EPO Practice
A View of the USPTO Myriad Guidance from Europe
The approach for determining the presence of patentable subject matter in a claim by the European Patent Office (EPO) and the U.S. Patent and Trademark Office (USPTO) has differed for many years due to differences in legislation and judicial interpretation. However, this difference has recently become more marked in light of the recent guidance issued by the USPTO to the Patent Examining Corps for determining the patent eligibility of claims relating to products of nature and laws of nature following recent U.S. Supreme Court decisions, including Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289 (2012).
Article 52 of the European Patent Convention (EPC) states that patents shall be granted for any inventions in all fields of technology, subject to certain conditions, but goes on to indicate that certain types of inventions shall not be regarded as patentable, including: “(a) discoveries, scientific theories and mathematical methods; (b) aesthetic creations; (c) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers; [and] (d) presentations of information.” Under the decisions of the Boards of Appeal of the EPO, in order to be patentable, the subject matter claimed must therefore have a “technical character” or, to be more precise, involve a “technical teaching,” i.e., an instruction addressed to a skilled person as to how to solve a particular technical problem using particular technical means. Article 53 EPC also specifies exclusions for exploitation that would be contrary to morality or “ordre public,” plant or animal varieties, essentially biological processes, and methods of treating the human or animal body for therapy or diagnosis.
In the United States, what is patentable is defined by statute in 35 U.S.C. § 101, which states merely that a patent may be obtained for an invention comprised in one of the four recited statutory categories (process, machine, manufacture, or composition of matter). A claim that does not fall within one of these four categories cannot be the subject of a valid patent. Further interpretation of that statute has been left to the U.S. courts. The courts have further defined the four statutory categories to exclude certain subject matter (namely, abstract ideas, laws of nature/natural principles, natural phenomena, and natural products). The USPTO refers to these court-made exclusions as “judicial exceptions.”
The legislative noninventions of the EPC and the judicial exclusions of the United States have significant overlap. However, neither the EPC nor the decisions of the EPO Boards of Appeal have any exclusion corresponding to the USPTO’s new natural products exclusion. Instead, provided that there is a technical character, claims involving natural products will be assessed by the EPO for patentability (novelty, inventive step, etc.) in the usual manner.
Under the USPTO Guidance, for a claim involving a natural product to be patent eligible, the claimed product must be both non-naturally occurring and “markedly different” from naturally occurring products. See Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products “ (Guidance”) (http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf) (Mar. 4, 2014). In particular, the Guidance is focused “in determining whether a claim reflects a significant difference from what exists in nature and thus is eligible [subject matter], or whether a claim is effectively drawn to something that is naturally occurring,” and thus ineligible for patenting. See id. at 1-2.
While the Supreme Court’s Myriad decision related to human genomic and cDNA sequences, the Guidance is addressed to claims reciting “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. at 3. Thus, the Guidance seems to suggest that claimed subject matter demonstrating “technical character,” in the EPO sense, is now excluded from patenting in the United States, irrespective of issues of novelty, obviousness, etc.
The analytical framework set forth in the Guidance seeks to establish patentability by asking three questions:
- Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?
- Does the claim recite or involve one or more judicial exceptions?
- Does the claim as a whole recite something significantly different than the judicial exception(s)?
If the answer to the first question is “no,” the claim is not eligible for patent protection and should be rejected under 35 U.S.C. § 101. If the answer is “yes,” the examiner must then ask the second question, i.e., whether the claim recites or involves one or more judicial exceptions (including natural products). The Guidance offers examples of subject matter falling within the natural products’ judicial exception, e.g., “chemicals derived from natural sources (e.g., anitibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); [and] metals and metallic compounds that exist in nature.” Id.at 3. If the answer is “yes,” or if it is unclear whether the claim involves a judicial exception, the examiner must proceed to the third question. Id. Under the third inquiry, the examiner must determine whether the claim, as a whole, recites something significantly different than the judicial exception.
With this as background, we now take a look at examples that illustrate the application of the USPTO Guidance and examine whether they would face a different fate in the EPO. The Guidance gives examples of the following situations and conclusions on patent eligibility. For some of the examples, the USPTO and the EPO would arrive at different conclusions regarding patentability. A claim reciting a purified product found in nature? – Possibly not eligible under the USPTO Guidance, if the claimed product is structurally unchanged from what is found in nature. See Guidance at 7-9, Example III.B, discussed in more detail below. In the EPO, if the natural product is capable of industrial application, it is potentially patentable; improved levels of purity are considered to be novel. A claim reciting a simple mixture of metallic elements (copper and tin are given in one example)? – Possibly not eligible under the USPTO Guidance, if each element is as found in nature so that the claimed composition is, in the view of the Guidance, merely the juxtaposition of two structurally unchanged natural products. See USPTO slide presentation of March 19, 2014, entitled Evaluating Subject Matter Eligibility Under 35 USC § 101: March 2014 Update, slides 44-45, available at http://www.uspto.gov/patents/law/exam/myriad-mayo_slides_20140319.pdf. In contrast, in the EPO, a mixture of metallic elements having a technical effect, e.g., a mixture of iron and aluminum forming a thermite mixture, would be considered patent eligible. A claim to a beverage comprising fruit juice and a preservative? – Potentially not eligible, if a natural product can act as a preservative such that the claim, in the USPTO’s view, encompasses a mere mixture of two natural products, with neither product structurally changed from its natural form. In the EPO, this would be patent-eligible subject matter due to the technical character imparted by the preservative to the beverage. A gunpowder composition that encompasses a simple mixture of three naturally occurring materials is also considered by the USPTO ineligible, as each of the three materials is naturally occurring and not structurally changed by formation of the mixture. See USPTO slide presentation of April 16, 2014, entitled Evaluating Subject Matter Eligibility Under 35 USC § 101, slides 52-57, available at http://www.uspto.gov/patents/announce/myriad-mayo_bcp_20140416.pdf. In the EPO, this would be patent eligible based on its technical character.
In other instances, the analysis under the USPTO Guidance and the EPC arrive at the same conclusion. For example, an alloy of metallic elements is patent eligible according to the USPTO, as the crystalline form with both elements is not known in nature. USPTO March 19, 2014, slide presentation, slide 45. The same conclusion would be reached in the EPO.
The Guidance makes particular reference to the specific wording of the claims under consideration. In some cases, it may be possible to avoid the exclusion by simple changes to claim wording, e.g., changing the word “mixture” to “alloy.” However, in other cases, further claim limitations might be necessary to avoid the exclusion, e.g., defining how a claimed molecule differs structurally from its naturally occurring variant due to the process used to purify it. For instance, Example III.B of the Guidance provides three claims:
Claim 1 directed to “[p]urified amazonic acid.”Guidance at 7. According to the Example, amazonic acid was not previously known to have activity in colon cancer but was known to be active against breast cancer. See id. at 7.
Claim 2, directed to “[p]urified 5-methyl amazonic acid.”
Claim 3, in turn, is directed 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, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.”
Under the USPTO Guidance, claim 1 does not qualify as patentable subject matter because the claim is a composition of matter that recites a naturally occurring chemical found in the leaves of Amazonian cherry trees, and the claim as a whole does not recite something “significantly different” than the natural product. Id. The claim also lacks features that demonstrate that the recited product is “markedly different” in structure from what exists in nature. Id.
In contrast, claim 2 is deemed to encompass patentable subject matter because the addition of the 5-methyl group renders the claimed product structurally different from the natural product. Id. at 8. The Guidance notes that, while the claim does not recite a functional difference, the presence of a functional difference resulting from the structural difference would make a stronger case for patent eligibility than the structural difference alone.
Claim 3 is also deemed to encompass patentable subject matter because the claim as a whole recites something “significantly different” than the natural product. Id. In discussing the factors in favor of subject matter eligibility, the Guidance notes that the specific dosage and treatment period limitations narrow the scope of the claims such that others are not substantially foreclosed from using amazonic acid in other ways.
In Europe, all three of these claims would fall outside the explicit exclusions of Article 52 EPC, but claim 3 would fall within the exclusions of Article 53 EPC (method of treatment). In the EPO, it is likely that the analysis of patentability for claims 1 and 2 would primarily focus on whether each of the claims has a concrete and technical character. In the case of claim 1, it is likely that the purified acid would qualify as patentable subject matter as it is provided in its purified state, instead of in its natural state. Similarly, the modification of the acid by addition of the methyl group in claim 2 would on its own have sufficient technical character to overcome the patentable subject matter threshold. With regard to claim 3, redrafting that claim as a second medical use claim covering amazonic acid for use in colon cancer may render it patent eligible in the EPO.
Furthermore, note that claim 3 above includes numerical ranges related to dosage and treatment duration. If the simple use of amazonic acid in colon cancer had not been previously demonstrated and could not be expected from its previously known activity in breast cancer, a claim covering amazonic acid for use in colon cancer, without specifying the dose or treatment duration as in the USPTO example above, should be novel and have inventive step. Accordingly, in the EPO, it might not be necessary to add the dosage and treatment duration limitations if the claim is otherwise novel, has inventive step, and is drafted in a patent-eligible format. Thus, there may be cases in which an applicant will narrow a U.S. process claim in ways that would not be necessary in the EPO merely to ensure that the claim satisfies the Guidance.
Thus, the application of the USPTO Guidance is likely to lead to more rejections for lack of patent-eligible subject matter in the United States. The application of the Guidance may also lead to some significantly divergent outcomes in the USPTO and EPO. Furthermore, applicants seeking to avoid patent eligibility rejection in the United States (for example, when claiming a natural product) should consider the implications of their strategy on inventive step at the EPO (where the corresponding claim is patent eligible).