United States Court of Appeals for the Federal Circuit

1 United States Court of Appeals for the Federal Circuit _____ NOVARTIS PHARMACEUTICALS CORPORATION, Plaintiff-Appellee v. ACCORD HEALTHCARE, INC., AUROBINDO PHARMA LTD., AUROBINDO PHARMA USA, INC., DR. REDDY S LABORATORIES, INC., DR. REDDY S LABORATORIES, LTD., EMCURE PHARMACEUTICALS LTD., HERITAGE PHARMACEUTICALS INC., GLENMARK PHARMACEUTICALS INC., USA, GLENMARK PHARMACEUTICALS LIMITED, HETERO USA, INC., HETERO LABS LIMITED UNIT-V, HETERO LABS LIMITED, MYLAN PHARMACEUTICALS, INC., PRINSTON PHARMACEUTICAL INC., STRIDES GLOBAL PHARMA PRIVATE LIMITED, STRIDES PHARMA, INC., TORRENT PHARMA INC., TORRENT PHARMACEUTICALS LTD., ZYDUS PHARMACEUTICALS (USA) INC., CADILA HEALTHCARE LTD.

2 , APOTEX INC., APOTEX CORP., SUN PHARMACEUTICAL INDUSTRIES, LTD., SUN PHARMACEUTICAL INDUSTRIES INC., SUN PHARMA GLOBAL FZE, Defendants HEC PHARM CO., LTD., HEC PHARM USA INC., Defendants-Appellants _____ 2021-1070 _____ Case: 21-1070 Document: 41 Page: 1 Filed: 01/03/2022 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 2 Appeal from the United States District Court for the District of Delaware in No. 1:18-cv-01043-KAJ, Circuit Judge Kent A. Jordan. _____ Decided: January 3, 2021 _____ JANE M. LOVE, Gibson, Dunn & Crutcher LLP, New York, NY, argued for plaintiff-appellee. Also represented by PAUL E. TORCHIA, ROBERT TRENCHARD.

3 PAUL SKIERMONT, Skiermont Derby LLP, Dallas, TX, argued for defendants-appellants. Also represented by SARAH ELIZABETH SPIRES; MIEKE K. MALMBERG, Los Ange-les, CA. _____ Before MOORE, Chief Judge, LINN and O MALLEY, Circuit Judges. Opinion for the Court filed by Circuit Judge O MALLEY. Dissenting opinion filed by Chief Judge MOORE O MALLEY, Circuit Judge. HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (col-lectively, HEC ) appeal from a district Court bench trial in which the Court found that a patent assigned to Novartis Pharmaceuticals Corp. ( Novartis ), Patent No. 9,187,405 ( the 405 patent ), is not invalid and that HEC s Abbreviated New Drug Application ( ANDA ) in-fringes.

4 HEC argues that the district Court erred in finding that the 405 claims do not fail the written description re-quirement of 35 112(a). Because we do not discern any clear error in the district Court s decision, we affirm. Case: 21-1070 Document: 41 Page: 2 Filed: 01/03/2022 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 3 I. BACKGROUND Novartis markets a mg daily dose of fingolimod hy-drochloride under the brand name Gilenya. The medica-tion is used to treat relapsing remitting multiple sclerosis ( RRMS ), a form of multiple sclerosis ( MS ). MS is a de-bilitating immune-mediated demyelinating disease in which the immune system attacks the myelin coating the nerves in the central nervous system.

5 Most MS patients initially present as RRMS patients, but many eventually develop a secondary progressive form of MS, causing them to experience growing disability. There is currently no cure for MS. The disease is managed by reducing or preventing relapses and thereby slowing disability. HEC filed an ANDA seeking approval to market a ge-neric version of Gilenya. Novartis sued, alleging that HEC s ANDA infringes all claims of the 405 A. The 405 Patent The 405 patent claims methods to treat RRMS with fingolimod (also known as FTY720 and 2- amino-2-[2-(4-oc-tylphenyl)ethyl]propane -1,3-diol in the 405 patent) or a fingolimod salt, such as fingolimod hydrochloride (also known as Compound A in the 405 patent), at a daily dosage of mg without an immediately preceding loading dose.

6 405 patent col. 12 ll. 49 55. A loading dose is a higher than daily dose usually given as the first dose. 27 ( 63) (quoting 23125 (Tr. 547:12 18) and citing 23344 (Tr. 766:4 6)). Both parties experts agreed with this definition. 23125 (547:12 18) (HEC s expert, Dr. Hoffman, testifying that a 1 Novartis sued several other defendants who had also filed ANDA applications. The cases as to those other defendants all settled or were stayed prior to trial, which proceeded only as to HEC. Case: 21-1070 Document: 41 Page: 3 Filed: 01/03/2022 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 4 loading dose is a higher-than-therapeutic level dose, usu-ally given.)

7 As the first dose in order to get therapeutic levels up quickly .. and it s usually for more acute situa-tions ); 23344 (Tr. 766:4 6) (Novartis s expert, Dr. Steinman, agreeing that a loading dose is a higher-than-daily dose ). It is undisputed that loading doses were well-known in the medical field generally and in the prior art. And the experts in this case agree that loading doses are used for some medicaments used in connection with MS. The 405 patent has six claims. Claim 1 of the 405 pa-tent recites: A method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis in a subject in need thereof, comprising orally ad-ministering to said subject 2-amino-2-[2-(4-oc-tylphenyl)ethyl]propa ne-1,3-diol, in free form or in a pharmaceutically acceptable salt form, at a daily dosage of mg, absent an immediately preceding loading dose regimen.

8 Claims 3 and 5 are similar but are directed to a method of treating RRMS and a method of slowing pro-gression of RRMS, respectively, rather than a method for reducing or preventing or alleviating relapses in RRMS. Id. col. 12 ll. 59 64, col. 13 ll. 1 6. Claims 2, 4, and 6 are dependent claims that limit the methods of claims 1, 3, and 5, respectively, to administration of 2-amino-2-[2-(4-oc-tylphenyl)ethyl]propa ne-1,3-diol hydrochloride, , fin-golimod hydrochloride. Id. col. 12 ll. 56 58, col. 12 ll. 65 67, col. 13 ll. 7 9. The 405 patent was filed on April 21, 2014. It claims priority to a British patent application that was filed on June 27, 2006.

9 The parties, for the most part, focus their discussion on the specification of the 405 patent, despite HEC s argument that the inventors did not possess the in-vention as of the 2006 priority date. HEC s argument that the 2006 application does not contain adequate written Case: 21-1070 Document: 41 Page: 4 Filed: 01/03/2022 NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. 5 description of the 405 claims requires reference to the 2006 application itself. Thus, w e find it necessary to look to the specification of the 2006 priority application, despite the parties failure to fully explain the contents of that applica-tion.

10 Although the specifications are different from each other, they are, in all aspects relevant to this appeal, sub-stantively similar. The specifications of the 405 patent and the 2006 pri-ority application both describe the use of a class of S1P re-ceptor modulators, including fingolimod, to treat or prevent neo-angiogenesis associated with a demyelinating disease, multiple sclerosis. 405 patent col. 1 ll. 5 8 ; 23751. The specifications each identify fingolimod hydro-chloride (Compound A) as a particularly preferred com-pound within the class of S1P receptor modulators. 405 patent col. 8 ll. 17 30; 23759 60.