Teva Pharms. U.S.A., Inc. v. Azar

Robins Kaplan LLP

February 26, 2019

Case Name: Teva Pharms. U.S.A., Inc. v. Azar, C.A. No. 18-2394 (RDM), 2019 U.S. Dist. LEXIS 30346 (D.D.C. Feb 26, 2019) (Moss, J.)

Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine); U.S. Patent No. 8,629,111 (“the ’111 patent”)

Nature of the Case and Issue(s) Presented: The case concerned the 180-day exclusivity period for the generic version of Restasis and whether the FDA’s interpretation of “first applicant” would have harmed Teva, who asserted first-applicant status. Teva filed suit against the FDA and immediately filed a motion for a preliminary injunction to bar the FDA from “depriving Teva of its statutory right to 180 days of marketing exclusivity for its generic version of the brand-name drug Restasis®.” The court determined that Teva did not have standing and denied its motion for a preliminary injunction, and granted defendants’ motion to dismiss the suit for lack of standing.

Why FDA Prevailed:  Teva filed a declaratory judgment action seeking a declaration that the FDA’s interpretation of “first applicant” in a letter decision relating to a different drug, Suboxone, (i) was invalid under the Administrative Procedures Act (“APA”) and (ii) that Teva was entitled to the 180-day exclusivity period. Teva also sought to enjoin the FDA from “approving any ANDA that references Restasis® … other than Teva’s ANDA” during the pendency of its declaratory judgment action.

Teva filed its ANDA for cyclosporine in January 2012. At that time, only one patent was listed in the Orange Book for Restasis – U.S. Patent No. 5,474,979 (“the ’979 patent”), which was due to expire in May 2014. Teva filed a Paragraph III certification on the ’979 patent. The FDA issued a letter in which it refused to receive Teva’s ANDA. While Teva was considering its response to the letter, new patents issued including the ’111 patent. The same day that the ’111 patent issued—January 14, 2014—Teva amended its ANDA to include a Paragraph IV certification to the ’111 patent. Once Teva received a formal acknowledgement from the FDA on July 9, 2015 that its ANDA had been received as of January 23, 2012, Teva sent its notice letter to the NDA holder, Allergan. Teva also filed Paragraph IV certifications for five other Orange Book-listed patents that had issued since its original ANDA filing and timely effected notice.

In August 2015, Allergan sued Teva for infringing the six unexpired Orange Book-listed patents. Allergan granted a covenant not to sue on two of the patents and the district court invalidated the remaining four patents, including the ’111 patent. Allergan appealed and the Federal Circuit summarily affirmed the district court’s decision. Allergan then petitioned for panel rehearing and rehearing en banc. That petition was pending at the time of the present decision.

One central dispute concerned whether the FDA should apply the “first effective” or “first submitted” approach to determining first applicant status. The “first effective approach,” which the FDA applied before the enactment of the Medicare Modernization Act of 2003 (the MMA) (which included a definition of “first applicant”), awarded exclusivity to the first generic to file a substantially complete ANDA containing a Paragraph IV certification and to effect notice. The “first submitted approach” would award first applicant status to the first generic to file a substantially complete ANDA containing a Paragraph IV certification.

In July 2018, the FDA issued a letter decision in an unrelated matter regarding Suboxone that addressed this question. In that matter, one or more first applicant(s) submitted a substantially complete ANDA with a Paragraph IV certification on May 14, 2013 but subsequently withdrew the application(s) and informed the FDA that they had not given notice to the NDA holder. At least one other applicant submitted a substantially complete ANDA with Paragraph IV certification after May 14, 2013. The FDA concluded that the May 14 applicant(s) were entitled to 180-day exclusivity, but forfeited it when they withdrew their application(s). The FDA noted that exclusivity did not roll over to the subsequent applicant. The FDA explained that prior to the MMA the agency applied the “first effective approach” but concluded that after the enactment of the MMA, the “first submitted approach” was more consistent with the statutory definition.

At the time of the present decision, no ANDA for cyclosporine had received final or tentative approval. Teva alleged that the FDA was poised to grant final approval to Mylan’s ANDA. Teva also alleged that it had spent significant resources preparing for its launch and that its own final approval was imminent.

Teva challenged the FDA’s interpretation of “first applicant” in the Suboxone letter and argued that if allowed to stand, it would deprive Teva of its statutory right to 180 days of generic exclusivity. Teva contended that the letter decision must be set aside under the Administrative Procedure Act (APA). The court, however, explained that it could not reach the merits of Teva’s APA challenge or its motion for preliminary injunction without first addressing standing. Teva argued that it pled two injuries sufficient to confer standing: (1) that the Suboxone letter decision already divested Teva of its statutory right to exclusivity and that it had adequately alleged that it would suffer greater harms when the FDA formally applied that decision and approved ANDAs in violation of that right; and (2) that by applying the “first submitted approach” the FDA deprived Teva of procedural rights under the APA, including the right to participate in notice-and-comment rulemaking.

Loss of Exclusivity: The parties agreed that loss of exclusivity is a concrete injury sufficient to confer standing. The issue, however, was whether Teva had sufficiently shown actual or imminent injury traceable to the Suboxone letter. Teva first argued that the FDA’s issuance of the Suboxone letter decision stripped the company of its 180-day exclusivity. Teva argued that “first applicant status” is a property right akin to a patent, that the right is “alienable,” and that the first applicant may waive or relinquish exclusivity for valuable consideration. Therefore, according to Teva, the Suboxone decision deprived it of a property right and its embedded value. The immediate nature of the loss foreclosed the defendants’ argument that it must establish that another ANDA would be approved to establish concrete injury. The court disagreed. First, the court explained that a patent differs from first-applicant status because, for example, a patent confers the ability to bring an infringement action against anyone who practices the invention without permission. Moreover, the Patent Act says that a patent has the “attributes of personal property.” 35 U.S.C. § 261. First-applicant status, on the other hand, only dictates in what order the FDA can approve ANDAs. And a first applicant’s rights are enforceable only against the FDA. The court went on to say that nothing suggests Congress intended to give first applicants an immediate property interest.

The court was further unconvinced that a putative first applicant obtains an alienable interest in its status immediately upon submitting its ANDA. In a prior letter decision, FDA explained that before the exclusivity period is triggered, a first applicant can relinquish only its claim to exclusivity. But after the period is triggered, a first applicant can either relinquish entirely or can selectively waive its exclusivity in favor of a particular ANDA. The FDA limited the availability of selective waiver before the trigger date because (i) an ANDA applicant might lose its eligibility, and (ii) allowing selective waiver prior to the trigger date might encourage filers to submit marginal ANDAs only to obtain the benefit of waiving exclusivity to a filer with a more viable ANDA. The court also noted that none of the cases Teva cited held that a first applicant can selectively waive and therefore monetize the right to exclusivity before the trigger date. Thus, Teva failed to show that it sustained any injury or was in immediate danger of sustaining a direct injury because of the Suboxone letter.

Future Loss of Right to Exclude: In the alternative, Teva argued that it would suffer tens of millions of dollars in lost sales if the FDA were to approve competitors during Teva’s exclusivity period. The court noted that Teva cited two lines of cases, but remained unpersuaded that Teva had met the standing threshold. First, Teva argued that based on Bennett v. Spear, it was sufficient at the pleading stage to allege future agency action and resulting harm. The court, however, explained that Teva’s reading of Bennett was overly broad and that the Supreme Court merely held that in that case, the plaintiffs had alleged an imminent and redressable injury.

Next, Teva relied on Teva Pharms. USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), for the proposition that “courts in this circuit routinely reach the merits of generic manufacturers’ claims to exclusivity before the FDA has granted final approval to any ANDA concerning the drug at issue.” While that may be true, the court also explained that “courts in this circuit have routinely declined to reach the merits of disputes of this type because the plaintiff lacks standing or because its claim is unripe.” The court then addressed two leading D.C. Circuit cases: Pfizer Inc.  v. Shalala, 182 F.3d 975 (D.C. Cir. 1999) and Teva v. Sebelius, 595 F.3d 1303. But the court explained that neither case was controlling here. Pfizer differed from the instant case because Teva was suing with respect to its own exclusivity. Thus, the court concluded that uncertainty about whether the ANDA would be approved was not dispositive. Teva differed because there Teva had already received tentative approval and there was no reason to doubt that Teva was the first applicant. Moreover, the FDA’s policy would have almost certainly forfeited Teva’s exclusivity in that case.

Here, the court noted that there was no guarantee that the FDA would approve any existing ANDA. None of the filers had tentative approval as an indicator of the status of the FDA’s review. Next, the court said it was possible that Teva’s ANDA would be rejected before the FDA were to issue its first approval. And finally, a dispositive factor of Teva was the ability to demonstrate no forfeiture event would occur. The court went on to explain that Teva had not cleared that hurdle with respect to two forfeiture events. First it was too soon to tell if Teva would fail to obtain approval of its ANDA within thirty months of its receipt by the FDA. Second, Teva may not be able to market its drug within 75 days after the entry of a final court decision of patent invalidity or non-infringement from which no appeal is taken. The Orange Book-listed patents had been invalidated by a district court and that decision was affirmed on appeal. Allergan moved for rehearing. The court explained that if the Federal Circuit were to reverse the district court’s decision invalidating the patents, Teva would forfeit exclusivity because it would need to amend its ANDA to assert a Paragraph III certification for the ’111 patent. If the Federal Circuit were to deny rehearing, Teva would have to market its drug within 75 days, or would forfeit exclusivity.  The court therefore concluded that Teva failed to satisfy the causation and redressability requirements for Article III standing.

APA Violation: The court next addressed Teva’s second claim to standing, which was that the FDA failed to abide by the procedural requirements of the APA. The court noted that the Supreme Court has held that the allegation of “a bare procedural violation, divorced of any concrete harm” did not “satisfy the injury-in-fact requirement of Article III.” Spokeo, Inc., v. Robins, 136 S. Ct. 1540, 1549 (2016). The injury Teva alleged was loss of exclusivity. The court held that, for the reasons addressed above, causation between the Suboxone letter and Teva’s alleged loss of exclusivity was “speculative at best,” and therefore Teva had failed to satisfy the constitutional minimum for standing on this procedural issue as well.

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

Related Case Law

"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 (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

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 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 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 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

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:

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at (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
  • New Relic - For more information on New Relic cookies, please visit
  • Google Analytics - For more information on Google Analytics cookies, visit To opt-out of being tracked by Google Analytics across all websites visit 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 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:

- 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.