Emtricitabine the chemical name of emtricitabine is 5-fluoro-1- 2 r , 5 s ; - cytosine. Rule is problematic, rather than "creating exceptions to solve the immediate problem, "105 as occurred in 1984 when 271 e ; 1 ; was appended to 35 U.S.C. 271. Introduction of 271 e ; 1 ; itself violated the zero-based budgeting principle by creating an exception safe harbor for uses reasonably related to FDA submission ; to solve an immediate problem de facto patent term extension ; . This increase in statutory complexity indeed increased administrative costs, as parties attempted to fit possibly infringing uses into the semantics of the new statutory provision, and courts sought to define the boundaries of the new provision, as seen in Merck and Classen. As the failed experiment of 271 e ; 1 ; suggests, adherence to the zero-based budgeting principle may require wholesale redrafting of 271, a task which, as noted earlier, is not presently visible on Congress's horizon.106 Finally, and perhaps most importantly, cost sensitivity requires consideration of the direct and indirect impact of the statute on all interested parties.107 This means that re-drafting must take into account the plight of research toolmakers and the general public in addition to that of the interest group with the largest immediate financial stake--in this case the pioneer drug industry. As we have seen, a statutory scheme that encourages either judicial approval of license-free use of patented inventions or increased infringement litigation will clearly not accomplish this goal, suggesting that both inaction and simple amendment are undesirable approaches to the safe harbor problem. It is hard to argue that 271 e ; 1 ; was drafted with the interests of the highest payer in mind, since the Hatch-Waxman Act arose precisely as a response to the inequities that rewarded a few large players at the expense of their smaller competitors. However, it now appears that despite Congress's best intentions, 271 e ; 1 ; is simply not equal to its complex task. It is likely that when cases like Classen are appealed and rise through the appellate system, the CAFC and the Supreme Court will speak specifically to the research tool issue, and will perhaps narrow the holding of Merck to apply only to inventions under study in anticipation of regulatory approval. Whether the solution to the research tool problem lies with the Congress or with the courts remains to be seen, but it seems likely that the Supreme Court's and enbrel.

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