United States: What Are The Top Hatch-Waxman And BPCIA Developments For October 2018?

Last Updated: November 9 2018
Article by David A. Manspeizer

This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware.


Supreme Court

Can the Government Petition to IPR Your Compound Patent?

Return Mail, Inc. v. United States Postal Service, 10/26/18 (No. 17-1594)

The Supreme Court granted certiorari on the following question: "Whether the government is a 'person' who may petition to institute review proceedings under the Leahy-Smith America Invents Act."

Unclaimed Disclosures as Prior Art

Ariosa Diagnostics, Inc. v. Illumina, Inc., 10/29/18 (No. 18-109)

The Supreme Court requested the views of the Solicitor General on the following question: "Whether unclaimed disclosures in a published patent application and an earlier application it relies on for priority enter the public domain and thus become prior art as of the earlier application's filing date."

Federal Circuit

Reasonable Expectation of Success for Dosing Patent Doesn't Require pk/pd Profile

Yeda Research and Development Co. v. Mylan Pharmaceuticals, Inc., 10/12/18 (Fed. Cir. Nos. 2017-1594, 2017-1595, 2017-1596)

In these consolidated appeals from IPR decisions invalidating the claims of three patents to glatiramer acetate, the Federal Circuit affirmed. The court first rejected appellant's argument that its due process rights and the APA were violated because it lacked notice of and an opportunity to respond to a non-prior art reference first raised in a reply expert declaration. The court also affirmed that the board could rely on that non-prior art reference (evidence of an ongoing clinical trial) as evidence of motivation to explore less frequent dosing options. The court then affirmed the PTAB's decision that the claims of all three patents were invalid as obvious. More specifically, the court rejected Yeda's argument that there was no reasonable expectation of success of the claimed regimen absent a pk/pd profile.

Statements of Intended Effect in Dosing and Method Claims Not Limiting

In re: Copaxone Consolidated Cases, 10/12/18 (Fed. Cir. No. 2017-1575)

In this companion action appealing the district court's decision that all asserted claims of the same three glatiramer acetate dosing patents (and an additional one) were invalid as obvious, the Federal Circuit first affirmed the district court's claim construction. More specifically, the court relied heavily on Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368 (Fed. Cir. 2001) in holding that terms such as "the regimen being sufficient to reduce the frequency of relapses in the patient" were not limitations on the claims. Those words did not "change the express dosing amount or method already disclosed in the claims, or otherwise result in a manipulative difference in the steps of the claims." Because the claims were already clear that the regimen was "therapeutically effective," the additional phrase "the regimen being sufficient to" was "superfluous, [did] not change the claimed method or require any additional required structure or condition for the claims, and [was] therefore non-limiting."

Picking and Choosing Support Doesn't Adequately Describe MS Treatment

FWP IP ApS v. Biogen MA, Inc., 10/24/18 (Fed. Cir. No. 2017-2109)

In this appeal from an adverse interference decision, the court held that substantial evidence supported the PTAB's finding that appellant's application did not adequately disclose the claimed method of treating MS with a particular dosage.

District Court

"Patient" or "Patient Population"?

Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharmaceuticals Ltd., 10/5/18 (D.N.J. Civil Action No. 18-2065 (SRC)) – subscription required

In this ANDA litigation, the court rejected the argument that terms directed to a patient not experiencing "a clinically significant weight gain" referred to a patient population. Rather, they referred to "one or more patients." The court deferred construing "clinically significant weight gain" until summary judgment or trial, as defendants contend the term is indefinite. The court also held that prosecution disclaimer limited the term "a pregelatinized starch" to those "with a content greater than or equal to 10% (wt/wt)."

Weak Infringement Theory Does Not Make Case Stand Out from Others

Shire Development LLC v. Amneal Pharmaceuticals LLC, (D.N.J. No. 1:15‐cv‐02865 (RBK/JS))

Following a settlement in which the parties voluntarily dismissed the infringement claims and invalidity counterclaims with prejudice in this Hatch-Waxman case, Amneal sought a declaration that the case was exceptional. More specifically, Amneal argued that plaintiffs knew their infringement theory was untenable when it filed its expert reports and pressed an "infringement argument it knew it couldn't win." But while plaintiff may not have had "the strongest scientific argument," one "need not set forth a strong argument to prevail" on exceptionality. Plaintiffs did not have to show they would have prevailed at trial, but rather "that they had some theoretical and chemical back‐up to support what could very well be a substantively weak infringement theory." They did so. Regarding other litigation conduct, "[b]itter discovery disputes and strong economic reasons that de‐incentivize settlement, even coupled to a weak infringement theory, are par for the course, and do not make this case 'stand out from others.'"

Country Roads Take Me Home to the Place I Belong ...

Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals Inc.¸ 10/18/18 (D. Del. C.A. No. 17-379-LPS)

The district court dismissed the action for lack of venue in this ANDA litigation after eight months of limited discovery and three discovery dispute teleconferences with the court. Plaintiff contended that the presence of a subsidiary in the district established proper venue. The court disagreed. While residency of one corporate entity can be imputed to another for venue purposes where there is an alter-ego relationship or piercing of the corporate veil, plaintiffs did not meet their "heavy burden" here. The court also rejected plaintiffs' argument that venue in Hatch-Waxman cases is not governed by 28 U.S.C. § 1400(b), but rather by § 1391.

Equitable Conditions on Dismissal Without Prejudice

Ferring Pharmaceuticals Inc. v. Novel Laboratories, Inc., 10/22/18 (D. Del. C.A. No. 17-894-RGA) – subscription required

Plaintiffs sought dismissal of the sole remaining infringement count without prejudice. The court analyzed the factors to be considering in weighing dismissal with, versus without, prejudice. As an equitable condition of dismissal without prejudice, the court required plaintiffs to reimburse defendants' reasonable costs and attorneys' fees attributable to that count, approximately $225,000. Following that requirement, each of the factors rated neutral or favored dismissal without prejudice.

Plaintiff Sufficiently Pled Infringement

Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc., 10/23/18 (D.N.J. Civil Action No: 18-3632-SDW-CLW) – subscription required

The court denied Teva's motion to dismiss in this ANDA litigation. Teva argued plaintiff did not sufficiently plead infringement, relying largely on an analysis of the specifics of its ANDA and a comparison of labels. The court found that plaintiff pled sufficient facts to place Teva on notice by "alleging that it is the holder of the patents-in-suit and that Teva has infringed or will infringe on at least one claim in each of the patents-in-suit."

Doses Only Different in Kind and Not Degree

Boehringer Ingelheim Pharmaceuticals Inc v. HEC Pharm Co., Ltd., 10/25/18 (D.N.J. Civil Action No: 15-cv-5982 (PGS)(TJB)) – subscription required

In this ANDA litigation, the district court found the asserted claims were invalid for obviousness-type double patenting. The asserted claims differed from the reference claims by specifying specific doses and dosage form. These differences did not render the asserted claims patentably distinct because through routine experimentation one skilled in the art would have a reasonable expectation of narrowing the prior art dosage range and arriving at the claimed dosages. Because the claimed doses fell within prior art ranges, they were also rendered obvious because the results obtained with such doses differed only in degree, and not kind, over the prior art.

That's the Sound of Inevitability, Mr. Anderson

BTG Int'l Ltd. v. Amneal Pharmaceuticals LLC, 10/25/18 (D.N.J. Civ. Nos. 15-cv-5909 (KM)(JBC); Civ. No. 16-cv-2449 (KM)(JBC); Civ. No. l7-cv-6435 (KM)(JBC)) – subscription required

In this consolidated ANDA litigation, the district court agreed with a prior PTAB decision that the asserted claims were invalid for obviousness. "In short, the anticipated combination therapy—irrespective of what was in the POSA's mind as to the exact mechanism—would have looked precisely the same. So understood, this begins to look less like serendipity and more like inevitability." There was, however, adequate written description. The court also found that, if valid, the claims would be infringed, either by inducement or contributory infringement.

No Judgment on the Pleadings Where Claim Construction Required

Eli Lilly and Co. v. Eagle Pharmaceuticals, Inc., 10/25/18 (D.N.J. Civ. No. 17-1293- MSG) – subscription required

In this "paper NDA" case, the district court denied defendant's motion for judgment on the pleadings. Eagle contended that its NDA Product cannot literally infringe the patent-in-suit, because the active ingredient is pemetrexed, also known as pemetrexed diacid, while the patent requires the use of pemetrexed disodium. Lilly argued the evidence would show that administering Eagle's NDA Product in accordance with its proposed labeling involves administering a solution covered by the patent-in-suit. The court denied the motion because resolution would require claim construction and such questions "are not suitable for resolution on a Rule 12 motion."


PTO Final Rulemaking Narrows Claim Construction for AIA Proceedings

The PTO published final rulemaking changing the claim construction standard for IPR, PGR, and CBM proceedings from "broadest reasonable construction" to the "same claim construction standard that is used to construe the claim in a civil action in federal district court." The final rule adds that the PTO will consider any prior claim construction in civil or ITC actions, if timely made of record. The final rule becomes effective on November 13, 2018.


Notifying the FTC and DOJ About Biosimilar Settlements Now Required

On October 10, the president signed into law the "Patient Right to Know Drug Prices Act," amending the Medicare Prescription Drug, Improvement, and Modernization Act. Under that Act, the same FTC and DOJ notification requirements applicable to settlement of ANDA litigation now apply to biosimilar litigation.


Branded to OTC Switch Makes Prescription Generic Misbranded

Breckenridge Pharmaceutical, Inc. v. Azar, 10/30/18 (D.C. Cir. Nos. 18-1112; 18-1120; 18-1130)

In 1999, the FDA approved prescription MiraLax. Petitioners filed ANDAs and those applications were approved starting in 2006. The FDA approved the NDA for OTC MiraLax in October 2006. According to the FDA, its approval of the NDA for an OTC version meant that PEG3350 (MiraLax's active ingredient) no longer met the criteria for a prescription drug and the prescription version would be misbranded unless there was a "meaningful difference" between the two versions of the drug. After "an unexplained six-year delay," in 2016 the FDA issued a notice withdrawing petitioners' ANDAs. That notice was made final in 2018. Petitioners challenged the ruling. The court concluded that the FDA's determination that prescription MiraLax was misbranded for lack of a "meaningful difference" with OTC MiraLax was not arbitrary or capricious. The court also rejected petitioners' procedural challenges.

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.

© Morrison & Foerster LLP. All rights reserved

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions