Continuation In Part (or) Divisional: Role of Section 121 Safe Harbor in G.D. Searle LLC v. Lupin Pharmaceuticals, Inc.,

The safe harbor provision of section 121 didn’t help Pfizer to save its reissued U.S. Patent No. RE44,048.

Recently the U.S. Court of Appeals for the Federal Circuit upheld a district court ruling that a reissue patent was invalid for obviousness-type double patenting. Case No. 14-1476.

Background:

Pfizer filed a patent infringement action against Teva Pharmaceuticals in the District Court for the District of New Jersey, wherein the district court held that Teva infringed three patents owned by Pfizer specifically,
i) claims 1-3, 7-9, 11, and 13 of U.S. Patent No. 5,466,823 (“the `823 patent”);
ii) claims 1-5 and 15-18 of U.S. Patent No. 5,563,165 (“the 165 patent”); and
iii) claims 1-4 and 11-17 of U.S. Patent No. 5,760,068 (“the `068 patent”).

The claims of the above patents related to Celecoxib (Celebrex®).

The district court also held that the asserted claims of the three patents were not invalid for a best mode violation and that the asserted claims of the `068 patent were not invalid for obviousness-type double patenting.

Further, Teva appeals the decision to the Federal Circuit which concluded that
i) the asserted claims of the US `068 patent are invalid for double patenting and reverse the district court on that aspect of its judgment;
ii) that claim 9 of the US `823 patent and claim 17 of the US `165 patent are not invalid for a best mode violation;
Finally, it affirm the district court’s judgment of infringement with respect to claim 9 of the `823 patent and claim 17 of the `165 patent.

In the above case Pfizer invoked the so called “safe harbor” provision of section 121 which in certain circumstances protects a patent that issues on a divisional application from invalidation based on a related patent that issued on an application as to which a restriction requirement was made, or on an application filed as a result of such a requirement.

In 2008 Pfizer filed U.S. Patent Application No. 12/205,319 (“the ’319 application”), seeking reissue of the ’068 patent, which sought to correct that alleged error by reissue. Pfizer has made the following changes to the US ‘068 patent (imp are given).
a) it deleted portions of the ’068 patent specification that were not present in the US 5,466,823 patent;
b) it designated the US ‘068 patent as a divisional of the US ‘823 patent and removed the priority claim to the US 5,521,207 patent.

Finally the examiner has allowed some technical errors; and also allowed to make additional changes, including designating the US ’068 patent issued as a divisional of the US ‘823 and removing subject matter not present in the US ‘823 patent. Finally in 2013 USPTO issued reissued patent RE44,048 for US ‘068.

On the day the RE ’048 patent issued, Pfizer filed the instant case against five generic drug manufacturers, alleging infringement of the RE ’048 patent. However, the court found that the RE ’048 patent was not a valid reissue patent, because Pfizer’s asserted error of prosecuting a prior patent application as a continuation-in-part, rather than as a divisional, was not correctable by reissue under section 251. The court further found that the safe harbor provision of 35 U.S.C. § 121 did not apply to the RE ’048 patent, and that the relevant claims of the RE ’048 patent were invalid for obviousness-type double patenting in light of the ’165 patent. A final judgment of invalidity was entered against Pfizer. This appeal followed.

In the Federal Circuit, the parties submitted their arguments. Finally the Federal Circuit concluded that the section 121 safe harbor provision does not apply to the RE ’048 patent, and AFFIRMED the district courts decision.

The following diagram can help to understand the above case.

image 3

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