Repaglinide (Prandin) tablets: CAFC refused to change patent use code

In a dispute between innovator Novo Nordisc and generic player Caraco on patent Use code listed for following Orange book listed patent on antidiabetic formulation Repaglinide tablets:

US6,677,358 (Expiry: Jun 12, 2018): which covers use of Repaglinide in combination with Metformin

The CAFC has refused to correct patent use code boundary.

The dispute is due to following patent use cod listed for ‘358 patent:
1) U-968: A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
2) U-546:USE OF REPAGLINIDE IN COMBINATION WITH METFORMIN TO LOWER BLOOD GLUCOSE

Innovator has earlier listed the use code U-546, which was narrow in terms of use coverage and generic player Caraco filed section viii (generic player would not market product for the patented indication) against this patent, however, innovator changed this use code to the broad U-968. The revised use code covers all approved uses of Repaglinide:
1) Use of Repaglinide as monotherapy
(2) Use of Repaglinide in combination with Metformin
(3) Use of Repaglinide in combination with thiazolidinediones

As the revised use code covers all approved uses of Prandin, USFDA refused to accept Sec viii statement of Caraco and directed them to revise the patent certification.

Caraco challenged Novo’s use code change in an FDC Act §505(j)(5)(C)(ii)(I) directing Novo to correct the listed patent information w.r.t use code, which is broad in comparison to the patent claims.

On September 24, 2009, the U.S. District Court for the Eastern District of Michigan directed innovator Novo Nordisk to change the use code from broad U-968 to narrow U-546. Court directed innovator to file the changes with USFDA with in 20 days, however, innovator appealed in CAFC, which reversed the lower court's decision. The court decided that as per FDC Act §505(j)(5)(C)(ii)(I), the innovator can correct erroneous patent listing or expiry date of the patent but not the use code.
The Judge Dyk was not in agreement with Judge Radar and Judge Clevenger and dissented against this opinion.
Related news by:

Kurt R. Kast of FDA Law Blog Here
Aaron Barkoff of Orange Book Blog here