{"id":73803,"date":"2016-10-18T07:15:04","date_gmt":"2016-10-18T11:15:04","guid":{"rendered":"https:\/\/ipwatchdog.com\/?p=73803"},"modified":"2019-04-11T21:30:07","modified_gmt":"2019-04-12T01:30:07","slug":"fda-updates-rules-patent-paragraph-iv-certifications-andas-505b2","status":"publish","type":"post","link":"https:\/\/ipwatchdog.com\/2016\/10\/18\/fda-updates-rules-patent-paragraph-iv-certifications-andas-505b2\/id=73803\/","title":{"rendered":"FDA rules updated on patent information, paragraph IV certifications for ANDAs and 505(b)(2) applications"},"content":{"rendered":"
On Thursday, October 6th, the <\/span>U.S. Food and Drug Administration<\/span><\/a> (FDA) <\/span>published a 79-page notice<\/span><\/a> in the <\/span>Federal Register<\/span><\/a> regarding new rules surrounding Abbreviated New Drug Applications (ANDAs) and 505(b)(2) new drug applications. Many provisions of the new rules affect information that must be submitted by applicants regarding patents which could affect the outcome of applications for new generic versions of drug treatments.<\/span><\/p>\n Both ANDAs and 505(b)(2) applications are mechanisms established by the <\/span>Hatch-Waxman Act of 1984<\/span><\/a> by which drug developers can more quickly enter the pharmaceutical market without all of the costs associated with filing an NDA. <\/span>505(b)(2) applications<\/span><\/a>, which are for new drugs, can include safety and efficacy information regarding administration of the drug from studies other than those conducted by the applicant. This creates a more cost-effective path for applying for FDA drug approval without taking on costly clinical trials. ANDAs, which are filed for generic versions of pharmaceuticals already approved by the FDA, do not need to include preclinical and clinical trial data if the applicant can demonstrate that the generic is bioequivalent, which means it produces the same effects in the human body, to the FDA-approved drug.<\/span><\/p>\n One of the objectives of the FDA\u2019s new rules regarding both ANDAs and 505(b)(2) is clarification of patent use codes which are found in the <\/span>Orange Book<\/span><\/a>, which includes a listing of identified drug products approved by the FDA. The Orange Book also lists the patents which have been identified by drug developers as protecting the pharmaceuticals approved by the FDA. Parties filing a New Drug Application (NDA) must include use codes in their application which describe only the specific approved method of use covered by the patent. The FDA includes this provision to prevent overbroad or ambiguous use codes from hampering the efforts of ANDA or 505(b)(2) petitioners.<\/span><\/p>\n The FDA\u2019s revised rule also attempts to facilitate prompt listing times for untimely filed patent information, or patent information filed by an NDA applicant with the FDA more than 30 days after patent issuance by the <\/span>U.S. Patent and Trademark Office<\/span><\/a>. Now, the category of untimely filed patent information will include amendments made by an NDA petitioner to the description of the approved method of use if changes aren\u2019t submitted within 30 days of either an approval of a corresponding change in product labeling or a decision by the USPTO or in federal court to alter the construction of the patent\u2019s claims. The FDA says that this should reduce approval delays caused by overbroad or ambiguous patent use codes.<\/span><\/p>\n Those filing ANDA or 505(b)(2) applications may find that they have an improved mechanism for challenging the accuracy or relevance of patent information submitted by an NDA applicant to the FDA. NDA holders now have a 30-day window in which it is required to respond to any patent listing disputes. NDA holders will also be required to correct or change patent information if a patent or patent claim no longer meets the statutory requirements for listing, if the NDA holder is required by court order to amend patent information or withdraw a patent from the list or the term of a listed patent is extended.<\/span><\/p>\n