Novartis Pharms. Corp. v. Accord Healthcare, Inc.

Novartis Pharms. Corp. v. Accord Healthcare, Inc.

Opinion

O'Malley, Circuit Judge.

HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (collectively, "HEC") appeal from a district court bench trial in which the court found that a patent assigned to Novartis Pharmaceuticals Corp. ("Novartis"), U.S. Patent No. 9,187,405 ("the '405 patent"), is not invalid and that HEC's Abbreviated New Drug Application ("ANDA") infringes. HEC argues that the district court erred in finding that the '405 claims do not fail the written description requirement of 35 U.S.C. § 112(a). Because we do not discern any clear error in the district court's decision, we affirm.

I. Background

Novartis markets a 0.5 mg daily dose of fingolimod hydrochloride [*2]  under the brand name Gilenya. The medication is used to treat relapsing remitting multiple sclerosis ("RRMS"), a form of multiple sclerosis ("MS"). MS is a debilitating immune-mediated demyelinating disease in which the immune system attacks the myelin coating the nerves in the central nervous system. 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 generic version of Gilenya. Novartis sued, alleging that HEC's ANDA infringes all claims of the '405 patent.¹

A. The '405 Patent

The '405 patent claims methods to treat RRMS with fingolimod (also known as FTY720 and 2-amino-2-[2-(4-octylphenyl) 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 0.5 mg without an immediately preceding loading dose. '405 patent col. 12 ll. 49-55.

A loading dose is a higher than daily dose "usually given 'as the first dose.'" J.A. 27 (P 63) (quoting J.A. 23125 (Tr. 547:12-18) and citing [*3]  J.A. 23344 (Tr. 766:4-6)). Both parties' experts agreed with this definition. J.A. 23125 (547:12-18) (HEC's expert, Dr. Hoffman, testifying that "a loading dose is a higher-than-therapeutic level dose, usually given . . . as the first dose in order to get therapeutic levels up quickly . . . and it's usually for more acute situations"); J.A. 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.

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