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.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions