Sanofi-Aventis Deutschland GmbH v. Glenmark Pharmaceuticals Inc. (Fed. Cir. 2014)

by McDonnell Boehnen Hulbert & Berghoff LLP

SanofiOn April 21, 2014, a Federal Circuit panel reiterated its interpretation and application to the chemical arts of the KSR obviousness standard.  Although applicable more broadly than the chemical arts, the opinion may be of particular interest to patent prosecutors in this technology field.  A jury found the patent at issue not obvious and the Federal Circuit affirmed.

In this Hatch-Waxman litigation, the plaintiffs (patent owners and licensees) brought suit after the defendants filed an ANDA with a paragraph IV certification alleging that the claims of plaintiffs' patent 5,721,244 ("'244 patent") were obvious.  The drug that was the subject of the ANDA was Tarka®, a single dosage form anti-hypertensive medication comprising a combination of the angiotensin converting enzyme (ACE) inhibitor trandolapril and the calcium antagonist verapamil hydrochloride.  There was evidence that the combination provided benefits not previously known for anti-hypertension treatment:  a single daily dosage form providing longer lasting control and improved kidney function and blood vessel structure.

Claim 3 of the ’244 patent was at issue:

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 . . . or a physiologically acceptable salt thereof, or quinapril … or a physiologically acceptable salt thereof.

Combinations of ACE inhibitors and calcium antagonists were known in the art, although the art taught the use of so-called "single ring" ACE inhibitors like enalapril,

Structure 1

whereas trandolapril of the claimed composition is a "double ring" ACE inhibitor,

Structure 2

The defendants argued that the claim was obvious because it merely substituted one type of ACE inhibitor for another.

Glenmark PharmaceuticalsAt trial, the defendants' expert acknowledged that the art had not suggested using a double ring ACE inhibitor in combination with a calcium antagonist but opined that the number of rings in the ACE inhibitor was unimportant to the analysis.  Of course, the plaintiffs' expert disagreed, opining that those of ordinary skill in the art generally believed that the double ring compounds were not more effective than the single ring compounds because the single ring compounds fit into the "pocket" of the ACE inhibitors better than the double ring compounds.  Furthermore, the plaintiffs' expert opined that combination treatments were not favored at the time of the invention.

Although there were these disagreements, what was not in dispute was that the advantages provided by the claimed combination were real and not present in, nor predicted or suggest by, the prior art.

The defendants argued that, given the prior art teaching of combinations of ACE inhibitors and calcium antagonists, (1) claim 3 was unpatentable as a matter of law because it would have been "obvious to try" other combinations of agents, and (2) because the claim was unpatentable as a matter of law, the fact that the combination was later shown to have unexpectedly advantageous properties was irrelevant.  This is where the Court's opinion gets interesting.

The Court rejected the defendants' arguments.  The Court first noted that the "obvious to try" standard is qualified and applicable only when "there are a finite number of identified, predictable solutions" to a known problem.  This "finite number" language is frequently encountered as a basis for rejecting chemical compound claims as obvious modifications of prior art compounds and appears often to be used merely in contradistinction to "infinite."  But the Court reiterated its opinion in Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F. 3d 1358, 1364 (Fed. Cir. 2008), where it stated that "finite" means that the number of options is small in the context of the art and easily traversed.  Elaborating on "easily traversed," the Court cited In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988), for the proposition that a claim is not "obvious to try" (and therefore obvious) where "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."

The Court also rejected the defendants' argument that the later-discovered unexpected advantages of the claimed composition cannot be considered in an obviousness analysis.  Referring to prior Federal Circuit case law and distinguishing case law cited by the defendants, the Court stated, "patentability may consider all of the characteristics possessed by the claimed invention, whenever those characteristics become manifest."

As this was an appeal from a jury verdict, the Court did not give its opinion as to application of the law to the facts, i.e., whether under the facts of the case there were a finite number of identified, predictable solutions to a known problem or even whether the (undisputed) unexpected advantages of the claimed composition were sufficient to render the composition obvious.  Rather, the Court finally merely held that the jury could have reasonably found that the art "would not have predicted the longer-lasting hypertension control demonstrated by the double-ring structures of quinapril and trandolapril in combination with calcium antagonists, because of the widespread belief that double-ring inhibitors would not fit the pocket structure of the ACE."  But if this is the sole and sufficient basis of non-obviousness, this holding is consistent with the proposition dating back at least to In re Papesch that an otherwise obvious invention is rendered non-obvious by unexpected properties.

Sanofi-Aventis Deutschland GmbH v. Glenmark Pharmaceuticals Inc. (Fed. Cir. 2014)
Panel: Circuit Judges Newman, Linn, and Wallach
Opinion by Circuit Judge Newman


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.