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«2014-1139, -1144 United States Court of Appeals for the Federal Circuit ARIOSA DIAGNOSTICS, INC., and NATERA, INC., Plaintiffs-Appellees, and DNA ...»

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2014-1139, -1144

United States Court of Appeals

for the Federal Circuit





Counterclaim Defendant-Appellee,








Appeals from the United States District Court for the Northern District of California in Nos. 3:11-cv-06391-SI, and 3:12-cv-00132-SI, Judge Susan Y. Illston.





INTELLECTUAL PROPERTY 5 Columbia Circle OWNERS ASSOCIATION Albany, NY 12203 1501 M Street, N.W., Suite 1150 (518) 452-5600 Washington, DC 20005 (202) 507-4500 Counsel for Amicus Curiae Intellectual Property Owners Association August 27, 2015


Ariosa Diagnostics, Inc v. Sequenom, Inc.

Nos. 2014-1139, -1144


Counsel for the Amicus Curiae, Intellectual Property Owners Association, certifies

the following (use “None” if applicable; use extra sheets if necessary):

1. The full name of every party or amicus represented by me is:

Intellectual Property Owners Association

2. The name of the real party in interest (if the party named in the caption is not

the real party in interest) represented by me is:

Intellectual Property Owners Association

3. All parent corporations and any publicly held companies that own 10 percent

or more of the stock of the party or amicus curiae represented by me are:

Intellectual Property Owners Association

4. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or agency or are

expected to appear in this court are:

Philip S. Johnson, Kevin H. Rhodes, and Herbert C. Wamsley, Intellectual Property Owners Association; and Teige Sheehan, Heslin Rothenberg Farley & Mesiti P.C.

–  –  –





I. The En Banc Court Should Clarify That a Claimed Invention Must Be Analyzed as a Whole to Determine Its Patent Eligibility

II. The En Banc Court Should Hold That Evidence of a Lack of Undue Preemption Supports a Finding of Patent Eligibility


–  –  –

Cases Alice Corp. Pty. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)

Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015)

Ass’n for Molecular Pathology v. Myriad Genetics, Inc.

133 S. Ct. 2107 (2013)

Bilski v. Kappos, 561 U.S. 593, 130 S. Ct. 3218 (2010)

Diamond v. Chakrabarty, 447 U.S. 303, 100 S. Ct. 2204 (1980)

Diamond v. Diehr, 450 U.S. 175, 101 S. Ct. 1048 (1981)

Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)

Statutes and Rules 35 U.S.C. § 101

Fed. R. App. P. 29

Fed. R. App. P. 35(a)(2)

Fed. Circ. R. App. P. 29

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amicus curiae pursuant to Fed. R. App. P. 29 and Rule 29 of this Court. IPO supports the petition for rehearing en banc filed by Sequenom Center For Molecular Medicine, LLC and Sequenom, Inc. (Sequenom) to clarify the analysis for determining the patent-eligibility of a claimed invention in view of the evolving Supreme Court jurisprudence on patent-eligible subject matter.

–  –  –

Amicus curiae IPO is a trade association representing companies and individuals in all industries and technology fields who own or are interested in intellectual property.1 IPO’s members include over 200 companies and 12,000 individuals involved in the association through their companies or as inventor, author, executive, law firm or attorney members. Founded in 1972, IPO represents the interests of all intellectual property owners. IPO regularly represents its members’ interests before Congress and the United States Patent and Trademark Office (PTO) and has filed amicus curiae briefs in this and other courts on No counsel for a party authored this brief in whole or in part, and no such counsel or party made a monetary contribution intended to fund the preparation or submission of this brief. No person other than the amicus curiae or its counsel made a monetary contribution to its preparation or submission. A Motion for Leave to File as Amicus is being filed with this brief.

significant intellectual property issues. The Appendix lists IPO’s Board of Directors, which approved filing this brief. 2

–  –  –

This appeal presents a question of exceptional importance: how to determine, in view of the extensive recent Supreme Court jurisprudence on the subject, whether a claimed invention includes sufficiently more than patentineligible subject matter and thus is eligible for patenting under 35 U.S.C. § 101, including whether evidence that a claim at issue does not unduly preempt ineligible subject matter is relevant to such an analysis? En banc review is therefore appropriate, see Fed. R. App. P. 35(a)(2), and is of great interest to the patent owning community represented by IPO. IPO urges this Court, sitting en banc to hold that a claimed method must be considered as a whole for purposes of determining patent eligibility, and may not be dissected into its individual steps when considering whether it claims more than routine, conventional, and wellunderstood activity. Further, IPO urges the Court to clarify that evidence that a claim does not unduly preempt use of ineligible subject matter strongly supports a finding that it recites a patent-eligible invention.

–  –  –

I. The En Banc Court Should Clarify That a Claimed Invention Must Be Analyzed as a Whole to Determine Its Patent Eligibility The Supreme Court described a two-step test to determine claimed inventions’ patent eligibility. First, claims are reviewed to determine if they are directed to one of the three categories of patent-ineligible subject matter: laws of nature, natural phenomena, and


ideas. Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014); Mayo Collaborative Servs. v. Prometheus Labs, Inc., 132 S. Ct. 1289, 1296-97 (2012). If so, the claims are then further reviewed to determine whether they contain an additional, inventive concept sufficient to transform them into a patent-eligible application of the ineligible subject matter.

Alice, 134 S. at 2355; Mayo, 132 S. Ct. at 1296-97. 3 The Supreme Court has long held that claimed inventions must be analyzed as a whole in order to determine their patent eligibility. Diamond v. Diehr, 450 U.S. 175, 188, 101 S. Ct. 1048, 1058 (1981) (stating that “a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was Significantly, the Supreme Court did not require this two-step formulation as the only mechanism for evaluating patent eligibility. Rather, the Court has eschewed overly rigid rules for analyzing patent-eligibility in favor of inquiries more attuned to the specific circumstances of each case. Bilski v. Kappos, 561 U.S. 593, 605, 130 S. Ct. 3218, 3227 (2010).

made.”). In Mayo, the Court reiterated the importance of considering claims as a whole as part of the eligibility analysis. 132 S. Ct. at 1298 (analyzing all the steps of a claimed method “as an ordered combination” when evaluating eligibility); see also Alice, 134 S. Ct. at 2355 n.3 (“Because the approach we made explicit in Mayo considers all claim elements, both individually and in combination, it is consistent with the general rule that patent claims ‘must be considered as a whole.’” (quoting Diehr, 450 U.S. at 188, 101 S. Ct. at 1057-58)). Thus, the Mayo Court did not establish some new, heightened requirement that individual elements of an invention must themselves be “inventive.” Nevertheless, since Mayo, courts and the PTO faced with questions of patent-eligibility have not consistently considered claimed inventions in their totality, improperly denying patent protection to deserving inventions. The panel’s decision suffers from the same infirmity of missing the forest for the trees, which will likely proliferate if its decision stands.

The claimed methods at issue here, which the panel agreed “revolutionized prenatal care,” involve making copies of cell-free fetal DNA (cffDNA) from a pregnant woman’s blood and testing it for the presence of fetal genes inherited from the father. 788 F.3d 1371, at 1373-74, 1379 (internal quotation marks omitted). In the first step of its patent-eligibility analysis, the panel held the claims were directed to patent-ineligible natural phenomenon – cffDNA in pregnant women’s blood. 4 788 F.3d at 1376. As to its second step, the panel acknowledged the requirement to consider claim elements both individually and as an ordered combination but then failed to do so. Id. at 1376-77. Rather, after characterizing “the method steps [as] well-understood, conventional and routine” (id. at 1377;

emphasis added), the panel explicitly dismissed the argument that the inventiveness required to confer patent eligibility lay in the inventors’ new ordered combination of steps (id. 1379-80).

In a concurring opinion, Judge Linn stated that the claimed method was “truly meritorious,” “groundbreaking,” a “breakthrough invention,” “deserving of patent protection,” and “nothing like the invention at issue in Mayo,” in large part because, as an ordered combination, it had “never been done before.” 788 F.3d at

1381. Nevertheless, concurring with the panel’s holding, Judge Linn read language from Mayo very broadly, divorced from the claims at issue therein, as “leav[ing] no room to distinguish Mayo from this case,” despite acknowledging the untoward consequences such a broad reading of Mayo would have on the patent regime. Id.

at 1381. Judge Linn further cautioned that applying an overly broad interpretation of language from Mayo could deny patent protection to inventions the Mayo Court Considering that the claims recite a method of detecting and analyzing cffDNA from pregnant women’s blood, not its existence, the panel’s unnecessarily broad conception of when a claim is “directed to” a natural phenomenon in the first step of this analysis also deviates from the analytic framework established by the Supreme Court.

itself explicitly characterized as patent-eligible, a clearly incongruous result. Id. at 1381 (“[D]espite Mayo’s declaration that a claim to ‘a new way of using an existing drug’ is patentable,... it is unclear how a claim to new uses for existing drugs would survive Mayo’s sweeping test.”) (quoting Mayo, 132 S.Ct. at 1302).

Judge Linn’s concerns are very well-founded, but the Mayo decision does not compel the result he laments. The claimed methods at issue in Mayo are distinguishable from the claims at issue here, because even as an ordered combination as a whole, they amounted to nothing more than enunciating a natural law in the context of a process that was already routine practice. See 132 S. Ct. at

1298. The Mayo claims recited administering a drug to a patient and measuring the resulting metabolite levels, wherein metabolite levels outside a defined range indicated a need to change the dose administered. Id. at 1297-98. Because it was already routine for doctors to administer the drug and measure metabolite levels to determine appropriate dosing, with the claims involving nothing more, the Court found the claims ineligible. Id. That method differs starkly from the one claimed here, which even the panel agreed was revolutionary. 788 F.3d at 1379.

The claims at issue here, when considered as a whole, also are distinguishable from the claims that were held to be ineligible for patenting in Ass’n for Molecular Pathology v. Myriad Genetics, Inc. (133 S. Ct. 2107 (2013)).

Although agreeing with Sequenom that its claimed method revolutionized prenatal care, the panel stated that “‘[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.’” (quoting Myriad, 133 S. Ct.

at 2117 (emphasis added)). However, in Myriad, the Court held that isolated genes were laws of nature, such that claims merely reciting them and nothing more were drawn to patent-ineligible subject matter. Myriad, 133 S. Ct. at 2117. In contrast, the claims here recite a use of cffDNA in pregnant women’s blood, not merely its existence. In applying the Myriad Court’s admonition against patenting even a “groundbreaking” discovery of a law of nature, the panel overlooked the real question here: whether the groundbreaking application of a natural phenomenon, as described in a claimed method as a whole, is patent eligible. Indeed, the Myriad court suggests it is. Id. at 2120 (“[A]s the first party with knowledge of the [ineligible subject matter, the patentee] was in an excellent position to claim applications of that knowledge.” (internal quotation marks omitted)).

The panel’s misapplication of the Supreme Court’s jurisprudence on this issue is representative of the difficulties courts and the PTO are often having in properly evaluating patent eligibility since Mayo. As a result, many inventions are improperly being denied protection and there is significant uncertainty among patentees and patent applicants as to the breadth of the judicially created exclusions from patent eligibility. To assist courts and the PTO in the proper analysis of patent eligibility, IPO urges this Court to emphasize how claimed methods must be evaluated as a whole when determining patent eligibility.

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