The District of Delaware recently rejected a patentee’s argument that non-production of an opinion letter from counsel, combined with knowledge of the patent, warranted a finding that defendant induced infringement. ...more
The Patent Trial and Appeal Board rejected a patent owner’s assertion that petitioner should have named a third party, which was a defendant in a related district court patent infringement litigation and a party to a joint...more
The Central District of California ruled that the heightened pleading standard of Federal Rule of Civil Procedure Rule 9(b) applies to all three prongs of a false patent marking claim, including the third prong, competitive...more
The Federal Circuit dismissed an appeal from an inter partes review (“IPR”) final written decision for lack of standing where it found the appellant failed to provide evidence sufficient to show it suffered an injury in fact....more
The Federal Circuit recently affirmed an ITC holding that the AIA’s § 102 on-sale bar applies to the sale of a product made according to a secret process when that sale occurs more than one year before the patent’s effective...more
The Patent Trial and Appeal Board has granted a petitioner’s motion to submit supplemental information, over patent owner’s objections, concerning the public availability of references that were relied upon to support grounds...more
The District of Delaware granted-in-part Shopify’s motion for judgment as a matter of law, or alternatively a new trial, citing gaps in the evidentiary record resulting in an insufficient basis for the jury verdict of...more
The Patent Trial and Appeal Board denied institution of a petition for inter partes review under 35 U.S.C. § 315(b) because the petition was filed more than one year after patent owner had served a complaint for patent...more
The Patent Trial and Appeal Board has denied institution and joinder of an inter partes review petition after determining that the petition was not only time-barred but that joinder was also foreclosed. In making its...more
The USPTO Director vacated a Patent Trial and Appeal Board decision denying institution of inter partes review for not addressing alleged differences between references in the petition and those considered during prosecution....more
In a patent infringement case, the district court granted plaintiff’s motion to strike portions of defendant’s technical expert’s rebuttal report on the basis that defendant failed to timely disclose non-infringing...more
The Federal Circuit held in Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) that for a pre-AIA 35 U.S.C. § 102(e) prior-art reference to be entitled to a provisional application’s priority...more
This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more
8/16/2023
/ Biden Administration ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Generic Drugs ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda
The Patent Trial and Appeal Board has denied a patent owner’s motion to terminate an inter partes review proceeding finding that the unidirectional nature of estoppel under 35 U.S.C. § 315(e) renders common-law claim...more
Patent Office Director Katherine Vidal recently issued a precedential decision addressing an issue of first impression before the Board: whether the patentability of multiple dependent claims must be determined separately for...more
The Biden-Harris administration and Congress appear poised to continue focusing on drug pricing issues this year, most notably with the Centers for Medicare & Medicaid Services moving forward with implementation of the drug...more
In a precedential 52-page sua sponte decision, the United States Patent and Trademark Office (USPTO) Director Katherine Vidal addressed several issues of first impression relating to sanctionable misconduct in inter partes...more
The Patent Trial and Appeal Board denied a petition to institute inter partes review, finding there was no reasonable likelihood that petitioners would prevail on their obviousness challenges. In rendering its decision, the...more
Key Points -
The new drug price negotiation process under the IRA takes into account a complex mix of price, competitive status, market exclusivity and scientific data.
New price setting provisions built into the IRA...more
The Inflation Reduction Act (IRA), P.L. 117-169, which became law on August 16th, included some of the most consequential prescription drug pricing reforms ever passed by Congress. This week marked a pivotal milestone in the...more
Petitioners moved for an order requiring Patent Owner to produce discovery comprising Final Infringement Contentions from related district court litigations between the parties. Petitioners set forth two independent bases...more
In a recent order, the Eastern District of Texas declined to preclude a defendant from raising prior art system references despite patentee’s argument that similar printed publications could have been raised in earlier inter...more
Applying recent Federal Circuit precedent requiring language evincing a present conveyance of patent rights, a district court in the Western District of Pennsylvania found that the contractual language “shall become the...more
In Kyocera Senco Industrial Tools Inc. v. International Trade Commission, the Federal Circuit held that an expert who did not possess the specific defined level of ordinary skill in the art could not testify about...more
Objective evidence of nonobviousness traces its roots to 19th century case law from the U.S. Supreme Court.
The analysis of such secondary considerations as commercial success, failure of others, and long-felt but...more