In Volume 2, Issue 7 of FDLI’s Food and Drug Policy Forum, authors Karin Gregory of Furman Gregory Deptula and the University of New Hampshire’s Margaret Sova McCabe assert that FDA should view new approaches to food labels, and in particular retailer initiated point-of-purchase (POP) systems, as an opportunity for consumers to individualize and tailor their food purchases to their dietary and health needs. Read more…

How Prometheus Pecks the Liver out of Personalized Medicine
On March 20, 2012, in Mayo Collaborative Services, DBA Mayo Laboratories, et al. v. Prometheus Laboratories, Inc., (“Prometheus”) The United States Supreme Court invalidated two medical diagnostic patents on grounds that the claimed methods subsumed a law of nature, and were, therefore, outside the bounds of patentable subject matter under 35 U.S.C. §101. The consequences of this decision potentially spell doom for an emerging science that promises to revolutionize healthcare in the United States and globally, personalized medicine.

The patents in question covered a diagnostic method for determining whether a dosage of thioguanine compounds would either be too toxic or ineffective for a particular patient, since different patients metabolize these drugs differently and can be expected to have different treatment outcomes at any given dosage. The inventors had discovered parameters for levels of metabolites of these drugs that are predictive of treatment outcomes. The Court decided that how these drugs are metabolized is a law of nature, and that the claimed methods did nothing more than to tell the practitioners to apply this law of nature. What the Court missed was that it was the discovery of the parameters for efficacy that made this unknown law of nature useful in the context of the claimed methods.

Personalized medicine promises to use genotyping and other techniques to determine which individual patients are likely to benefit from a particular medical regimen for a particular disease. This has the potential to dramatically improve efficacy, avoid ineffective treatments and reduce costs in healthcare. By extension, Prometheus would invalidate patents on the diagnostic tests necessary to provide personalized medicine. After all, in the broadest sense, the correlation between a particular genotype and which medical regimen is likely to be efficacious for a particular patient can be construed to be a law of nature, and the diagnostic test would merely instruct the practitioner to apply that law in any given case.

Without the ability to patent these diagnostic methods, the likelihood of raising funding for personalized medicine looks very grim. Pharmaceutical companies have no incentive to fund this research. It is far more profitable to produce and sell a single blockbuster “one-size-fits-all” billion dollar drug than to produce and sell multiple smaller-market drugs that target specific individuals. Thus, private capital is necessary to move personalized medicine forward.

Discovering the parameters that make this unknown “law of nature” useful is time and labor intensive and very costly. Once discovered though, it is easy for anyone to cheaply make a test kit for performing the diagnostic test.

In Bilski v. Kappos, a 2010 Supreme Court opinion, Justice Stevens wrote a “concurring” opinion (supporting the result of the majority opinion, but thoughtfully eviscerating its reasoning) that squarely addressed this issue. Justice Stevens discussed whether a patent monopoly is necessary to “motivate the innovation.” “Although there is certainly disagreement about the need for patents, scholars generally agree that when innovation is expensive, risky, and easily copied, inventors are less likely to undertake the guaranteed costs of innovation in order to obtain the mere possibility of an invention that others can copy. Both common sense and recent economic scholarship suggest that these dynamics of cost, risk, and reward vary by the type of thing being patented. And the functional case that patents promote progress generally is stronger for subject matter that has ‘historically been eligible to receive the protection of our patent laws.’”

Interestingly, the Federal Circuit had already raised this important issue, stating: “Prometheus contends that adoption of the district court’s reasoning would have the effect of eliminating all medical treatment and diagnostic patents, when future medical advances will depend on optimizing treatment based on genetic or other testing.” “A number of amici curiae filed helpful briefs on both sides. …They also argue that the future of personalized medicine will involve knowledge of the physiological or biological significance of biomarkers and how to use them in diagnostic or therapeutic procedures and that patents on those biomarkers should be granted.”

Strangely, Prometheus fails to even discuss the point. By using the sledgehammer of patentable subject matter, rather than the scalpel of obviousness, as urged by the United States as Amicus curie, The Supreme Court has threatened one of the most promising emerging technologies in medicine. Personalized medicine promises to be one of the most important human developments since the tragic Greek figure Prometheus brought fire to humanity. The Supreme Court is giving personalized medicine the same reward Prometheus got. Congress should act, and act now.

More than 300 alumni of the University of New Hampshire School of Law attended the school’s annual alumni dinner March 7, held at the Center of New Hampshire in Manchester. The evening was an emotional one, as UNH Law alumni, faculty and staff gathered to celebrate six faculty members who will retire at the end of the year.

Dean Broderick also honored alumna Karin Gregory JD ’88, who received the school’s inaugural Distinguished Alumni Award, which is presented to a graduate of the school who has demonstrated outstanding professional accomplishment, community service, and support to UNH Law.

Gregory, a former trustee, has spent more than 25 years in the health care field. She currently represents Boston-based life sciences, medical device, and high-technology companies, and she serves as in-house general counsel for the Maine Institute for Human Genetics and Health and several for-profit clients.

Gregory, in receiving the award, offered her own thank you to the retiring faculty. “None of my success would have been possible without the professors being honored tonight,” she said. “I want to thank all of you for the efforts you made on my behalf and on behalf of the people in this room tonight.”

New York recently adopted new legislation (New York Wage Theft Prevention Act) requiring private employers to provide an annual wage notice form to its employees. The form must be given to each new hire and to each current employee between January 1 and February 1 each year.

Click here to read more about this new legislation.

FGD welcomes Emily Danchuk to co-manage the firm’s trademark and copyright practice. She will based in the Biddeford, Maine office.

Ms. Danchuk is an intellectual property attorney with significant experience in business and law. Before joining Furman Gregory Deptula, she managed her own practice for seven years, handling copyright and trademark prosecution and litigation, infringement matters and business and licensing agreements for various types of commercial clients. She has also gained significant experience working with both large and small clients, assisting in various intellectual property-related matters while working as an associate at The Webb Law Firm. She served as in-house counsel for Film Movement, LLC, a film distribution company specializing in independent and foreign films, and as an Associate/Of Counsel and Legal Intern with other New York and Pittsburgh firms. Ms. Danchuk received a J.D. degree from the University of Pittsburgh School of Law and a B.A. degree in dual areas, Political Science and Spanish, from Miami University of Ohio. She is a member of numerous bar associations and legal organizations and is licensed to practice law in New York, Pennsylvania and Maine.

Karin Gregory, Managing Partner, comments, “We welcome Emily as a member of the team to assist our clients in their trademark, commercial and copyright questions. She will also complement our offering to our creative economy clients.”

October 4 & 5, 2011: CAPA system deficiencies counted for nearly one-third of all inspectional observations and were cited in 91 percent of warning letters in 2010, percentages that have increased slightly from the previous five years. The risk of enforcement actions, however, is only one reason for companies to reexamine their CAPA systems.  A properly integrated and well-implemented CAPA program can help improve internal processes and products and better achieve business objectives. Karin Gregory, Speaker & Panelist. Click here for additional information.

FGD congratulates Karin Gregory on her election by The Wells College Alumni Association. The election took place on Saturday, June 4, 2011, during the Wells College Alumnae Association Annual Meeting and the position became official during the Alumnae Weekend Retreat that took place on September 29, 2011, through October 2, 2011. Karin graduated from Wells College in 1980, with a degree in Biochemistry and Psychology.

How to Build the Bioscience Industry in Maine, Navigating through the Federal and State Waters in Uncertain Times. Join Karin Gregory, Managing Partner of FGD and President of Maine Bioscience. Click here for more information.

Visit FGD, Booth #104, while you join businesses to network at the “The Largest Networking Event of the Year”, noon to 6:00pm at the SportZone, 400 North Street, Saco Maine. Sponsored by the Biddeford-Saco Chamber of Commerce. Click here for additional information.

Stop by our Biddeford office to see the work of landscape painter Eileen Foley, at ArtWalk, Friday 5:00 – 8:00pm.