UK: The Recent US Supreme Court Decision - Helsinn v Teva, And (Not So) Secret Sales

Last Updated: 26 March 2019
Article by Robyn Hardisty

The recent US Supreme Court decision Helsinn Healthcare S.A v. Teva Pharmaceuticals USA Inc. gives an insight into the definition of prior art under the Leahy-Smith America Invents Act (AIA), in particular, whether a 'secret sale' can deprive a claimed invention of novelty in a US patent application.

Background

In 2000, Helsinn entered clinical trials relating to the dosage of a drug named palonosetron for treating chemotherapy induced nausea. Shortly thereafter, under a series of confidential agreements, Helsinn agreed a licensing agreement with MGI Partners Inc. who acquired the rights to distribute and market the product. While the cooperation between parties was publicly known, the technical details of the invention were not disclosed.

On January 30th 2003, Helsinn filed a provisional patent detailing the specific dosage of palonosetron. A series of patents were filed claiming priority from this application, the fourth of which, US 8,598,219 (US '219), was granted by the USPTO in May 2013.

In 2011, Teva Pharmaceuticals sought approval from the FDA to create a generic version of Helsinn's product. When Helsinn sued for infringement of their patent, Teva counterclaimed that the patent was invalid.

The amended AIA 35 U.S.C § 102 conditions for patentability stipulate that "a person shall be entitled to a patent unless (1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention" [emphasis added] (see here). An exception to this rule includes anything disclosed by the inventor 12 months before filing a relevant patent application (known as the "grace period").

Pre-AIA, Pfaff v. Well Electronics (1998) had previously established that a 'secret sale' in the US could invalidate a US patent. However, changes to the conditions for patentability raised questions about whether this interpretation was still valid. In particular, did the inclusion of the term 'or otherwise available to the public,' not present in the previous statute, change the on-sale bar?

Decision

The Supreme Court held that the AIA rewording of this provision did not change the established case law with respect to "secret sales" as explained in Pfaff. Two conditions had to be met for there to be a sale: first, the product must be the subject of a commercial offer for sale and second the invention must be ready for patenting. The Supreme Court affirmed the Federal Circuit's ruling that "if the existence of the sale is public, the details of the invention need not be publicly disclosed in terms of sale in order to fall under the AIA 'on sale' bar."

The Courts found that there was overwhelming evidence that Helsinn's dosing invention was ready for patenting and reduced to practice before the critical date (i.e. January 30th 2002, one year before filing the provisional patent application). Since Helsinn had sold this invention before the critical date, the sale to MGI Partners Inc. was deemed to deprive the US '219 patent claims of novelty.

It is important to note that the AIA definition of novelty now has no geographic restriction. It is therefore important to be aware that a confidential sale of a product anywhere in the world, more than one year before filing the relevant patent application, is likely to deprive a US patent application directed to that product of novelty.

A comparison with Europe

At the European Patent Office (EPO), under Article 54(2) EPC, the state of the art comprises everything made available to the public by means of a written or oral description, by use, or in any other way, before the filing or priority date of the European patent application. Unlike the US, there is no grace period for inventor disclosures 12 months before filing a European patent application.

The situation regarding 'secret sales' is also quite different at the EPO. According to the EPO's Case Law of the Boards of Appeal a single sale of a prototype was sufficient to render the article available to the public, but only because the buyer was not bound by an obligation to maintain secrecy (see here). While a secret sale does not deprive a claimed invention of novelty, the patentee is required to provide suitable evidence to prove that the sale was bound by confidentiality.

Furthermore, a product sold to the public is only deemed to be part of the art if it can be analysed and reproduced by the skilled person (see G 1/92). For example, the EPO Board of Appeal in T 1833/14 held that the opponent could not sufficiently prove that the skilled person had enough information to prepare a claimed polymer without knowing, among other things, which catalyst system was used to prepare said polymer product, despite the product being sold before the priority date.

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
 
In association with
Practice Guides
by Mondaq Advice Centres
Relevancy Powered by MondaqAI
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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