Biotech Values

[hptaxis]

By entering the US, does that necessarily mean FDA approval? For argument sake, it has entered the US by being submitted to the FDA. Or does it have to be on the open market and available to the public? This would seem to be a broad interpretation since there must have been case law on products not yet made available for public sale, but infringing on patents and blocked from any sales.

35 U.S.C. 271(a) and (g) cannot apply until product made by a process that is patented in the U.S. actually enters the U.S.

From below, it appears the mere manufacture (makes) will cover the complaint.

35 U.S.C. 271 Infringement of patent.

(a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.

http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_271.htm