The past three months have been a busy period for those following the U.S. patent eligibility law. Recent examination guidance published by the U.S. Patent and Trademark Office (USPTO) may affect patent applications with composition or method claims in a variety of chemical, materials science, and biological arts. The Federal Circuit's recent decision in In re Roslin Institute (Edinburgh), No. 2013-1407 (Fed. Cir. May 8, 2014), also provides information about how the U.S. courts may consider patent eligibility of composition claims in the wake of recent U.S. Supreme Court case law. We provide an update of recent events to help practitioners keep an eye on this unsettled area of law. A more detailed article on the USPTO Guidance is also included in this edition of Full Disclosure.
As readers of Full Disclosure may recall, in 2012 and 2013 the U.S. Supreme Court issued two key decisions concerning patent eligibility. In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012), the Court held that a correlation between the concentration of a biomarker in a patient and the efficacy of a drug treatment was a law of nature. The Court concluded that, while an application of such a law of nature may be patent eligible, the claim-at-issue was, in effect, drawn to the correlation itself and was not patent eligible. Id. In Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___, 133 S. Ct. 2107 (2013), the Court addressed the patent eligibility of composition claims drawn to certain isolated genomic DNA and cDNA segments. The Court held that the claims drawn to isolated genomic DNAs were not patent eligible because the claimed sequences were the same as the naturally occurring gene sequences. Id. But the Court found the claims drawn to cDNAs patent eligible because the claimed cDNA sequences differed from the naturally occurring gene sequences due to the removal of introns. Id.
On March 4, 2014, the USPTO published new guidance for examination of the subject matter eligibility of product and process claims in view of the Mayo and Myriad cases. The document is entitled Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products ("Guidance"), and is available at http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf. The March 2014 Guidance is for use in subject matter eligibility determinations of all claims reciting or involving laws of nature, natural principles, natural phenomena, and/or natural products, which the Guidance collectively terms "judicial exceptions" to patentability. Guidance at 1-2. The USPTO also noted that earlier guidance concerning claims reciting abstract ideas remains unchanged by the March 4 Guidance. Id. at 1.
In particular, while the Myriad decision concerned certain isolated DNA segments, the USPTO noted that its Guidance applies to claims that recite or involve a variety of natural products. Id. at 3. Examples may include "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." Id.
According to the Guidance, if a claim involves, or may involve, a so-called "judicial exception" to patentability, such as a law of nature, a natural phenomenon, or a natural product, the claim is patent eligible if "the claim as a whole is significantly different than the judicial exception(s)." Id. The Guidance provides a multifactor analytical framework designed to assist examiners in answering whether the claim recites something "significantly different" than a judicial exception. Id. at 3-5. If the claim is drawn to a product or composition, the factors assess whether there are sufficient structural differences between the claimed product and a natural product to render the claimed product "markedly different" from the natural product. In the case of method claims, the factors are aimed at, for example, determining whether the claim elements or steps impose limits on claim scope, provide specific instructions on how to apply or use the judicial exception(s), or add features that are more than well understood, conventional, or routine in the relevant field of study. Id. The Guidance then notes that "if the totality of the relevant factors weigh[s] toward eligibility, the claim qualifies as eligible subject matter," but "[i]f the totality of the relevant factors weighs against eligibility, [then] the claim should be rejected." Id. at 4.
The Guidance provides a handful of examples to illustrate the analysis, one of which includes a hypothetical claim to a "[p]urified amazonic acid," a chemical isolated from the leaves of a tree found in the Amazon rainforest and known to have therapeutic effects for treating breast cancer. Id. at 7, Example B, claim 1. That claim is concluded to be ineligible for patenting because the amazonic acid is structurally identical to the amazonic acid found in leaves and the claim does not provide other distinguishing features. Id. In contrast, a hypothetical claim to a "[p]urified 5-methyl amazonic acid," a derivative created in the laboratory with additional therapeutic functions, is considered patent eligible, because the claimed compound is "markedly different [in structure]" from what exists in nature.&td Id. at 7-8, Example B, claim 2.
If the claim to the purified amazonic acid is considered ineligible for patenting, what about methods of using that compound? The USPTO considers a hypothetical claim to "[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 . . . [at a daily dose of] about 0.75 to about 1.25 teaspoons of amazonic acid" to be patent eligible, because the claim as a whole recites something "significantly different" than the natural product by adding specific limitations as to the patient population (colon cancer, not breast cancer), administration schedule, treatment duration, and dosage. Id. at 7-9, Example B, claim 3. The Guidance does not consider a simpler method claim drawn to amazonic acid in colon cancer that omits the treatment schedule and/or dosage range limitations, however. Indeed, the example claims of the Guidance as a whole tend to be either relatively broad or relatively narrow in scope, which leaves uncertainty about how the USPTO will evaluate claims with a scope in between these extremes.
Two weeks after publication of the Guidance, on March 19, 2014, the USPTO published a set of slides used in its examiner training program on patent eligibility, entitled Evaluating Subject Matter Eligibility Under 35 USC § 101: March 2014 Update. The slides are available at http://www.uspto.gov/patents/law/exam/myriad-mayo_slides_20140319.pdf. Practitioners should review the slides as well as the Guidance because the slides provide additional instructions to examiners beyond what is included in the Guidance, as well as additional claim examples. On April 16, 2014, the USPTO held a public presentation with a further slide presentation intended in part to clarify some of the thinking behind a few of the example claims in the Guidance. This presentation may be downloaded at http://www.uspto.gov/patents/announce/myriad-mayo_bcp_20140416.pdf.
Then, on May 9, 2014, the USPTO held a public forum at which several organizations and individual practitioners provided their views of the USPTO's Guidance. Presentations from that meeting may be downloaded at http://www.uspto.gov/patents/announce/myriad-mayo.jsp. The USPTO is also currently accepting comments from the public on the Guidance. Comments may be submitted until June 30, 2014, on-line at the above web address. Whether public comments will influence the USPTO to change any aspects of the Guidance and, if so, how, remains unclear at present.
It is important to note that the USPTO Guidance reflects the USPTO's analysis of the Supreme Court case precedent, and is not binding on U.S. courts. It remains to be seen whether courts will agree with the USPTO's position. Only when the U.S. courts hear further cases concerning patent eligibility, including cases stemming from appeals of USPTO claim rejections, will it become clear whether the U.S. courts agree with the USPTO's interpretation of Mayo and Myriad. This could take several years. In the meantime, however, patent applicants in the chemical and biopharmaceutical industries have to grapple with the new examination strategy of the USPTO. Thus, applicants should consider adapting claim drafting and disclosure strategies for new U.S. patent applications to meet the requirements for patent eligibility outlined in the new USPTO Guidance. In addition, applicants may also review relevant claims in pending U.S. patent applications and take appropriate action to amend claims as necessary.
While it may take some time for courts to substantially weigh in on the patent eligibility debate, on May 8, 2014, one day before one of the USPTO's public forums on the Guidance, the Federal Circuit issued a decision regarding the patent eligibility of the Roslin Institute's claims drawn to certain cloned mammals. In re Roslin Institute, No. 2013-1407 (Fed. Cir. May 8, 2014). The Roslin Institute is the creator of Dolly the Sheep—the first mammal ever cloned from an adult somatic cell. Id., slip op. at 2. The Roslin Institute's claims recited, inter alia, a "live-born clone of a pre-existing, non-embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats." Id. at 3 (citation omitted). The court considered the claimed clones to be "exact genetic copies of patent ineligible subject matter" and "[a]ccordingly . . . not eligible for patent protection." Id. at 8. The court further noted that, while the Roslin Institute argued that there were environmental factors leading to phenotypic differences between its clones and their donor mammals, and that there were also differences in the mitochondrial DNA of the cloned mammals, those differences were not expressed in the claims. Id. at 9-10. According to the court, "[The Roslin Institute's] claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies." Id. at 11. In view of this decision, as well as the USPTO Guidance, when drafting composition claims, patent applicants should consider ensuring that their specifications include a basis to add limitations to the claims that illustrate structural differences between the claimed subject matter and any natural products from which the claimed subject matter is derived.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
