United States: After District Court Invalidates Pharmaceutical Product Patent Based On Clinical Trials, Federal Circuit Reverses Because Clinical Trial Was Not Public

Last Updated: July 22 2013
Article by Stanley M. Gibson

Sunovion Pharmaceuticals, Inc. ("Sunovion") and Dey L.P., Dey, Inc., and Mylan, Inc. (collectively, "Dey") develop pharmaceutical products to treat lung disease. Sunovion filed a patent application, followed by an application to test its products in human subjects. After it received a patent, it held a series of clinical trials before it finally released a commercial product, known as Brovana, in 2007.

Dey also filed a series of patent applications, for which it received several patents. It also ran clinical trials and ultimately released a commercial product. Dey's patent applications were filed after Sunovion's, and its patents were issued after Sunovion's patent was considered.

As explained by the Federal Circuit, "[b]oth parties own patents and sell products concerning the treatment of chronic obstructive pulmonary disease ("COPD") by storing the compound formoterol in an aqueous solution and administering it through a nebulizer. Sunovion owns U.S. Patent No. 6,040,344 (the "Gao patent"), which issued in March 2000 from an application filed in 1998. Dey owns two families of patents, the second of which includes U.S. Patent Nos. 7,348,362; 7,462,645; 7,465,756; 7,473,710; and 7,541,385. The patents in the second Dey family all issued in 2008 or 2009 but claim the benefit of an application filed on July 10, 2003. According to Dey, the significant difference between the two companies' patents relates to the stability of the formulations during long-term storage."

During the case, the parties stipulated that the formulation of a particular batch of the product, Batch 3501A, is identical to the formulation that Sunovion ultimately marketed as Brovana. As part of the clinical trials, a total of 587 subjects participated in the study. Of those, 124 received Batch 3501A. At least some of those individuals received Batch 3501A prior to July 10, 2002, which was more than one year before Dey filed the patent application that led to its second family of patents.

In March 2007, before Brovana launched, Dey filed a patent infringement action asserting that Sunovion infringed its first and second families of patents. Sunovion moved for partial summary judgment, and the district court granted the motion. As explained by the Federal Circuit, as part of that motion, Sunovion conceded that "the Batch 3501A composition [fell] within the asserted claims stemming from Dey's second family of patents," which meant that the composition would anticipate Dey's asserted claims if it was in "public use," under 35 U.S.C. § 102(b). The district court concluded that Sunovion's clinical trial of Batch 3501A did constitute a "public use" of Dey's inventions, and, accordingly, held the asserted claims of Dey's second family of patents invalid. Dey appealed from the district court's ruling on summary judgment.

On appeal, the Federal Circuit analyzed whether the prior use of the formulation in clinical trials constituted an invalidating public use. "To decide whether a prior use constitutes an invalidating 'public use,' we ask 'whether the purported use: (1) was accessible to the public; or (2) was commercially exploited.'" Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005).

The Federal Circuit analyzed the facts as follows: "[t]he district court focused its analysis on two fact-bound issues. On both, we view the record differently than did the district court. First, we do not share the court's belief that the use of Batch 3501A by Study 50 participants was indisputably open and free. The district court observed that participants were given the drugs, took them home, and, 'whether or not they would have been able to reverse engineer batch 3501A . . . used the invention as intended.' The court also highlighted the fact that a few participants failed to return unused medication, as they were required to do, but nonetheless were given more of the medication. Based on those facts, the court concluded that the participants 'were not prevented from using their personal supply of that substance however they saw fit' and that 'the participants' unfettered use of the composition for weeks at a time itself constituted a public use.'"

The Federal Circuit was not persuaded that confidentiality was broken: "The fact that a tiny fraction of the thousands of vials were lost without penalizing the responsible test subject(s), or that the practicalities of the study required self-administration at home rather than physician administration in a closed facility, does not preclude a reasonable jury from concluding that the use of Batch 3501A was sufficiently controlled and restricted, rather than unfettered and public."

As result, the Federal Circuit concluded that the case did not involve undisputed evidence of a complete lack of confidentiality protections, "as there was in prior cases basing invalidity on third-party public use. See Eolas, 399 F.3d at 1335; Baxter, 88 F.3fd at 1058-59; Beachcombers, 31 F.3d at 110. And the fact no formal obligation of secrecy was imposed on the study subjects does not automatically transform Sunovion's clinical trial into a public use. We have never required a formal confidentiality agreement to show non-public use, e.g., Bernhardt, 386 F.3d at 1379-81; in the absence of such an agreement, we simply ask whether there were 'circumstances creating a similar expectation of secrecy,' Invitrogen, 424 F.3d at 1382. The 'public use' inquiry is replete with factual considerations, such as the (disputed) extent to which study participants were informed of and able to disclose the pertinent details of the claimed prior art. See, e.g., W.L. Gore, 721 F.2d at 1549. Because a finder of fact could conclude that the study was conducted with a reasonable expectation of confidentiality as to the nature of the formulations being tested, summary judgment on the public use issue was inappropriate."

The Federal Circuit also found that the district court's decision was premised on misconceptions regarding Section 102(b). As the Federal Circuit explained, "[f]irst, the court found it significant that the patent holder, Dey, did not control Sunovion's clinical studies and that study participants did not owe any obligation of confidential to Dey." The Federal Circuit explained that this analysis was not correct because "we measure the adequacy of the confidentiality guarantees by looking to the party in control of the allegedly invalidating prior use. In third-party use cases, that is the third party." As a result, the Federal Circuit found that "[b]ecause a secret third-party use is not invalidating, our task is to assess whether the third party's use was sufficiently 'public' to impose the section 102 bar. That Sunovion's trial subject owed no duty of confidentiality to Dey is, of course, true, but it does not bear on that question."

Finally, the Federal Circuit concluded that "[b]y allowing publicly accessible prior uses to block a later-filed patent, the public use bar seeks to prevent assigning a monopoly to "inventions that the public reasonably has come to believe are freely available." Tone Bros., 28 F.3d at 1198. Study 50, with all of its restrictions on the use of the drugs and information concerning the formulations, does not indisputable fall within that description. Accordingly, we decline to hold, on summary judgment, that Sunovion"s clinical trials of its own product represent clear and convincing evidence that Deys inventions were accessible to the public more than a year before Dey sought to patent them."

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
Stanley M. Gibson
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
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