Janssen Pharmaceutica v. Teva Pharmaceuticals USA, Inc. Case Brief Summary | Law Case Explained

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Janssen Pharmaceutica v. Teva Pharmaceuticals USA, Inc., 583 F.3d 1317 (2009)
Janssen Pharmaceutica versus Teva Pharmaceuticals, also called In re '318 Patent Infringement Litigation, concerned what it takes to meet the enablement requirement.
Bonnie Davis applied for a patent claiming a method for treating Alzheimer’s disease with the molecule galantamine. The specification summarized six papers in which galantamine had been administered to humans or animals. It suggested that chemical deficiencies in animals can cause deficits in learning ability and concluded that a drug that could address these deficiencies could reasonably be expected to help Alzheimer’s patients, but it didn’t refer to any actual animal test results.
After an examiner at the United States Patent and Trademark Office initially rejected the claims, Davis resubmitted the application, stating that experiments were underway using animals treated with galantamine and the results would be available shortly.
The office issued the patent. The test results, suggesting that galantamine might be a promising Alzheimer's treatment, were available two months later but never submitted to the office.
Davis licensed the patent to Janssen, which received approval from the Food and Drug Administration to produce galantamine for treatment of mild to moderate Alzheimer's.
Several generic drug manufacturers, including Teva Pharmaceuticals, filed abbreviated new drug applications seeking to manufacture galantamine drugs.
Janssen sued the companies for patent infringement. Teva argued that the patent claims were invalid for lack of enablement.
The district court found that the patent’s specification didn’t demonstrate utility because the animal tests weren’t finished when the patent was issued. It also found that the application only surmised how galantamine might be used in Alzheimer’s patients without providing specific dosages. The court found that the patent was invalid for lack of enablement.
Janssen appealed to the Federal Circuit.
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