Amicus Briefs in Support of Sequenom's Petition for Certiorari: Eli Lilly and Company et al.

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In March, following the Federal Circuit's denial of Sequenom's petition for rehearing en banc, Sequenom filed a petition for certiorari for Supreme Court review of the Federal Circuit's decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc.  In response to that petition, twenty-two amicus briefs were filed encouraging the Supreme Court to grant certiorari.  With the Court scheduled to consider Sequenom's petition in conference next Thursday, Patent Docs will examine selected amicus briefs in the coming week.  Today, we review the amici curiae brief submitted by Eli Lilly and Company, Eisai Inc., Upsher-Smith Labroatories, Inc., Pfizer Inc., and Etiometry, Inc.

The amici begin by noting that the Supreme Court has applied a nonstatutory "implicit exception" to patentability to ensure that patents cannot be granted for "concepts" (which, according to the amici, refer to laws of nature, natural phenomena, and abstract ideas), and that "[t]he Court has applied the implicit exception as part of a 'threshold test' for patentability that operates before other patentability requirements may be considered."  The amici contend, however, that the implicit exception "does no more than duplicate the [Patent Act's] effects when statutory provisions would also invalidate the same patent," and ask:

Given the current explicit statutory limitations on patenting in the Patent Act—and the proper interpretation of those limitations—should the Court's judicially imposed implicit exception to subject matter considered to be eligible for patenting be abrogated, such that patentability and patent validity are to be determined solely under such explicit statutory provisions?

Citing the amicus brief of Paul Gilbert Cole, the amici point out that "[t]he most pointed criticism of the Court's implicit exception is that the Court's recent jurisprudence has expanded the reach of the exception such that today it applies to invalidate U.S. patents that would be clearly eligible for patenting under international norms."  The amici note that the analytical framework devised by the Court for applying the threshold test for patentability is "intended to operate as a surrogate for the broader policy question of whether a patent claim is so conceptual that rights under the patent might dominate or otherwise preempt access to a law or product of nature, a natural phenomenon, or an abstract idea."  The amici suggest, however, that "[l]ike many surrogate tests, it risks overreaching its policy objectives."  Stating that "the Court has never considered whether the proper interpretation of the current statutory requirements, considered together rather than piecemeal, would fully address the policy considerations that caused the Court to mandate the non-statutory implicit exception," the amici argue that "it is now essential as an exercise of judicial restraint for the Court to consider whether to abrogate the implicit exception in deference to the present explicit statutory scheme" (emphasis in brief).

The amici spend the remaining pages of their brief explaining how the statutory patentability requirements prevent valid claims from protecting or dominating a law of nature, natural phenomenon, or abstract idea, or covering or otherwise precluding access to naturally-occurring subject matter.  Noting that 35 U.S.C. § 101 requires that a valid claim must be drafted in terms of a "process, machine, manufacture, or composition of matter" or an improvement thereto, the amici contend that "[t]hese four statutory categories, by forcing valid patent claims to be expressed in terms of the applications that physically embody an invention, represent subject matter that is mutually exclusive with respect to mere concepts—such as laws, phenomena, and ideas."  According to the amici, "the patent statute explicitly limits patenting to physical embodiments, things and act-based processes that can only ever be applications of any related concept and can never be the concept itself" (emphasis in brief).  The amici argue that when 35 U.S.C. §§ 101, 103 and 112(a) are considered together, these statutory requirements, which limit valid patent claims to inventive and useful applications of any related concept, "operate to limit valid patent claims to inventive and practically useful applications of any law, phenomenon, or idea to which a claimed invention relates" (emphasis in brief).

The amici acknowledge, however, that "[w]hile these various statutory provisions address whether valid patent claims can literally cover a law, phenomenon or idea, they do not necessarily foreclose resort to patent drafting techniques that might be used to craft valid patent claims preempting access to such concepts."  Nevertheless, the amici argue that "[t]he Patent Act of 1952 contains two provisions that, if properly interpreted and applied, fully negate the potential effectiveness of such drafting techniques: § 112(a) and § 112(f)."  According to the amici, "the combination of § 112(a) and § 112(f) forecloses the possibility that patent drafting techniques might secure protection over a concept to which an invention relates beyond the physical embodiments of the invention as set out in terms of the specific structures, materials, or acts disclosed in the patent."

With respect to the statutory requirement for novelty, the amici argue that this requirement -- and more specifically the "inherent anticipation" aspect of this requirement -- "bars the patenting of any subject matter that exists or operates in nature," and "assures that patent rights cannot impair access to the basic tools of science or technology or in any other way impede the ability of the patent system to promote progress in the useful arts."

The amici conclude their brief by declaring that:

Interpreting the current statutory provisions in a manner consistent with the Court's precedents makes it impossible to identify any scenario under which a valid patent could provide protection for a law of nature, a natural phenomenon, or an abstract idea—either directly or through drafting techniques aimed at yielding a valid patent claim that might dominate or otherwise preempt access to such a law, product, phenomenon, or idea.  The same applies with respect to patents relating to entirely mental processes and products of nature.

Given the manifest difficulties that the implicit exception presents to the proper functioning of the patent laws, the Court should address whether judicial restraint now dictates deference to the statutory framework.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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