United States: Federal Circuit Affirms Validity Of Tarka Patent On Combination Pharmaceutical Product

The Federal Circuit decision in Sanofi-Aventis Deutschland GmbH v. Glenmark Pharmaceuticals Inc., USA, addresses several interesting issues, but is most likely to be cited by other patent holders for its affirmance of the jury verdict that upheld the Tarka patent at issue. The jury found that claims directed to a pharmaceutical composition comprising a combination of active agents were not invalid, even though the compounds per se were known in the art.

The Patent at Issue

The patent at issue was U.S. Patent 5,721,244, which is listed in the Orange Book for the antihypertension drug Tarka®.

Claim 3 was at issue, and depends from claim 1. These claims are presented in the Federal Circuit decision as follows:

1. A pharmaceutical composition comprising:
(a) an angiotensin-converting enzyme inhibitor (ACE inhibitor) . . . , and
(b) a calcium antagonist or a physiologically acceptable salt thereof;
wherein said ACE inhibitor and said calcium antagonist are present in said composition in amounts effective for treating hypertension; . . .

3. A composition according to claim 1, wherein said ACE inhibitor is trandolapril [formula omitted] or a physiologically acceptable salt thereof, or quinapril [formula omitted] or a physiologically acceptable salt thereof.

The District Court Litigation

The district court litigation arose from Glenmark's filing of an Abbreviated New Drug Application (ANDA) to obtain FDA approval to market a generic version of Tarka®. The 30-month stay of approval of the ANDA expired in 2010, and Glenmark launched its product "at risk" while the litigation was still pending, after the district court denied the plaintiffs' motion for a preliminary injunction.

The case was tried to a jury, before which Glenmark admitted infringement but asserted invalidity based on obviousness. The jury upheld the validity of the patent, and awarded damages of $15,200,000 for lost profits and $803,514 for price erosion.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Newman and joined by Judge Linn and Judge Wallach.

The Federal Circuit decision summarizes Glenmark's obviousness arguments as follows:

Glenmark argues that the verdict cannot stand, as a matter of law, on the premise that if a combination of classes of components is already known, all selections within such classes are obvious to try, as a matter of law. Glenmark argues that it is irrelevant that the combination is ultimately found to have unpredicted or superior properties if those properties, though unknown in the prior art, could be attributed to one of the prior art components of the combination.

The Federal Circuit decision identifies the following evidence of non-obviousness that the jury was entitled to rely on:

  • The claimed trandolapril ACE inhibitor is a "double-ring" compound, while the prior art had focused on "single-ring" compounds such as enalapril and captopril.
  • The previously tested combinations of ACE inhibitors and calcium channel blockers required more than the once daily dosing that was possible with the claimed combination.
  • The claimed combination results in improved kidney function and improved blood vessel structure as compared to prior art hypertension treatments.

The Federal Circuit decision provides the following counterpoints to Glenmark's arguments:

Glenmark argues that because the single-ring inhibitors had been tested in combination with calcium antagonists, it was "obvious to try" every combination of effective ACE inhibitor and calcium channel blocker. Glenmark Br. at 35 ("It is not invention merely to select something from a list of items in the prior art.").

In KSR International Co. v. Teleflex Inc., ... the [Supreme] Court explained that "obvious to try" may apply when "there are a finite number of identified, predictable solutions" to a known problem. ... This court has elaborated that the identified path must "present a finite (and small in the context of the art) number of options easily traversed to show obviousness." .... As illustrated in In re O'Farrell, .... it would not be "obvious to try" when "the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful."

Glenmark argues that the inventors' selection of the double-ring ACE inhibitors for testing in combination with calcium antagonists is of itself evidence that it was obvious to try this combination.

Patentability does not turn on how the invention was made, but on whether it would have been obvious to a person of ordinary skill in the field. In Eisai Co. v. Dr. Reddy's Laboratories, Ltd., ... the court observed that in the medical arts "potential solutions are less likely to be genuinely predictable," ... as compared with other arts such as the mechanical devices in KSR.

Glenmark also argues that later-discovered benefits cannot be considered in an obviousness analysis, here referring to the improved kidney and blood vessel function that were observed after the patent application was filed.

That is incorrect; patentability may consider all of the characteristics possessed by the claimed invention, whenever those characteristics become manifest.

Does "Obvious to Try" Ever Apply to Pharmaceutical Products?

In addressing Glenmark's reliance on KSR, Judge Newman emphasizes that the "obvious to try" rationale holds much less sway in the context of "the medical arts." However, she does acknowledge that combination pharmaceutical products can be obvious when the components have been specifically identified in the prior art and the combination does not exhibit any unexpected results. Thus, when supporting patentability of a combination product, it can be important to establish unpredictability and, where possible, unexpected results.

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
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
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