navigating the patent maze

Since 1991, when the NIH (National Institutes of Health) in the U.S. filed a patent application claiming thousands of EST sequences, controversy and disagreement about the legalities and wisdom of patenting such sequences has permeated law reviews and scientific journals. Now, despite other U.S. patents issuing with claims to EST (expressed sequence tags, i.e., partial sequences of cDNA molecules) sequences, the Board of Appeals of the USPTO recently affirmed a rejection of claims to EST sequences. (Ex parte Fisher, Appeal No. 2002-2046). The bases for the rejection upheld by the Board were (i) lack of utility and (ii) lack of enablement. The opinion of the Board is being appealed to the Federal Circuit, who will hear and decide on the case early next year.

Is there a difference between the EST sequences in Fisher and those in already issued patents? The EST sequences in Fisher are “naked sequences”, that is, sequences with no known function, sequence motifs, or other features that would demonstrate a specific use of the EST. Fisher argued that several uses were taught in the application, including: identification and detection of polymorphisms, use as probes in hybridization, and as primers for amplification. But without more information, such as the genes these ESTs are derived from, the Board concluded that the stated uses are general uses for nucleic acids and thus do not satisfy the particularity requirement for utility.

The opinion of the Board contains some useful guidance of the degree of disclosure that might be required to have patentable EST sequences in the future, assuming that the Federal Circuit ultimately agrees.

Under United States patent law, if you are found to be a ‘willful infringer’(infringing a patent while knowing that you are infringing), liability can include up to triple damages and in exceptional cases, payment of the prevailing party’s attorney fees. The severity of the penalty spurs many companies to obtain a legal opinion about whether or not the company is infringing because a well-done opinion that concludes non-infringement will protect the company from a finding of willful infringement. In a recently-decided critical case, Knorr-Bremse, the Federal Circuit examined several issues about willful infringement. (See … recent post discussing one of the holdings in this case.) One of the issues decided was about the legal obligation to respect valid patent rights.
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I have been asked many times to give an opinion about a patent and sometimes asked if a particular use is infringing on a patent. Mostly there seems to be confusion or misunderstanding about what is an “opinion” and the necessity or not for an opinion. In U.S. patent law practice, an “opinion” is either a “non-infringement opinion” (you are not infringing the patent in question) or an “invalidity opinion” (the patent in question is invalid because of prior art) and serves a singular purpose: to protect the client against charges of willful infringement. A finding of willful infringement can inure triple damages and attorney fees for the infringer.

A variety of reasons (e.g., cost - opinions can cost tens of thousands of dollars) may encourage or discourage a client from wanting an opinion. But what are the ramifications of a decision to forego an opinion or to claim that the opinion is privileged and not disclose it? Could this infer that the client knows it is infringing?

In one of the most important Federal Circuit patent cases this year, Knorr-Bremse Systeme Fuer Nutzfahrzeuge GMBH v. Dana Corporation, et al., the Court emphatically said, “no adverse inference that an opinion of counsel was or would have been unfavorable flows from an alleged infringer’s failure to obtain or produce an exculpatory opinion of counsel.”

Under U.S. patent law,

a person shall be entitled to a patent unless–
the invention was … described in a printed publication in this or a foreign country….

While we all recognize that a printed publication includes journal articles, books, etc., and that speaking at a conference is not a printed publication, what about a poster that is presented at a conference?
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By this time, most of you have heard that ‘Monsanto won’ over Percy Schmeiser in the Canadian Supreme Court. Actually, Mr Schmeiser was found to have infringed Monsanto’s patent but no damages were assessed. It was a close decision and a momentous one for two main reasons. Several commentators have written about how genetically-engineered plants are essentially, if not expressly, protectable because of the gene introduced. In another blog entry, I will discuss that issue. For this entry, however, I raise the possibility that the Court has defined “use” of a patented invention in such a way that that there may now be an exemption for basic science research in Canada.
Monsanto Canada Inc v Schmeiser 2004 SCC 34.
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How many times have I reminded the scientists to keep proper notebooks, including witness signatures? Mostly I was ignored. Now along comes a case in the United States District Court in California that shows again the importance of good notebook habits. This time the notebooks were needed to evidence inventorship of an unnamed inventor on a patent. Evidence of inventorship needs to corroborated, and generally a putative inventor’s notebooks are insufficient corrobaration of testimony, at least where the notebooks are not witnessed.

Huang v California Institue of Technology, C.D. Cal., No. 03-1140 MRP, 17.02.04
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One of the frequent criticisms I hear of the U.S. patent system in particular is the existence of “submarine” patents. This term refers to patents that issue very long after their filing. So a company or organization that has been happily proceeding along a path of commercialization of their product is blind-sided by a patent issuance, the existance of which was secret.

For several reasons, the number of submarine patents is diminishing: the U.S. now has a patent term of 20 years counted from the date of filing, and for the most part, patent applications are published 18 months after filing. Because these changes only took place in 1995 (patent term) and 2000 (publication), a few submarine patents have been lurking stealthily along, grandfathered in under the old rules.

The most prolific user of the old U.S. patent system has to be Jerome Lemelson. Patent applications he filed in the mid-1950s and that were granted between 1978 and 1994 are now being asserted against manufacturers of bar code readers and machine vision systems. While this strategy has netted Lemelson and the Lemelson Foundation as much as $1 billion in royalty payments, the gold mine is being shut down.

A U.S. District Court recently ruled that 14 patents of Lemelson’s are invalid because “Lemelson’s delay in securing the asserted patent claims is unexplained and unreasonable”. While this is good news for the manufacturers, it is not the end of the story as the Lemelson Foundation is expected to appeal the decision. In the opinion of yours truly, Lemelson Foundation is going to be sunk for good on this one. In the last few years, the Federal Circuit Appeals Court has not looked favorably on delays initiated by the patent applicant.