Just last week, the USPTO released its revised subject matter eligibility guidance (2014 Interim Guidance on Patent Subject Matter Eligibility “Interim Guidance” reviewed in my prior post of December 16th, 2014). The Interim Guidance replaced the March 2014 Guidance that was much-criticized for its expansive application of U.S. Supreme Court jurisprudence relating to the judicial exceptions to patent-eligibility: abstract ideas, laws of nature and natural phenomenon. Unlike the March 2014 Guidance (that was not circulated to the public for comment prior to its issuance), the Interim Guidance notes that the USPTO’s analysis of patent-eligibility will be an iterative process continuing with “periodic supplements based on developments in patent subject matter eligibility jurisprudence and public feedback.” Interim Guidance at page 4. Embedded within footnote 5 of the Interim Guidance, the USPTO references an appeal pending before the Federal Circuit – University of Utah Research Foundation v. Ambry Genetics Corp. (In re BRCA1- & BRCA2- Based Hereditary Cancer Test Patent Litigation), No. 14-1361 (Fed. Cir. Filed Mar. 18, 2014 (“Myriad II”) that may impact the USPTO’s Interim Guidance. Interestingly, the next day on December 17th, 2014 the Federal Circuit issued its Myriad II decision (attached here) holding that Myriad’s asserted claims were not patent-eligible. The decision is interesting not only because it evaluates yet more claims from Myriad’s impressive patent portfolio but also because it provides an early test of the USPTO’s Interim Guidance.
The history of the dispute and the oral argument are covered in my prior posts of September 29th and October 20th, 2014, respectively. The claims at issue relate to the tools and methods that support Myriad’s successful BRCA1/2 genetic tests.
Several plaintiffs that include Myriad Genetics, Inc. (collectively “Myriad”) sought to enjoin the alleged infringement by defendant Ambry Genetics Corp. of six claims of three patents: claims 7 and 8 of U.S. Patent No. 5, 753,441 (the ‘441 patent); claims 16 and 17 of U.S. Patent No 5,747,282 (the ’282 patent); and claims 29 and 30 of U.S. Patent No. 5,873,492 (the ’492 patent). The District Court for the District of Utah denied Myriad’s motion for preliminary injunction. Myriad appealed.
Claim 17 of the ’282 patent and claims 29 and 30 of the ’492 patent were considered similar to claim 16 of the ’282 patent.
Slip Op. at page 7.
Slip Op. at page 9.
Slip Op. at page 14.
The Federal Circuit stated that the first step of the methods are not patent-eligible because the steps comprise nothing more than comparing sequences. The court also focused on the breadth of the claims, noting that the covered comparisons were not restricted by the purpose of the comparison or the alteration being detected, and therefore may pre-empt future use outside the field of cancer detection.
Having determined that the first step of the claims were abstract ideas under an Alice analysis, the court then looked at the second step to determine if this step alone or in combination with the first step, transform the patent-ineligible method to a patent-eligible one. The court noted that “[t]here must be a further inventive concept to take the claim into the realm of patent-eligibility.” Slip Op. at page 16.
The Federal Circuit also determined that the use of conventional methods in the second steps, such as sequencing or hybridization, did not add a further inventive concept to the abstract idea embodied by the first steps of the claims.
The court also dismissed Myriad’s argument that the method claims were similar to claim 21 of the ‘441 patent which Judge Bryson suggested was patent-eligible in the Federal Circuit’s earlier 2012 Myriad I decision. Myriad asserted that Judge Bryson indicated that as a first party with knowledge of sequences, they were in an excellent situation to claim applications of that knowledge. The court noted that even if claim 21 was patent-eligible, which the court expressly declined to opine on, the claim was qualitatively different from the method claims at issue in this dispute. The court noted that claim 21 is limited to particular mutations that the inventors had discovered whereas the claims in Myriad II were significantly broader and more abstract, as they claim all comparisons between the patient’s BRCA genes and wild-type BRCA genes.
The USPTO’s Interim Guidance and the Federal Circuit’s recent Myriad II decision appear fairly aligned in their respective application of the Supreme Court patent-eligibility precedent. For claims that relate to a product of nature, the court’s and the USPTO’s analyses consider not only the structural differences between the claimed subject matter and its natural counterpart, but also whether the claimed product exhibits markedly different characteristics from its naturally occurring counterpart in its natural state. Interim Guidance at page 15. However, the USPTO Interim Guidance also notes that if the claimed product does not appear to monopolize or tie-up a judicial exception, it is not necessary to conduct a markedly different analysis. Interim Guidance at page 16. The Federal Circuit’s opinion, in contrast, only evaluated the product claims in terms of structural and functional differences between the claimed material and its natural counterpart.
For claims that may related to natural phenomenon or an abstract idea, the current opinion and the Interim Guidance similarly note that the claim elements must be evaluated to determine whether the elements of the claim, considered in both individually and as an ordered combination, are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself. Interim Guidance at page 20. The Interim Guidance and the Federal Circuit each look to whether a claim contains elements in addition to the judicial exception that amount to significantly more that the judicial exception itself, and that the claim does not monopolize the exception. Interim Guidance on page 21.
The USPTO Interim Guidance is less restrictive in its approach to patent-eligibility. Application of the Interim Guidance is anticipated to allow patenting of more nature-based inventions as compared to the 2014 Guidance. However, even with the Interim Guidance, it is clear that the Federal Circuit will not find broad, expansive claims that relate in whole or in part to a judicial exception to subject matter eligibility to be valid and patent-eligible. Thus, challenges remain and patentees should continue to pay careful consideration to the USPTO’s Interim Guidance and the evolving jurisprudence involving subject matter eligibility.