To address the challenges of building and retaining a diverse, talented work force in a competitive environment, the FDA is rolling out a pilot program to more directly align its hiring procedures with the scientific staffing objectives of its programs. The pilot will initially focus on filling PDUFA-related positions in the agency's drug and biologics programs. "Too many of these positions remain vacant, and the backlog is substantial," FDA Commissioner Scott Gottlieb said Monday in announcing the hiring program. The model will rely on a group of full-time FDA staff with experience recruiting specialized scientific and medical experts to ensure that the agency predictably identifies, recruits and efficiently hires the needed personnel. In addition to testing new hiring procedures, the agency is conducting a comprehensive evaluation of its current practices.

Although numerous generic drug companies have filed ANDAs referencing Millennium Pharmaceuticals Inc.'s Velcade (bortezomib), it could be a while before a generic version hits the market. The U.S. Court of Appeals for the Federal Circuit Monday overturned a lower court ruling in Millennium Pharmaceuticals Inc. v. Sandoz Inc. that had invalidated a key patent on the life-saving multiple myeloma drug. In its precedential decision, the appellate court said the district court clearly erred in its interpretation of obviousness on several grounds. "The unexpected properties of an unexpectedly produced new compound, and the ensuing pharmaceutical efficacy and benefit, negate the district court's ruling of obviousness," Judge Pauline Newman wrote in the unanimous decision. At the heart of the dispute were several claims included in the '446 patent, issued March 30, 2004. The patent describes a boronate ester of bortezomib and D-mannitol and asserts claims involving the new compound as a lyophilized cake, the method of preparation of the compound and its reconstitution with a pharmaceutically acceptable carrier. Despite its known efficacy against various cancers, bortezomib had failed to get FDA approval because of its instability, rapid degradation in liquid formulations and insolubility. Millennium researchers spent years trying to stabilize the molecule using multiple formulations, but the formulations weren't stable enough for transportation, storage and administration to patients. Then researchers began work on a lyophilized, or freeze-dried, formulation for injection, using various solvents and bulking agents, but they all failed. Finally, researchers hit on a promising formulation when they tried mannitol, a known bulking agent, as it unexpectedly created a new chemical compound during lyophilization – the claimed ester of bortezomib and mannitol, which acts as a prodrug. Sandoz argued that although the lyophilization with mannitol produced an unexpected result, "that result was 'inevitable' and thus 'inherent,' and thus not 'inventive,'" according to court documents. The Federal Circuit disagreed, pointing out that "invention is not a matter of what the inventor intended when the experiment was performed" and adding that no expert witnesses in the case "testified that they foresaw, or expected, or would have intended, the reaction between bortezomib and mannitol, or that the resulting ester would have the long-sought properties and advantages." The Federal Circuit awarded costs to Millennium, now Cambridge, Mass.-based Takeda Oncology. The appeals court also vacated and remanded a related case, filed by Apotex Inc. and Teva Pharmaceuticals USA Inc., to the lower court.

The U.S. Trade Representative (USTR) requested a meeting with South Korean officials to consider possible amendments and modifications to the U.S.-Korea Free Trade (KORUS) Agreement, which among other provisions called for the elimination of an 8 percent tariff charged on U.S. drugs exported to South Korea, market-based pricing for drugs, regulatory transparency and the acceptance of biopharmaceutical test results performed in the U.S. In asking for a special session of the KORUS Joint Committee, the USTR didn't spell out specific changes, but said, "It is imperative that we work together to ensure that the economic partnership between our two countries is not only strong and vibrant, but also fair, and that the KORUS Agreement benefits the U.S. economy as much as it does that of Korea." The USTR noted that since the agreement went into force, the overall U.S. trade deficit with South Korea has increased, and the goods deficit has doubled. Congressional leaders wrote to the USTR Monday urging Ambassador Robert Lighthizer to consult closely with Congress before meeting with South Korean officials and throughout any discussions on the agreement, in accordance with U.S. law.

The U.S. Federal Trade Commission (FTC) approved a sublicense submitted by Mallinckrodt ARD Inc., part of Staines-upon-Thames, U.K.-based Mallinckrodt plc, granting West Therapeutic Development LLC certain rights to develop and market Synacthen Depot (tetracosactide) in the U.S. A synthetic version of adrenocorticotropic hormone (ACTH), Synacthen Depot is approved in Europe and elsewhere to treat infantile spasms, nephrotic syndrome and other disorders. The sublicensing agreement stemmed from a $100 million settlement in January of an FTC complaint charging Mallinckrodt ARD, formerly Questcor Pharmaceuticals Inc., with antitrust violations when it acquired rights to Synacthen. The FTC claimed the acquisition stifled competition by preventing other companies from developing a synthetic ACTH drug for the U.S. market, thus preserving a monopoly for Questcor's Acthar Gel, which contains naturally derived ACTH. As part of the agreement, the FTC approved a sublicense to Marathon Pharmaceuticals LLC, but Marathon has since spun off the assets to West Therapeutic. (See BioWorld Today, Jan. 20, 2017.)