Do Pharmaceutical Compositions Have Patent Subject Matter Eligibility Under the New USPTO Guidelines?

10 March 2014 PharmaPatents Blog

The USPTO’s new patent subject matter eligibility guidelines  (the “Guidelines”) include examples that apply the multi-factored analysis mandated by the Guidelines to compositions that include one or more “natural products” as a component. Do these examples indicate that pharmaceutical compositions with an active ingredient that can be obtained from a natural source no longer can be patented?

The USPTO’s Definition of “Natural Product”

The Guidelines provide this information on the meaning of “natural product”:

[N]atural product includes, but is not limited to: chemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature.

The Guidelines take the position that “a product claim reciting something that initially appears to be a natural product” is directed to patent eligible subject matter only if the claimed product “is determined to be non-naturally occurring and markedly different in structure from naturally occurring products.”

Drawing from the Myriad Supreme Court decision, the Guidelines explain that not all structural differences rise to the level of “markedly different,” because while “isolating a nucleic acid changes its structure (by breaking bonds)” isolated DNA “is not markedly different from the chromosomal DNA because its nucleotide sequence has not been changed.” On the other hand, the guidelines note that “[t]he fact that a marked difference came about as a result of routine activity or via human manipulation of natural processes does not prevent the marked difference from weighing in favor of patent eligibility.”

(Please see this article for a more detailed review of the Guidelines and the factors to be considered when assessing patent eligibility.)

The USPTO Examples of Composition Claims Reciting Multiple Natural Products

Examples D and E of the Guidelines relate to composition claims reciting multiple “natural products.”

Example D (based on Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948)):

Claim: An inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.

Background: Rhizobium bacteria are naturally occurring nitrogen-fixing bacteria. While it was assumed in the prior art that all Rhizobium species were mutually inhibitive, the Applicant had discovered that there are particular strains that do not exert a mutually inhibitive effect on each other, and sought to patent mixtures of such strains.

Based on the Supreme Court decision in Funk Brothers, the Guidelines hold that this claim is not patent-eligible. Applying the Guidelines factors, the example explains, “none of the natural products recited in the claim are markedly different.” Rather, “[t]he specification describes that applicant has not changed the bacteria in any way, but instead has simply combined various strains of naturally occurring bacteria together.” No other factors support patent eligibility “because the claim does not include any elements in addition to the natural products, i.e., there is nothing in the claim other than the bacteria.”

Example E:

Claim 1: A pair of primers, the first primer having the sequence of SEQ ID NO: 1 and the second primer having the sequence of SEQ ID NO: 2.

Background: SEQ ID NOs: 1 and 2 are naturally occurring DNA sequences found on a human chromosome.

The Guidelines hold that this claim is not patent eligible, because, although the recited primers “are isolated nucleic acids,” that structural difference “is not significant enough to render the isolated nucleic acid markedly different, because the genetic structure and sequence of the nucleic acid has not been altered.” The Guidelines also note that “the claim does not include any elements in addition to the natural products.”

The Guidelines also discuss the function of the recited primers, stating “the first and second primers have the same function as their natural counterpart DNA, i.e., to hybridize to their complementary nucleotide sequences.”

Is this taking too narrow a view of the function of the primers? While both primer DNA and naturally-occurring DNA hybridize to complementary nucleotide sequences, the primers can function to amplify target DNA (as recited in claim 2 of Example E). Isn’t that a significantly different function than the natural function of naturally-occurring DNA?

The USPTO Examples of a Manufacture Claim Reciting Natural Products

Example C of the Guidelines considers a claim directed to an article of manufacture that includes natural products:

Claim: A fountain-style firework comprising: (a) a sparking composition, (b) calcium chloride, (c) gunpowder, (d) a cardboard body having a first compartment containing the sparking composition and the calcium chloride and a second compartment containing the gunpowder, and (e) a plastic ignition fuse having one end extending into the second compartment and the other end extending out of the cardboard body.

Are you surprised that such a claim would even trigger a patent eligibility analysis? The Guidelines characterize the calcium chloride  as a “natural product” and the gunpower as a mixture of “natural products.”

The Guidelines explain that this claim is directed to patent eligible subject matter “because the claim as a whole recites something significantly different than the natural products by themselves, i.e., the claim includes elements in addition to calcium chloride and gunpowder (the sparking composition, cardboard body and ignition fuse) that amount to a specific practical application of the natural products.”

In this regard, the Guidelines state, “the claimed elements in addition to the calcium chloride and gunpowder narrow the scope of the claim so that others are not foreclosed from using the natural products in other ways, e.g., others can still use calcium chloride in products such as concrete, foods, fire extinguishers, etc., and can still use gunpowder in other products such as rifle cartridges.” The Guidelines also note that the fact that “the combination of the claimed elements forms a structure into which the calcium chloride and gunpowder are physically integrated” supports patent-eligibility. The Guidelines note further that “the claimed elements are not recited at a high level of generality, but instead are recited with specificity such that all substantial applications of the natural products are not covered,” and that “the claimed elements … are substantial limitations that integrate the calcium chloride and gunpowder into a specific application as opposed to being mere fields of use.”

Reckoning With Funk Brothers

The treatment of compositions in the Guidelines reflects a reckoning with the problematic Supreme Court Funk Brothers decision. Although there had been some debate as to whether Funk Brothers was a patent eligibility case applying principles codified in § 101 or a patentability case applying principles codified in § 103, since the Supreme Court’s Myriad decision cites Funk Brothers in the context of patent eligibility, we must accept Funk Brothers as a § 101 case, at least for now. However, Funk Brothers should not be interpreted and applied in a vacuum, and must be considered in the context of the Supreme Court’s patent eligibility jurisprudence as a whole, including Diamond v. Chakrabarty, 447 U.S. 303 (1980), where the Court held that genetically engineered bacteria were patent eligible as “nonnaturally occurring manufacture or composition of matter—a product of human ingenuity ‘having a distinctive name, character [and] use.’” Id., at 309–310 (quoting Hartranft v. Wiegmann, 121 U. S. 609, 615 (1887); alteration in original).

Thus, while the USPTO’s Guidelines focus on the structural differences that were lacking Funk Brothers, it may have overlooked the importance of functional differences that were relevant in Chakrabarty.

Do Pharmaceutical Compositions Have Patent Eligibility Under the New USPTO Guidelines?

A typical pharmaceutical composition claim might read as follows:

A pharmaceutical composition comprising Drug X in a pharmaceutically acceptable carrier.

Before the new Guidelines were issued, such a claim would not have raised patent eligibility issues, because the claimed composition is “a nonnaturally occurring manufacture or composition of matter,” in accordance with Chakrabarty. However, because the mixture at issue in Funk Brothers also was a “nonnaturally occurring manufacture,” the USPTO may apply its patent eligibility analysis to pharmaceutical composition claims.

If Drug X is a “natural product,” e.g., a compound that can be isolated from a natural source, then the analysis may turn on whether providing Drug X in a pharmaceutically acceptable carrier “imposes meaningful limits on claim scope” or is deemed to be a “conventional” element “recited at a high level of generality.”

The Guidelines suggest that the answer could depend on whether there are non-pharmaceutical uses of Drug X. For example, the recitation of a pharmaceutically acceptable carrier could be found to “imposes meaningful limits on claim scope” because others still could use Drug X as long as they do not formulate it with a pharmaceutically acceptable carrier. On the other hand, if the only known use of Drug X is for pharmaceutical purposes, the recitation of a pharmaceutically acceptable carrier could “amount to nothing more than a mere field of use.”

This example underscores the complexity of the new patent eligible subject matter inquiry.  Not only does patent eligibility turn on the state of the art (for the “well-understood, routine and conventional” factors), but now the patent eligibility of a composition claim may turn on possible alternative uses of the claimed composition.

Is this any way to promote innovation and investment in new technologies?

Other Patent Subject Matter Eligibility Questions

In an upcoming IPO Chat Channel webinar, Myriad and Mayo: New USPTO Examination Guidelines, scheduled for Thursday, March 20, 2014, at 2:00 PM ET, my co-panelists Raul Tamayo of the USPTO and Duane Marks of Roche Diagnostics Operations, Inc. and I will consider these and other patent subject matter eligibility questions. You can register for the webinar here.

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