United States: The Patent Prosecution Highway Pothole For Pharmaceutical Patents

The USPTO promotes the Patent Prosecution Highway (PPH) as a way to "fast-track" a U.S. patent application when a corresponding foreign application has been allowed, or when a corresponding PCT application has received a favorable Written Opinion from a Searching Authority that participates in the PPH program. While a USPTO Examiner still will conduct an independent search and examination of the application, USPTO statistics indicate that PPH applications do enjoy a more compact patent prosecution process and a higher allowance rate. Applicants considering the PPH program for a pharmaceutical patent application should be aware of one pothole that could lead to an improper (in my view) denial of a Request to participate in the PPH.

The PPH Requirements

The USPTO has PPH agreements with a number of foreign patent offices. The most liberal PPH program is called "PPH 2.0″ or "MOTTAINAI" and is available when claims in a corresponding application have been allowed by IP Australia (IPAU), Canada (CIPO), Finland (NBPR), Japan (JPO), Russia (ROSPATENT), Spain (SPTO) and United Kingdom (UKIPO)). The requirements for PPH 2.0 include:

  1. At least one claim was determined by a PPH 2.0 participating patent office to be allowable/patentable.
  2. The U.S. application and the corresponding allowed application have the same priority/filing date, and the U.S. application:

is an application that validly claims priority under 35 U.S.C. § 119(a) and 37 CFR 1.55 to one or more applications filed with the PPH 2.0 participating office or

is an application which is the basis of a valid priority claim under the Paris Convention for the allowed application or

is an application which shares a common priority document with the allowed application or

along with the allowed application is derived from/related to a PCT application having no priority claim.

  1. The claims of the U.S. application, as originally filed or as amended, "sufficiently correspond" to one or more of the allowed claims.
  2. Examination of the U.S. application has not yet begun.
  3. A Request to participate in the PPH 2.0 program is filed in the U.S. application
  4. The applicant submits a copy of the office action issued just prior to the "Decision to Grant a Patent" in the allowed application(e.g., the latest "Notification of Reasons for Refusal") and an English translation thereof.

The Pharmaceutical Application Pothole

The pothole for pharmaceutical applications arises from requirement (3), the requirement that the U.S. claims "sufficiently correspond" to the allowed claims. The USPTO provides the following additional guidance on this requirement:

A claim is considered to "sufficiently correspond" where, accounting for differences due to translations and claim format, the claim in the U.S. application is of the same or similar scope as a claim indicated as allowable in the application filed in the PPH 2.0 participating office.

A claim in the U.S. application which is narrower in scope than the claims indicated as allowable in the application filed in the PPH 2.0 participating office will also sufficiently correspond if presented as a claim dependent upon a claim which is of the same or similar scope as a claim indicated as allowable in the application filed in the PPH 2.0 participating office. The additional limitation that makes the claim in the U.S. application narrower in scope than the allowable/patentable claims in the application filed in the PPH 2.0 participating office must have support in the written description of the U.S. application.

A claim in the U.S. application which introduces a new/different category of claims to those claims indicated as allowable in the application filed in the PPH 2.0 participating office is not considered to sufficiently correspond. For example, if the only allowable/patentable claims in the application filed in the PPH 2.0 participating office are claims to a process of manufacturing a product, then any product claims in the U.S. application are not considered to sufficiently correspond, even if the product claims are dependent on process claims which sufficiently correspond to allowable/patentable claims in the application filed in the PPH 2.0 participating office.

The applicant is required to submit a claims correspondence table in English. The claims correspondence table must indicate how all the claims in the U.S. application correspond to the allowable/patentable claims in the application(s) filed in the PPH 2.0 participating office. Any dependent claims with additional limitations must be clearly identified in the claims correspondence table.

The pothole arises in the context of therapeutic method claims, which are permitted in the U.S., Australia and Russia, but are not permitted in most other countries. Instead, most other countries permit "medical use" claims. While practitioners may view the differences between therapeutic method claims and medical use claims as differences in format, the USPTO Petitions Office considers therapeutic method claims and medical use claims to be different categories of claims.

This means that if the allowed foreign application includes medical use claims, a U.S. claim set that includes corresponding therapeutic method claims may not be accepted into the PPH program. Instead, Applicants may be advised to present medical use claims for the purposes of the PPH program, even though such claims are rejected by Examiners as being directed to non-statutory subject matter. Presumably, Examiners will permit Applicants to amend the claims into therapeutic method claims without losing PPH status, because Examiners will understand that the claims do "sufficiently correspond" despite their different format.

Who Can Pave Over This Pothole?

It is frustrating to have to present claims that will trigger a rejection in order to be able to participate in a program intended to expedite prosecution. I am hopeful that someone at the USPTO who is involved with overseeing the PPH program understands that therapeutic method claims can, in principle, "sufficiently correspond" to medical use claims, and that their difference are, indeed, permissible differences in format. Until that person paves over this pothole, Applicants who would like to have pharmaceutical applications participate in the PPH may want to consider presenting non-statutory medical use claims if such claims were allowed in the corresponding foreign application.

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.

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