Claims Not Obvious Over Prior Art Aren’t Enabled By That Art

Posted on | October 31, 2008 | No Comments

2008-1594 Janssen Pharma v. Teva
In re: '318 Patent Infringement Litigation
D/DE 05-356
Judge Sue Robinson

Plaintiff Janssen appeals from the judgment of Judge Sue Robinson, after a bench trial, finding 4,663,318 invalid as not enabled under § 112 ¶ 1.  The patent relates to the treatment of Alzheimer's disease with galanthamine and is sold by Janssen as Razadyne®.  This is a consolidation of approximately 7 cases by Janssen against various ANDA filers–Teva was the first lawsuit and Purepac appears to have filed the first ANDA.  Defendants conceded infringement and tried invalidity.

Claims 1 and 4 of the '318 claim:

1. A 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.

4. A method according to claim 1, wherein said administration is oral and is in the range 10-2000 mg per day.

The court provides a fairly detailed history of the prior related to Alzheimer's research, noting that galanthamine is discussed with respect to some dementias [but not Alzheimer's].  For this reason the court rejected defendants' anticipation argument.

The court also rejected defendants' obviousness argument, which it described as:

Defendants assert that there were indeed "a finite number of identified, predictable solutions" to improve cognitive function in AD patients, and Dr. Davis did nothing more than substitute one reversible tertiary amine CI with proven capabilities (galanthamine) for another (physostigmine or THA) to achieve this purpose.

55. Defendants' "obvious to try" argument has two premises: first, that a person of ordinary skill in the art would have followed the intra-synaptic approach, insofar as it was the only approach with "proof of concept" in 1986; and second, that such a person would have been led "directly" to galanthamine, a reversible tertiary amine CI like physostigmine and THA, because the prior art disclosed that galanthamine had a better side effect profile and longer duration of action.

The court found that the evidence showed that galanthamine had an unexpected benefit with Alzheimer's disease, and that those skilled in the art at the time of filing would not have been looking in that direction (again noting that the prior art discussed galanthamine for different conditions).

Enablement.  The unexpected and non-obvious success of galanthamine, however, seems to have led to an enablement problem.  The evidence showed that while Dr. Bonnie Davis, the inventor, conceived of using galanthamine for Alzeimer's, there were no pre-filing (or pre-issue) tests, clinical studies, or the like:

31. Having conceived of using galanthamine for AD, Dr. Davis sought to procure a sample of galantharnine for preclinical studies. (ld..:. at 715:13-718:15; PTX-121; PTX- 122; PTX-123) Galanthamine was unavailable in the United States in 1985 and 1986. (0.1. 389 at 718:12-15) Dr. Davis was unable to obtain galanthamine prior to filing her patent application. (ld..:. at 718: 16-25) Likewise, no clinical studies were performed prior to filing. 

* * *

79. As discussed previously, Dr. Davis did not have galanthamine when her
patent application was filed; Dr. Coyle's experiments were not completed until after the '318 patent was allowed. Nevertheless, and despite Dr. Davis' offer to provide experimental data once it was obtained (PTX-14 at 2), the examiner allowed the application, implicitly finding that adequate evidence of utility existed. Defendants assert, in view of the minimal disclosure of the specification, that the '318 patent cannot be both non-obvious and enabled. That is, if no one would have believed that galanthamine would work as a treatment for AD, persons of ordinary skill in the art would not accept the statements as to the effects of galanthamine "without question."

80. Defendants lift this language from Rasmusson v. SmithKline Beecham
Corp., 413 F.3d 1318 (Fed. Cir. 2005), wherein the Federal Circuit discussed the
enablement requirement of § 112, first paragraph, in the context of a pharmaceutical patent application. [Emphasis by PATracer].

While the court disagreed with some of defendants' argument regarding Rasmusson, it did conclude that Dr. Davis failed to enable the claim:

In the case at bar, Dr. Davis stated that, even after conceiving of her invention and constructively reducing it to practice, she "certainly wasn't sure, and a lot of other people weren't sure[,] that [CIs] would ever work." (0.1. 389 at 712:14-17) As stated in Rasmusson,

[i]f mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to "inventions" consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the "inventor" would be rewarded the spoils instead of the party who demonstrated that the method actually worked.

413 F.3d at 1325. Dr. Davis did not receive any confirming data until after the '318 patent was allowed. In view of the prior art disclosures regarding the flaws of physostigmine in AD treatment, discussed previously in the context of obviousness, it does not follow that a person of ordinary skill in the art, reading the '318 patent, would have recognized that galanthamine would be effective in treating AD in the absence of any experimental proof. See Application of Fisher, 427 F.2d 833, 839 (C.C.P.A. 1970) ("In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved."). Put another way, since plaintiffs rely exclusively on the prior art to establish enablement, the court agrees with defendants that the '318 patent cannot both be non-obvious and enabled.

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