Legal: No Exception? - Pharmaceutical Executive


Legal: No Exception?
An important legal loophole has made patented tools available for research. Today, though, it appears to be closing.

Pharmaceutical Executive

Integra subsequently claimed Merck violated its patents covering the peptides. Merck argued that its research was covered by the safe harbor. The United States Court of Appeals for the Federal Circuit disagreed, stating, "In this case, the Scripps work sponsored by Merck was not clinical testing to supply information to the FDA, but only general biomedical research to identify new pharmaceutical compounds. The FDA has no interest in the hunt for drugs that may or may not later undergo clinical testing for FDA approval." The upcoming Supreme Court decision should help researchers develop a better sense of just how far the experimental defense goes. In fact, there's a good chance that it will end up providing more protections than in the past.

Working Solutions Fortunately, savvy researchers on all sides of the issue have come up with creative ways to work around the limitations of the experimental use defense. Both academia and the private sector have been forced to adjust to the realities of today's integrated research community. In light of these further restrictions to such defenses, this will only continue. As with most changes, the younger generation adapts more quickly—here, younger scientists assume that patented research tools will be marketed—that is, not free to use without consent.

In fact, some universities and most of the industry have developed smart, working solutions to the issue of access to patented research tools—solutions that guarantee that the climate for research will remain robust.

Here are a few of these solutions, and how they can be applied:

Taking licenses One of the most frequently used solutions, this involves targeting a research tool, approaching the patent owner and negotiating a license for use. Patent owners are compensated with a royalty plan or upfront payments.

Inventing around patents This strategy demands creative thinking by the R&D team. Once they identify the tool they want, the challenge is to find another route to the end result, without infringing on the patent. Legal counsel can advise if their solutions are legally outside of the infringement issue. The successful R&D team may even receive a patent of its own.

Going offshore "Location, location, location" applies as much to the world of biotech patents as it does to the real estate marketplace. A coveted tool may be covered by patent in the United States, but up for grabs in another part of the world. While you may be prohibited from using a certain peptide for gene sequencing in the United States, that may change if you move the lab to another country.

Building and using public databases The open sharing of information has always been the goal of research. Many individuals and entities further this goal through contributions to public databases such as those created by the National Institutes of Health. One example is GenBank, an annotated database of all publicly available DNA sequences. Researchers savvy enough to know where such databases exist, and how to extract vital information from them, have a distinct advantage.

Court challenges Patent holders know that challenging an infringer in court can be a significant deterrent, putting competitors on notice that your company is monitoring the situation and won't take infringement lightly. Conversely, a company that wants to use a specific research tool may choose to mount a patent invalidity challenge in court for the rewards a positive decision would bring.

Flying under the radar While not a recommended strategy, there are some smaller, less-than-shrewd parties that decide to take their chances and use patented research tools in their work, gambling that the infringement will remain undetected.

Although there has been much commentary on the hazards of royalty stacking and patent thickets, this is less of a concern with biomedical patents. Here, it has been shown that research generally concerns only a handful of interfering patents. Working solutions, therefore, will continue to offer researchers access to the tools they need to conduct their work.


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