PharmaPatents

Timely Insights On Emerging Developments

In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the Novartis Gilenya patent, the court confirmed that the statute permits an extended product patent to “effectively” block the practice of an earlier-expiring method patent, and refused to elevate the judicially-created doctrine of obviousness-type double patenting over the statutory grant of PTE. Pharmaceutical…
In an opinion issued November 19, 2018, Judge Chesler of the U.S. District Court for the District of New Jersey found two Orange Book-listed patents for VIMOVO® invalid for indefiniteness in the way certain pharmacokinetic (PK) properties were recited. The opinion supports the court’s summary judgement of invalidity of the patents.…
In Yeda Research & Development Co., v. Mylan Pharmaceuticals Inc., the Federal Circuit affirmed the decisions of the USPTO Patent Trial and Appeal Board (PTAB) finding three Copaxone patents invalid as obvious in parallel Inter Partes review (IPR) proceedings. The companion decision pertaining to related district court litigation caught my attention for its use of originally confidential statements to FDA as evidence of the state of the art that supported obviousness. This decision caught my attention for its use of a…
The USPTO has devised a plan to address the IDS PTA deduction error that incorrectly charges a Patent Term Adjustment (PTA) deduction for Information Disclosure Statements (IDSs) filed with a “safe harbor” statement. Although the USPTO won’t be able to correct the underlying problem until it rolls out its “next generation” information technology systems, it has devised a plan to make it easier for applicants to flag safe harbor IDSs, and easier–and cheaper–to request recalculation of a PTA…
In an October 25, 2018 Federal Register Notice, the USPTO announced staged implementation of the first phase of an initiative aimed at “leveraging electronic resources to retrieve information” of record in one patent application for consideration in another. While the first phase of the Access to Relevant Prior Art Initiative is limited to importing citations from a parent application into its immediate child, it represents an important first step towards reducing the burdens of satisfying the Duty…
In In re Copaxone Consolidated Cases, the Federal Circuit affirmed the district court decision finding four patents directed to a specific dosing regimen for using COPAXONE® 40 mg/ml to treat patients with relapsing multiple sclerosis invalid as obvious. One thing that caught my attention was the use of originally confidential statements to FDA as evidence of the state of the art that supported the obviousness holding.…
In Natural Alternatives Intl. Inc. v. Iancu, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that the patent at issue was not entitled to its earliest claimed priority date because NAI had deleted priority claims in a parent application that broke the priority chain. This decision highlights that a priority claim chain must be continuous and remain unbroken in order for a priority claim to be valid.…
In Roche Molecular Systems, Inc. v. Cepheid, the Federal Circuit affirmed the summary judgment decision of the U.S. District Court for the Northern District of California that held nucleotide primer claims and detection method claims invalid under 35 USC § 101. This decision may be at odds with USPTO guidance that claims directed to a method of detection without a diagnostic correlation are patent-eligible. Judge O’Malley’s concurrence highlights the problem of giving precedential effect to patent eligibility…
The Federal Circuit decision in Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. addressed several aspects of obviousness doctrine. We previously wrote about the impact of a blocking patent on consideration of objective indicia of non-obviousness. Here, we look at the court’s treatment of the requirement for a reasonable expectation of success.…