Patent Eligibility Under Section 101: Has the United States ‘TRIPPED’ Up?

Following my previous article for IPWatchdog on Athena and the refusal of the Federal Circuit to reconsider the case en banc, there remain five relevant questions that were put to the U.S. Supreme Court in an amicus brief in Recognicorp v. Nintendo. These questions plainly deserve an authoritative answer, but none has yet been forthcoming.

Five Questions

1.Can claimed subject-matter which falls as a matter of substance and not mere outward presentation within one of the eligible categories of 35 USC §101 positively enacted by Congress be denied patentable eligibility by a U.S. court using the doctrine of judicial exception without contravening the doctrine of separation of powers?

It is apparent that the eligible categories of Section 101 and the judicial exceptions form distinct and non-intersecting sets, as shown in the Venn diagram below:

There is no objection of principle against invoking the two-part Mayo test to check whether subject matter seemingly falling into one of the four eligible categories in fact falls as a matter of substance into one of the three ineligible categories. However,  invoking a judicial exception against subject matter that falls as a matter of substance within an eligible category amounts to impermissible judicial legislation. See Antonin Scalia and Bryan A. Garner, Reading Law: The Interpretation of Legal Texts, Thompson/West, 2012, pages 93-100, Omitted-Case Canon.

2. Is a court entitled to hold that claimed subject matter falls into one of the judicially excepted categories without considering whether or not it falls into one of the categories positively enacted by Congress as being eligible, the general rule being that exceptions to the positive provisions of a statute are read narrowly in order to preserve the primary operation of the statute?

The Recognicorp brief commented that, in its opinion, the Federal Circuit gave no attention to the positive eligible categories but instead launched immediately into consideration of judicial exceptions under Mayo. That practice is consistently followed in Federal Circuit opinions, positive eligibility analysis being nowadays almost unknown. The recent Athena opinions, on the whole, follow the same pattern. The undesirability of considering only the exceptions to a section of a statute without also considering the positive provisions of that section needs no elaboration. A student at Bournemouth University in the United Kingdom who repeatedly and wilfully followed this approach would not only receive a failing grade, but would be interviewed to discuss his or her aptitude for a career in law. The opportunity to correct this plainly undesirable practice within the Federal Circuit in one that needs to be taken.

3.What scope is attributable to the phrase “directed to” in the first stage of the Alice test, at what level of abstraction is interpretation of a representative claim impermissibly untethered from the express language of that claim, and is an abstraction permissible where it omits reference to elements positively recited in a representative claim?

The words “directed to” lack clear definition, which may account for the risk of inappropriate paraphrasing of specific and detailed claim language leading to unacceptable flexibility, so that the doctrines of patent eligibility risk changing with every succeeding judge or USPTO examiner in a manner reminiscent of John Selden’s jibe published in 1689 that “equity varied with the length of the Chancellor’s foot” (See H. Jefferson Powell, “CARDOZO’S FOOT”: THE CHANCELLOR’S CONSCIENCE AND CONSTRUCTIVE TRUSTS, Law and Contemporary Problems, 56(3), 7-27 (1993).)  Restoration of respect for the “all elements” rule is a precondition for return to a more logical and predictable section 101 regime.

4. Is a new and beneficial result improving a technological process available to rebut an objection that claimed subject matter falls within the law of nature, natural phenomenon or abstract idea exception?

Such results are routinely ignored both in the software arts, as demonstrated by Recognicorp, and in life sciences as evidenced by Ariosa and Athena. The principle of granting patentable weight in cases that involve beneficial ordered combinations is aptly summarized by Justice Bradley in Webster Loom Co. v. Higgins, 105 U.S. 580, 591 (1881): “It may be laid down as a general rule, though perhaps not an invariable one, that if a new combination and arrangement of known elements produce a new and beneficial result, never attained before, it is evidence of invention.” That opinion was cited with approval by Justice Brown in Washburn & Moen Mfg. Co. v Beat-‘Em All Barbed Wire Co., 143 U.S. 275 (1892) and in Carnegie Steel Co. v. Cambria Iron Co., 185 U.S. 403 (1902). Similarly, in KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007), the Court observed of the Adams invention: “The fact that the elements worked together in an unexpected and fruitful manner supported the conclusion that Adams’s design was not obvious to those skilled in the art.” No credible reason has been put forward why new functions or results which suffice under Section 103 should not be equally persuasive under Section 101 or why the specific provisions enacted by Congress under section 103 and recently approved by the US Supreme Court in KSR should be freely and summarily disregarded under section 101.

5. Is the Alice test, as applied in the breadth of the present decisions, incompatible with the obligations of the United States under Article 27 of TRIPS?

In the software arts, it is plainly arguable that the outcome in Recognicorp conflicts with the landmark opinion of the EPO Appeal Board in T 208/84 Computer-related invention/VICOM, where the Appeal Board agreed with the Examining Division that a method of digitally filtering a two-dimensional data array was a mathematical method, but that as a matter of broad general principle, a method for image processing is patent-eligible subject matter under Articles 52(2) and (3) EPC. Corresponding patents were granted for that invention in the U.S. and Canada, and the principles involved would be respected in many other countries. In the Chartered Institute of Patent Attorneys (CIPA) amicus brief in Athena, it was pointed out that the Case Law of the Boards of Appeal of the European Patent Office, 7th Ed. 2013, explains at page 15 that discoveries, scientific theories and mathematical methods excluded under Article 52(2)(a)-(d) EPC share the common feature that they do not aim at any direct technical result but are rather of an abstract and intellectual character, and that:

[i]f 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 unrecognized 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 TRIPS Factor

This statement encapsulates the proper bounds of the exclusion under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Article 27 (on Patentable Subject Matter) and any difference in United States law arises from over-expansive interpretation of Mayo, Myriad, and Alice. The Athena invention was published as WO 01/96601, subsequently granted in Europe as EP-B-1327147 and granted in Canada as Patent No. 2455271.  Quoting from Judge Moore’s dissenting opinion in Athena:

“Since Mayo, we have held every single diagnostic claim in every case before us ineligible… We have turned Mayo into a per se rule that diagnostic kits and techniques are ineligible.”

The view of many U.S. colleagues is that her view is correct, and there is now a per se exclusion of diagnostic method inventions in the United States, which is fundamentally more limited than the subject matter allowable in the European Patent Office and in most other countries worldwide.

Very notably, the Federal Court of Australia recently held Sequenom’s patent for methods of prenatal testing to be valid and infringed, confirming that diagnostic methods which involve the practical application of a natural phenomenon remain patentable in Australia. See Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011. The court held that the conclusion of the U.S. Federal Circuit was problematic and was a result of its dissection of the claims into their constituent parts, which was contrary to National Research Development Corporation v. Commissioner of Patents (1959) 102 CLR 252 (NRDC) and D’Arcy v. Myriad Genetics Inc (2015) 258 CLR 334 (Myriad) [524]. In summary, at [526] that:

The Patent does not simply claim the discovery of cffDNA in maternal blood. Rather, it claims a new and inventive practical application of the discovery comprising a method requiring human action to detect, in an artificially created sample of maternal plasma or serum, a DNA sequence as being of fetal rather than maternal origin. And prior to the invention, no-one had worked or was working a method comprising the detection of cffDNA in plasma or serum samples extracted from pregnant females.

The Violation Must be Corrected to Avoid Complaint

The present U.S. eligibility jurisprudence, and especially that of the Federal Circuit, not only creates serious issues of U.S. domestic law but also arguably places the U.S. in violation of its obligations under the TRIPS treaty with respect to inventions at both ends of the subject-matter spectrum. Acts of Congress, including Section 101, where fairly possible, ought to be construed so as not to conflict with international law or with an international agreement with the United States, particularly where, as with TRIPS, the United States was the moving spirit behind the treaty. See Murray v. The Schooner Charming Betsy, 6 U.S. (2 Cranch) 64, 118 (1804). Although there may have been room for doubt prior to the en banc refusal in Athena and the Australian decision in Ariosa, it is submitted following Judge Moore’s dissent that the situation has become a virtual certainty.

It will be recalled that the TRIPS treaty came into effect in 1995 providing for the grant of patents in all fields of technology. In Europe, partly as a result of the increasing importance of biotechnology and genetic engineering inventions and partly in response to TRIPS article 27 the European Union passed Directive 98/44/EC in July 1998. Recital 12 reads:

“Whereas the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) (5) signed by the European Community and the Member States, has entered into force and provides that patent protection must be guaranteed for products and processes in all areas of technology; …”

See also Article 1 of the Directive which gives over-riding importance to the obligations of Member States under the TRIPS agreement.

The Directive concerns biological material, i.e. any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. Art. 3(2) provides that: “Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.” Furthermore, Art 5(2) provides that an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element, subject to the condition (Art 5(3)) that its industrial application must be disclosed in the patent application. The Directive has been incorporated into the Implementing Regulations of the EPC (Rules 27-29) and into United Kingdom domestic law. The proposition that the EU would have passed this Directive if it had been contrary to what was generally understood at the time to U.S. law defies credibility. There are therefore serious arguments that the Supreme Court opinion in Myriad was at least partly per incuriam since its denial of eligibility to an isolated DNA coding for a BRCA1 polypeptide is inconsistent with the Directive and also arguably contrary to the understanding of the TRIPS contracting states. Compare the Myriad holding with T 1213/05 UNIVERSITY OF UTAH/Breast and ovarian cancer affirming eligibility of nucleic acid probes comprising partial DNA sequences of the human BRCA1 gene which were held to be isolated elements of the human body as defined in r.29(2) EPC and thus patentable subject-matter. It is difficult to see how the categorical exclusion of diagnostic methods presently created by successive decisions of the Federal Circuit can be reconciled with the obligations of the United States to grant patents in all fields of technology.

The interests of Oxford University, a world-famous research institution, have been damaged by the decisions in both Ariosa and Athena. The interests of the equally famous and respected Max-Planck Gesellschaft have also been damaged in Athena. It would therefore seem that there are now grounds of complaint for TRIPS violations open to both the United Kingdom and the German governments. Reliance on U.S. exceptionalism is especially inappropriate and unseemly with reference to the provisions of a treaty that was the result of lobbying by the United States in relation to TRIPS Article 27. Hopefully, once these facts become acknowledged, Congress or the U.S. courts will take appropriate remedial steps before any such complaint need be pressed.

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