United States: Metallizing Forfeiture Post-Helsinn

In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit had its first opportunity to address the impact of the "or otherwise available to the public" clause contained in post-AIA 35 U.S.C. § 102. In finding that the AIA "did not change the statutory meaning of 'on sale' in the circumstances involved here," the Federal Circuit provided insight into the continued relevance of the forfeiture doctrine of Metallizing Engineering v. Kenyon Bearing.

The critical issue in Helsinn was whether the post-AIA definition of prior art requires public disclosure of the details of an invention in order to trigger the on-sale bar. In the AIA, Congress revised § 102—otherwise known as the "novelty provision." As revised, the new novelty provision states:

(a)  NOVELTY; PRIOR ART. — 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.

While the AIA maintained the pre-AIA language of "patented," "described in a printed publication," "in public use," and "on sale," it added the emphasized clause above (the "catch-all clause"). The AIA does not provide any elaboration on the import of the catch-all clause, leaving many to wonder exactly what its presence means for the interpretation of the other, well-known categories of prior art.

Since its enactment in 2011, scholars have debated the effect of the catch-all clause on the "public use" and "on sale" statutory bars.* Helsinn asserted that the catch-all clause modifies prior-art categories such that only disclosures that publicly disclose the details of the invention qualify as prior art. Advocates like Helsinn contend that the intention of Congress was to overrule "secret" use and sale decisions, like Metallizing Engineering.

Others, including Teva, argue that the addition of the catch-all clause does not invalidate the years of case law interpreting "public use" and "on sale." These advocates contend that interpreting the catch-all clause to impose a "public" requirement would be a foundational change to the purpose and rationale for the public use and on sale bars support—in the absence of a clear repudiation by Congress of the pre-AIA law.

*The number of articles discussing both sides of the debate is far too numerous to provide a full list. You can find a few of these articles listed  here.

The facts of Helsinn presented a unique situation in which to consider this important question. Helsinn sued Teva for allegedly infringing four patents directed to a formulation of palonosetron for reducing chemotherapy-induced nausea and vomiting ("CINV"). All the asserted claims covered a specific palonosetron amount in a solution—0.25 mg. The parties agreed that the critical date for all four patents was the same—but different laws were implicated by the patents. Three of the patents were governed by the pre-AIA patent laws, while the last patent fell under the AIA.

Teva alleged that Helsinn's asserted patents were invalid under § 102. The conduct in question concerned an agreement entered into by Helsinn with another party to market and distribute Helsinn's palonosetron formulation. Almost two years before the critical date, Helsinn agreed with MGI Pharma, Inc., that MGI would market and distribute one or more formulations of palonosetron, contingent on approval by the FDA. The agreement identified the 0.25 mg dosage as one of the potential formulations to be purchased and sold. Although the existence of the deal was made public (through a required SEC filing), the specific formulation details were redacted.

Thus, the district court faced analyzing the same conduct under two sets of laws: pre-AIA and post-AIA. Under either, however, the same two-prong framework explicated in Pfaff v. Wells Electronics applied: the on-sale bar is triggered where before the critical date (1) there is a sale or an offer for sale and (2) the claimed invention was ready for patenting. Under the Pfaff framework, the district court found that the distribution agreement constituted a sale with respect to the three pre-AIA patents. But the district court interpreted Congress' addition of the catch-all clause as a modification to the "on sale" category that placed a public requirement on the disclosure itself. The district court found that under the AIA, a § 102-triggering sale must publicly disclose the details of the invention; a public sale that did not disclose the claim limitations was insufficient.

The Federal Circuit reversed this decision and provided an analysis may prove instructive in future cases concerning public uses and other non-informing disclosures. In its opinion, the Federal Circuit noted that the support for Helsinn's argument that § 102's requirements changed with Congress' addition of the catch-all phrase rested outside of the text of the amended provision; Helsinn relied primarily on floor statements by a few individual members of Congress.

The Federal Circuit noted that those floor statements appeared to show "at most" an intent to do away with case precedent concerning "public use" cases, not "on sale" cases. According to the Court, the only "precedent" cited by the Congressmen were cases in which the invention was used in public, but that use did not disclose to the public the details of the claimed invention. E.g.Egbert v. LippmanBeachcombers International v. Wildewood Creative ProductsJumpsport, Inc. v. Jumpking, Inc. Moreover, the Federal Circuit explained that even assuming the statements could be stretched to cover sale cases as well, the "secret sale" cases "were concerned entirely with whether the existence of the sale or offer was public," not whether the details of the invention were disclosed. Thus, the Court found the floor statements were of little support for a different interpretation of the statutory meaning of "on sale" under the AIA.

The Federal Circuit further found Helsinn's argument unpersuasive because imposing a publicity requirement would "work a foundational change in the theory or the statutory on-sale bar." In fact, the Federal Circuit noted that the issue of whether to impose a publicity requirement was exactly the situation in Pennock v. Dialogue, in which Justice Story created the on-sale bar. In Pennock, Justice Story found that allowing a patent to stand after a sale that did not disclose the claim limitations "would materially retard the progress of science and the useful arts, and give a premium to those who should be least prompt to communicate their discoveries." Relying heavily on its prior case law, the Court also explained why such a publicity requirement has never been considered necessary. The Federal Circuit concluded by hold that at most, the catch-all clause just requires that the sale must put the patented product in the hands of the public,* not that it must be informed of all the limitations of the claim.

*Of course, the Federal Circuit did not mean that the product must be  explicitly in the hands of the public. As discussed in the opinion, "our prior cases have applied the on-sale bar even when there is no delivery, when delivery is set after the critical date, or, even when, upon delivery, members of the public could not ascertain the claimed invention."

Looking at the Federal Court's reasoning in Helsinn and The Medicines Co. v. Hospira, Inc., that Metallizing Engineering may remain good law under the AIA. As the Federal Circuit made clear, it does not view the floor statements in Congress as evidencing a clear intent to overturn the "on sale" precedent, instead "at most" supporting an argument that the intent was to overturn the "public use" case law. In The Medicines Co., the Federal Circuit referred to Metallizing as an "on sale" case: the conduct at issue in Metallizing was the sale of performing a particular claimed process for compensation before the critical date, i.e. activity triggering the on-sale bar. Thus, the Federal Circuit would likely find mere floor statements to be of little relevance to a factual situation similar to Metallizing. Moreover, as the Federal Circuit identified, the law regarding "secret sales" has always been concerned with whether the existence of the sale itself was publicly disclosed—not the details of the invention. There is no indication in Metallizing that the sales at issue were not publicly known, so the same rationale from Helsinn should apply.

In Helsinn, the Federal Circuit anchored its holding on the fact that imposing a requirement that a triggering sale disclose the details of the invention directly contradicts Justice Story's reasoning in Pennock for creating the on-sale bar. As Justice Story saw it, to allow an inventor to exploit commercially his or her invention for an extended period and still maintain the ability to seek patent protection would undercut the "progress of science and the useful arts" and promote undesirable behavior. This principle has been consistently reiterated by the Federal Circuit. See The Medicines Co.Atlanta Attachment Co. v. Leggett & Platt, Inc. ("The overriding concern of the on-sale bar is an inventor's attempt to commercialize his invention beyond the statutory term."). The aim of discouraging the inventor from improperly extending the monopoly was one of the underlying reasons behind Judge Learned Hand's decision in Metallizing. Thus, it is possible that the Federal Circuit may find Metallizing to remain applicable after the AIA, despite the reduced ability for such conduct under the first-to-file concept of the AIA.*

*This is one argument raised in support of the view that the AIA explicitly overrules  Metallizing. Under the first-to-invent approach, this type of secret commercialization provided a greater incentive because even if another filed a patent on the claimed invention prior to the commercial exploiter, the exploiter could, in theory, establish prior invention and obtain the patent. As prior invention is no longer a valid argument under first-to-file, the incentive to secretly exploit an invention is diminished. However, the fact that success may be more difficult does not, in and of itself, mean the forfeiture doctrine no longer has value or applicability. As long as one person is still able to commercially exploit his or her invention in a manner like that in  Pennock or  Metallizing, the reasoning for the doctrine would still apply.

The recent Supreme Court decision in TC Heartland LLC v. Kraft Food Grp. Brands LLC also provides support for the continued relevance of MetallizingSee  No. 16-341 (May 22, 2017). At issue in TC Heartland was the impact of Congressional amendment of the general venue statute (28 U.S.C. § 1391(c)) on the interpretation of the patent venue statute that was not amended (28 U.S.C. § 1400(b)). The patent venue statute has remained unchanged since the Supreme Court interpreted its scope, holding that a domestic corporation only "resides" for purposes of venue in a patent infringement action in its state of incorporation. See  Fourco Glass Co. v. Transmirra Products Corp. (1957). However, after Congress amended the general venue statute in 1988, the Federal Circuit held that Congress's amendment also changed the scope of where a corporation "resides" under § 1400(b) (although § 1400(b) remained unchanged). See  VE Holding Corp. v. Johnson Gas Appliance Co. (1990). In TC Heartland, the Supreme Court reversed the Federal Circuit's ruling in VE Holding, emphasizing that "[w]hen Congress intends to effect a change [to the statutory meaning of legal language], it ordinarily provides a relatively clear indication of its intent in the text of the amended provision."

Accordingly, the TC Heartland decision can be interpreted as requiring clear congressional intent within the text of an amended provision itself to modify the settled meaning of statutory language.  Such an interpretation would further undermine the persuasiveness of the minimal floor statements discussed in Helsinn, given that those statements were by individual senators, put forth their interpretations of post-AIA § 102, and are not included within the text of the AIA. Moreover, the Federal Circuit in Helsinn appears to have found the catch-all clause to not be a "clear indication if [Congress's] intent in the text of the amended provision" to change the interpretation of "on sale" in the statute. In light of the large amount of scholarly debate on the meaning of the clause, it seems unlikely that the Supreme Court would disagree with the Federal Circuit's apparent determination.

After Helsinn, it appears that on-sale bar precedent has survived the AIA. Applying the Court's reasoning, and in view of other recent cases such as The Medicines Co. and TC Heartland, it appears the Metallizing Engineering precedent may also have survived the AIA, at least for now. However, there is still the possibility that the Federal Circuit may take the opportunity presented by the ambiguity caused by the catch-all clause to revisit the ultimate decision in Metallizing. Although the Federal Circuit may consider Metallizing  to be an "on sale" case, Judge Hand's opinion does rely on principles underlying both the "public use" and "on sale" bars.  As such, the forfeiture doctrine of Metallizing  would appear to be an extra-statutory bar, not falling within either the "public use" or "on sale" categories entirely. Because of this, some have questioned whether Judge Hand's decision is actually correct. See Dimitri Karshtedt, Did Learned Hand Get It Wrong?: The Questionable Patent Forfeiture Rule of  Metallizing Engineering, 51 Vill. L. Rev. 261 (2012). Moreover, although the Federal Circuit was not persuaded as to the "clear indication" of intent to change the meaning of "on sale" as advocated by Helsinn and others, that is not to say the Supreme Court would hold the same.

This article was originally published on PatentlyO.com.

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
19 Oct 2017, Webinar, Los Angeles, United States

Please join Oliver Wyman and Sheppard Mullin for an upcoming webinar to discuss the critical topic of pharmacy value. "Driving Value in Pharmacy: How the Industry Can and Must Deliver Change" will highlight where the industry can and must evolve to bring needed relief to consumers and improve health.

19 Oct 2017, Webinar, Los Angeles, United States

Stay tuned on the latest developments in Europe that may affect your business and join Sheppard Mullin’s Antitrust & Competition “Breakfast with Europe” drive-time webinars, bringing you up to speed on what you need to know about the month back, the present and month forward in European competition law developments.

24 Oct 2017, Seminar, Los Angeles, United States

Presented by The American Bar Association White Collar Crime Committee.

 
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.

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.