Biotech Values

[mouton29]

The Bolar amendment

Thank you, yes, clearly I was misreading the provision.
A tax lawyer should not make such a mistake. My question about whether Lovenox is manufactured using genetic manipulation would have been a good one if it were a veterinary product.

In fact, this article, The Hatch-Waxman (Im)Balancing Act, has a long chapter on the Bolar Amendment and starts out with this paragraph, which does not even bother to mention the veterinary/genetic manipulation kickout -- not surprising given its narrowness. See http://leda.law.harvard.edu/leda/data/551/Paper1.pdf

The Hatch-Waxman Act amended § 271 of the Patent Code, adding section (e)(1), which provided that it was not “an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs or veterinary biological products.” The terms in the statutory language differ in certain respects from those in other provisions of the Act, and the nuances inherent in those terms underscore the importance of responsible judicial interpretation in applying the provision in accordance with its underlying legislative intent. Several words and phrases in the Bolar amendment raised several important questions that were left to the courts to determine. This chapter will examine the efforts of several courts to respond to these questions, whether their responses can reasonably be aligned with the legislative intent underlying the Act, and the potential consequences, both intentional and unintentional, of their determinations.