Drug Litigation News

Until The Final Rule Effective Date, Pending Generic Drug Applications May Be Subject To Multiple Overlapping 30-Month

If a patent is listed in the "Orange Book," an applicant seeking approval for an ANDA must submit a certification to the patent. Even an applicant whose ANDA is pending when additional patents are submitted for listing by the sponsor must certify to the new patents, unless the additional patents are submitted by the patent holder more than 30-days after issuance by the U.S. Patent and Trademark Office. Until the final rule effective date, pending generic drug applications may be subject to multiple overlapping 30-month stays if new patents are listed for the innovator drug and those patents result in litigation. FDA does not undertake an independent review of the patents submitted by the NDA sponsor. The statute requires FDA to publish patent information upon approval of the NDA. This strongly suggests - and FDA has long held - that the Agency's role in the patent-listing process is intended to be ministerial. Issues of patent claim and infringement are matters of patent law, and FDA lacks the authority, the resources, and the capability to assess whether a submitted patent claims an approved drug and whether a claim of patent infringement could reasonably be made against an unauthorized use of the patented drug. As such, FDA has implemented the statutory patent listing provisions by informing interested parties of what patent information is to be submitted, who must submit the information, and when and where to submit the information. Generic and innovator firms may resolve any disputes concerning patents in private litigation.

Over the past few years, new patents have occasionally been submitted to FDA for listing in the "Orange Book" shortly before patents already listed in the "Orange Book" were scheduled to expire. These new patents have been submitted to FDA within the required 30-days of issuance by the Patent and Trademark Office. If the NDA sponsor complies with the requirements of the statute and regulations in submitting a patent for listing in the "Orange Book," the Agency may not reject a patent merely on the basis that, but for the filing of the patent, ANDAs would be eligible for final approval.

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	Did You Know?
	Many over the counter drugs were once prescription drugs Americans buy about 5 billion over-the-counter drugs each year, according to government estimates, to treat their headaches, heartburn, coughs and colds, and other routine health problems. According to the Consumer Healthcare Products Association, a trade