In the ordinary operation of the Biologics Act (i.e., for a drug where the reference product sponsor files its BLA tomorrow), the reference product sponsor receives 12 years of exclusivity. 42 U.S.C. 262(k)(7)(A). After the first four years, a biosimilar applicant can file its own application, leaving an 8-year period for patent resolution under the Biologics Act.

Amgen’s (3)(B) statement contains over a thousand pages setting forth its invalidity, unenforceability, and non-infringement analysis. Genentech replied with its (3)(C) Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 9 of 20 PageID #: 11428 5 statement, which purported to set forth its validity and infringement positions for a subset of the original patents on its (3)(C) list. 42 U.S.C. § 262(l)(3)(C). After this series of information exchanges, the BPCIA provides that the parties shall engage in good faith negotiations to identify the patents that should be asserted in the resulting district court litigation. Genentech and Amgen negotiated a list of patents, and Genentech filed suit in this Court.

10 judgment in good faith, or file later with a penalty of limited recovery. See 42 U.S.C. § 262(l)(6)(A); 35 U.S.C. § 271(e)(6)(B). As the BPCIA makes clear, efforts to frustrate expedited patent litigation result in a remedy limited to “a reasonable royalty”: In an action for infringement of a patent described in subparagraph (A) [i.e., a lawsuit brought more than 30 days after agreement on the patent list, or a patent claim that “was dismissed without prejudice or was not prosecuted to judgment in good faith”], the sole and exclusive remedy that may be granted by a court, upon a finding that the making, using, offering to sell, selling, or importation into the United States of the biological product that is the subject of the action infringed the patent, shall be a reasonable royalty.

10 And consistent with this goal, the BPCIA provides DJ actions can be filed by either party upon the biosimilar manufacturer’s notice of commercial marketing, which Sandoz has given here. See 42 U.S.C. § 262(l)(8)-(9). (Ex.

14 Although approved through the BLA process (as opposed to a New Drug Application or “NDA”), the relevant FDA regulations and case law relating to NDAs and FDA-approved drugs are applicable to biological products, like Humira. See 42 U.S.C. § 262(j) (“The Federal Food, Drug, and Cosmetic Act . . . applies to biological product subject to regulation under this section.”); see also, e.g., App. 112, 21 C.F.R. § 201.

See id. (citing 42 U.S.C. § 262, 21 U.S.C. §§ 352 & 353, 21 C.F.R. §§ 610.60- 610.

The Texas preemption statute establishes a rebuttable presumption that manufacturers are not liable for failure-to-warn claims where the FDA approved the relevant warnings or instructions. The relevant portion of that statute provides: In a products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product, there is a rebuttable presumption that the defendant or defendants, including a health care provider, manufacturer, distributor, and prescriber, are not liable with respect to the allegations involving failure to provide adequate warnings or information if: (1) the warnings or information that accompanied the product in its distribution were those approved by the United States Food and Drug Administration for a product approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), as amended, or Section 351, Public Health Service Act (42 U.S.C. Section 262), as amended . . . Tex. Civ. Prac. & Rem.

Like any drug or medical product, Northfield could not market PolyHeme without the FDA’s express approval, which for a product such as PolyHeme requires submission of a Biologics License Application (“BLA”). See 42 U.S.C. § 262(a). FDA regulations provide that before the FDA will approve a BLA for a new product, a “clinical investigation” — often referred to as a clinical trial — must have been performed to evaluate the safety and effective- ness of the product for its intended use.

The defendants continue to contend that it is. The Public Health Service Act, 42 U.S.C § 262(a)(2), authorized the FDA to establish a licensing scheme, and that scheme provides that once a drug is licensed, it remains so until the FDA takes affirmative steps to suspend or revoke the license, 21 C.F.R. § 601.4(2).

Biologics. Biological products are approved under authority of section 351 of the Public Health Service Act (PHS Act) (42 U.S.C.§ 262). Under section 351, as in effect since 1944, licenses for biologics have been issued only upon a showing that the products meet standards designed to ensure the “continued safety, purity, and potency” of the products.