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Brand name pharmaceutical and biotechnology companies have been quietly spending millions to lobby Congress for changes in US patent law. Specifically, these companies want to overhaul the intellectual property rules dealing with the doctrine of “inequitable conduct”. When a company or individual engages in inequitable conduct, it means that the company or individual has misrepresented or concealed information with the intent to deceive the US Patent and Trademark Office (USPTO). In such cases, a federal judge has the legal authority to void the patent and declare that it is unenforceable. Not surprisingly, brand-name drug companies are lobbying Congress to eliminate or curtail inequitable conduct penalties.
According to the New York Times, in the last 15 years the US Court of Appeals for the Federal Circuit (which handles appellate patent litigation) have ruled in the affirmative on 40 cases of inequitable conduct–14 of which involved pharmaceutical or healthcare companies. Similar rulings have been issued by federal district judges in an indeterminate number of cases that were not appealed (and never reached the Federal Circuit court). The article contends that some drug makers knowingly submitted false statements to the USPTO, inaccurately described experiments in patent applications or concealed information (usually prior art) that contradicted their claims. In one high profile case, the appeals court ruled that the Danish drug maker Novo Nordisk failed to disclose that it had not performed an experiment described in a patent application for human growth hormone. In another notable case, the court contends that Pharmacia (now Pfizer) used an “inaccurate and misleading” affidavit to win a patent for a new glaucoma drug. Personally, I am aware of several instances in which companies willfully and knowingly failed to disclose prior art in patent applications that were ultimately approved.
Those of us in the biz know that patents are valuable commodities and that the financial stakes surrounding patent estates and intellectual properly are extremely high. A robust patent estate can either make or break a company. Nevertheless, in my opinion, if a company (or individual) cheats by falsifying, concealing or omitting pertinent information in a patent application, they ought to be penalized for it. As one former USPTO commissioner, who served under George HW Bush puts it: “Patents can be very valuable. There are strong incentives to want to get them. Cheating occurs from time to time. The inequitable conduct doctrine says that if you cheated to get a patent, you should not be able to enforce it.”
Brand name drug manufacturers contend that generic drug makers routinely attack their patents by accusing them of inequitable conduct, whether they are guilty or not. Further, they claim that unwarranted and endless patent litigation impinges on their ability to discover and bring new drugs to market. Consequently, brand name drug markers argue that the inequitable conduct doctrine should be eliminated from US patent law. Not surprisingly, this would seriously hinder or curtail the ability of generic drug manufacturers to bring their products to market—something that brand name drug makers desperately want to protect their multibillion dollars drug franchises from generic encroachment.
The number of patent applications submitted to the USPTO has doubled in the past 10 years and more than tripled since 1987. According to Jon Dudas, the current undersecretary of commerce for intellectual property “We are getting more and more unpatentable ideas and worse and worse quality applications”. Historically, the annual number of patents that are allowed (approved) ranges from 62 to 72%. After reaching a high of 72% in 2000, it dropped to 43% in the first quarter of 2008. These data suggest that, the probability of getting new patents allowed is diminishing. This is making brand name drug companies anxious and extremely competitive when it comes to patent applications. And, when competition increases, it is not uncommon for companies and individual to resort to unorthodox (and sometimes overtly unethical or illegal methods) to insure success. In my opinion, the doctrine of inequitable conduct and the penalties associated with it are what keep illegal and unethical behaviors in check. With this in mind, I think it would be extremely unwise for Congress to eliminate or severely curtail the penalties for inequitable conduct.
Based on the small number of inequitable conduct cases that have reached the Federal Circuit, it appears that the current system is working the way it was designed to function. This begs the question: “Why fix something that isn’t broken? “ Oh wait, this debate isn’t really about ethics or legality–it is about making money–silly me!
Until next time….
Good Luck and Good Job Hunting (try intellectual property law)!!!!!!!!
