The U.S. Court of Appeals for the Federal Circuit ruled yesterday in the case of Integra LifeSciences v. Merck that "Because the language and context of the safe harbor [of 35 U.S.C. § 271(e)(1)] do not embrace the Scripps-Merck general biomedical experimentation * * * this court affirms that aspect of the district court's decision."
Re the statutory "safe harbor" of 35 U.S.C. §271(e)(1), the Court states that "35 U.S.C. §271(e)(1) defines a safe harbor against patent infringement" and quotes the statute:
It shall not be 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 (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) 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 court notes that this case poses a new question for this court:
This court has not considered the question arising in this case, namely, whether the pre-clinical research conducted under the Scripps-Merck agreement is exempt from liability for infringement of Integra's patents under § 271(e)(1). The Scripps-Merck experiments did not supply information for submission to the United States Food and Drug Administration (FDA), but instead identified the best drug candidate to subject to future clinical testing under the FDA processes. Thus, this court must determine whether the § 271(e)(1) safe harbor reaches back down the chain of experimentation to embrace development and identification of new drugs that will, in turn, be subject to FDA approval. [emphasis added]The court's answer is "no."
[T]he district court correctly confined the § 271(e)(1) exemption to activity that would contribute (relatively directly) to information the FDA considers in approving a drug. Intermedics, 775 F. Supp. at 1280.Footnote 2 of the majority opinion of Circuit Judges Rader and Prost responds to the dissent of Circuit Judge Newman:The exemption viewed in this context does not endorse an interpretation of §271(e)(1) that would encompass drug development activities far beyond those necessary to acquire information for FDA approval of a patented pioneer drug already on the market. It does not, for instance, expand the phrase "reasonably related" to embrace the development of new drugs because those new products will also need FDA approval. Thus, § 271(e)(1) simply does not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process. The safe harbor does not reach any exploratory research that may rationally form a predicate for future FDA clinical tests.
As noted, the text of § 271(e)(1) limits the exemption "solely" to activities "reasonably related to the development and submission of information" to the FDA. Moreover, the context of this safe harbor keys its use to facilitating expedited approval of patented pioneer drugs already on the market. Extending § 271(e)(1) to embrace new drug development activities would ignore its language and context with respect to the 1984 Act in an attempt to exonerate infringing uses only potentially related to information for FDA approval. Moreover, such an extension would not confine the scope of § 271(e)(1) to de minimis encroachment on the rights of the patentee. For example, expansion of § 271(e)(1) to include the Scripps-Merck activities would effectively vitiate the exclusive rights of patentees owning biotechnology tool patents. After all, patented tools often facilitate general research to identify candidate drugs, as well as downstream safety-related experiments on those new drugs. Because the downstream clinical testing for FDA approval falls within the safe harbor, these patented tools would only supply some commercial benefit to the inventor when applied to general research.
Thus, exaggerating § 271(e)(1) out of context would swallow the whole benefit of the Patent Act for some categories of biotechnological inventions. Needless to say, the 1984 Act was meant to reverse the effects of Roche under limited circumstances, not to deprive entire categories of inventions of patent protection.
In her dissent, Judge Newman takes this opportunity to restate her dissatisfaction with this court's decision in Madey v. Duke. * * * However, the common law experimental use exception is not before the court in the instant case. The issue before the jury was whether the infringing pre-clinical experiments are immunized from liability via the "FDA exemption," i.e., 35 U.S.C. § 271(e)(1). The district court did not instruct the jury on the common law research exemption with respect to the Merck"s infringing activities. On appeal, Merck does not contend that the common law research exemption should apply to any of the infringing activities evaluated by the jury. Neither party has briefed this issue to this court. Moreover, during oral arguments, counsel for Merck expressly stated that the common law research exemption is not relevant to its appeal. Judge Newman's dissent, however, does not mention that the Patent Act does not include the word "experimental," let alone an experimental use exemption from infringement. See 35 U.S.C. § 271 (2000). * * *Thanks to How Appealing for the pointer. Currently the opinion appears to be accessible only in MS Word format via the link provided in How Appealing's entry.
Here is a link to a 3/24/03 writeup on the threatened expansion of the research exemption that gives some context to this decision. It cites two other cases, one from the Southern District of New York, and one from The District Court for Deleware, that have held that "in certain circumstances, research on new drugs using U.S. patented tools does not infringe those patents under the 'research exemption.'"
Posted by Marcia Oddi at June 7, 2003 07:54 AM