nature." It should be noted that the evidence for patent law adversely affecting follow-on innovation is not universally accepted; another recent economics study found no effect of patents on follow-on gene research.

The point is, patents should not deter follow-on research, and innovators should continue to create unique and useful IP that builds on prior art. To that end, more research needs to be done to determine the scope of patent law's unintended consequences in all industries.