Anthony Kennedy

“ Congress did not act in an irrational manner when it drew a distinction between drugs and medical devices. True, like medical devices, some drugs have a very high cost. See ante, at 673, n. 5. Testing a patented medical device, however, often will have greater effects on the patent holder's rights than comparable testing of a patented drug. As petitioner has asserted, manufacturers may test generic versions of patented drugs, but not devices, under abbreviated procedures. ”

“ See App. 39-42; see also 21 CFR § 812.7 (b) (1989) (permitting manufacturers to recover their costs in clinical trials) . Although the Court gives examples of high cost drug dosages, it does not demonstrate that the testing of these drugs detracts from a patent holder's sales. Congress could have determined that the differences in testing or some other difference between drugs and devices justified excluding the latter from the ambit of § 271 (e) (1) . ”

“ Cort- landt, 68 Misc.2d 645, 653, 327 N.Y.S.2d 143, 153 (1971) (" [U] nder the home rule power to enact local laws, a town may enact a law which regulates the powers, duties, qualifications, [etc. ] of its officers and employees ") (emphasis added) ”