Monday, January 28, 2013

Allergan prevails over Barr/Teva at CAFC

The appellants lost in Allergan v. Barr/ Teva/ Sandoz

The issue:

The only claim term disputed before the district court was –N(R4)2 as used in claim 5, on which asserted claim 10 depends. The parties disagree whether or not –N(R4)2 requires identical R4 substituents. If it does, bimatoprost’s use of nonidentical R4 substituents— hydrogen (H) and an ethyl group (CH2CH3)—would fall outside the protection of the ’819 patent.

Allergan got the nod at district court:

it ultimately found that Allergan had acted as its own lexicographer by defining –N(R4)2 to permit nonidentical R4 elements. Therefore, the district court held that, as used in the ’819 patent, the –N(R4)2 limitation did not require the R4 substituents to be identical. Allergan, Inc., 808 F. Supp. 2d at 726-27.

Reasoning by the district court had to be explained:

Barr and Sandoz nevertheless focus on the district court’s preliminary conclusion that the plain and ordinary meaning of –N(R4)2 required identical R4 elements. However, this preliminary conclusion was based on ex- trinsic evidence, such as expert testimony that “[t]he (X)y nomenclature” was “commonly used” to represent identi- cal substituents, Allergan, 808 F. Supp. 2d at 725, which failed to consider the –N(R4)2 term as it was used in the ’819 patent. Phillips, 415 F.3d at 1321 (“Properly viewed, the ‘ordinary meaning’ of a claim term is its meaning to the ordinary artisan after reading the entire patent.”) (emphasis added).

***The CAFC was oblique on "what" was going on as to the -N(R4)2 business.

One thinks back to Pfizer v. Ranbaxy, 457 F.3d 1284, 79 USPQ2d 1583 (Fed. Cir. 2006). Ranbaxy argued, and won on, failure to comply with
35 USC § 112, paragraph 4:

“Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.”

If -N(R4)2 were construed according to the customary usage (both R4 entities the same), then dependent claim 10 (in allowing R4 to be different) is broader in scope than claim 5.

Also, with claim 5 referencing a "formula", dependent claims 6-10, speaking of a "compound" lack antecedent basis.

Claim 5, in pertinent part: A method of treating ocular hypertension or glaucoma which comprises applying to the eye an amount sufficient to treat ocular hypertension or glaucoma of the formula ##STR16##

Claim 6, in pertinent part: The method of claim 5 wherein said compound


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