1. Caraco Pharm. Labs, Ltd v. Novo Nordisk A/Set al.Case No. 10A380. Supreme Court. 26 June 2011.
2. Claim 4 of US Patent No. 6,677,358 (‘A method for treating non-insulin dependent diabetes mellitus (NIDDM) comprising administering to a patient in need of such treatment repaglinide in combination with metformin’).
3. 68 Fed. Reg. 36,767, 36,683. (‘Use codes are intended to alert ANDA and 505(b)(2) applicants to the existence of a patent that claims an approved use’) 18 June 2003.
4. FDA regulations. 21 C.F.R. §314.53(c)(2)(O)(2) (2011).