Who Invented First?
Reality television shows have covered everything from dancing competitions to worm eating. Now, two different networks have shows about inventors and inventions, Made In USA (USA) and American Inventor (ABC). The race is on: who is going to be the next big inventor? But don't expect the competing inventions in either show to involve new formulations for treating irritable bowel syndrome. No, the inventions are more in the line of simple consumer products, like saltshakers that can be located with a beeper or ladders that can fold-up into a handbag—€”the kind of things you can sell on TV, of course. It all seems straightforward enough: competing groups of people have good, useful ideas and someone is willing to buy the best idea, make it and sell it. The best idea is the one that will sell the most. It's all so entertaining.
Patent lawyers already know how entertaining inventorship issues are. This is particularly true in the United States where the first-to-invent, rather than the first-to-file a patent application, gets the patent. Competitions to determine who invented something first, called "interferences," can come as a complete surprise to a U.S. patent applicant or U.S. patent owner. One day, after a lengthy and seemingly successful prosecution, a patent applicant receives an action from the patent examiner stating that all prosecution is suspended pending the declaration of an interference. Or, in the midst of celebrating a long-awaited and hard-earned Letters Patent, a patent owner receives a notice that it is now a party to an interference and needs to get a lawyer quickly. On the other hand, the interference may not be a surprise to one of the parties. The U.S. Patent and Trademark Office (USPTO) has rules that dictate how an applicant can "provoke" an interference, if one is warranted.
Although the rules governing interferences are complicated, the basic idea is that two different entities present the same invention to the USPTO at the same time. The Board of Patent Appeals and Interferences decides which entity invented the common invention first and that party wins the interference. However, at one stage of the proceedings, both parties have an opportunity to destroy or limit the other party's patent or application for reasons unrelated to who invented first. At this stage, one party might argue that the other party should never have gotten its patent in the first place for a variety of reasons. It might argue that the other party didn't have data to show that the claimed drug formulation works; that the claims are too broad; or that the invention is only one species, not the whole genus of compounds. Alternatively, one party may voluntarily surrender subject matter that overlaps with the other party's invention to pursue an invention that doesn't overlap and is patentable over the common invention. The idea is that if the inventions don't overlap, there is no basis for an interference. The goal might be to get just what one needs and walk away as quickly and cheaply as possible. Another option is to argue that neither party should have a patent because the invention is already in the public domain. This last option might appeal to the party that knows it would lose anyway and doesn't want to be dominated by the winner. Strategies vary with the facts of each case and the business objectives of the parties.
Because interferences are complicated and therefore expensive and time consuming, many parties are motivated to settle as early as possible.
In order to understand how the priority of invention contest part of an interference works, one needs to understand what it legally means to have invented something or better yet, how to prove it. In sharp contrast to the happy scenario on the TV invention reality shows, pinning down who invented what, when and where is one of the most difficult exercises there is for a patent attorney. Start with this type of judicial guidance:
"—€¦the man who first reduced an invention to practice is prima facie the first and true inventor but that the man who first conceives, and, in a mental sense, first invents a machine art, or composition of matter, may date his patentable invention back to the time of its conception, if he connects the conception with its reduction to practice by reasonable diligence on his part, so that they are substantially one continuous act."
Although this confusing quote is an excerpt from a 1893 case, it is still the law applied today in determining which inventor invented first. Clearly, there is more than one concept to understand in order to apply this law. An invention is a "conception" and a "reduction to practice" of an idea. The party who wins the contest is the first one to reduce to practice the invention, unless the other party conceived the invention first and then diligently worked towards reducing the invention to practice. The legal meaning of "conception" is the mental formation of a definite and permanent idea of the complete and operative invention as it is applied in practice. An invention is "complete" when all that would be necessary to reduce to practice the invention would be ordinary skill without extensive research or experimentation. "Reduction to practice," is the act of showing that the invention will work as intended; if the inventor never got around to proving that something actually worked, the filing of a patent application is a constructive reduction to practice, which is as good as an actual reduction to practice under U.S. law. "Diligence" means continuous activity towards reducing to practice the invention. Case law on diligence indicates that although it is not necessary to show daily activity towards the invention, there should be good excuses for any lapses in activity.
And if understanding all of the above were not fun enough, once the concepts are clearly understood and corresponding milestones recognized, the next hurdle is to find evidence in the record that supports such milestones. Generally, evidence must be corroborated, although the nature and sufficiency of such corroboration varies depending upon the purpose of the evidence and the particular facts of the case.
Interferences are not the only place where inventorship issues entertain patent attorneys. Disputes arise about the listing of inventors. Many people can contribute to an invention but not everyone is necessarily an inventor.
Inventors must contribute to the conception of the invention, not just the testing or making of it. Contributors who believe they should have been listed as inventors, can and do go to court. In a recent case, Stern v. The Trustees of Columbia University, the federal circuit considered whether a medical student should have been named a co-inventor on a patent for a method of treating hypertension and glaucoma. The medical student believed that his experiments showing that topical application of a single dose of prostaglandin reduced intraocular pressure in a rhesus monkey rendered him a co-inventor. He also argued that his notebooks that had been destroyed by the listed inventor would have proven his claim to inventorship. The court disagreed. It noted that the medical student simply carried out an experiment previously done on a different animal by the named inventor. And, because the medical student's notebooks had not been witnessed, the notebook entries were uncorroborated and therefore would have been insufficient to support his claim anyway.
The lesson here is that it is important to get inventorship right for a variety of reasons and it is equally important to be able to prove it is right. A patent that lists improper inventors is invalid. Although it is possible to correct inventorship if someone is mistakenly included or excluded as an inventor, it is fraud on the USPTO to deliberately list the wrong inventors and fraud renders a patent unenforceable.
In the pharmaceutical and drug delivery industries, interferences are not uncommon, as patent fields are very crowded. Also, claims to inventorship rights are always more likely when there is commercial product involved.
Finally, any business that relies on collaborations for creating or testing drugs has to be careful about inventorship issues. Collaborations may be very efficient and may spawn great ideas but they also spawn hotly contested inventorship disputes. Consequently, every institution should have a reliable system for recording ideas and all the work related to such ideas. It is equally important that witnesses be a part of such system. The stakes are high and the reality is that there is usually only one winner. It's not a game you want to lose.
Patricia Donovan Granados is a shareholder at Heller Ehrman PC, Washington, D.C., and a member of the patents and trademarks practice group and the life sciences and technology practice group. This column was originally published in Drug Delivery Technology, April 2006.

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