Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)").  Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention.  On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc.  Over the next few weeks, Patent Docs will examine these amicus briefs.  Here, we review the brief submitted by Paul Gilbert Cole.

In the brief's Statement of Interest, the amicus states that he is "a practising UK and European patent attorney, is a visiting professor in IP Law at Bournemouth University in the UK and has been writing about and teaching patent law for over 35 years."  He is "concerned with the integrity of the legal system and the correctness of the consequential guidance that is given to patent examiners in the USPTO" and in his professional opinion "the panel decision's application of § 101 exceeds the scope of the Supreme Court's § 101 jurisprudence and the scope of Article 27 of the TRIPS agreement."

Mr. Cole makes several arguments.  First, he contends that the panel decision is contrary to controlling Supreme Court and other precedent, citing a dozen cases ranging from Mayo and Myriad to Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911), and Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156 (4th Cir. 1958).  He also argues that it is "based on a legally incomplete and a legally and factually incorrect interpretation of the invention described and claimed in U.S. Patent No. 6,258,540."  The brief then sets forth three "precedent-setting questions of exceptional importance":

(1) Should the context in which a claimed method that involves a newly discovered natural phenomenon be disregarded for the second part of the test in Mayo, so that steps that are known but only in different contexts do not count towards eligibility?
(2) How relevant to the natural phenomenon exclusion of § 101 is a new and beneficial result never attained before and evidencing inventive step under § 103?
(3) Is the second part of the Mayo test applied in the breadth of the Panel Opinion incompatible with the obligations of the United States under Article 27 of TRIPS?

The brief then sets forth Mr. Cole's reasons for urging the court to grant Sequenom's en banc petition.

The first reason Mr. Cole asserts is that the decision will "likely" be the basis of further guidance from the U.S. Patent and Trademark Office.  This is problematic, according to Mr. Cole, because the Office "has a history of over-broad interpretation of Supreme Court and other decisions, which has created widespread difficulty for patent applicants and hence widespread adverse comment from both individuals and organizations."  This tendency should not be encouraged.

Second, Mr. Cole asserts that the District Court and the panel "mischaracterized" the amplified cffDNA as being a natural phenomenon, when instead it should be considered as a manufacture and hence to fall within an expressly recited patent-eligible category of invention according to the statute.  (It could be argued that this rationale underlay the Supreme Court's distinction between patent-ineligible genomic DNA and patent-eligible cDNA in its Myriad decision).  In addition, Mr. Cole argues that the amplification primers are not natural phenomena, because they do not exist in the bloodstream; he further states that "[t]he fact pattern here diverges materially from that in Myriad where neither wild-type BRCA1 nor the corresponding cDNA were reported as having been isolated as real and tangible molecules" (based on the lack of description of actually isolating a BRCA cDNA clone, which while true doe not answer the Section 112 issue: the entire coding sequence was disclosed and it was within the skill of the ordinarily skilled artisan to make such a cDNA clone from the information disclosed in Myriad's patents).  Mr. Cole also argues (citing Learned Hand in Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911)) that the real and tangible oligomer sequences in their amplified form have become for every practical purpose a new thing commercially and analytically (wherein the amplified PCR fragments can be detected visually by ethidium bromide staining, something that the unamplified cffDNA cannot be).  The brief also cites Hartranft v. Wiegmann, 121 U.S. 609 (1887), as that case was cited in support of the Court's Diamond v. Chakrabarty decision, wherein "a change of form accompanied by new utility is the hallmark of a manufacture." 447 U.S. 303 (1980).  Along these lines, the brief echoes the Chakrabarty decision in stating that "[t]he amplified sequences are the product of human ingenuity being a non-naturally occurring composition of matter having (following the wording in Chakrabarty and Myriad) a distinctive name (amplified maternal plasma sequences), character (short oligomer sequences in high and analyzable concentration) and use (analytical detectability) not possessed by maternal cffDNA," and hence that the sequences themselves met the eligibility test and thus negated the panel's basis for applying the Mayo/Alice test.

In the brief's third basis for urging en banc reconsideration, Mr. Cole argues that the panel found patent ineligibility based on a consideration of the claim limitations individually and ignored the Court's exhortation that "ordered combinations" can recite patent-eligible subject matter.  Under a proper application of the law, the brief argues that the "starting point" for the claimed methods was maternal plasma or serum (not cffDNA), and thus the selection of this source "set[s] the claimed method apart from the prior art," citing United States v. Adams, 383 U.S. 39 (1966).  Considered as such an ordered combination, the brief maintains that the claims are directed to "a hitherto unavailable test of high sensitivity for a range of medical conditions that can be applied early in pregnancy and avoids the risks to the fetus inherent in amniocentesis and that revolutionized prenatal care," i.e., something that is patent eligible.

Point four of the brief expands on this assessment of Sequenom's claims as reciting "an ordered combination" by applying the rule from Webster Loom Co. v. Higgins, 105 U.S. 580, 591 (1881), that "if a new combination and arrangement of known elements produce a new and beneficial result, never attained before, it is evidence of invention."  Here, according to the brief, "the claimed combination of starting material and method steps here produced a new and beneficial test for fetal abnormalities and the like [that] is affirmative evidence of invention" and the panel erred in not considering this.

Finally, Mr. Cole cites the conflict of the panel's decision with U.S. treaty obligations including the TRIPS agreement, citing a comment from the Japan Intellectual Property Association to the effect that "the U.S. was introducing special eligibility criteria contrary to the international trend of intellectual property protection."  The brief also cites Article 27.1 of the TRIPS agreement, which the brief asserts is binding on member nations and requires patents to be available "for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application, and that patent rights should be enjoyable without discrimination as to the field of technology."  And the brief cites Art. 52(2)(a)-(d) for the provisions that define unpatentable subject matter in Europe that are limited to those satisfying these criteria:

If a new property of a known material or article is found out, that is mere discovery and unpatentable because discovery as such has no technical effect and is therefore not an invention within the meaning of Art. 52(1) EPC.  If, however, that property is put to practical use, then this constitutes an invention which may be patentable.  To find a previously unrecognised substance occurring in nature is also mere discovery and therefore unpatentable.  However, if a substance found in nature can be shown to produce a technical effect, it may be patentable...."

The brief closes by accusing the panel decision as being "an internationally discordant, not harmonious, result, contrary to the eligibility requirements of TRIPS Article 27," and notes that the European counterpart was challenged on inventive step not eligibility grounds (and was found to satisfy the EPC requirements).

For additional information regarding this topic, please see:

• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Bioindustry Association," September 20, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: WARF, Marshfield Clinic, and MCIS, Inc.," September 17, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: BIO and PhRMA," September 16, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Amarantus Bioscience Holdings, Personalis, Inc., and Population Diagnostics, Inc.," September 15, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Coalition for 21st Century Medicine," September 14, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO," September 8, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), June 22, 2015