Paragraph IV Certification definition

Paragraph IV Certification means any certification filed pursuant to 21 U.S.C. § 355(b)(2)(A)(iv), 21 U.S.C. § 355(j)(2)(A)(vii)(IV), or any comparable Applicable Law (or any amendment or successor statute thereto) in any country or regulatory jurisdiction in the Territory.

Paragraph IV Certification has the meaning specified in Section 6.17(b)(iii).

Paragraph IV Certification will have the meaning set forth in Section 9.3(a)(i)(A).

Examples of Paragraph IV Certification in a sentence

• Accordingly, Defendants’ Paragraph IV Certification was wholly unjustified, and this case is exceptional under 35 U.S.C. § 285.

• On September 20, 2012, we announced that we had received a Paragraph IV Certification Notice under 21 U.S.C. 355(j) (a Paragraph IV Notice) from a generic sponsor of an ANDA for a generic drug listing Oxaydo (formerly known as Oxecta) as the reference listed drug.

• In January 2013, we dismissed our suit against Watson on the grounds that Watson had amended its ANDA from a Paragraph IV Certification to a Paragraph III Certification, which indicated its intent not to market its generic Oxaydo product in advance of our patent expiring.

• The Hatch-Waxman Act requires an applicant for a drug that references one of our branded drugs to notify us of their application if they assert in their application that the patents we have listed in the Orange Book will not be infringed or otherwise are invalid or unenforceable (a Paragraph IV Certification).

• Depending on the type of certification made, the approval of the 505(b)(2) NDA may be delayed until the relevant patent(s) expire, or in the case of a Paragraph IV Certification may lead to patent litigation against the applicant and a potential automatic approval delay of 30 months or more.

More Definitions of Paragraph IV Certification

Paragraph IV Certification means a certification pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417), as amended, which shall include but not be limited to any such certification pursuant to 21 U.S.C. §355(b)(2)(A)(iv) or 21 U.S.C. §355(j)(2)(A)(vii)(IV), or any reasonably similar or equivalent certification or notice in the United States or any jurisdiction outside the United States, included in (or made with respect to or in connection with) a regulatory filing concerning a Product and challenging the validity, infringement, or enforceability of any Patent.

Paragraph IV Certification means a certification described in section 505(j)(2)(A)(vii)(IV) and 505(b)(2)(A)(iv) of the U.S Food, Drugs and Cosmetics Act.

Paragraph IV Certification means a certification by an applicant filing an ANDA or 505(b)(2) NDA referencing a drug listed in Approved Drug Products with Therapeutic Equivalence Evaluations to the FDA that the patent relating to such listed drug is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the ANDA or 505(b)(2) NDA is submitted.

Paragraph IV Certification has the meaning set forth in Section 11.4 (Enforcement of Listed Patents).

Paragraph IV Certification means certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) to any patents listed in the Orange Book in connection with the Alkermes NDA.

Paragraph IV Certification has the meaning given to such term in the Sublicence

Paragraph IV Certification means a certification provided under §§ 505(b)(2)(A)(iv) or 505(j)(2)(A)(vii)(IV) of the FDCA, or a similar certification in any other country or jurisdiction.