Patent Office’s Rulebook Update Supports Personalized Medicine Claims

At best, patent owners and applicants with such claims are experiencing mixed results in district court and the Patent Office. And, to date, the Federal Circuit has not issued a precedential decision involving a subject matter eligibility challenge of personalized medicine. However, the Patent Office’s recent update to its Manual of Patent Examining Procedure (MPEP) could signal a turning point for life science companies.

Mayo Sets the Standard for Subject Matter Eligibility

In Mayo, the Supreme Court invalidated claims reciting a method of optimizing therapeutic efficacy for lack of subject matter eligibility under 35 U.S.C. § 101. The method involved administering a drug providing 6-TG to a subject, and determining the level of 6-TG in the subject, wherein the level of 6-TG indicated a need to increase or decrease the amount of drug.² The Court found that the “wherein” clause set forth laws of nature—i.e., relationships between concentrations of 6-TG and dosage of the drug. The Court held that the claims were invalid because, other than the natural laws, the method steps had already been performed in the prior art.³ The court did, however, contrast the claims with new ways of using an old drug or particular applications of a natural law:

For here, as we have said, the steps add nothing of significance to the natural laws themselves. Unlike, say, atypical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws.⁴

Therefore, the Court struck down a method that involved “determining” levels of 6-TG and informing a doctor about a natural law (levels of 6-TG and dosage requirements)—not a claim reciting a particular application of the natural law (e.g., a further step of increasing or decreasing the dosage).

Personalized Medicine in the Post-Mayo World

Personalized medicine claims generally recite administering a therapeutic intervention to a specific population. These methods typically involve a judicial exception (e.g., a mental step of selecting a subject having an increased expression of a biomarker X), and a particular application (e.g., treatment of the selected population).

A number of district courts, relying on Mayo, have invalidated claims directed to methods of treatment and personalized medicine.⁵ Similarly, the Patent Trial and Appeal Board (the Board) has affirmed Examiner rejections that personalized medicine claims are unpatentable.⁶ For example, in Ex Parte Ramsey, the Board concluded that a personalized medicine claim fell “squarely into the category of inventions” held ineligible in Mayo, and rejected appellant’s argument that, “under current USPTO examination guidelines, ‘method of treatment’ claims that identify a subpopulation of patients for treatment with a particular drug … are allowable.”⁷

The Court of Appeals for the Federal Circuit has not yet issued a precedential decision involving a post-Mayo 101 challenge to a personalized medicine claim, but may do so soon.⁸ In Classen Immunotherapies, Inc. v. Biogen IDEC—a pre-Mayo decision—the court held that a method of immunizing based on immunization schedules was patent eligible.⁹ More recently, in Rapid Litigation Management v. CellzDirect, the court explained, in dicta, that “methods of treating disease,” like “methods of producing things,” are patent eligible.¹⁰

Therefore, while the Federal Circuit’s pre- and post-Mayo decisions suggest personalized medicine claims are patent eligible, lower tribunals have held they are not. As a result, the validity and the patentability of such claims remains in flux.

Patent Office Provides Glimmer of Hope

The Patent Office recently updated the MPEP to include an extensive discussion of subject matter eligibility.¹¹ The update includes two key aspects that suggest personalized medicine claims are patent eligible. First, relying on Rapid Litigation, the Office explains that methods of treatment are not “directed to” a law of nature or natural phenomenon:

The courts have also noted, however, that not every claim describing a natural ability or quality of a product, or describing a natural process, is necessarily “directed to” a law of nature or natural phenomenon. For example, a method of treating cancer with chemotherapy is not directed to the cancer cells’ inability to survive chemotherapy, and a method of treating headaches with aspirin is not directed to the human body’s natural response to aspirin.¹²

Second, the Office indicates that Classen provides an example of claims that recite “meaningful limitations” sufficient to transform a judicial exception into patent-eligible subject matter:

In Classen, the claims recited methods that gathered and analyzed the effects of particular immunization schedules on the later development of chronic immune-mediated disorders in mammals in order to identify a lower risk immunization schedule, and then immunized mammalian subjects in accordance with the identified lower risk schedule (thereby lowering the risk that the immunized subject would later develop chronic immune-mediated diseases). … Although the analysis step was an abstract mental process that collected and compared known information, the immunization step was meaningful because it integrated the results of the analysis into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application.”¹³

The Patent Office evaluates patent eligibility using the two prong Mayo test: (1) determining whether the claims are “directed to” a judicial exception (e.g., abstract idea, natural phenomenon); and (2) if so, determining whether the claim recites additional elements that amount to significantly more than the judicial exception.¹⁴ The new passages in the MPEP should help patent applicants claiming methods of treatment and personalized medicine under both prongs. The first passage indicates that methods of treatment are not “directed to” a judicial exception and thus the eligibility inquiry should end after the first prong. The second passage supports patentability for a claim that involves a judicial exception (e.g., identifying a subpopulation), and integrates the judicial exception by providing a specific application (e.g., treatment of the subpopulation). 

The MPEP does not have the force of law. However, the Office’s recent update should prove useful to patent applicants seeking claims to personalized medicine, and may be a persuasive source of authority for patent holders currently ligating such claims.

<sup>1. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289 (2012).
2. Id. at 1296-97.
3. Id. at 1294, 1298-1300.
4. Id. at 1302.
5. See, e.g., Boehringer Ingelheim Pharms., Inc. v. HEC Pharm Co., No. 15-cv5982 (D. N.J. Dec. 7, 2016); Natural Alternatives Int’l, Inc. v. Allmax Nutrition, Inc., Case No.: 16-cv-01764-H-AGS, 2017 WL 2733923 (S.D. Cal. June 26, 2017); Mallinckrodt Hospital Products IP Ltd., Praxair Dist., Inc., Case No. 15-170-GMS (D. Del. September 5, 2017).
6. Ex parte Atwood, Appeal No. 2015-001611 (Bd. Pat. App. & Int. Aug. 16, 2016); Ex parte Chettier, Appeal No. 2016-003639 (Bd. Pat. App. & Int. Aug. 25, 2016); Ex parte Chamberlain, Appeal No. 2014-009849 (Bd. Pat. App. & Int. Jan. 20, 2017); Ex Parte Ramsey, Appeal No. 2016-000321 (Bd. Pat. App. & Int. Aug. 14, 2017).
7. Ex Parte Ramsey at 4, 9.
8. See Vanda Pharmaceuticals Inc. et al. v. West-Ward Pharmaceuticals, Case No. 16-2707 (Fed. Cir.).  Oral argument was held on December 5, 2017.  
9. Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1066 (Fed. Cir. 2011).
10. Rapid Litigation Management v. CellzDirect, 827 F.3d 1042, 1048-1049 (Fed. Cir. 2016).
11. See https://www.uspto.gov/web/offices/pac/mpep/index.html.
12. MPEP § 2106.04(b), I. (citing Rapid Litig. Mgmt., 827 F.3d at 1042, 1048-49).
13. MPEP § 2106.05(e) (citing Classen, 659 F.3d at 1057, 1060-61, 1066-68).
14. MPEP § 2106.</sup>