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is a patent attorney whose practice focuses on prosecution of domestic and international patent applications. Sanjeev helps clients obtain patents across a wide technology spectrum including biotechnology, pharmaceuticals, chemistry, materials science, and medical devices.
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In The Chemours Company FC, LLC v. Daikin Industries, Ltd., Nos. 2020-1289, 2020-1290 (Fed. Cir. July 22, 2021) (“Chemours v. Daikin”), the Federal Circuit clarified three doctrines involved in the determination of obviousness: teaching away, commercial success, and blocking patents. While all three panel judges agreed that the Patent Trial and Appeal Board (“Board”) misapplied the commercial success and blocking patents doctrines, they disagreed as to the Board’s application of the teaching away doctrine. In contrast to the Board, the majority found evidence of teaching away in the prior art. But Judge Dyk, dissenting, found no such evidence and called the majority’s determination an impermissible expansion of the doctrine that now encompassed a reference’s mere preference for a particular alternative.
Section 156 of the Hatch-Waxman Act provides for restoring some of a patent’s term consumed during clinical testing and Food and Drug Administration (FDA) review of a New Drug Application (NDA) for a product covered by the patent. The extension afforded under Section 156 is of great importance to a drug manufacturer given that development of a new drug from discovery through FDA approval often takes a decade or more (10-15 years), leading to the loss of a significant portion of the term of a patent covering the drug. The dispute in Biogen International Gmbh v. Banner Life Sciences LLC, No. 2020-1373 (Fed. Cir. April 21, 2020) (Biogen v. Banner) centers around the very meaning of the term “product” as used in Section 156.
The doctrine of equivalents allows a patentee to raise a claim of infringement even when each and every element of the patented invention is not identically present in the allegedly infringing product/process. The doctrine is aimed at preventing an infringer from gaining the benefit of a patented invention by making insubstantial changes. Disclosure-dedication doctrine is a bar to the doctrine of equivalents. Under the disclosure-dedication doctrine, when a patentee discloses subject matter but does not claim it, the patentee dedicates the unclaimed subject matter to the public and cannot recapture it through the doctrine of equivalents. The public can then practice the unclaimed subject matter without fear of infringement.Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC, No. 2019-1924 (Fed. Cir. May 8, 2020) (“Eagle Pharm”) is the most recent Federal Circuit case involving this doctrine. In Eagle Pharm, the Federal Circuit considered whether a patentee can avoid dedication on the ground that the disclosure occurred in an embodiment distinct from the claimed invention. The court answered the question in the negative.
The Federal Circuit recently found that a method for preparing an extracellular DNA fraction from a pregnant human female and using it for analyzing a genetic locus involved in a fetal chromosomal aberration was not directed to a natural phenomenon, and thus eligible for patenting. Illumina, Inc. v. Ariosa Diagnostics, Inc., No. 2019-1419 (Fed. Cir. March 17, 2020) (“Illumina v. Ariosa”). The decision includes a dissent. Appreciation of the reasoning of both the Majority and the Dissent is essential to understanding the current state of the debate on subject matter eligibility of processes involving natural phenomenon. The all-important question in such cases centers on how to determine whether such an invention is directed to a judicial exception. Stated differently, when does an invention that uses a natural phenomenon turn into a patent-eligible process rather than being directed merely to the natural phenomenon?