What Are the Top Hatch-Waxman and BPCIA Developments for October 2018?

11/06/2018
Client Alert

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.

CASES

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

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.

LEGISLATION

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.

FDA

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.

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