Myriad’s Continuing Patent Debate

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On October 6, 2014, the U.S. Court of Appeals for the Federal Circuit entertained oral argument in the interlocutory appeal of the district court’s denial of Myriad’s motion for preliminary injunction against Ambry Genetics. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. If you missed oral argument, the parties’ Supplemental Briefs filed in late September set forth some of the key points raised during oral argument. My prior post of September 29, 2014 summarizes the status of the dispute and the parties’ positions on patent-eligibility.

Myriad and Alice

Myriad focused its Supplemental Brief on the application of the U.S. Supreme Court’s most recent patent-eligibility opinion, Alice Corp. Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014) (“Alice”),arguing that application of Alice confirms the patent-eligibility of Myriad’s contested claims. According to Myriad, Alice’s two-part test asks (1) is the claim directed to one of the three categories of unpatentable subject matter, and if the answer to the first question is yes, then (2) do the claim elements both individually and as a whole recite “enough” to transform the unpatentable subject matter into a patent-eligible application? Myriad Supplemental Brief at page 1.

In applying Alice, Myriad notes that the district court failed to apply the test to the claims as a whole. Indeed, Alice explicitly “reiterates the importance of looking at the claims as whole and expressly confirms the rule in Diehr [Diamond v. Diehr, 450 U.S. 175 (1981)].” Myriad’s Supplemental Brief at page 7. Rather, the district court separated anything related to the BRCA genes from the claims and then found the remaining claim elements routine and conventional in the abstract.

The Primer Claims

Myriad first asserts that the claims directed to primer pairs are not directed to a “product of nature” because the pair is structurally and functionally different than a single fragment of DNA, that was found to fail Section 101 in the Supreme Court’s Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (“AMP”). Myriad argues that the coordinated pair is not found in nature (even in un-isolated form) and that the primers work together to prime a PCR reaction – a reaction that does not occur in the human body.

The Method Claims

Myriad’s claims to detecting BRCA1/2 mutations are noted to rely on specific techniques for the mutation detection and therefore yield valuable diagnostic information to the benefit of patients. In applying the Alice two part test, Myriad argues that that steps of the method claims, when considered together, effect an improvement in a technical field – by using Myriad’s probes and primers that Myriad invented. As such and in particular claims 7 and 8, are applications of Myriad’s knowledge of the BRCA sequences.

Ambry and Alice

The Primer Claims

In contrast, Ambry argues that the primer claims are patent-ineligible because, in addition to reciting patent-ineligible products of nature, the claims fail under Alice because they are a generic component (i.e., natural BRCA sequence) used to amplify a person’s gene sequence to access the sequence information for the patent-ineligible sequence comparison.

The Method Claims

Ambry’s argues that under Alice, the combination of unpatentable subject matter and a generic physical application is no more patent eligible than a claim reciting only the unpatentable subject matter.” Ambry Supplemental Brief at page 3. As applied to Myriad’s method claims, they argue, the additional steps are merely conventional and generic – e.g., generic steps of, hybridization, amplifying, and sequencing. Ambry also counters Myriad’s arguments that their claims are the application of knowledge discovered from the sequencing the BRCA genes and notes that Alice (and other precedents) precludes such distinction between the knowledge itself and its application. Therefore, Ambry argues that the human action of sequencing, hybridizing or amplifying BRCA DNA does not make the patent ineligible subject matter, patent eligible.

A Single Test?

As this case illustrates, the Federal Circuit has the challenge of developing a workable test to determine patent-eligibility, without regard to the exclusionary category of the claim. It is difficult to apply precedent developed to address an “abstract idea” (Alice) to claimed methods (laws of nature) or claimed products (products of nature). The question is then, whether one test is appropriate to determine patent-eligibility without regard to the particular technology. Perhaps, that is the first issue the Federal Circuit will address for the parties to this dispute and for the benefit of clearer guidance for the public.

FDA Issues Draft Guidance for Regulation of LDTs

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On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance“). The publication of the draft Guidance is the next step in FDA’s implementation of its risk based approach to oversight of LDTs. In addition to noting FDA’s intention for bringing under its review many devices or tests that previously were exempt under the FDA’s enforcement discretion, the FDA’s draft Guidance also imposes new requirements, such as registration and notice, for all LDTs. Continue reading this entry

Privacy Issues in the Sharing of Genetic Information

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Low cost sequencing of a patient’s genome and advances in the interpretation of a patient’s genetic information is promised to transform the delivery of health care. To date, much of personalized medicine has focused on the use of genetics and data analytics to match a patient to the best treatment, especially in the area of oncology. However the use of genetics and data analytics is moving into the design of clinical trials, the validation of biomarkers, and point of care diagnostics. Thus, there is a growing interest in the aggregation, analysis, and use of a patient’s genetic information for commercial and research purposes. However, in the United States, the use of such information depends on a variety of state and federal privacy laws. Continue reading this entry

Myriad Set for Another Round

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On Monday, October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad’s BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. In the words of Myriad “[t]his appeal … presents this Court with one of the most basic issues under patent law: should Myriad be able to enforce its patents to enjoy its remaining exclusivity or does section 101 of the Patent Act effectively say that Myriad can patent almost nothing related to its ground-breaking discovery?” Myriad Opening Brief (“Opening”) at page 4. In addition to responding to Myriad’s query regarding its patent estate, the Federal Circuit’s review has the potential to provide much needed clarity for diagnostic innovators and patent holders, as well as the U.S. Patent and Trademark Office, regarding the scope and reach of the U.S. Supreme Court’s recent patent-eligibility decisions. Continue reading this entry

FDA's Proposed Oversight of Laboratory Developed Tests - Industry Impact

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The U.S. Food and Drug Administration (FDA) recently announced that the Agency is lifting its enforcement discretion over high-risk laboratory developed tests (LDTs). The FDA’s “LDT Guidance” was reviewed in detail in my prior post of August 4th, 2014. In brief, the LDT Guidance proposes a risk-based, phased-in framework for oversight of LDTs that is in accordance with FDAs current regulation of in vitro diagnostic devices (IVDs). The LDT Guidance creates uncertainty for diagnostic innovators and providers of LDTs. What tests will be subject to enhanced oversight? How will innovators adapt to increased regulation? What additional reporting requirements will be required by FDA? Continue reading this entry