The Latest Trends in Drug Monopolies

by Zelle LLP
Contact

Zelle  LLP

Competition Law360
November 29, 2017

Brand-name pharmaceutical companies employ a variety of strategies to preserve and extend their branded drug products’ monopolies. Challenges by generic drug manufacturers and consumers to those efforts as allegedly manipulative of regulatory and administrative processes have met with varying degrees of success. This article focuses on the antitrust implications of three such strategies that have the effect of blocking or delaying lower-priced generic drugs from entering the market: (1) using citizen petitions to inhibit final approval of generics, (2) introducing a reformulated version of a patented drug that effectively prevents generic substitution (a strategy referred to as “product hopping”); and (3) transferring drug patents to entities with sovereign immunity — like Native American tribes — to foreclose certain patent challenges. 

Drug companies engage in these strategies to avoid the substantial decline in revenue that coincides with competition from generic drugs, either after the expiration of regulatory exclusivities, or after a patent expires, a concept referred to as the “patent cliff.” Given the significant impact that generic competition has on a company’s bottom line, coupled with long development and testing cycles required to successfully develop and market a new drug,[1] brand-name pharmaceutical companies are incentivized to adopt strategies that could potentially extend the life of their patents.

These “anti-generics” strategies can have a significant negative impact on competition and consumers. Generic manufacturers enter the market with bioequivalent but less expensive alternatives. Delaying the entry of, or blocking access to, affordable generic alternatives results in consumers and insurers paying higher prescription prices. As discussed below, given the potential of these strategies to stymie generic competition, antitrust scrutiny likely will only intensify. The ramifications for generic and brand-name pharmaceutical companies, consumers, payors and sovereign entities could be significant as courts consider more claims challenging these burgeoning strategies.

Citizen Petitions

The U.S. Food and Drug Administration allows individuals and firms to raise safety and efficacy concerns about new generic drug products through “505(q)” citizen petitions.[2] While such petitions are not inherently anti-competitive, certain drug companies have filed allegedly dubious petitions that delay generic entry and extend the branded drug’s exclusivity period, thus raising antitrust concerns. Between 2011 and 2015, brand-name pharmaceutical companies submitted 92 percent of all 505(q) citizen petitions filed with the FDA; only 8 percent overall were successful.[3] Because the FDA generally does not approve a generic drug until it resolves any pending citizen petitions, brand companies can delay the approval process by filing one or more citizen petitions, allowing the branded drug to earn potentially additional monopoly profits during the pendency of the review even if the petition is ultimately rejected.[4]

Accordingly, generic drug manufacturers may seek to challenge their branded counterparts for allegedly abusing the citizen petition process.[5] While these unlawful monopolization challenges require proof of a relevant market, monopoly power, and antitrust injury, they also require analysis as to whether the petitioning activity is protected under the Noerr-Pennington doctrine,[6] which generally immunizes from antitrust liability efforts to petition the government for a redress of grievances. Petitioners are not protected under the doctrine, however, if they use the citizen petition process as a sham to interfere with competitors.[7]

To establish that a citizen petition is a sham, a generic manufacturer must show that (1) a petition is “objectively baseless in the sense that no reasonable [party] could realistically expect success on the merits;” and (2) the subjective intent of the defendant brand-name pharmaceutical company is to inhibit competition, not to petition the FDA for redress.[8] If the petition is shown to be both objectively and subjectively baseless, the Noerr-Pennington doctrine will not immunize the defendant from antitrust liability. In determining whether a citizen petition is a sham, courts have considered the presence of the following four “plus” factors: whether (1) the petition has suspect timing (i.e., is filed on the eve of generic entry); (2) a sophisticated petitioner seeks relief that is contrary to FDA regulations and practice; (3) the FDA, when rejecting a petition, criticizes it for lacking any basis or convincing evidence; and (4) the petition actually caused delay (i.e., final approval was granted on the same day as the FDA denied the citizen petition).

In a significant development in the sham petition arena, the Federal Trade Commission filed an enforcement action in February, alleging that Shire ViroPharma Inc. violated the antitrust laws through “repetitive, serial, and meritless petitioning” to delay the approval of a generic drug and exclude competition.[9] According to the FTC, between 2006 and 2012, “ViroPharma made at least forty-three submissions to the FDA and initiated three more proceedings in federal court to obstruct and delay the FDA’s approval of [the generic competitor], including: [t]wenty-four citizen petition filings.”[10] ViroPharma’s motion to dismiss (on Noerr-Pennington and other grounds) is currently pending. How this case plays out could have significant antitrust ramifications for citizen petition challenges going forward.

Product Hopping

While introducing a reformulated version of a drug alone typically does not raise anti-competitive issues, courts have increasingly scrutinized product reformulations combined with other anti-competitive conduct aimed at avoiding the patent cliff or maintaining a monopoly. This so-called “product hopping” strategy gained prominence in Abbott Laboratories v. Teva Pharmaceuticals USA Inc. (“TriCor”).[11]

In TriCor, the defendant introduced a slightly reformulated product (switching from capsules to tablets), stopped selling the old capsules, bought back existing supplies of capsules, and changed the National Drug Data File code for the old capsules, essentially preventing pharmacies from filling prescriptions with a generic capsule formulation.[12] In denying defendant’s motion to dismiss, the court applied a rule of reason analysis, concluding that “if Plaintiffs show anticompetitive harm from the formulation changes, that harm will be weighed against any benefits presented by Defendants.”[13]

Other courts have since applied their own interpretations of TriCor and its progeny. In Walgreen,[14] for example, the plaintiffs alleged that defendant AstraZeneca (1) introduced Nexium as the patent for its equivalent drug, Prilosec, was about to expire; (2) aggressively promoted Nexium to doctors; and (3) stopped promoting Prilosec. In granting defendant’s motion to dismiss, the court distinguished TriCor because AstraZeneca had not removed the old formulation from the market. “AstraZeneca added choices,” the court concluded, by introducing a new drug to compete with its own drug and other generic substitutes.[15] The marketplace, not courts, could and should determine which product was superior.

Subsequent decisions have grappled with TriCor and Walgreen, which established “endpoints” — with “hard switches” (introducing a reformulated drug and withdrawing the old drug) at one end and “soft switches” (introducing a reformulated drug to compete alongside the old drug and generic substitutes) at the other.[16] The Suboxone court in 2014, in finding that the defendant’s conduct fell “somewhere between that alleged in Walgreen and TriCor,” examined whether the defendant’s combination of its reformulation with other wrongful conduct sufficiently reduced consumer choice.[17] The court concluded that defendant’s introduction of a new formulation combined with the threatened removal and disparagement of the old formulation plausibly constituted anti-competitive conduct.

In Namenda,[18] the Second Circuit upheld a preliminary injunction precluding the defendant from withdrawing Namenda IR in favor of its new formulation, Namenda XR. The court focused on the potential for consumer coercion had the defendant removed its old formulation from the market prior to generic entry, thus appearing to adopt the hard switch/soft switch test. But in Doryx,[19] despite allegations of product withdrawal, buybacks, inventory destruction, and new formulation promotion, the Third Circuit took a different approach in affirming summary judgment to a defendant. The Doryx court distinguished Namenda by emphasizing (1) the different procedural postures; (2) that plaintiff was not foreclosed from the market but rather entered the market with 180-day regulatory exclusivity, set its generic price higher than the brand drug, and profited on the generic sales; and (3) the defendant’s nonpretextual reasons for various product changes.[20]

Recent decisions have tried to reconcile these differing product hopping analyses. In Asacol,[21] the court upheld a product hopping claim as to one new formulation (via hard switch) but not another (via soft switch), specifically noting the Second Circuit’s “important distinction between hard and soft switches” in Namenda.

The Suboxone court built upon its 2014 opinion with subsequent decisions in September and October 2017. Applying the “cumulative lessons” of product hopping cases, the court again denied certain defendants’ motion to dismiss, noting plaintiffs’ allegations of (1) new product introduction without substantial benefits over the old product in an attempt to avoid the expiration of a regulatory exclusivity, similar to a “patent cliff;” (2) “extreme coercion of physician prescribing decisions;” and (3) a “hard switch” from tablets to film.[22] The court did grant one defendant’s motion to dismiss because it participated only in the development and introduction of a new product, and not any additional exclusionary conduct, as required for a viable product hopping claim.[23] Finally, the court again allowed claims against two other defendants for conspiring to restrain trade and monopolize in violation of Sherman Act Sections 1 and 2.[24]

Despite the uncertainty of the case law in this evolving area, three principles have emerged. First, product hopping claims by consumers, competitors, and states remain viable, even in the wake of Doryx. Second, the distinction between hard and soft product switches remains relevant, though not dispositive. Finally, product reformulations absent additional exclusionary conduct are unlikely to form the basis of a viable claim — though it remains unclear exactly what and how much exclusionary conduct is required to make such a claim plausible.

Patent Transfers to Entities with Sovereign Immunity

Drug manufacturer Allergan PLC recently made headlines when it transferred patents for its eye drug, Restasis, to New York’s St. Regis Mohawk Tribe. In exchange for a $13.75 million up-front payment and $15 million in annual royalties, the tribe agreed not to waive its sovereign immunity defense in inter partes review proceedings before the Patent Trial and Appeal Board.[25] Because such a defense could block a PTAB challenge to branded drug patents,[26] thus extending their exclusivity period, brand-name pharmaceutical companies and entities with sovereign immunity should be aware of the intense antitrust scrutiny such a strategy draws.

Though not unprecedented — the tribe recently sued Amazon.com Inc. and Microsoft Corp. for allegedly infringing patents the tribe acquired from SRC Labs, a technology firm[27] — Allergan’s actions immediately drew legal and political criticism. Senators called the deal “blatantly anti-competitive” and vowed to investigate.[28] Sen. Claire McCaskill, D-Mo., introduced a bill to block tribal immunity in IPR proceedings.[29] Senior U.S. Circuit Judge William Bryson — in a related patent infringement proceeding — expressed “serious concerns” about the transfer, writing that “sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities ... [b]ecause that is in essence ... what the agreement between Allergan and the Tribe does.”[30] Consumer groups have urged the FTC to investigate Allergan’s “anti-competitive ploy to shield Allergan’s patents from appropriate review [as it] will artificially prolong its monopoly profits;”[31] several other groups asked the Senate Judiciary Committee to investigate, worried that “lost competition will force Americans to pay many billions more.”[32]

Allergan is now facing a host of monopolization lawsuits that refer to its agreement with the tribe as a sham and an anti-competitive conspiracy.[33] Many others nonetheless worry that such patent transfer agreements will gain popularity as drug manufactures continue to explore ways to avoid the patent cliff. Key questions remain: whether such agreements should be disregarded as mere “shams;” whether the act of transferring a patent for the purposes of derailing IPR proceedings constitutes anticompetitive conduct to maintain a monopoly; or how plaintiffs will prove causation, antitrust injury, or damages arising from patent transfers.

Conclusion

The three strategies discussed above that brand-name pharmaceutical companies employ to extend their drugs’ exclusivity period can have far-reaching antitrust implications for consumers and competition alike. Accordingly, brand-name and generic pharmaceutical companies should consult with antitrust counsel when respectively engaging in and responding to strategies that have the potential to stymie generic competition.

​​Miriam R. Vishio is counsel and Nicholas S. Cheolas is a senior associate in the Washington, D.C., office of Zelle LLP.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio​​ Media Inc., or any of its​​ or their respective affiliates. This article is for general info​​rmation p​​urposes an​​d is​​ ​​not ​​intended to be and​​ should not be taken as legal advice.

[1] See PhRMA, Prescription Medicines: Costs in Context, June 2017, at 22, available at http://phrma-docs.phrma.org/files/dmfile/Prescription-Medicines---Costs-in-Context---June-2017.pdf (“On average, it takes more than 10 years and $2.6B to research and develop a new medicine.”); see also Rick Mullin, Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B, SCIENTIFIC AMERICAN, Nov. 24, 2014, available at https://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/. But see Aaron E. Carroll, $2.6 Billion to Develop a Drug? New Estimate Makes Questionable Assumptions, N.Y. TIMES, Nov. 18. 2014, available at https://www.nytimes.com/2014/11/19/upshot/calculating-the-real-costs-of-developing-a-new-drug.html.

[2] 505(q) citizen petitions under the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Food and Drug Administration Amendments Act and the Food and Drug Administration Safety and Innovation Act, involve a pending generic application. 21 U.S.C. § 355(q).

[3] See Michael A. Carrier & Carl J. Minniti, Citizen Petitions: Long, Late-Filed, and At-Last Denied, 66 Am. U. L. REV. 305, 306, 308 (Aug. 30, 2016) (finding “39% of petitions are filed within 6 months of the expiration of a patent or FDA exclusivity, with almost all of these petitions denied”).

[4] The FDCA, which requires the FDA to close 505(q) citizen petitions within 180 days, authorizes the FDA to summarily deny any citizen petition if the FDA determines that the petition’s primary purpose is to delay competition. While Section 505(q)(1)(A) of the FDCA includes important language to prevent generic approval delays unless “necessary to protect the public health,” the FDCA’s effectiveness in eliminating abuses of the citizen petition process to thwart generic competition remains unclear. See Department of Health & Human Services, FDA, Eighth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2015, at 8, available at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM517279.pdf.

[5] For recent cases involving citizen petition challenges against brand-name pharmaceutical companies by generic drug manufacturers, drug wholesalers, and direct and indirect purchasers, see In re Wellbutrin XL Antitrust Litig., No. 08-2433 (E.D. Pa. 2011) (pending); In re Flonase Antitrust Litig. (Roxane Labs., Inc. v. SmithKline Beecham Corp., No. 09-cv-1638 (E.D. Pa. April 17, 2009)) (pending); La. Wholesale Drug Co., Inc. v. Sanofi-Aventis, No. 07-cv-7343(HB), 2008 WL 169362 (S.D.N.Y. Dec. 9, 2008) (unanimous judgment for defendant Aventis following full trial on the merits). See also In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d 677, 694 (2d Cir. 2009). The case settled in August 2011.

[6] See E. R.R. Presidents Conference v. Noerr Motor Freight, 365 U.S. 127 (1961) (Noerr); United Mine Workers v. Pennington, 381 U.S. 657, 669 (1965) (Pennington).

[7] Noerr, 365 U.S. at 144.

[8] Prof’l Real Estate Investors, Inc. v. Columbia Pictures Industries, Inc., 508 U.S. 49, 60 (1993).

[9] Compl., FTC v. Shire ViroPharma Inc., Civil Action No. 17-cv-00131-RGA (D. Del. Feb. 7, 2017), at 41 ¶ 144, available at https://www.ftc.gov/system/files/documents/cases/170216viropharma_unredacted_sealed_complaint_.pdf. [10] Id. at 14 ¶ 49.

[11] 432 F. Supp. 2d 408, 416 (D. Del. 2006).

[12] Id.

[13] Id. at 422.

[14] Walgreen Co. v. AstraZeneca Pharm., 534 F. Supp. 2d 146 (D.D.C. 2008).

[15] Id. at 151.

[16] Some commentators have criticized this approach. See, e.g., Michael A. Carrier & Steve D. Shadowen, Product Hopping: A New Framework, 92 Notre Dame L. Rev. 167, 194, 210-22 (2016). Others have questioned whether competition law is suited to address product hopping claims at all. See, e.g., Joshua D. Wright & Douglas H. Ginsburg, Comment on the Canadian Competition Bureau’s Draft Updated Intellectual Property Enforcement Guidelines (Aug. 10, 2015), available at https://www.ftc.gov/system/files/ documents/public_statements/734661/150810canadacomment.pdf.

[17] In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litig., 64 F. Supp. 3d 665, 681–83 (E.D. Pa. 2014).

[18] New York ex rel. Schneiderman v. Actavis PLC (Namenda), 787 F.3d 638 (2d Cir. 2015).

[19] Mylan Pharm. Inc. v. Warner Chilcott Pub. Ltd. Co. (Doryx), 838 F.3d 421 (3d Cir. 2016).

[20] Id. at 430-31, 439.

[21] In re Asacol Antitrust Litig., 233 F. Supp. 3d 247, 267-270 (D. Mass. 2017).

[22] In re Suboxone, No. 13-MD-2445, 2017 WL 3967911, at *12 (E.D. Pa. Sept. 8, 2017).

[23] In re Suboxone, No. 13-MD-2445, 2017 WL 4642285, at *9 (E.D. Pa. Oct. 17, 2017).

[24] In re Suboxone, No. 13-MD-2445, 2017 WL 4910673, at *6-11 (E.D. Pa. Oct. 30, 2017).

[25] https://www.law360.com/articles/962125/allergan-transfers-restasis-patents-to-ipr-immune-tribe. Pharmaceutical companies are not fond of IPR proceedings, which they argue subject companies to duplicative litigation and different standards of proof than in district court challenges under the Hatch-Waxman Act. See, e.g., Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131 (2016).

[26] Some have questioned whether sovereign immunity could defeat patent challenges outside IPR proceedings. See http://blogs.harvard.edu/billofhealth/2017/09/09/be-very-very-concerned-about-what-allergan-just-did/. Other commentators see the agreement as a justifiable maneuver around to avoid unfair and duplicative IPR proceedings. See https://truthonthemarket.com/2017/09/14/the-allergan-mohawk-deal-an-ingenious-strategy-to-avoid-an-unbalanced-ipr-process/.

[27] https://www.law360.com/articles/975877/ny-tribe-texas-co-slap-patent-suits-on-amazon-microsoft. State universities have also asserted sovereign immunity on behalf of patent licensees. See also https://www.law360.com/articles/885432/patent-board-s-immunity-finding-a-win-for-state-universities.

[28] https://www.law360.com/articles/968797/sens-seek-investigation-of-allergan-s-patent-deal-with-tribe.

[29] https://www.law360.com/articles/972079/mccaskill-drafts-bill-to-block-tribal-immunity-in-patent-review.

[30] Allergan, Inc. v. Teva Pharm. USA, Inc., 2:15-CV-1455-WCB, 2017 WL 4619790, at *2-3 (E.D. Tex. Oct. 16, 2017).

[31] https://docs.wixstatic.com/ugd/1859d0_4652e33a4c3249f5bae0d851bf1a810a.pdf.

[32] https://www.citizen.org/system/files/case_documents/civil-society-to-senate-judiciary-re-allergan-mohawk- restasis-deal.pdf.

[33] See, e.g., Compl., 1199 SEIU Nat’l Benefit Fund v. Allergan, Inc., No. 17-cv-06755 (E.D.N.Y. Nov. 17, 2017); Compl., FWK Holdings, LLC v. Allergan, Inc., No. 17-cv-00747 (E.D.T.X. Nov, 17, 2017); Compl., AFSCME Dist. Council 37 Health & Sec. Plan v. Allergan, Inc., No. 1:17-cv-06684 (E.D.N.Y. Nov. 15, 2017). See also Compl., Cesar Castillo, Inc. v. Allergan, Inc., No. 17-cv-06474 (E.D.N.Y. Nov. 6, 2017); Shire US, Inc. v Allergan, Inc., No. 17-cv-07716 (D.N.J. Oct. 2, 2017); https://www.law360.com/articles/970189.

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.

© Zelle LLP | Attorney Advertising

Written by:

Zelle  LLP
Contact
more
less

Zelle 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.