Teva Pharmaceuticals is going all out to prevent Meda Pharmaceuticals from asserting a patent claim that the United States Patent Office corrected via certificate of correction, and so far it has succeeded. The reported decision is at Meda Pharms., Inc. v. Teva Pharms. USA, Inc., 2016 U.S. Dist. LEXIS 157036 (D. Del. Nov. 14, 2016).
The patent, U.S. Patent No. 9,259,428 (“the ‘428 patent”), issued with claim 28 reciting:
“from 0.001% (weight/weight) % (weight/weight) of azelastine hydrochloride”
As can be seen, the claim lacks an upper bound on the percentage of azelastine hydrochloride. Teva contends that the lack of an upper bound, when one was clearly intended, renders the claim indefinite and invalid under 35 U.S.C. § 112.
Meda secured the ‘428 patent in the middle of its p.4 litigation with Teva, and was permitted to amend its complaint to add the patent. Meda immediately sought a certificate of correction from the Patent Office, which was promptly granted, but Meda did not ask permission to amend its complaint to add the certificate until 4 months after the certificate issued, and well into the claim construction process.
The Court denied Meda leave to amend its complaint a second time under Rule 16(b)(4) of the Federal Rules of Civil Procedure because Meda had not shown good cause for the amendment. According to the Court:
Instead of moving to amend at these earlier dates, Plaintiffs waited until after the parties had submitted their opening claim construction briefs to seek leave to amend. Plaintiffs’ decision had the consequence of requiring Defendant to engage in a significant amount of litigation under the assumption that the parties were litigating the uncorrected version of the ‘428 patent. It was Plaintiffs, not Defendant, who were in control of when to move for leave to amend their complaint or to amend the Scheduling Order.
The decision has put Meda into a difficult position. Meda has asked the Court to correct the error under the Court’s common law authority, under the holding of Novo Industries L.P. v. Micro Molds Corp., 350 F.3d 1348, 1354 (Fed. Cir. 2003), but Teva vigorously opposes the request, arguing that it is not clear how the error should be corrected. According to Teva, claim 28 should be invalidated.
It seems to me that the issue is moot, and that the parties are wasting a lot of time and energy on this moot issue. The Court surely cannot invalidate the uncorrected version of claim 28 now that it has been corrected by the Patent Office. Meda might not be able to assert the claim in its current dispute with Teva, but it ought to be able to assert the claim in a different lawsuit.