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By Rachel Sachs

On Thursday, the FDA finally began to take an action that it had been publicly contemplating for over four years: the regulation of laboratory-developed tests (LDTs). In the FDA’s words, LDTs are diagnostic tests which are “designed, manufactured and used within a single laboratory.” There are thousands of LDTs, including very high-profile ones, such as Myriad Genetics’ test for assessing breast cancer risk. Although these diagnostic tests fall under the Federal Food, Drug, and Cosmetic Act’s (FDCA) definition of “medical device,” the FDA has for decades stated it was exercising its enforcement discretion in declining to regulate LDTs. (The FDA has exercised its regulatory powers over diagnostic tests that are designed and manufactured by one laboratory and sold to another for use.)  Although the official draft guidelines have not yet been released, the FDA’s report regarding their anticipated contents suggests that regulation of LDTs will follow a risk-based framework similar to the one in place now for other medical devices.

Much (though not all) of the relevant industry opposes the FDA’s actions here, and it’s easy to see why. Many of these LDTs would now be subject to premarket review, or at the very least additional reporting requirements, which make the development of these tests both riskier and more expensive.  Some firms argue that the FDA lacks jurisdiction to regulate LDTs, but they also argue that their LDTs are already sufficiently regulated by the Clinical Laboratory Improvement Amendments (CLIA), under the auspices of the Centers for Medicare and Medicaid Services. But here’s the problem: CLIA and the FDCA regulate different aspects of LDTs. And it can be detrimental to patient health to leave the FDCA aspects of LDTs unregulated.

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By Rachel Sachs

Last month, as it wrapped up the 2014 Term, the Supreme Court decided a patent law case that could have a major impact on method patents in the medical arena. No, I’m not talking about Alice Corp. v. CLS Bank, the most Rorschach-like of the Term’s many patent opinions. I’m talking about Limelight Networks v. Akamai Technologies, Inc., in which the Supreme Court unanimously reversed the Federal Circuit’s ruling on the scintillating question of divided infringement under 35 U.S.C. § 271(b).

In Limelight, a splintered en banc decision, a majority of the Federal Circuit had overturned prior case law in ruling that liability for induced infringement of a method claim under § 271(b) was possible where no single entity had performed all the steps of that claim, but where those steps were divided between two or more parties, one of whom had induced the other(s) to infringe. (Previously, various opinions had held that induced infringement under § 271(b) required a single actor, just like direct infringement under current § 271(a) precedent.) In a unanimous opinion by Justice Alito, the Supreme Court reversed, essentially reinstating the single entity rule by holding that direct infringement under § 271(a) is required for inducement liability under § 271(b). Read More