Plaintiffs object to this statement as incomplete and misleading. While Plaintiffs do not dispute that the PTO extended the term of the ’703 Patent by five years (from April 11, 2010 to April 11, 2015), Plaintiffs submit that, had Forest not materially failed to comply with the requirements of 35 U.S.C. § 156 and submitted a patent term extension application that was complete and disclosed all material information, the PTO would likely have arrived at a different result. Forest’s Objection: DPPs’ suggestion that “the PTO would likely have arrived at a different result” is speculation that cannot defeat a summary judgment motion.

The PTE statute contains a specific provision requiring a third party petition, leading to an FDA determination of a lack of diligence, before a PTE applicant’s extension can be cut short. 35 U.S.C § 156(c)(1) (requiring FDA to subtract from the regulatory review period “any period determined under subsection (d)(2)(B) during which the applicant . . . did not act with due diligence”) (emphasis added); 35 U.S.C § 156(d)(2)(b) (defining the third party petition process for determining a lack of due diligence). It is undisputed that neither Mylan nor any other party filed any such petition here.

c. Mylan Was Likely to Prevail on its PTE Validity Challenge At trial, the jury could further determine that Mylan was more likely than not to prevail on its challenge to the validity of Forest’s PTE. Under 35 U.S.C. § 282, “[i]nvalidity of the extension Case 1:15-cv-07488-CM-RWL Document 498 Filed 01/18/18 Page 60 of 77 50 of a patent term or any portion thereof” may be based on “the material failure . . . by the applicant for the extension . . . to comply with the requirements of [35 U.S.C. § 156].” During the PTE proceeding, Forest claimed a 1,250 day extension based on a “testing phase” that began in 1997.

Notice of this filing will be sent to all counsel of record by operation of the court’s electronic filing system. /s/ Gretchen F. Richards 4 Stephen G. Kunin, Consolidated Listing of Patents Extended Under 35 U.S.C. § 156(e)(1), (June 30, 2003) United States Patent and Trademark Office OG Notices: 29 July 2003, http://www.uspto.gov/web/offices/com/sol/og/2003/week30/patxten.htm (last visited March 21, 2017). 5 Rec.

On the other side, Hatch-Waxman authorized patent term extensions for innovative drugs to compensate for patentlife lost during premarket review by the Food and Drug Administration (FDA) and created FDA-administered data exclusivities for new products and indications. See 35 U.S.C. § 156(c); 21 U.S.C. § 355()(5)(F)Gi),(iii). Hatch-Waxmanthusprescribes a comprehensive pathway for generic manufacturers to free ride on brand manufacturers’ research and developmentefforts and marketing expenditures. The federal scheme does not, however, force brand manufacturers to act as insurers for their generic competitors.

) In return, Hatch-Waxman extended patent protection for brand-name drug manufacturers to account for the time spent in the FDA’s drug approval process. (35 U.S.C. §156(a)(4).) Under Hatch-Waxman, generic drugs can obtain FDA approval simply by showing (1) equivalence to a brand-name drug that has already been approved by the FDA (PLIVA, supra, 564 US. at p. 612 [citing 21 U.S.C. § 355G)(2)(A)]); and (2) that the generic drug’s label “ig the sameasthe labeling approved for the [brand-name] drug.”

53(e). The Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch- Waxman Amendments”), codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271, and 282, permits manufacturers to submit abbreviated new drug applications (“ANDAs”) requesting approval of generic versions of approved drug products. 21 U.S.C. § 355(j).

Finally, even assuming that the compositions tested by Xhonneux at the time contained some stereoisomer(s) of nebivolol other than RSSS- and SRRR-, the applicants later amended the claims to exclude unrecited stereoisomers. e. Patent term extension is irrelevant to the meaning of “consisting of” Forest asserts that in 2008—several years after the ‘040 patent issued—the applicants “confirmed that they envisioned” a broader meaning of “consisting of” when seeking patent term extension (PTE) pursuant to 35 U.S.C. § 156. (Opp.

V, W. 5 This patent application could have been easily amended to add joint inventors, if legally required. See 35 U.S.C. § 156. 6 See Knox Decl., Ex.

The requirements for entitlement to a patent term extension do not include a duty to submit Case 1:06-cv-00033-SLR Document 107 Filed 04/06/2007 Page 9 of 16 6 information relating to information or test results after the grant of the patent. See 35 U.S.C. § 156 (2000); 37 C.F.R. § 1.720.