Oh the appeal of a patent, an issued document enabling one to create a "velvet rope" and include a select few (with an admission price and perhaps an "X drink minimum") and exclude many others from attending and enjoying the party one has invested in creating. But oh the wee number of patent parties that are delineated by the velvet rope and have duly compensated and able security staff willing to use force to exclude and remove those that enter without an invitation or payment.

Among the many scores of patents issued very few are actively enforced. The onus-both economic and human-to raise the periscope and vigilantly monitor the landscape for intruders into the patent party is vested solely in the owner of the patent and/or its licensed entity. Patent litigation that terminates through a trial is terribly expensive-costing north of $1 million and closer to $3 million on the average. A Herculean revenue or royalty stream would be necessary to mandate and protect such an investment. The communication of an intent to enforce a patent against a "velvet rope intruder" establishes a precarious dynamic that can result in a backlash, like a defendant seeking to invalidate your patent, for example.

Nutramax Laboratories (NML) is a leading marketer of human and animal dietary supplements for joint health, and is the only company in the U.S. that has the rights and supply to the same chondroitin sulfate used in the GAIT study-the most widely researched chondroitin sulfate ingredient. NML has been issued a number of patents germane to its product suite and is "experienced" in patent litigation.

On April 6, 2007, NML filed a lawsuit against Soundview Publications (SP), a marketer of dietary supplements, in particular one called Advanced Joint Support. The lawsuit-not served as of May 4, 2007-alleged that SP was infringing on U.S. patent 6,797,289 (granted September 28, 2004). This '289 patent claims a composition comprised of an amino­sugar e.g. a glucosamine and avocado/soybean unsaponifiables (ASU), which is exploited by NML in its own Avoca ASU dietary supplement.

Attorneys for SP filed a request for declaratory judgment (DJ) on May 4, 2007, asserting that the '289 patent is invalid, unenforceable, and that SP's product did not infringe any of the claims. It is outside of my purview of expertise-and the scope of Nutraceuticals World-to opine on the merits of SP's seeking of a DJ from the U.S. District Court in Atlanta. However, it is salient to address the dynamics of what such legal communications can portend.

NML-which is to be lauded simply for its commitment to enforcing its patent-placed SP on explicit notice that it believed it was infringing the '289 patent. Because NML has its own product in commerce, practicing the invention, it likely was unwilling to grant a non-exclusive license to SP. One does not know the communications between NML and SP prior to NML's filing of a lawsuit BUT it is likely their counsel-and the executive team-suspected that SP would seek a DJ and the '289 patent would endure the subsequent scrutiny. Had NML (not its IP counsel) simply informed SP of its '289 patent, and kindly included a print or digital copy of it in a written communication, SP would have been put on formal notice of the patent's existence (many companies do not perform freedom to operate searches and thus are unaware). This would have effectively prevented SP from seeking the DJ-as NML could assert that it conveyed no intention to enforce the patent.

What is distinctive about this case is that the '289 patent itself lacks any data from a randomized controlled (clinical) trial demonstrating the synergistic efficacy of the invention, let alone efficacy in comparison to placebo. The presence of the often invoked "S" word in the single independent claim of the patent may become a merit axis around which the case is adjudicated.NW