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Posts Tagged: "obviousness type double patenting"

Federal Circuit Upholds Patent for Biologic Drug Enbrel; Judge Reyna Dissents

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.

Damage to Our Patent System by Failure to Honor the U.S. Legal Framework: Double Patenting

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.

CAFC Refuses to Find Post-URAA Patent to be Invalidating Reference Against Pre-URAA Patent

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

Federal Circuit Upholds Patent Term Extension for Novartis Drug

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).

Expectation of Success – How Much is Reasonably Needed for Obviousness

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. 

Patent Cannot Retroactively Be Filed As Divisional Application to Avoid Obviousness-Type Double Patenting

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.

Obviousness-Type Double Patenting Considerations

Obviousness-type double patenting (“ODP”) is a judicially created doctrine aimed at preventing patent owners from extending patent protection beyond the statutorily afforded term. Prior to the Uruguay Round Agreements Act (“URAA”) of 1994, which changed the term for a U.S. patent from seventeen years from patent issuance to twenty years from the earliest (non-provisional) filing date, patent applicants could theoretically extend their patent term without end. For example, a series of patent applications covering the same or similar subject matter, with slightly different claims could be filed. Further, applicants could try to intentionally delay prosecution and, thus, stagger issuance of the resulting patents. After the switch to a twenty year term from the earliest (non-provisional) filing date by the URAA, it has been advocated that the ODP doctrine is now moot and should be eliminated, because applicants can no longer serially extend patent term. However, the Federal Circuit’s decisions in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), and Abbvie v. Mathilda & Terence Kennedy Institute, 764 F. 3d 1366 (Fed. Cir. 2014), have reaffirmed the ODP doctrine.

News & Notes for September 2013

Clouding IP Faces Inter Partes Review at the USPTO. ***** Goodlatte’s Second “Discussion Draft” of Patent Reform Legislation. ***** IPO White Paper Calls for Update to Patent Examination System. ***** The After Final Consideration Pilot 2.0 (AFCP 2.0), which had been scheduled to expire on September 30, 2013, has been extended through December 14, 2013. ***** Patent Litigator Becomes Managing Partner at Kilpatrick Townsend & Stockton. ***** The requirement for consonance applies to both the patent challenged for double patenting (i.e., the challenged patent) and the patent being used as a reference against the challenged patent (i.e., the reference patent).

America Invents: The Unintended Consequences of Patent Reform

Notwithstanding the inherent unreliability of legislative history and the truly scary prospect of trying to get inside the head of Members of Congress, it seems fairly clear to me that the America Invents Act, which was signed into law by President Obama on September 16, 2012, contains at least a handful of things that can only be characterized as unintended consequences. Among them are: (1) U.S. patents issued from foreign filings will be prior art as of the foreign filing date; (2) commonly owned patent applications cannot be used against each other for novelty purposes; and (3) the creation of an post grant challenge limbo because of the delay in initiating post-grant review procedures.

CAFC: A Divisional By Any Other Name Is Not a Divisional

The Federal Circuit, in Amgen Inc. v. F. Hoffman-La Roche Ltd, has made it clear that you had better characterize an application as a “divisional” if you want to the benefit of the “safe harbor” provided by 35 U.S.C § 121. And if you don’t, you’re going face obviousness-type double patenting problems.  The Federal Circuit in Amgen also went on…