District Court Orders Patent Use Code Change; Novo Nordisk Appeals

By Kurt R. Karst –      

In what could shape up to be a very interesting (and important) precedent, the U.S. District Court for the Eastern District of Michigan (Southern Division) recently ruled and issued an Order and Injunction requiring Novo Nordisk, Inc. (“Novo”) to change an Orange Book-listed patent use code for a patent (U.S. Patent No. 6,677,358 (“the ’358 patent”)) on its drug product, PRANDIN (repaglinide) Tablets.  Novo has appealed the decision to the U.S. Court of Appeals for the Federal Circuit.  The district court’s decision follows an earlier decision in which the district court ruled that the counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I), as added by the Medicare Modernization Act (“MMA”), could be used to correct or delete a patent use code, and not only the patent number and expiration date.

For the uninitiated, patent use codes are listed in an Orange Book Addendum with a number and a descriptor.  Those patent use codes correspond with various patents with method-of-use claims listed in the Orange Book for a particular approved drug product.  Although FDA created patent use code descriptors prior to the Agency’s June 2003 finalization of its revised patent submission and listing requirements, with the new regulations, NDA sponsors are now required under 21 C.F.R. § 314.53(c)(2)(ii)(P)(3) to supply the descriptor language on Form FDA 3542. 

This case has quite a bit of back-story.  It stems from a patent infringement action Novo brought against Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”) and Sun Pharmaceutical Laboratories, Ltd (“Sun”) with respect to the ’358 patent.  It is also related to two citizen petitions Novo and Caraco initially submitted to FDA in 2008 (FDA-2008-P-0343  FDA-2008-P-0441 – see our 505(q) Citizen Petition Tracker) concerning generic drug labeling carve-out and split patent certification (i.e., a Paragraph IV Certification and a “section viii” statement to the same patent) issues.  Novo submitted its petition to FDA after the Agency required the company to amend PRANDIN’s labeling to reflect a new Indications and Usage statement.  Previously, the PRANDIN Indications and Usage labeling statement discussed both monotherapy and combination therapy.  FDA required a unitary indication statement stating: “PRANDIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.” 

In FDA’s December 2008 citizen petition decision, the Agency ruled that an ANDA for repaglinide that omits patent-protected information on metformin combination therapy would not be less safe or effective for the remaining, non-protected conditions of use, and that a split certification is appropriate as to the ’358 patent.  Novo subsequently filed a Petition for Reconsideration (“PRC”) and a Petition for Stay of Action (“PSA”) requesting FDA to reconsider its December 2008 petition decision and to stay the response and to refrain from taking any regulatory action consistent with the petition response (including granting any tentative or final approval for an ANDA for a generic version of PRANDIN that omits metformin combination information from the labeling).   

During FDA’s consideration of Novo’s PRC and PSA, Novo amended its Orange Book patent listing for the ’358 patent.  Previously, the ’358 patent was listed in the Orange Book with a “U-546” code, which is defined as “USE OF REPAGLINIDE IN COMBINATION WITH METFORMIN TO LOWER BLOOD GLUCOSE.”  The new use code, “U-968,” is defined as “A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS.” 

FDA, as a result of this use code change, denied Novo’s PRC and PSA as moot, stating that:

Because the use code for the ‘358 patent has changed since our issuance of the Citizen Petition Response and because our analysis and conclusions regarding labeling carveouts in that Citizen Petition Response were based on the previous use code, the factual predicate on which our previous response was based no longer applies.  As a result, your PRC and Petition for Stay are denied as moot. 

Although FDA denied the Novo PRC/PSA as moot, the district court deciding the patent infringement action has stated that “[a]s a result of the revised use code, the FDA will no longer permit Caraco to file a ‘section viii statement’ carving out the patented repaglinide-metformin combination therapy as a predicate for securing approval of Caraco’s ANDA to market its generic repaglinide for non-infringing uses.”  In other words, FDA has apparently required a “full” Paragraph IV Certification from Caraco as to the ‘358 patent as a result of the use code change.

Caraco challenged Novo’s use code change in a counterclaim submitted pursuant to FDC Act §505(j)(5)(C)(ii)(I) seeking an order from the court requiring Novo to amend the ‘358 Orange Book patent listing to revert back to the U-546 use code.  In granting Caraco’s Motion for Summary Judgment, the court found that Novo “improperly filed with the FDA for listing in the Orange Book the use code narrative for the method of use of claim 4 of the ’358 patent relating to Prandin,” and that Caraco and Sun “are entitled to a mandatory injunction requiring Novo to request the FDA to delist the U-968 listing for Prandin, and reinstate its former U-546 listing for Prandin.”  The court issued an Order and Injunction requiring Novo to submit to FDA a revised Form FDA 3542 reinstating the former U-546 listing for PRANDIN within twenty days from the date of the Order and Injunction.  Novo promptly appealed the decision to the Federal Circuit, where the company is seeking a stay of the district court’s Order and Injunction.

The district court’s decision is, to our knowledge, the first instance in which a court has interpreted the counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I) added by the MMA to order a company to correct or delete patent use code information.  That provision states:

If an owner of the patent or the holder of the approved application under [FDC Act § 505(b)] for the drug that is claimed by the patent or a use of which is claimed by the patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder under [FDC Act § 505(b)] or (c) on the ground that the patent does not claim either – (aa) the drug for which the application was approved; or (bb) an approved method of using the drug. [(emphasis added)]

Under FDC Act §§ 505(b) and (c), an NDA holder must submit with its application and after NDA approval “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture use, or sale of the drug” (emphasis added).

As it did in the district court, Novo argues in its Emergency Motion to Stay the district court’s injunction that the statute authorizes only two specific counterclaims by an ANDA filer for correction of the patent information submitted by an NDA holder; namely, the correction of the patent number and the patent expiration date.