Another great conference session this afternoon: “Timing Is Everything: Balancing Access and Uncertainty.” This one was moderated by Jeff Skopek, with presentations by Shannon Gibson, Trudo Lemmens, and Efthimios Parasidis.
First, we heard from Gibson and Lemmens on “Overcoming ‘Premarket Syndrome,’” AKA the various problems associated with relying solely on premarket data for safety and efficacy determinations. These problems include the fact that industry studies have been shown to be more likely to be biased in favor of demonstrating a positive result, and premarket studies also cannot really demonstrate how a product will be used in clinical practice. Moreover, for niche market drugs (e.g., those for orphan indications or pharmacogenomics), which are becoming more and more popular, there are fewer patients available to serve as clinical trial subjects, thereby inherently limiting the data that may be generated prior to approval and increasing uncertainty around safety and effectiveness.
So what should we do? Develop an improved post-market research agenda, say Gibson and Lemmens, and explore “adaptive licensing,” by which they mean rendering regulatory decisions based on the entire body of evidence collected throughout a product’s life cycle. They argue that drug access decisions should not be binary, but instead, should be incremental and continually reassessed based on new data, including data that becomes available after a drug has been initially made available to patients. They closed by pointing out the importance of data transparency at all points in drug regulation.
Next, we heard from Efthimios Parasidis on “Innovative Regulating as a Public Health Imperative.” Parasidis focused on the ways in which FDA can leverage its existing post-market regulatory authorities granted under the Food and Drug Administration Amendments Act of 2007, including requiring post-market studies and imposing Risk Evaluation and Mitigation Strategy requirements (REMS).
The Supreme Court will consider the patentability of human genes when it reviews the Myriad case this term. As Bill of Health readers are likely to know, the Myriad case centers on Myriad’s patents on gene sequences for BRCA mutations that are associated with the propensity to develop breast or ovarian cancer. Myriad does not claim ownership over the mutations as they exist in nature, but rather on isolated BRCA sequences that the company has “created”. The Myriad case will give the high Court another chance to clarify the scope of subject matter that is eligible for patent protection. The Court’s track record in this area is less than stellar.
As I have argued (here), the legal uncertainty at to the scope of patentability for claims that implicate products of nature is largely the result of the lack of a uniform framework for determining what areas are excluded from patent-eligible subject matter. More specifically, while patent law prohibits patent protection for inventions that equate to a law of nature, natural phenomenon, mental process, mathematical equation, or abstract idea (collectively referred to as the product of nature doctrine), no court has defined these terms adequately. Uncertainty is bad for business and bad for patients — the Court should seize upon this opportunity and offer clear guidance as to the contours of the product of nature doctrine.
With respect to gene sequences, the mere fact that a sequence is isolated is inconsequential. Rather, courts should analyze the precise subject matter of the isolated gene sequence to determine if it differs substantially from its natural counterpart. I’ve created a three-part test to help make this determination:
- Does the isolated sequence exhibit characteristics or contain properties that are substantially different from the non-isolated sequence?
- Is the proximate cause of any difference between the isolated and non-isolated sequences the result of natural phenomenon that govern the properties of the sequence when isolated?
- Would a patent on the isolated sequence grant a property interest that extends to anything other than the isolated sequence?
If the answer to these questions is anything other than (1) yes, (2) no, (3) no, the claim must be invalidated pursuant to Section 101 of the patent act because the claim does not constitute patent-eligible subject matter. My article explains why…
The Environmental Protection Agency has determined that Monsanto’s request to plant a new strain of genetically-modified corn “may be of regional and national significance.” As a result, the agency is seeking public comment on Monsanto’s application.
Monsanto seeks permission to test the new corn in Puerto Rico and 22 states over the next two years. The corn is bioengineered to produce Bacillus thuringiensis (BT), a bacteria that is known to kill rootworm. The risks of BT-engineered crops are not fully known. In addition to impacting the biodiversity of the soil and environment, BT toxin is known to kill other insects such as moths and butterflies, and some have argued that crops genetically-engineered to produce BT toxin have led to colony collapse disorder which has devastated beehives all over America for a number of years.
To be sure, naturally-occurring BT-products are allowed for USDA certified-organic production, and genetically modified BT-corn may be more environmentally friendly that other strains of genetically-modified corn since the corn itself produces the toxin, and thus theoretically would require less spraying of pesticides. However, rootworm is known to adapt quickly and become resistant to bioengineered BT toxin. In fact, farmers have had to spray their corn with chemical pesticides that the bioengineered BT corn was supposed to avoid. Notably, studies have found that genetically-modified BT crops adversely impact the health of humans and livestock, while BT toxin has been discovered in the blood of pregnant women and fetuses. Given the widespread health and environmental concerns, to the extent the EPA is inclined to grant Monsanto’s request, the agency should condition the experimental use on funding for independent research that evaluates the long-term effects of bioengineered BT crops on humans, livestock, and the environment.
One week prior to the Supreme Court’s landmark ruling in the health care cases, Democrats and Republicans overwhelmingly voted in favor of health-related legislation (387-5 House; 96-1 Senate). Industry and HHS were quick to congratulate our elected officials on a triumphant bipartisan achievement, while the FDA enthusiastically welcomed its latest collaboration with Big Pharma. Lobby groups boasted of their ability to “craft” legislation with FDA and praised the “unprecedented level of public input” into the new law.
We should all be concerned.
This past weekend was the eleventh annual Health Law Scholars Workshop, and I wanted to take a minute to congratulate the 2012 Scholars: Alena Allen (Memphis), Leo Beletsky (Northeastern), Christina Ho (Rutgers-Newark), and Lindsay Wiley (American). Each scholar had two hours dedicated to a discussion of their work, with expert reviewers including Rebecca Dresser (Wash U), Elizabeth Weeks Leonard (Georgia), Kevin Outterson (Boston University), Ted Ruger (Penn), and Rob Schwartz (New Mexico/Hastings), along with the health law faculty at the Center for Health Law Studies, Saint Louis University. The Workshop is sponsored by the American Society of Law, Medicine & Ethics and SLU’s Center for Health Law Studies, and scholars are selected by a health law committee through blind peer review. To date there have been 44 scholars, including many contributors to Bill of Health.
We’re excited to introduce and welcome Efthimi Parasidis to our blogging community as a regular contributor.