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Federal Circuit Upholds Application of Dedication-Disclosure Doctrine at the Pleading Stage

On May 8, 2020, the Court of Appeals for the Federal Circuit affirmed the District of Delaware’s application of the disclosure-dedication doctrine in granting a motion for judgment on the pleadings in Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC, No. 19-1924.  The district court’s judgment held that under the disclosure-dedication doctrine, the asserted patents disclosed – but did not claim – a particular solvent, and that Slayback’s use of that disclosed but unclaimed solvent could therefore not infringe under the doctrine of equivalents.

Plaintiff Eagle Pharmaceuticals Inc. holds a New Drug Application (NDA) No. 205580 for BELRAPZO®, a drug with the active ingredient bendamustine approved by the FDA to treat patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma.  After defendant Slayback Pharma LLC submitted an NDA for a bioequivalent drug, Eagle filed suit in the United States District Court for the District of Delaware asserting that Slayback infringed Eagle’s U.S. Patent Nos. 9,265,831, 9,572,796, 9,572,797, and 10,010,533.  All four asserted patents shared essentially the same written description, and the independent claims recited essentially the same limitations: a pharmaceutical composition consisting of (i) bendamustine or a pharmaceutically acceptable salt thereof; (ii) a pharmaceutically acceptable fluid that contains some combination of two solvents (propylene glycol and polyethylene glycol); and (iii) a stabilizing amount of an antioxidant.

Slayback conceded that its bioequivalent drug literally infringed all limitations except for the “pharmaceutically acceptable fluid” limitation because it used ethanol and not propylene glycol or polyethylene glycol.  Eagle argued that because the use of ethanol is insubstantially different from propylene glycol and polyethylene glycol, Slayback infringed under the doctrine of equivalents. 

Slayback moved for judgment on the pleadings pursuant to Federal Rule of Civil Procedure 12(c), arguing that Eagle was barred from asserting infringement under the doctrine of equivalents because the asserted patents had dedicated the use of ethanol as a solvent to the public by disclosing the use of ethanol in the specification, but not claiming the use of ethanol in any issued claim.  Eagle opposed, asserting that the claimed embodiment did not disclose ethanol as an alternative solvent, and that the specification only discussed ethanol in conjunction with unclaimed embodiments that contain a chloride salt.  Eagle also submitted expert testimony opining that a skilled artisan would not understand the disclosure of the use of ethanol as a solvent with chloride salt formulations to be applicable to the claimed embodiments.  Unpersuaded by Eagle’s arguments, the district court granted Slayback’s motion, concluding that it had “sufficient context to decide a question of law – i.e., that the disclosure-dedication doctrine applies to bar Eagle’s claims for infringement under the doctrine of equivalents.”

On appeal, Eagle first argued that the district court erred in its finding that the asserted patents disclosed, but did not claim, ethanol as a solvent.  Eagle contended that the asserted patents disclosed three types of formulations: (i) chloride salt formulations; (ii) antioxidant formulations; and (iii) dimethyl sulfoxide formulations, and that the specification only disclosed ethanol with unclaimed chloride salt formulations.  Further, Eagle posited that a skilled artisan would recognize that these are three independent formulations with different ingredients, and a solvent that works in conjunction with chloride salt would not be a suitable alternative in the claimed formulations.  The Federal Circuit rejected these arguments, reasoning that the disclosure-dedication doctrine does not require a specification to disclose a dedicated subject matter in an embodiment that matches the claimed embodiment.  Instead, this doctrine only requires that the specification disclose the unclaimed subject matter as an alternative to the relevant claim limitation.  The Federal Circuit noted that the specifications of the asserted patents unequivocally identified ethanol as an alternative pharmaceutically acceptable fluid, and nothing in the specifications indicated that the use of ethanol was limited to certain formulations.

Additionally, Eagle argued that the district court erred in applying a judgment of law on the pleadings when a factual dispute still remained – namely, whether a skilled artisan would have understood the specifications to disclose ethanol as an alternate pharmaceutically acceptable fluid.  According to Eagle, the district court failed to draw all reasonable inferences in Eagle’s favor when it neglected to consider Eagle’s expert testimony.  The Federal Circuit disagreed, noting that district courts have discretion to decide whether to consider extrinsic evidence and convert a motion for judgment on the pleadings into one for summary judgment.  Upon reviewing Eagle’s expert testimony, the district court determined that it was an attempt to manufacture a factual dispute.  Further, Eagle conceded that it would have been improper for the court to consider expert testimony at the pleadings stage.  Thus, the Federal Circuit held that the district court did not abuse its discretion, and affirmed.

©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume X, Number 136

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About this Author

Thomas H. Wintner Intellectual Property Litigation Attorney Mintz, Levin, Cohn, Ferris, Glovsky and Popeo Boston, MA
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Tom is an intellectual property and commercial litigator who is equally at home handling cases in trial and appellate courts. Tom counsels clients in a variety of industries, including life sciences, health care, higher education, and real estate. He has extensive experience with patent litigation, trade secrets, and other intellectual property matters, especially those involving pharmaceutical and biologic drugs and diagnostics. Tom also has extensive experience with non-IP commercial litigation matters, including class action litigation in both federal and state court, and commercial...

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Adam Samansky IP Attorney Mintz Law Firm
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Adam is an experienced IP litigator who primarily serves pharmaceutical, medical, high tech, and defense industry clients. He handles patent, trademark, and trade secret matters for innovators and investors. Adam has a strong record of success in multiparty, highly contested Hatch-Waxman litigation, in addition to other litigations involving advanced biochemistry, polymers, optics, manufacturing processes, and electronics. He has tried cases before multiple US district courts, briefed and argued cases before the US Court of Appeals for the Federal Circuit, and briefed bet-the-company issues before the US Supreme Court.

Adam’s practice focuses on intellectual property litigation. He handles patent, trademark, and trade secret matters on behalf of innovators and investors in a range of industries. His core practice includes patent and trade secret litigation involving complex technologies in the pharmaceutical, medical, high-tech, and defense industries. Adam has tried cases before multiple US District Courts, briefed and argued cases before the US Court of Appeals for the Federal Circuit, and has briefed bet-the-company issues before the US Supreme Court.

For pharmaceutical clients, Adam leverages his trial and appellate experience in litigation when advising on new product development, regulatory strategy, Orange Book listing, citizen petition practice, and the settlement of multiparty, highly contested Hatch-Waxman litigation. Adam regularly conducts due diligence on blockbuster pharmaceutical assets, including reviewing and assessing litigation, regulatory, and competitive strategies.

Prior to joining the firm, he was a partner in the Boston office of another international law firm.

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Nana Liu Associate Mintz Life Sciences, Pharmaceuticals,Patent Litigation, International Trade Commission, Hatch-Waxman,  ANDA Litigation,
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Nana focuses her practice on intellectual property litigation, including matters at the International Trade Commission (ITC) and Hatch-Waxman pharmaceutical cases. She also assists with litigation in federal district courts and appellate litigation at the US Court of Appeals for the Federal Circuit. She primarily represents companies in the life sciences industry.

Prior to joining Mintz Levin, Nana served as a judicial law clerk to the now-retired Hon. Andrew R. Grainger of the Massachusetts Appeals Court.

While earning her law degree, Nana was a law clerk at a Massachusetts-...

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