United States: Post Grant Review: § 112 And Eligibility Issues In Chemical And Life Sciences

Last Updated: November 30 2016
Article by Samuel A. McMahon

Post Grant Review (PGR) petitions are on the rise, and nearly half of all petitions to date have challenged patents in Biotechnology and Organic Chemistry, or Chemical and Materials Engineering technology centers.1 We have reviewed PGR petitions filed against patents in these technology categories.2 One final written decision issued on Nov. 14, 2016,3 and more are expected in the coming weeks and months. We see this moment as an opportunity to summarize some of the key trends and likely impacts of PGRs in the chemical and life sciences.

To date, 12 PGR petitions have been filed against chemical and life sciences patents. Of these, five petitions were denied and seven were instituted. Among instituted cases, four included successful institutions based on anticipation (one of which was based on public use), five included successful institutions based on obviousness, and four included successful institutions based on written description, enablement, or indefiniteness. One case asserted subject matter eligibility as a grounds of invalidity, but that lone § 101 challenge was not instituted.

Petitioner Standing in PGR

A threshold issue in institution decisions is whether the patent is eligible for PGR.45, According to Patent Trial Appeal Board (PTAB) rules, the petitioner must "certify" that the patent is PGR-eligible.6 Exactly what is meant by "certification" is not clear in every case.

Under America Invents Act (AIA) section 3(n)(1), a patent is PGR-eligible if it contains or contained at any time a claim subject to AIA first-inventor-to-file (FITF) provisions (and meets other PGR requirements7). Applications filed after March 16, 2013 that do not have any benefit claims to an effective filing date prior to March 16, 2013 are FITF applications eligible for PGR. Eligibility in these cases is straightforward, and simple "certification" by the petitioner should suffice.

However, applications filed after March 16, 2013 that do have at least one claim with the benefit of an effective filing date prior to March 16, 2013 are "transition applications." These patents may or may not be eligible, depending on whether the claims find written description and enablement support in the earlier-filed (pre-AIA) priority application.

In order for a petitioner to establish that a patent that issued from a transition application is eligible for PGR, the PTAB requires a persuasive showing (considerably more than mere "certification") that the application contains or contained at any time a claim that was subject to FITF provisions.8 To show that a claim in a transition application is subject to FITF provisions, the petitioner must show that "the patent contains, or the corresponding application contained at any time, at least one claim that was not disclosed in compliance with the written description and enablement requirements of § 112(a) in the earlier application for which the benefit of an earlier filing date prior to March 16, 2013 was sought."9

The picture is muddled by the fact that the AIA requires that a PGR petitioner "shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence."10 And in order to institute PGR in the first place, the petitioner must establish that "it is more likely than not that at least 1 of the claims of the challenged patent is unpatentable."11 The PTAB has referred to all of these burdens in determining whether patents are eligible for PGR, though it has not explicitly stated the standard it applies.12

In some cases, the Board has simultaneously addressed § 112 eligibility and § 112 patentability issues, applying the "more likely than not" standard to both. Inevitably, the requirement to certify eligibility is subsumed by the need to establish unpatentability as more likely than not.

The bottom line for transition application patent owners is that they must be prepared with strong enablement and written description arguments in order to overcome a petitioner's assertion that the patent is PGR-eligible. A strong showing of enablement and written description support in the earlier-filed priority application will often hinge on:

  1. data in the earlier-filed application clearly demonstrating enablement;13
  2. articulation of how analysis of the Wands factors favors enablement;14
  3. a clear description in the specification of each element in the claims;15 and
  4. congruence of the scope of claims and scope of disclosure in specification.16

This is especially important for patent owners because in every case we analyzed where the Board assessed § 112-based eligibility, the Board agreed with the petitioner that the priority application lacked § 112 support and therefore the patent was eligible for PGR. In each of these cases, successfully refuting the petitioner's assertions of eligibility would have cut off the proceeding at the pre-institution stage. With trials underway in all of these cases, and more petitions expected, it remains to be seen how important the strategy of refuting eligibility will be for patent owners undergoing PGR.


1 Brian C. Kwok, Nicholas V. Martini and Nicole Johnson, "An Update on Post Grant Review Filings and Decisions" law360, Nov. 2, 2016, 12:05 p.m. EDT, https://www.law360.com/articles/858429/an-update-on-post-grant-review-filings-and-decisions.

2 All PGR institution decisions were reviewed for patents within National Bureau of Economic Research technology categories "Chemical" (and all subcategories) and "Drugs and Medical" (and all subcategories).

3 Altaire Pharmaceuticals Inc. v. Paragon Bioteck Inc., Case PGR2015-00011 (PTAB Nov. 16, 2015) (Paper 48).

4 US Endodontics LLC v. Gold Standard Instruments LLC, Case PGR2015-00019 (PTAB Jan. 29, 2016) (Paper 17) at 9-12 [hereafter PGR2015-00019].

5 Out of 12 PGRs analyzed, seven included a § 112 eligibility analysis. In four of the 12 cases, a § 112 inquiry was not required for eligibility because the patents at issue did not claim priority to pre-AIA effective filing dates. In one case, the patent was summarily deemed ineligible because it had an issue date prior to March 16, 2013. Out of the seven cases in which the PTAB undertook a § 112 eligibility analysis, all seven were found eligible for lack of written description or enablement in the priority application.

6 37 C.F.R. § 42.204(a).

7 See 35 U.S.C. § 321-22.

8 Inguran LLC v. Premium Genetics (UK) Ltd., Case PGR 2015-00017 (PTAB Dec. 22, 2015) (Paper 8) at 9-18 [hereafter PGR2015-00017].

9 Id. at 10-11.

10 35 U.S.C. § 326(e).

11 35 U.S.C. § 324(a).

12 See PGR2015-00019 at 11-12.

13 See, e.g., PGR2015-00019 at 17.

14 See, e.g., PGR2015-00017 at 18 (assessing enablement for purposes of unpatentability) (citing In re Wands, 858 F.3d 731, 737 (Fed. Cir. 1988)).

15 See, e.g., Dr. Reddy's Labs Ltd. v. Helsinn Healthcare S.A., Case PGR2016-00008 (PTAB Aug. 17, 2016) (Paper 11) at 12-13.

16 Arkema Inc. v. Honeywell Int'l Inc., Case PGR2016-00012 (PTAB Sept. 2, 2016) (Paper 13) at 19.

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.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
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.


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.


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