Patent Law Weblog
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- Allen v. Cooper (4th Cir. 2026)
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Category: Enablement
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By Donald Zuhn — Last month, in Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., the Federal Circuit affirmed a decision by the U.S. District Court for the District of Delaware finding the asserted claims of U.S. Patent Nos. 6,992,180 and 8,097,405 invalid for lack of enablement. Enzo had asserted the '180 patent in…
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By John E. Conour — Even with billions of dollars of funding and the cumulative knowledge and experience of over a hundred years of experimental pharmacology, de novo discovery of effective and safe therapeutics remains a costly and risky endeavor. The number of unsuccessful attempts to obtain Food and Drug Administration (FDA) approval of drugs…
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By Kevin E. Noonan — It is black-letter law that a claim must be enabled throughout its full scope in order to satisfy the enablement requirement of 35 U.S.C. § 112(a); see, e.g., Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1378–79 (Fed. Cir. 2007). And in the Federal Circuit's recent decision in Trustees of…
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By Donald Zuhn — Last month, in Promega Corp. v. Life Technologies Corp., the Federal Circuit determined that U.S. Patent Nos. 5,843,660; 6,221,598; 6,479,235; and 7,008,771, which are owned by Promega Corp., are invalid under 35 U.S.C. § 112, first paragraph, for lack of enablement, and therefore reversed the District Court's denial of a motion…
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By Andrew Williams — Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is jointly assigned to Helsinn Healthcare S.A. and Roche Palo Alto, LLC (collectively "Helsinn"). As a reminder, PGRs…
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Barr does not infringe, Alcon's patents not invalid By Kevin E. Noonan — In ANDA litigation between branded drug maker Alcon Research and generic drugmaker Barr Laboratories, the Federal Circuit affirmed a District Court finding of non-infringement and reversed a finding of invalidity for failure to satisfy either the enablement or written description requirements of…
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By Andrew Williams — The standard of review at the Federal Circuit is important. Even though it often appears like cases are re-litigated at the Appeals Court, it is actually very difficult (or at least should be) to overturn a lower court's factual determinations. This is especially true for a finding that a patent was…
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By Kevin E. Noonan — The Patent Trial and Appeals Board (PTAB), a creation of the Leahy-Smith America Invents Act that replaced the Board of Patent Appeals and Interferences (BPAI) overruled the Reexamination Unit's decision that the claims of U.S. Patent No. 6,777,231 were invalid for failing to satisfy the written description and enablement requirements…
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By Donald Zuhn — Last month, in an opposition brief filed by attorneys for the U.S. Patent and Trademark Office and Department of Justice, the Office asked the Supreme Court to deny petitioner's writ of certiorari in Finjan, Inc. v. United States Patent and Trademark Office. The question presented by petitioner was: Whether, in proceedings to…
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By Andrew Williams — A claim term that can have different meanings or values depending on the method used to measure it renders the claim indefinite because it is impossible for a potential infringer to discern the boundaries of the claim. This is because it is not possible to determine whether potential infringing activity will…
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