Preparation: The Silver Bullet

The answer lies in how the third company prepared in advance. That preparation didn't require more modest advertising claims, nor expensive clinical studies. The preparation, however, enabled the third company to respond in a very convincing way. Further, the preparation not only reduced the company's downside false advertising liability risk, it also increased the product's sales nearly 30 percent.

Recall the fair-advertising standard: Therapeutic claims must be supported by "competent and reliable scientific evidence" which has been "evaluated by people qualified to review it." The FTC enjoys significant expertise in law and in economics. In contrast, scientific expertise is not generally considered one of the FTC's comparative strengths. Another Washington agency, however, enjoys significant scientific expertise, employing scores of medicinal chemists, toxicologists, and pharmacists who are qualified to review scientific evidence and, based on that review, decide whether the evidence supports therapeutic claims. That agency, of course, is ... The United States Patent & Trademark Office (PTO).

The Patent Office has that expertise, and the third defendant used it—and used it well. The company gathered scientific evidence for its advertising claims, and submitted that evidence to the Patent Office, asking the PTO to evaluate it and make a legal ruling on whether that evidence supports the advertising claims. The Patent Office evaluated the evidence and concluded that the evidence did support the claims, awarding the company a patent (U.S. Letters Patent No. 6420350) in the process.

Several years after the patent was issued, the FTC demanded the company substantiate its advertising claims. The approved US patent, however, was confirmation that the company had indeed produced the necessary scientific evidence evaluated by proper reviewers. Put simply, the patent showed that the US government had already investigated the issues at hand and found the evidence adequate to support its claims. Thus, like the proverbial third little pig that took the pains to build a house of brick, the third defendant, by taking the effort to pursue a patent, built itself a stable legal home.

Manufacturers may, of course, use internal research (or hire a contract research organization) to substantiate advertising claims. Adding a patent to the mix, however, has several unique advantages. For example, the FTC may argue that internal research or external sponsored research is improperly biased in favor of the sponsor. In contrast, it would be difficult to credibly allege that the PTO is biased in favor of particular companies.

Similarly, corporate research does not legally bind the FTC unless and until the FTC actually accepts that research. In contrast, where the Patent Office accepts certain research as cogent on a particular issue, that legal conclusion can be binding not only on the Patent Office, but also, thanks to a 1940 Supreme court case (Sunshine Anthracite Coal Co. v. Adkins), on the FTC.

The difference between the three defendants was a seemingly minor one: the first two defendants did not bother to get patents on their advertised indications; the third one did. That seemingly minor difference, however, made the difference between corporate failure and survival—and boosted product sales to boot.

Mark Pohl is a registered patent attorney with Pharmaceutical Patent Attorneys LLC in Morristown, NJ. He can be reached at Mark.Pohl@LicensingLaw.Net