Inventions are all about being new. They embody the very essence of change. But in the United States, the patent laws and rules for implementing them—effectively, the guidelines by which inventions find the protection necessary to enter the market—have traditionally been remarkably staid and free of drama.

For the past several years, however, that long tradition has seemed destined to undergo significant change as a result of new rules proposed by the U.S. Patent and Trademark Office (PTO). Implementation of those proposed changes has been on hold since last fall, when the federal district court for the Eastern District of Virginia issued a temporary restraining order. But a ruling issued by the court at the beginning of this month has now stopped PTO's proposal in its tracks—at least for the time being.

Since the first U.S. patent statute of 1790, major revisions of the law have occurred only three times, in 1793, 1836, and 1952. Against this glacially slow backdrop, the rule changes proposed by PTO in early 2006 burst on the scene like global warming, and aroused a similar level of alarm.

The rule changes proposed by PTO included a number of features. But what most caught the attention of inventors and patent attorneys was that the new rules would have starkly limited the number of claims that could be filed in a single invention's patent application, and would also have limited the number of continuation applications that could follow an initial patent filing.

Other than cost considerations, there have never been any constraints on the number of patent claims that could be made for an invention. Indeed, the detailing, granularity, and nuance of claiming is at the heart of capturing inventions in words, and thereby protecting them. Similarly, there has never been a numerical limit on the practice of elaborating on an initial invention by filing continuing applications, which has become a central part of patent practice.

Thus, because PTO's proposed rule changes would have imposed novel limits on the scope of patent protection, they were widely opposed within the community of patent lawyers, patent holders, and active inventors. Nevertheless, the perception was that PTO and its rule changes were unstoppable, and lawyers and clients spent a great deal of costly time reviewing their portfolios of active patent applications and reformulating long-standing patent strategies, so that they would be able to go forward, playing under the new rules.

PTO tried to sell the rule changes under the banner of streamlining the patent process and strengthening the system. But patent attorneys and their clients interpreted PTO's actions as an effort to find a way through the enormous backlog of cases pending in the office, and also as a way to shift the burden of patent prosecution onto the applicants themselves.

Throughout 2006 and 2007, a number of efforts to derail PTO's rule changes were mounted. Among those efforts were independent suits filed by pharmaceutical giant GlaxoSmithKline and by Dr. Triantafyllos Tafas, an inventor and chief technology officer at Ikonysis (New Haven, CT), a laboratory instrumentation company. Those suits were joined together in the Eastern District of Virginia, where the plaintiffs sought a declaratory judgment to stop implementation of the rules on a number of grounds. On October 31, 2007, the day before the new rules were to go into effect, the court issued a temporary restraining order and preliminary injunction, temporarily blocking implementation of the new rules.

With that decision, most patent lawyers and their clients breathed a sigh of relief, put their revised strategies in a drawer, and continued business as usual. There appeared to be no consensus on predicting the ultimate fate of the temporary injunction, but PTO was still generally cast as the 800-lb gorilla. Thus it came as a surprise, and not without irony, that on April 1, the court granted the motion for summary judgment (Tafas and GSK v. Dudas, Jon Dudas being the PTO commissioner), thus permanently enjoining the patent office from implementing the new rules.

The judge in the Eastern District of Virginia based his ruling primarily on the view that the rules proposed by PTO were substantive to the extent that they reached beyond the scope of implementing law. Instead, PTO's proposal had moved the office into the role of making law—a power that is under the purview of Congress, not an agency or department of the executive branch.

In spite of the district court's ruling, however, the story may not be over yet. PTO has reportedly indicated that it will appeal the ruling, and it may approach the same ends more incrementally. A typical appeal to the Court of Appeals for the Federal Circuit takes more than a year, but such a timeframe can often be shortened for important cases.

An even more radical shift in the patent landscape could be brought about if Congress passes legislation specifically granting PTO authority to make changes such as those that were just permanently enjoined. The House version of the Patent Reform Act of 2007, passed in September 2007, does in fact give such rule making authority to PTO. The Senate version, on the other hand, does not contain such a provision and is still under consideration.

Douglas C. Limbach is an attorney at Shay Law Group LLP (San Mateo, CA), where he counsels technology companies, primarily in the medical device industry. David C. Cohen, PhD, is a patent agent at Shay Law Group. Both focus on representing early stage medical device companies.

© 2008 Canon Communications LLC

Return to MX: Issues Update.