HZNP Medicines LLC v. Actavis Labs. UT, Inc.

Robins Kaplan LLP

[co-author: Haroon Mian]

October 10, 2019


Case Name: HZNP Medicines LLC v. Actavis Labs. UT, Inc., No. 2017-2149, -2152, -2153, -2202, -2203, -2206, 940 F.3d 680 (Fed. Cir. Oct. 10, 2019) (Circuit Judges Prost, Newman, and Reyna presiding; Opinion by Reyna, J.; Opinion Concurring-in-part and Dissenting-in-part by Newman, J.) (Appeal from D.N.J., Hillman, J.)

Drug Product and Patent(s)-in-Suit: Pennsaid® 2% (topical diclofenac sodium); U.S. Patents Nos. 8,217,078 (“the ’078 patent”), 9,132,110 (“the ’110 patent”), 8,618,164 (“the ’164 patent”), 9,168,304 (“the ’304 patent”), 9,168,305 (“the ’305 patent”), 8,546,450 (“the ’450 patent”), 9,101,591 (“the ’591 patent”), 8,563,613 (“the ’613 patent”), 9,220,784 (“the ’784 patent”), 8,871,809 (“the ’809 patent”), 8,252,838 (“the ’838 patent”), and 9,066,913 (“the ’913 patent”)

Nature of the Case and Issue(s) Presented: Pennsaid 2% is Horizon’s topical non-steroidal anti-inflammatory drug (NSAID) approved for treating pain of osteoarthritis in the knees. Horizon sued Actavis for infringement of various claims of the patents-at-issue based on Actavis’ filing of an ANDA for a generic version of Pennsaid 2%. During claim construction, the district court found three terms in the asserted claims of the formulation patents to be indefinite. At summary judgment, the district court found no induced infringement of the asserted method of use claims. One claim remained at trial: claim 12 of the ’913 patent. Actavis stipulated that if claim 12 were not obvious, then its ANDA product would infringe. After trial, the district court found claim 12 not obvious and enjoined Actavis from launching its ANDA product. Horizon appealed the district court’s findings of indefiniteness and non-infringement. Actavis cross-appealed the district court’s finding that claim 12 of the ’913 patent was not obvious. The Federal Circuit affirmed. Judge Newman concurred in part and dissented in part.

Why Horizon Prevailed: Although the district court invalidated most of the claims or found non-infringement, Horizon ultimately prevailed on claim 12 of the ’913 patent.

Indefiniteness: The district court found the following three terms of the formulation patents indefinite: 1) “the topical formulation produces less than 0.1% impurity A after 6 months at 25 degrees C and 60% humidity”; 2) “the formulation degrades by less than 1% over 6 months”; and 3) “consisting essentially of.” The Federal Circuit agreed with the district court that “impurity A” was indefinite because a POSA would not know with reasonable certainty the identity of the claimed substance. The term “impurity A” only appeared in claim 4 and example 6 of the ’913 patent. Example 6 described a stability study in which the samples were tested for impurities by high performance liquid chromatography (HPLC). One finding of the stability test was that certain formulations showed a lower quantity of “impurity A.” While it was undisputed that “impurity A” was not defined in specification, Horizon argued that “impurity A” referred to USP Related Diclofenac Compound A (“USP Compound A”). Horizon argued that even though the specification did not refer to USP Compound A, a POSA consulting the available pharmacopeias would know “impurity A” refers to a specific impurity of diclofenac sodium. Because the specification referred to “impurity A” as a degradation of diclofenac sodium, a POSA would know the impurity to be USP Compound A.

Actavis argued that the specification did not provide any clues as to the identity of “impurity A” therefore implying that it was an unknown impurity. Actavis’ expert stated that a POSA would infer that “impurity A” referred to an unknown impurity because the specification did not disclose the chemical name of the impurity, used quotation marks to refer to “impurity A,” and justified not conducing additional tests to identify the impurity because it occurred in such low amounts. Additionally, the expert opined that because Example 6 did not disclose the HPLC procedure used (e.g., column type, mobile solvent, and temperature), a POSA would not be able to determine the identity of the impurity. Moreover, Example 6 suggested that more testing was necessary to determine the identity of the impurity.

The Federal Circuit found no clear error in the district court’s conclusion that “impurity A” was indefinite. First, the Federal Circuit held that the claims did not specifically relate “impurity A” to diclofenac sodium, but rather more broadly to the entire claimed topical formulation. Thus, there was no clue in the claim itself that “impurity A” related to diclofenac sodium. The Federal Circuit further explained that beyond the claim language, the other intrinsic evidence provided no clue as to the identity of “impurity A” and the Federal Circuit specifically referenced the lack of information regarding the conditions of the HPLC experiment. Looking at the extrinsic evidence, the Federal Circuit agreed with the district court’s determination that a POSA would not relate Example 6 to the available pharmacopoeias that Horizon’s expert relied on. Next the Federal Circuit considered and affirmed the district courts determination that “degrades” was indefinite. The Federal Circuit explained that because Horizon’s proposed definition of “degrades” referred to “impurity A,” and because “impurity A” was indefinite, it followed that “degrades” which relies upon an indefinite term for its construction, was also indefinite. Finally, the Federal Circuit considered and affirmed the district court’s determination that “consisting essentially of” was indefinite in the context of the patents-at-issue. “Consisting essentially of” signals a partially open claim. The parties’ dispute therefore focused on the basic and novel properties of the formulation patents. The district court found, and the Federal Circuit agreed, that one of the basic and novel properties of patented formulation was “better drying time.” Next, the Federal Circuit addressed whether the Nautilus definiteness standard applies to the basic and novel properties of an invention. In Nautilus, the Supreme Court held that “a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014). Horizon argued that the Nautilus standard focused on the claims and did not apply to the basic and novel properties of the invention. The Federal Circuit disagreed. The court explained that because the claims were drafted using “consisting essentially of,” the claims were open to the inclusion of any ingredient that did not materially affect the basic and novel properties of the invention. Thus, the Nautilus standard applied.

Next, Horizon argued that the basic and novel properties of an invention were not properly considered at the claim construction stage because they were fact issues. The Federal Circuit rejected Horizon’s argument, and held that courts evaluating claims using the phrase “consisting essentially of” may determine the basic and novel properties of an invention at claim construction, and then may consider whether the intrinsic evidence establishes what constitutes a material effect on those properties. The Federal Circuit reasoned that “the definiteness inquiry focuses on whether a [POSA] is reasonably certain about the scope of the invention. Indeed, if a [POSA] cannot ascertain the bounds of the basic and novel properties of the invention, then there is no basis upon which to ground the analysis of whether an unlisted ingredient has a material effect on the basic and novel properties.” The basic and novel properties must be known and definite, and therefore the district court did not err. Finally the Federal Circuit affirmed the district court’s conclusion that “better drying time” was indefinite because the specification discloses two different methods for evaluating “better drying time” and methods did not provide consistent results at consistent times.

Non-infringement: Horizon premised its induced infringement arguments for the method-of-use patents on the label for Actavis’ ANDA product. The district court found that the asserted claims of the method of use patents required the following steps: (i) application of the medication to the knee; (ii) waiting for the area to dry; and (iii) application of sunscreen, insect repellant, or a second topical medication. The district court further found that to infringe the claimed method, all steps must be completed. Actavis’ label contained a warning to “wait until area is completely dry before covering with clothing or applying sunscreen, insect repellent, cosmetics, topical medications or other substances.” The district court found that Actavis’ label merely permitted, without encouraging, the application of a second topical medication. Thus, the district court held the label was insufficient to show induced infringement. The Federal Circuit agreed, explaining that the warning “operates in an ‘if/then’ manner: if the user wants to cover the treated area with clothing or apply another substance over it, then the patient should wait until the area is dry.” This did not encourage infringement because it did not require application of a second substance, whereas the claim language did. Therefore, the district court did not err in granting summary judgment of non-infringement.

Obviousness: Actavis’s argument regarding obviousness of claim 12 of the ’913 patent was premised on the predecessor product to Pennsaid 2% -- Pennsaid 1.5%. Actavis argued that the changes made to Pennsaid 1.5% to arrive at Pennsaid 2% would have been obvious to a POSA. Actavis further argued that the district court erred in requiring that the prior art predict the “exact formulation” of the claim. The Federal Circuit held that the district court’s factual findings regarding the unpredictability of the formulation were not clearly erroneous, and therefore affirmed.

Dissent by Judge Newman: Judge Newman dissented from the majority’s holdings that “consisting essentially of” was indefinite and that the ANDA label did not induce infringement of the method-of-use patents.

Judge Newman argued that the majority were incorrect in incorporating into the scope of the claims an evaluation of the basic and novel properties of the invention. She further argued that the claims using “consisting essentially of” were definite because they listed the ingredients that the claimed formulation consists essentially of. The majority’s distinction between “consisting of” and “consisting essentially of” did not comport with precedent. She stated that there is no precedent for the majority’s ruling that “’consisting essentially of’ claims are invalid unless they include the properties of the composition in the claims.” Finally, Judge Newman stated that the clear and convincing evidence standard for invalidity was not met in this case as there was no evidence that a POSA would not understand the claims with reasonable certainty. Thus, she asserted that the claims were not invalid for indefiniteness.

Judge Newman also disagreed with the majority that the ANDA product label would not induce infringement. She asserted that the label instructed a method of use that is identical to the claimed method. She further stated, “patients may not always comply with instructions. However, this does not insulate the provider from infringement liability.”


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.

© Robins Kaplan LLP | Attorney Advertising

Written by:

Robins Kaplan LLP

Robins Kaplan 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:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide

JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at www.jdsupra.com) (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. 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. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our 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 are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy 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 our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.