PharmaPatents

Timely Insights On Emerging Developments

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.…
In Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court decision finding four Acorda Orange Book-listed patents for Ampyra® invalid as obvious. Acorda raised a number of arguments on appeal, but this article focuses on the impact of a blocking patent on consideration of objective indicia of non-obviousness.…
In his keynote address at the Intellectual Property Owners Association Annual Meeting, USPTO Director Iancu revealed that the USPTO is working on revised patent eligibility guidelines he hopes will help keep patent eligibility issues and conditions-for-patentability issues “in their own distinct lanes.” While that goal sounds like a good one, we all know the devil will be in the details. According to Director Iancu, it could be several months before those have been worked out enough to…
In E.I. DuPont De Nemours & Co. v. Synvina C.V., the Federal Circuit reversed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that had upheld Synvina’s chemical process patent against an obviousness challenge brought in an Inter Partes Review (IPR) proceeding. In so doing, the court outlined four ways to prevail against an obviousness rejection based on routine optimization.…
One of the many concerns raised by the recent outage of the USPTO’s electronic filing system was the requirement to pay the surcharge due when a new U.S. application is not filed electronically. The surcharge is statutory (enacted as part of the AIA), so the USPTO could not waive the fee. However, it has prescribed a process for applicants to obtain a refund that involves re-filing the application electronically in the record for the originally filed application.…
Petitioners in Inter Partes Review proceedings have looked beyond typical patent and scientific literature to find a “printed publication” that might invalidate a patent. This has given the USPTO Patent Trial and Appeal Board (PTAB) and Federal Circuit an opportunity to explain and further define that category of prior art. GoPro, Inc. v. Contour IP Holding LLC is the latest Federal Circuit decision in this category. There, the court reversed the PTAB and…
In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit affirmed decisions of the Patent Trial and Appeal Board (PTAB) that invalidated seven Orange Book-listed patents for Xyrem®. The main issue on appeal was whether FDA meeting materials available on a web page published in a Federal Register Notice qualified as a “printed publication” under 35 USC § 102. The Federal Circuit agreed with the PTAB that they did.…
In Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., the Federal Circuit affirmed the district court’s finding that two patents listed in the Orange Book for Aveed® had not been shown to be obvious. Although prior art disclosed clinical studies that used the formulation, the Federal Circuit agreed the disclosures were not sufficient for inherency-based invalidity. This decision provides an illustrative reminder of the difference between prior art challenges based on a prior art publication…