Why Are Method of Treatment Claims and Method of Manufacture Claims Subject to Scrutiny Under the USPTO Patent Subject Matter Eligibility Guidance?

15 July 2014 PharmaPatents Blog

The USPTO has asked for written comments on its patent subject matter eligibility guidance by July 31, 2014. In this article, I discuss why therapeutic method claims and method of manufacture claims should not be subject to scrutiny under the USPTO’s multi-factored § 101 analysis.

The USPTO Guidance

Under the USPTO’s ”Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, and Natural Products” issued on March 4, 2014, all claims directed to methods that “recite or involve” a “natural product” are subject to scrutiny under § 101. In particular, the Guidance instructs examiners to determine whether the claims recite elements or steps in addition to the natural product that demonstrate that the claimed subject matter as a whole is “significantly different” from the product of nature. However, no Supreme Court decision undermines the patent eligibility of a method claim simply because it recites the manipulation or use of a natural product.

Supreme Court Guidance

In Myriad, the Supreme Court made clear that it was not addressing the patent eligibility of method claims:

It is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. ….

Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications.”

In Funk Brothers, the the Supreme Court made clear that it was not addressing the patent eligibility of method claims:

We do not have presented the question whether the methods of selecting and testing the non-inhibitive strains are patentable.

Even in Prometheus the Supreme Court distinguished the claims at issue from typical method of treatment claims:

Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims [here] do not confine their reach to particular applications of those laws.

Moreover, in each of the recent patent subject matter eligibility cases (Prometheus, Myriad, and Alice), Supreme Court has approached the exceptions to patent eligibility with caution. As the Court stated in Prometheus, for example:

The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscer­ate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas. Thus, in Diehr the Court pointed out that “‘a process is not unpatentable simply because it contains a law of nature or a mathematical algorithm.’” …. It added that “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent ­protection.”

So then, why does the USPTO Guidance sweep in two categories of subject matter that have not been held ineligible by the Supreme Court?

Method of Treatment Claims

The analysis of Example B, claim 3, of the USPTO Guidance has left examiners believing that only very detailed therapeutic method claims are patent eligible:

3. A method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.

Instead of going through its multi-factored analysis, the Guidance should explain that this claim satisfies § 101 because a “new way of using a drug” is patent eligible subject matter.

Method of Manufacture Claims

The USPTO Guidance does not include any examples of method of manufacture claims, but examiners are subjecting such claims to the multi-factored analysis if the claims recite the use of “natural products.” While such claims should satisfy at least factor (e) (“transformation of a particular article”), because the Guidance instructs examiners to identify elements in addition to the natural product(s) that support eligibility, claims that recite only the manipulation of natural products are being rejected.

I can’t even think of a Supreme Court case close enough to distinguish. In Prometheus, Diehr, and Flook, for example, the method claims were subject to scrutiny not because they involved the manipulation of natural products, but because the inventions were focused on a natural phenomenon, algorithm, or mathematical principle. Because method of manufacture claims are not directed to any category of subject matter that the Supreme Court has held ineligble for patenting under § 101, such claims should not be subject to scrutiny under the Guidance.

Submit Your Comments by July 31

If you agree that the USPTO Guidance goes too far and holds ineligible subject matter that the Supreme Court would not invalidate, please consider submitting written comments by July 31, 2014, by email to myriad-mayo_2014@uspto.gov.

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