During FDLIs Annual Conference in Washington DC, Karin Gregory officially joined the Food and Dietary Supplements Committee. The Committee advises FDLI staff in formulating and implementing policies and strategies consistent with FDLI’s mission, relating to programs and publications of interest to the food and dietary supplement industries. The Committee advises staff on the appropriateness of conferences and publications relating to foods and dietary supplements by reviewing and commenting on proposals.

As a non-profit organization, FDLI’s mission is to provide education, training, and publications on topical food and drug law; act as a liaison to promote networking as a means to develop professional relationships and idea generation; and ensure an open, balanced marketplace of ideas to inform innovative public policy, law, and regulation. For more information click here.

FGD’s New Address in Boston
Effective April 1, 2013 Furman Gregory Deptula’s Boston office moves to a new location. Please visit us at our new address:

Furman Gregory Deptula
100 Franklin Street, 7th Floor
Boston, MA 02110

New phone numbers:
617.275.4225
857.233.4150 fax

“Big Box” Theft Culture
Intellectual property infringement has become increasingly prevalent, even in our own country. Although the word “infringement” conjures up visions of Chinese factories and dusty marketplaces in India, the practice has become a striking and integral part of many U.S. companies’ business models, to the significant detriment of small businesses and independent artisans.

Click here to learn more about infringement and how to protect your intellectual property rights.

Understanding the JOBS Act
The Jumpstart Our Business Startups Act, or JOBS Act, was signed into law by President Obama in April 2012 to ease federal regulations to encourage small business and start-up funding, permit companies to remain private for a longer period of time and, alternatively, make it easier for companies to go public, and reduce the regulatory burdens on certain public companies.

Click here for further information on key provisions of the legislation, and their effect on companies looking to raise funds.

Interim Guidance and Request for Comments; Medical Device Excise Tax; Manufacturers Excise Taxes; Constructive Sale Price; Deposit Penalties
Notice 2012-77 provides interim guidance relating to the excise tax on medical devices imposed by section 4191 (the “medical device excise tax”). Specifically, this notice provides interim guidance for determining price under section 4216(b). This notice also provides interim guidance relating to donated taxable medical devices, the licensing of taxable medical devices, and the tax treatment of medical convenience kits. In addition, this notice provides transition relief to medical device manufacturers from the failure to deposit penalties imposed by section 6656. Finally, this notice requests comments from taxpayers about the rules described in this notice. Read Notice 2012-77 now.

Furman Gregory Deptula welcomes new Partner, Nicholas P. Alexander. He will based in the firm’s Boston office.

An accomplished litigator in the area of business, commercial, intellectual property and general liability law, Mr. Alexander represents business in state and federal courts throughout the Commonwealth and in jurisdictions throughout the country in areas such as complex commercial litigation, intellectual property, including licensing, copyright, trademark and trade secrets, technology law and business disputes of all types including employment law, class actions, product liability and technology law. He has lectured before various bar and trade associations and has served as a senior editor of the Massachusetts Law Review, one of the oldest law review journals in the country and a journal frequently cited as legal authority by courts of many jurisdictions.

Test Caption

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.