Tuesday, July 24, 2007

Inventorship/Ownership Issues Lead to Invalidity by Double-Patenting

In Re Metoprolol Succinate Patent Litigation (06-1254), July 23, 2007

Companies Astra and Lejus Medical AB had a dispute over the ownership of a Lejus patent (the '318 Patent), which was originally developed by ex-Astra employees. When the ownership dispute was settled, Lejus agreed to divide claims to "metropol succinate" and to a "pharmaceutical composition" having metropol succinate as an active substance, and assigned those claims to Astra. Curiously, inventorship issues were never resolved.

Lejas subsequently filed a CIP off of the disputed patent (the '167 Patent), and followed with another continuation (the '154 Patent). The applications were then assigned back to Astra. Astra did not mention the inventorship dispute to the USPTO.

Astra filed suit on the two patents, and the defendants argued that the original Lejus patent ('318) created obviousness-type double patenting against the subsequent patents. Also, the defendant's argued that Astra's failure to disclose the inventorship dispute was inequitable conduct. The district court granted SJ in favor of the defendants on both counts. Due to the inventorship/ownership issues, Astra was unable to file a terminal disclaimer on the subsequent patents.

On appeal, Astra only challenged the invalidity of the '154 patent. The district court found the ’154 Patent to be a genus of the species claimed by the ’318 Patent. Since the species claimed by the ’318 Patent issued prior to the genus claimed by the ’154 Patent, the district court concluded that the ’154 Patent was "void for double patenting because it is not patentably distinct f[ro]m" Claim 8 of the ’318 Patent.

The CAFC agreed, stating that the critical inquiry remains whether the claims in a prior application define an obvious variation of the invention claimed in the patent:

[I]n this case, Claim 1 of the ’154 Patent claiming a compound (A1) is an obvious variation of Claim 8 of the ’318 Patent claiming a composition comprised of one compound of an enumerated list (A1, A2, A3, etc.), an inner layer (B), and an outer layer (C). Specifically, it would have been an obvious variation of Claim 8 of the ’318 Patent to omit the inner layer (B) and the outer layer (C).
The court also added in a footnote:

Moreover, the omission of the known elements from the composition in this case is "the product not of innovation but of ordinary skill and common sense." KSR Int’l Co. v. Teleflex Inc., 550 U.S. ----, 127 S. Ct. 1727, 1742 (2007).
Regarding the inequitable conduct, the CAFC reversed the finding of enforceability, stating that disputed material facts precluded summary judgment.

Judge Schall's Dissent:
Allowance of claim 1 of the ’154 patent to metoprolol succinate will not result in the improper extension of the patent for the invention claimed in the ’318 patent. That is because in this case, each patent is capable of being practiced by itself, without infringing the other. The public can practice the invention in claim 8 of the ’318 patent when it expires by using any of the ten active ingredients recited in the claim other than metoprolol succinate. While some may find it desirable to use metoprolol succinate as the active ingredient in claim 8 of the ’318 patent, and those individuals will be unable to do so until the ’154 patent expires, that does not result in the "extension" of claim 8 in the ’318 patent, or in any recognized form of double patenting.

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