The Court of Appeal for Federal Circuit (CAFC) bench of Circuit Judges Mayer, Gajarsa, and Dyk (with dissent from Gajarsa) in 2-1 decision has upheld the U.S. District Court of Delaware’s decision (as detailed by this blog Here ) that innovator ORTHO MCNEIL JANSSEN’s key patent on Galantamine was invalid because of lack of enablement under 35 USC 112, lack of utility under 35 USC 101.
The various generic players like Teva, Barr, Mylan, Dr. Reddy, Purepac, Alpharma opposed innovator’s following patent:
US4663318 (Expiry: Dec 14, 2008): Which covers method of treating Alzheimer's disease and related dementias which comprises administering to a patient suffering from such a disease a therapeutically effective amount of Galanthamine or a pharmaceutically-acceptable acid addition salt thereof.
Innovator has listed the said patent for Galantamine tablets (Razadyne) 4 mg, 8 mg and 12 mg tablets and Galantamine tablets (Razadyne ER) 8 mg, 16 mg and 24 mg extended release capsules
The court opined the patent covers an abstract idea only, without sufficient details on how a person having ordinary skilled in the art can use the invention. Also, the specification (which is of 1 page only) does not disclose full utility of the invention and there is no information about dosage forms to be used for the prevention of Alzheimer’s disease.
Galantamine is used for the treatment of mild to moderate Alzheimer’s disease and various memory impairments. Galantamine is a competitive and reversible cholinesterase inhibitor. It is believed it works by enhancing cholinergic function by increasing the concentration of acetylcholine in the brain.
The increased concentration of acetylcholine is directly linked to memory enhancement. The inventor of the patent Dr. Davies identified this fact and correlated the use of Galantamine with Alzheimer’s disease; however, at the time of filing of patent application, the test data to validate the same fact was not ready.
The CAFC opinion Here
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