United States: For Obviousness, A Motivation To Combine Does Not Require A Suggestion That The Claimed Combination Is Preferred Or Most Desirable

In Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., Nos. 12-1397, -1398, -1400, -1424 (Fed. Cir. Apr. 16, 2013), the Federal Circuit reversed the district court's entry of SJ that asserted claims 13 and 15 of U.S. Patent No. RE37,564 ("the '564 patent") were not invalid for obviousness.

Bayer Healthcare Pharmaceuticals, Inc. and Bayer Schering Pharma AG (collectively "Bayer") own the '564 patent, directed to low-dose, extended-regimen combined oral contraceptive ("COC") products.  To address the risks of side effects, "escape" ovulation, and unintended pregnancy, Bayer developed a low-dose COC containing synthetic estrogen ethinylestradiol ("EE") and synthetic progestin drospirenone ("DRSP") administered according to a dosing regimen of either twenty-four active pills followed by four pill-free days (24/4) or twenty-three active pills followed by five pill-free days (23/5), as opposed to the traditional dosing regimen of twenty-one active pills followed by seven pill-free days (21/7).

Asserted claims 13 and 15 of the '564 patent cover Bayer's COC product, marketed under the brand name YAZ®.  Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., Sandoz, Inc., Lupin Ltd., and Lupin Pharmaceuticals, Inc. (collectively "Defendants") filed ANDAs with the FDA seeking approval to market generic versions of YAZ® and asserting that the '564 patent was invalid.  Bayer responded by suing Defendants for infringement of claims 13 and 15 of the '564 patent, and Defendants counterclaimed that the asserted claims were invalid for obviousness.  The district court ultimately granted SJ in favor of Bayer, concluding that the asserted claims were not invalid for obviousness.  Defendants appealed.

On appeal, the Federal Circuit agreed with Defendants that the district court erred in concluding that asserted claims 13 and 15 were not invalid for obviousness.  The Court first observed that it was undisputed that the cited prior art set forth every limitation required by the asserted claims.

"[A] finding that the prior art as a whole suggests the desirability of a particular combination need not be supported by a finding that the prior art suggests that the combination claimed . . . is the preferred, or most desirable, combination."  Slip op. at 15 (alterations in original) (quoting In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004)).

The Court also found that the prior art provided express motivation for a person of ordinary skill in the art to combine the limitations to derive the claimed COC products with a reasonable expectation of success.  The Court noted that one prior art reference expressly referenced another, which together with the first disclosed every limitation of the asserted claims.  The Court also noted that several of the cited references highlighted evidence that unregulated ovarian activity occurring during a seven-day pill-free interval could achieve significant follicular development, and that those references expressed concern that inadvertently extending the traditional pill-free interval via one or more missed pills could lead to escape ovulation and unintended pregnancy.  The Court also reasoned that Bayer's expert acknowledged that one of skill in the art at the time of the invention would have expected an even greater risk of such "missed pill" ovulation for users of low-dose COCs.

The Court thus concluded that missed-pill ovulation was a recognized concern with traditional 21/7 COCs, particularly for those on the market by 1993 that, like the claimed COC preparations, relied on low-dose EE.  "As the Supreme Court has stated, 'any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.'"  Slip op. at 13 (quoting KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007)).  The Court further reasoned that the references went beyond just illuminating a known problem—they also expressly proposed the claimed solution.

The Court rejected Bayer's argument that two of the references were primarily directed to older women who reached premenopause and were in need of hormone replacement therapy such that a skilled person setting out to design an oral contraceptive using EE and DRSP would not have used the 24/4 regimen intended to achieve effective hormone replacement therapy.  The Court stated that those references plainly disclosed preparations with hormone replacement and contraceptive applications, and that the product claims-at-issue did not distinguish between target patient populations by age or otherwise.

The Court also rejected Bayer's argument that the prior art taught away from the claimed COC preparations, focusing on statements in the "Guillebaud" reference as indicating that the conventional wisdom in the field favored 21/7 dosing for most patients and as suggesting that a reduced pill-free interval should be used together with higher-dose COCs for patients perceived to be at risk of escape ovulation.  The Court reasoned that those statements did not overcome the express teachings of multiple references, including Guillebaud, that a shorter pill-free interval would improve COC efficacy.  Furthermore, the Court noted that Guillebaud may have suggested condensing the pill-free interval while concurrently increasing the hormone dose for at-risk patients, but those two measures were never described as mutually dependent, and each could be expected to reduce missed-pill ovulation risks with or without the other.  "[A] finding that the prior art as a whole suggests the desirability of a particular combination need not be supported by a finding that the prior art suggests that the combination claimed . . . is the preferred, or most desirable, combination."  Id. at 15 (alterations in original) (quoting In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004)).  The Court stated that just because one of several references indicated a preference for using 24/4 or 23/5 dosing regimens in tandem with higher-dose COCs did not mean the same missed-pill rationale could not also motivate applying the shorter pill-free interval to similarly improve other COC preparations.

Finally, the Court held that Bayer's evidence of secondary indicia of nonobviousness, including alleged unexpected results, expert skepticism, industry praise, and copying by others, was legally insufficient.  Regarding unexpected results, the Court found that data showing that 23/5 administration resulted in reduced follicular activity compared to 21/7 dosing of the same COC formulation merely confirmed that administering additional active pills resulted in additional follicular suppression, a matter of common sense.

Regarding expert skepticism, Bayer cited an FDA request for clinical safety data and data demonstrating efficacy benefits sufficient to justify the added synthetic hormone exposure required for the proposed 24/4 dosing regimen.  The Court found that that request in no way indicated FDA experts would have been surprised to receive such data, since the cited request reflected attention to the FDA's normal duties ensuring the safety and efficacy of new drugs by requiring actual data to corroborate statements in a new drug application.

Regarding industry praise, Bayer claimed that its invention was widely praised by experts in the COC field, relying on journal citations that referenced the findings stated in Bayer's published efficacy studies or discussed possible noncontraceptive indications for 24/4 COC regimens.  Bayer also relied on an article that was authored by the first-named inventor of the '564 patent describing Bayer's 24/4 COC regimen as an innovative strategy.  The Court found that the bare journal citations and self-referential recommendation fell well short of demonstrating true industry praise.  The Court also stated that industry praise of what was clearly rendered obvious by published references was not a persuasive secondary consideration.

Regarding copying by others, the Court rejected Bayer's contention that copying of its COC preparations by the defendants and other generic manufacturers supported its validity position, noting that such evidence of copying in the ANDA context was not probative of nonobviousness because a showing of bioequivalence was required for FDA approval.  Accordingly, the Court held that claims 13 and 15 of the '564 patent were invalid for obviousness in view of the cited references, and reversed the district court's SJ.

Judges:  Lourie (author), Schall, Prost
[Appealed from D. Nev., Judge Dawson]

This article previously appeared in Last Month at the Federal Circuit, May, 2013

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
Events from this Firm
27 Nov 2017, Seminar, London, UK

Finnegan partner Anthony Tridico will present “U.S. Patent Case Law Update” at the Chartered Institute of Patent Attorneys’ annual Patent Case Law Review.

28 Nov 2017, Seminar, Milan, Italy

Finnegan partner John Paul will present “Internet of Things: Patent Liability, Enforcement and Licensing” and will join the Mock WIPO Mediation at International Technology Transfer—Licensing and ADR, co-hosted by Licensing Executives Society and World Intellectual Property Organization.

29 Nov 2017, Seminar, Tel Aviv, Israel

Finnegan is a platinum sponsor IVC Research Center’s start-up forum, “The Most Promising Start Ups for 2017 – A Synergy of Big Data, Artificial Intelligence, Machine Vision and IoT.”

 
In association with
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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Emails

From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.