Posts Tagged: "Neulasta"

Biologics Applicant Must Give Post-Approval Notice to Reference Product Sponsor

The Federal Circuit held that there was no statutory language that made section (8)(A) non-mandatory. Further, Amgen v. Sandoz disposed of Apotex’s argument that (8)(A) would extend the 12-year exclusivity period given to a sponsor by 180 days (six additional months). Even when market entry is delayed under (8)(A) by 12 years plus 180 days, the result is the same, because the 12-year date is established as the earliest date, not the latest date, on which a biosimilar license can take effect. The Court affirmed that section (8)(A) covers applicants that filed (2)(A) notices as well as those that did not. This is to ensure that the necessary decision-making regarding further patent litigation starts from when the applicant’s product, uses, and processes are fixed by the FDA license. The 180-day period gives the sponsor essential time to assess its infringement position for the final FDA approved product and the as to yet-to-be-litigated patents. This is confirmed by the legislative history of the Biologics Act. Thus, an applicant must provide a reference product sponsor with the 180-day notice under 8(A), after approval and before commercial marketing begins, whether or not the applicant previously provided a (2)(A) notice of the FDA review.

The Amgen Quagmire: Federal Circuit Rules Patent Dance Does Not Excuse Biosimilar Applicants from Providing Notice of Intent to Market

The Supreme Court is currently considering whether to review Amgen Inc. v. Sandoz Inc., the Federal Circuit’s first decision regarding the Biologics Price Competition and Innovation Act (BPCIA). Although the Federal Circuit does not technically have any input into the Supreme Court’s grant or denial of certiorari, it nonetheless took the opportunity last week to bolster one of the challenged holdings: that a biosimilar applicant cannot provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product until that product is licensed. Specifically, in the course of ruling in Amgen Inc. v. Apotex Inc. that a biosimilar applicant must provide such notice even if it participated in the BPCIA’s so-called “patent dance,” the Federal Circuit addressed a primary criticism of its earlier decision, namely, that permitting only post-licensure notice effectively extends by 180 days the twelve-year exclusivity term of the biologic product. The solution suggested by the panel, however, is far from a legal certainty.

Why Bipartisanship Matters

The Bayh-Dole Act unlocked those discoveries that were made with taxpayer money. It allowed businesses and nonprofits, such as universities, to retain title to their inventions that were made with federal funds and to license them to private companies for commercialization. It was a brilliant piece of bipartisan legislation that set the stage for commercializing hundreds of products, including life-saving treatments to which many of us cancer survivors owe our lives.