Classen Immunotherapies v. King Pharmaceuticals 2006 WL 3716920 D. Maryland, decided Aug. 16, 2006 Judge Quarles Thanks to Peter Zura at the Two-Seventy-One Blog for writing a post about this case. Some academics have called for an exception to the safe harbor protection of �§ 271(e)(1) for research tools. One notable criticism came from Donald Chisum who argued the Patent Act of 2005 was incomplete for not including a research tool exception. See 4 J. Marshall Rev. Intell. Prop. L. 336, 342. �§ 271(e)(1) states:

It shall not be an act of infringement to make, use, offer to sell or sell . . . 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.

Europe allows research ââ?¬Å?onââ?¬Â? an invention, but research ââ?¬Å?withââ?¬Â? an invention can be patent infringement (thereby excepting research tools from the safe harbor). For example, imagine a patent which covers a laser. The laser can be used for research in a laboratory. Conducting research on the laser would be permissible, but conducting research with the laser (without a license) would be patent infringement. The plaintiff in this case argued:

Elan [the defendant] infringed the 472 and 674 patents when it: 1) studied the effect of food on the bioavailability of Skelaxin; 2) used the study data to identify a new use of the drug; and 3) commercialized the new use.

The Supreme Court has said in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, that the safe harbor ââ?¬Å?extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA.ââ?¬Â? Judge Quarles concluded in full:

Even assuming that Elan employed Classen’s patented process when it studied Skelaxin’s bioavailability problem and used the results to repatent the drug, the results of the 2001 study were submitted to the FDA in Elan’s Citizen Petition and labeling supplement to its NDA. Therefore, Elan’s use of the patented process was reasonably related to the submission of information under the FDCA and so is protected under Ã?§ 271(e)(1). Accordingly, Elan’s motion for summary judgment will be granted.

Under this reasoning, research tools are not exempted from the safe harbor of �§ 271(e)(1). The policy of patent law is being undermined by not exempting research tools. Although maybe technically correct, letâ��s hope other jurisdictions donâ��t follow this lead. For further analysis see IPBiz.

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