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

by Morrison & Foerster LLP

Morrison & Foerster LLP

This month we highlight two reversals by the Federal Circuit and a summary judgment of indefiniteness from New Jersey.


Federal Circuit

Grant of Preliminary Injunction Reversed

Indivior Inc. v. Dr. Reddy’s Laboratories, 11/20/18 (Fed. Cir. Nos. 2018-2167, 2018-2169)

In this appeal from the grant of a preliminary injunction, the Federal Circuit reversed. The court held that the patent specification disclaimed “solely using conventional top air drying to produce films with the claimed content uniformity” by distinguishing and disparaging their use. Accordingly, Indivior could not prove likelihood of success on infringement. The court also held that claim preclusion likely bars Indivior’s suit. Judge Newman dissented. 

Reversal and Remand Required to Permit Effective Appellate Review

Tris Pharma Inc., v. Actavis Laboratories Fl, Inc., 11/20/18 (Fed. Cir. Nos. 2017-2557, 2017-2559, 2017-2560)

The district court found all asserted claims invalid as obvious. The Federal Circuit reversed and remanded, stating that the trial court “failed to make the necessary factual findings and provide sufficient analysis of the parties' arguments to permit effective appellate review.” The district court opinion “merely recites the parties' arguments but fails to explain or identify which arguments it credits or rejects. We thus cannot reach the merits of whether the Quillivant XR® formulation would have been obvious over the prior art.” Accordingly, the Federal Circuit remanded for the “district court to conduct further fact-findings and detailed analysis consistent with this opinion.”

District Court

Out of State Pharmacy License Not a Regular and Established Place of Business

Metuchen Pharmaceuticals LLC v. Empower Pharmaceuticals LLC, 11/01/18 (D.N.J. Civil Action No. 18-11406 (JLL)) – subscription required

In this non-ANDA litigation, plaintiff alleged infringement by “knock-off” versions of its avanafil product. Defendants moved to dismiss for improper venue, and did not contest that their internet activities constitute infringement in New Jersey.  Defendants argued, however, that they lacked a regular and established place of business in New Jersey. The district court agreed, holding that an out-of-state pharmacy license issued by New Jersey did not constitute a regular and established place of business. Rather than dismiss, the court transferred the case, including the non-patent claims, to the Southern District of Texas.

Orange Book Listing Is Not Marking

Horatio Washington Depot Technologies LLC v. Tolmar, Inc., 11/01/18 (D. Del. Civil Action No. 17-1086-LPS) – subscription required

In this non-ANDA litigation, plaintiff, who acquired the patents in suit after expiry, sued for past damages only.  Defendants moved to dismiss and the magistrate recommended dismissal in part. Regarding two formulation patents, the magistrate found that plaintiff failed to plead adequate marking. Listing the two patents in the Orange Book in connection with a different brand did not constitute actual or constructive notice. Moreover, as the successor in interest to the original patentee, plaintiff could not escape the original patentee’s failure to mark its differently branded product. The magistrate recommended dismissal with prejudice as to those patents. 

No Good Cause to Amend Complaint to Add DOE Claim

Symed Labs Ltd. v. Roxane Laboratories, Inc., 11/2/18 (D.N.J. Civil Action No. 15-8304 (CCC)) – subscription required

In this ANDA litigation, the court denied plaintiffs’ motion to amend the complaint to alleged willful infringement and “to reserve the right to assert the doctrine of equivalents after the Court’s claim construction.” Because the scheduling order deadline (9/8/16) had long passed, plaintiff failed to show “good cause” to amend. The court also found that, even if good cause were shown, the amendment would be disallowed under Fed. R. Civ. P. Rule 15 based on prejudice to Defendants and the burden on the Court.

Court Rejects First Mover Argument, No Preliminary Injunction

Ferring B.V. v. Serenity Pharmaceuticals, LLC, 11/8/18 (S.D.N.Y. No. 17 Civ. 9922) – subscription required

Ferring sought declarations of non-infringement, invalidity and unenforceability. Serenity counterclaimed for infringement and, after approval of Ferring’s product, sought a preliminary injunction against its launch. The district court denied the motion. Substantial questions regarding infringement precluded a finding of likelihood of success on the merits. The district court also rejected Serenity’s argument that its “first mover” advantage—having obtained an earlier approval of its own product—would be irreparably lost with resultant harm that could not be adequately compensated by money damages.  

Transfer Denied

Duke University v. Sandoz, Inc., 11/13/18 (D. Col. Civil Action No. 18-cv-00997-MSK-KLM) – subscription required

The district court denied a motion to transfer this Hatch-Waxman litigation to the Middle District of North Carolina under 28 U.S.C. § 1404(a). First, the Court held that plaintiffs’ past willingness to litigate in the target district did not constitute consent to always litigate there, and, as a result, it was not shown that the case could properly have been brought in the target district. 

Claims Indefinite Because Inanimate Objects Set No Goals

Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., 11/19/18 (D.N.J. Civil Action No. 15-3324 (SRC)) – subscription required

The district court granted summary judgment of invalidity based on indefiniteness of all asserted claims. The dispute centered on the use of the term “target” in the claims, for example, that the “unit dose forms target” a certain pharmacokinetic (pK) or pharmacodynamics (pD) profile. After first deciding that the “target” clauses did constitute limitations on the claims, the court turned to indefiniteness. During claim construction, the court construed the word “target” to mean “set as a goal,” requiring that “the PK and PD profiles stated in the target clauses define the goals to be set.”  But “[t]he fact that a goal is clearly defined does not mean that the act of targeting that goal is clearly defined, and this is the crux of the definiteness problem here.” The court explained that it “is not possible to comprehend what these phrases mean, because pills cannot be said to set goals. In ordinary usage, we understand a goal to be something that people, or perhaps living creatures, set; inanimate objects set no goals.” The court further explained that “the patent provides no discernable standard for drawing the line that distinguishes infringing acts from noninfringing ones–because the target clauses are incomprehensible.”

No Estoppel, but Prior Claim Construction Order Is “Persuasive Authority”

Amgen Inc. v. Mylan Inc., 11/20/18 (W.D. Pa. No. 2:17-cv-01235) – subscription required

In this BPCIA litigation, the district court issued its claim construction ruling. First, the court held that Amgen was not collaterally estopped from asserting its claim construction by prior litigation involving closely related patents and was not precluded and had not waived its constructions. However, recognizing “the importance of uniformity in the interpretation of claim terms across related patents,” the prior claim construction order will be treated "as persuasive authority" and given “the deference provided any legal holding by a respected colleague." The court then construed numerous terms of the protein purification patents at issue. 

Judgment on the Pleadings

Impax Laboratories, Inc. v. Zydus Pharmaceuticals USA, Inc., 11/29/18 (D.N.J. Civil Action No. 17-13476) – subscription required

The district court granted judgment on the pleadings. In answering defendants’ counterclaims, plaintiff admitted that “[a]s of this date, based on the current proposed products that are the subject of ANDA No. 210911,” did not infringe literally or under the doctrine of equivalents. The court rejected  plaintiff’s speculation that “sometime in the future, and in some unknown way, Zydus will change its ANDA formulation from one that does not infringe to one that does.”

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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.

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