July 29, 2013

Post-AMP, Myriad Files Patent Infringement Suits Against BRCA1 and BRCA2 Testing Competitors

Several developments have followed last month's Supreme Court decision that invalidated Myriad Genetics patent claims to isolated genes; (AMP v. Myriad opinion). Within hours of the Court’s decision, several competitors announced plans to offer BRCA1 and BRCA2 genetic tests. Myriad has recently filed patent infringement suits against Ambry Genetics (California) and Gene by Gene (Texas), based on the assertion of patent claims from ten patents it holds to BRCA1 and BRCA2 related genetic materials and methods (including some with contested claims in the Supreme Court). The complaint against Ambry is here; the complaint against Gene by Gene complaint is here. The suits, filed in Utah federal court, could be an opening play to fully litigate these other patents or a maneuver to create licensing structures for these patented materials and methods. A strategy by Myriad to obtain a preliminary injunction against these companies would have to contend with the more rigorous scrutiny for such requests after eBay v. MercExchange (2006), where the Supreme Court reaffirmed the need to consider "public interest" in the award of injunctions, and the current climate might lend support for such an argument against any injunction. Ambry has indicated that it will “vigorously defend” its right to offer testing services.The Court’s invalidation of some of Myriad’s patent portfolio related to BRCA1/2 testing has clearly led to altered expectations regarding the state of the genetic testing marketplace. Evidence of this is the response from Senator Patrick Leahy, Chair of the Senate Judiciary Committee, to Myriad’s lawsuit, calling for the National Institutes of Health (NIH) to exercise “march-in” rights that it holds pursuant to the Bayh-Dole Act of 1980. That option applies to patents for which NIH provided federal funding (or other federal agencies). Apart from the march-in authority, the U.S. government retains a default mechanism, a compulsory license that allows it to use any patented invention (or authorize 3rd parties to do so) under the statutory authority of 28 U.S.C. 1498, which requires “reasonable and entire compensation for such use and manufacture.” Since the march-in authority has never been exercised by the NIH (see here), it is unlikely to respond to Leahy’s call. Nor is it likely that the government would regard the BRCA1/2 genetic testing controversies as critical enough to trigger the compulsory license mechanism. These disputes are likely to be settled more informally, and more quickly, as the high visibility of these tests will retain public attention and maintain pressure on Myriad to support the expansion of genetic testing options.

July 1, 2013

Connecticut and Maine Enact Genetically Engineered Food Labeling Laws But Delay Effect

Connecticut and Maine have become the first states to pass laws mandating the labeling of foods with genetically engineered (GE) ingredients (Maine law; Connecticut law). The laws, however, are conditional in that they will not take effect until a critical mass of similar laws is enacted by other states; thus, they remain pending in actual effect. The battles over the labeling of GE food have continued for years, with efforts at state and national levels (see here and here). Maine will mandate the phrase “Produced with Genetic Engineering" and the Maine law contains this synopsis: 
This bill requires disclosure of genetic engineering at the point of retail sale of food and seed stock and provides that food or seed stock for which the disclosure is not made is considered to be misbranded and subject to the sanctions for misbranding. The bill provides that food or seed stock may not be labeled as natural if it has been genetically engineered. The bill exempts products produced without knowledge that the products, or items used in their production, were genetically engineered; animal products derived from an animal that was not genetically engineered but was fed genetically engineered food; and products with only a minimum content produced by genetic engineering. The bill also provides that the disclosure requirements do not apply to restaurants, alcoholic beverages or medical food. 
The Maine law embeds the following trigger: it “goes into effect when five other states, or any state, or states with a total population of 20 million people, enact labeling requirements for genetically modified (GM) foods.” The Connecticut law dictates labeling “in the case of such food for retail sale contained in a package, with the clear and conspicuous words: "Produced with Genetic Engineering." Here is a similar trigger in Connecticut, activating the law in a year where the following conditions occur: 
(1) Four states, not including this state, enact a mandatory labeling law for genetically-engineered foods that is consistent with the provisions of this subsection, provided one such state borders Connecticut; and (2) the aggregate population of such states located in the northeast region of the United States that have enacted a mandatory labeling law for genetically-engineered foods that is consistent with this subsection exceed twenty million based on 2010 census figures. 
The northeast region defined in the Connecticut law consists of Maine, Vermont, New Hampshire, Massachusetts, Rhode Island, New York, New Jersey and Pennsylvania. It could be argued that the approach of Maine and Connecticut to a GE food labeling law – not with immediate effect, but conditional on other political developments – can recruit support from hesitant politicians because it remains aspirational. That might encourage other states to follow suit. At the federal level, the Genetically Engineered Food Right-to-Know Act, has been introduced to mandate a federal scheme for GE food labeling; such bills have been introduced for years in Congress. Prospects for federal legislation, however, remain dim.