Posts Tagged: "obviousness type double patenting"

Just before the Thanksgiving break, a number of amici submitted briefs to the U.S. Court of Appeals for the Federal Circuit (CAFC) asking the en banc court to rehear a case that many feel has a good chance of helping to clarify the law around the judicially-created doctrine of non-statutory obviousness-type double patenting (ODP). Cellect, LLC filed its petition for rehearing en banc on November 13, asking the full court to consider whether the August panel decision should be overturned. In that decision, authored by Judge Lourie, the court held that patent term extension (PTE) and patent term adjustment (PTA) are not the same for purposes of an obviousness-type double patenting (ODP) analysis.

In an IPWatchDog post of September 6, 2022, Anthony Prosser and I traced the history of the doctrine of “Non-Statutory Judicially Created Obviousness-Type Double Patenting” (ODP). We confirmed (as its name indicates) that no Congressional statute has ever codified this doctrine. It is ultra vires because Congress has the sole right to create patent law…. In the Cellect decision issued yesterday, the Federal Circuit stretches the word “disclaimer” in Section154(b)(2)(B) beyond credibility as justification for the ODP doctrine itself and assumes that is what Congress was talking about without actually saying it (stating with agreement that “The Board also reasoned that terminal disclaimers arise almost exclusively in situations to overcome ODP rejections, and so Congress, by addressing terminal disclaimers in §154, effectively addresses ODP”).

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision today in In re Cellect holding that patent term extension (PTE) and patent term adjustment (PTA) are not the same for purposes of an obviousness-type double patenting (ODP) analysis. Specifically, the court said that “ODP for a patent that has received PTA, regardless whether or not a terminal disclaimer is required or has been filed, must be based on the expiration date of the patent after PTA has been added.” The opinion was authored by Judge Lourie.

In a June 20, 2022, article on IPWatchdog, I addressed a portion of the June 8, 2022, letter from Senators Leahy, Blumenthal, Klobuchar, Cornyn, Collins and Braun  to U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal requesting the USPTO to issue a notice of rulemaking or request for comments in the Federal Register by September 1, 2022, on curbing continuation practice as a means to address “patent thickets.”  As of the date of this article, the USPTO has not issued the notice. In this article, I, along with co-author Anthony Prosser, address the other issue raised in the Senators’ June 8 letter—whether elimination of terminal disclaimers that “allow” patents to issue that are “obvious variations of each other” would increase patent quality and whether patents that are tied by a terminal disclaimer should be considered an admission of obviousness and stand or fall together in litigation.

On July 1, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a holding of the U.S. District Court for the District of New Jersey in Immunex Corporation, Amgen Manufacturing, Limited, Hoffman-La Roche Inc. v. Sandoz, Inc., Sandoz International GMBH, Sandoz GMBH, holding that Sandoz failed to prove that the asserted claims were invalid for obviousness-type double patenting (ODP), failure to meet the written description requirement, and obviousness for lack of motivation to combine the prior art references. The ruling for now blocks Sandoz from marketing its biosimilar version (Erelzi) of the popular rheumatoid arthritis drug, Enbrel. Judge Reyna dissented, arguing that certain clauses of the licensing agreement were illusory, thereby rendering the agreement an effective assignment for purposes of ODP.

As the summer winds down, it is time again to focus on how to fix the U.S. patent system. In June, the Senate Judiciary’s IP Subcommittee held unprecedented hearings on patent eligibility. They are now back in closed door sessions with selected stakeholders to further consider language to amend Section 101, having received extensive feedback. My testimony in part addressed the unconstitutionality of the U.S. Supreme Court’s cases on patent eligibility, which have created judicial exceptions that arrogantly ignore the plain wording of Congress’ statute (“invention or discovery” in the disjunctive in Sections 100(a), (f) and (g) and Section 101) and its legislative history, and despite the fact that the U.S. Constitution gives Congress the sole power to create patent law. The doctrine of judicially-created non-statutory obviousness-type double patenting is the flip side of the coin of the patent eligibility issues.  A rejection for “non-statutory obviousness-type” double patenting is based on a “judicially-created doctrine” grounded in public policy and which is primarily intended to prevent prolongation of the patent term by prohibiting claims in a second patent not patentably distinct from claims in a first patent. This is problematic for at least the following reasons.

The Federal Circuit recently reversed a decision by the United States District Court for the District of Delaware holding that a patent filed after the Uruguay Round Agreement Act (“URAA”) is a proper obviousness-type double patenting reference against an earlier-filed, yet later-expiring, pre-URAA patent. Applying the Federal Circuit case Gilead Sciences, Inc. v. Natco Pharma Ltd., the district court invalidated the earlier-filed compound patent by asserting the later-filed method of treatment patent as a double patenting reference. The Federal Circuit reversed the decision by holding the analysis in Gilead “was limited to the context of when both patents in question are post-URAA patents.” While the Court limited the present opinion to the specific facts of this case, the Court applied pre-URAA double-patenting practices to the pre-URAA patent and reasoned that the invalidating reference “did not exist as a double patenting reference” when the pre-URAA patent issued

The United States Court of Appeals for the Federal Circuit recently affirmed a district court decision finding the ‘229 patent valid, unexpired, enforceable, and infringed, and granting an injunction until February 2019. Specifically, the Federal Circuit held that the ‘229 patent’s five-year term extension pursuant to 35 U.S.C. § 156 was valid, even though it effectively extended the term of a related patent. The Court also held that the ‘229 patent was not invalid based on obviousness-type double patenting because obviousness-type double patenting cannot invalidate a patent which has received a valid term extension. Novartis AG v. Ezra Ventures LLC, No. 2017-2284, (Fed. Cir. Dec. 7, 2018) (Before Moore, Chen, and Hughes, Circuit Judges) (Opinion for the court by Chen, Circuit Judge).

How much is needed to reasonably prove obviousness? In UCB, the majority found UCB, Inc.’s asserted claim nonobvious under non-statutory double patenting.  The dissent, however, found overwhelming evidence in support of obviousness.  The majority determined that prior art teaching was insufficient for a skilled artisan to have a reasonable expectation of success.  To the dissent, however, the majority’s analysis was flawed because it ignored the fact that the law required only a reasonable expectation of success, not a guarantee.  One might say the majority viewed the glass as half full and the dissent half empty. 

To fall within the safe-harbor protection against obviousness-type double patenting, a patent application must be properly designated as a divisional application before the patent issues. Attempts to retroactively re-designation a CIP application as a divisional does not bring the patent granted from that application within the protection of the safe-harbor, whether or not any benefit was gained from the initial CIP designation.