Patents governing research tools were left unaffected by a US Supreme Court decision this week that could have had widespread, and potentially negative, implications for the industry.
The Court reversed an earlier ruling in the case Merck KGaA v. Integra LifeSciences I, Ltd. in effect, granting pharmaceutical companies greater leeway in ignoring other firms' patents when conducting early-stage research. However, the Court specifically refused to decide whether a statutory exemption from patent infringement '271 (e)(1) applied to research tools.
Text of 35 U.S.C. 271 (e)(1)
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 question now is whether the Court has left open the opportunity for research tool patents to be targeted by future challenges of what is covered under the statutory exemption (see sidebar for text of the exemption).
In a footnote to the ruling, the Court wrote, "The Court of Appeals … suggested that a limited construction of '271 (e)(1) is necessary to avoid depriving so-called 'research tools' of the complete value of their patents. We … need not and do not express a view about whether, or to what extent, '271 (e)(1) exempts from infringement the use of 'research tools' in the development of information for the regulatory process."
Though the case involved a statute that normally is of interest primarily to parties involved in late-stage drug research, research tool companies were worried that a decision in Merck's favor could broaden that exemption to include the types of technologies they sell.
In an amicus brief filed March 22, 2005, in support of Integra, several research tool firms, including Invitrogen, Affymetrix, and Quantum Dot, urged the court not to extend the exemption to patented research tools. "If patents on such tools can be readily infringed in the course of developing information for submission to the Food and Drug Administration, the economic value to the patents will be essentially lost and the incentives crucial to support creation of new and better tools in the future will be slowed, if not completely eliminated, along with the related discoveries, efficiencies, and cost-savings," they argued in the brief.
The tool providers noted that the major pharmaceutical companies are customers of either the firms joining in the brief or other research tool providers and regularly purchase patented tools for use in drug research and development. "None has suggested before that they could purchase such tools once and then freely infringe the patents by replicating the tools in their own labs," they argued.
Earlier rulings from lower courts, including the ruling from the US Court of Appeals for the Federal Circuit last year, had suggested that the exemption was intended to be narrow and might only apply to generic versions of patented drugs. But the Supreme Court unanimously ruled in favor of a broader interpretation that the "use of patented compounds in preclinical studies is protected under '271 (e)(1) at least as long as there is a reasonable basis to believe that the compound tested could be the subject of an FDA submission and the experiments will produce the types of information relevant to an IND or NDA."
Is the Issue Settled?
Although research tool providers can breathe a sigh of relief following the court's decision, the ruling is likely to cause continued questioning over what is and isn't covered under the exemption.
Even though the Court refused to decide whether the exemption applied to research tools, "a reversal of the Court of Appeals' judgment to hold that petitioner's use of the patents is covered by the … exemption could be interpreted to suggest that research tools are covered by" the exemption, filers of the amicus brief cautioned in March.
Alan Hammond, chief intellectual property counsel for Invitrogen, however, said, "The ruling will not have a material effect on Invitrogen's business."
Bio-Rad Treasurer Ron Hutton offered a similar take on the Court's decision, saying, "As of right now, we don't see that it affects us." He told BioCommerce Week, "It would only be speculation as to what might happen in the future, and we're not going to speculate on that."
"What is important here is that the Supreme Court has clearly indicated that the exemption to patent infringement is not limited to development of generic drugs, but applies to any potential drug whether or not it ultimately makes it to a human patient," said Richard Warburg, an intellectual property attorney who works in the San Diego office of Foley & Lardner. "This leaves open where in the continuum from research tools to drug development experimental work will fall within the stated 'reasonably related' standard. This question will plague big pharma and biotech companies for the years to come."
Warburg told BioCommerce Week that tool providers, such as those tracked by the BCW Index (see BCW Index), "can rest happy for now. They've dodged a bullet."
Edward Winnick ([email protected])