FDA should specify that ANDAs which change certification from Paragraph III to Paragraph IV should trigger for a 30-month stay, the Pharmaceutical Research & Manufacturers of America states in comments on FDA's proposed rule.

"Under the proposed rule, there is a serious potential for ANDA and 505(b)(2) applicants to avoid any 30-month stay," ¹ PhRMA's comments state.

Using the example of a product with a drug substance patent and a formulation patent, PhRMA said that an ANDA applicant could file a Paragraph III certification on the drug substance patent and a Paragraph IV certification on the formulation patent.

"If the NDA holder determines that the ANDA formulation does not infringe, it could not sue," PhRMA said.

"The proposed regulation would then permit the ANDA applicant to convert its earlier Paragraph III certification to the drug substance patent to a Paragraph IV certification without providing notice to the NDA or patent holder."

"Under FDA's proposal, there would be little reason for an ANDA or 505(b)(2) applicant ever to make more than one Paragraph IV certification in an initial application," PhRMA said.

"FDA should provide that amendments to ANDA and 505(b)(2) applications that are made to change a patent certification that the applicant had already made relate back to and substitute for the original patent certification," PhRMA said.

PhRMA said that the proposed change would still allow ANDAs to avoid stays from later listed patents since the "fix" applies only when the "applicant itself changes a patent certification it previously made."

Also, FDA should require ANDA applicants to "provide amended patent certifications whenever they make changes to the chemistry, manufacturing and controls section of an application," PhRMA said. Biovail has submitted a citizen petition asking for such a stipulation (² Also see "ANDA Amendments Should Trigger New Paragraph IV Certifications – Biovail" - Pink Sheet, 14 January, 2002., p. 7).

President Bush announced the proposed rule, which would permit only one 30-month stay per ANDA, in October (³ Also see "Waxman/Hatch Reinterpretation Underpins Change In 30-Month Stay Policy" - Pink Sheet, 28 October, 2002., p. 6). PhRMA said it prefers the rule as an alternative to legislation (⁴ Also see "Bush Generic Rx Proposal Has PhRMA Backing As Alternative To Legislation" - Pink Sheet, 9 December, 2002., p. 10).

In its comments, PhRMA requests that FDA begin posting "Paragraph IV certifications on its website, or otherwise making the information public."

The mechanism would allow brand name companies to learn about "new patent certifications even where no 30-month stay is available," PhRMA said.

"FDA assumes in the preamble to the proposed rule that NDA and patent holders will somehow learn about all subsequent Paragraph IV certifications, even when no notice is provided, and will be able to enforce their rights by seeking a court injunctions and/or damages," PhRMA said. "This is not accurate."

FDA maintains a list on its website of products which have Paragraph IV certifications filed against them, which aids generic firms in making development plans, but does not list the applicant or application date (⁵ Also see "Generic Drug Patent Challenge Notifications Will Be Announced By FDA" - Pink Sheet, 22 May, 2000., p. 30).

FDA has said it does not post the additional information because of confidentiality concerns, but PhRMA argued that providing it "would be entirely consistent with FDA's implementation of the Freedom of Information Act" because the initial notice to a manufacturer is "a form of public disclosure."

PhRMA's call for disclosure of all patent certifications is similar to the recommendation by the Generic Pharmaceutical Association that the rule allow voluntary notices even for patents that are ineligible for a stay (see ⁶ [A#00650010022] ).

PhRMA also wants FDA to establish a system under which patent holders specify an agent to receive notices, and ANDA applicants "serve all notices on that agent by registered mail."

"There have been instances in which a notice of a Paragraph IV certification was served upon an NDA holder but did not reach the proper location within the corporation in a timely manner, and the opportunity to bring suit within the 45-day period and obtain a stay was inadvertently lost," PhRMA noted.

Most recently, Pfizer acknowledged that it failed to sue Mylan in time to obtain a stay on its ANDA for generic Norvasc (⁷ Also see "Pfizer Norvasc Challenges: Mylan ANDA, Dr. Reddy’s 505(b)(2)" - Pink Sheet, 21 October, 2002., p. 20).

PhRMA Wants Amended ANDAs To Trigger 30-Month Stays

More from Archive

More from Pink Sheet