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July 23, 2006

as martha would say, patent infringement is not "a good thing"

Incorrect naming of inventors on a patent is “not a good thing” — the curse of Martha appears to not be letting up on 4_Large_Erbitux_Mode_of_WorImClone (which experienced strong revenue growth last quarter.)

Complex biomedical research leads to complex determinations of individual contribution: questions of inventorship and ownership often arise at very inopportune moments – for example, when a licensee appears, when tenure is debated and so forth.  Many researchers view patents in the same light as journal articles – the more contributors listed as authors, the merrier.  

Unfortunately, such a cavalier attitude can result in the invalidity/unenforceability of any patent that issues with an incorrect naming of inventors and especially with regards to joint inventors (which is covered by 35 USC 116).

In the U.S. patents are issued in the name of individuals and not to corporations/assignees as is the case in many non-US jurisdictions.  Incorrect naming of inventors goes against the specific outline of patent protection set forth in the Constitution “…by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”  U.S. Constitution Art. I, Section 8

ImClone System Inc., the company at the heart of the Martha Stewart stock scandal, is finding this out the hard way while being embroiled in a “bitter patent dispute that threatens its bottom line and has led some world-renowned cancer researchers into a courtroom for a highly unusual showdown.”

Judge Naomi Reice Buchwald, of the U.S. District Court for the Southern District of New York, is deciding who is the rightful owner of a patent used for ImClone Systems Inc.'s blockbuster cancer drug Erbitux.  The case no is 1:03-cv-08484-NRB entitled Yeda Research v. Imclone Systems, et al.

According to the complaint (which is unfortnately not available on the court’s electronic database), a team of three esteemed scientists from Israel who pioneered a cancer treatment technique claim a former colleague stole their idea and was credited on a patent now owned by Aventis Pharmaceuticals Inc. and licensed to ImClone.

In the 2003 suit, Yeda Research and Development Co. of Israel sued ImClone -- which has an exclusive license for the formula used in Erbitux to inhibit tumor cells -- and Aventis, claiming three of its researchers should be named as the inventors. The current patent names Dr. Joseph Schlessinger, Chairman of Pharmacology at the Yale School of Medicine, as the inventor along with six others, three of whom even the defense has agreed do not belong on the patent.

You know that things are not looking good for you when the judge “telegraphs” her intentions in the case.  For example, according to the MercuryNews article:

Several times, the judge indicated she believed ImClone and Aventis should have settled when Yeda approached the company before trial to seek a deal. ``I cannot decide this based on what the economic consequences may be. That's the risk you take when you don't resolve it,'' she told the Aventis lawyer.

She seemed poised to at least put the Weizmann scientists on the patent, telling one defense lawyer: ``One might wonder why you didn't put the Weizmann people on your patent in the first place.''

Hmmmmm…..  That is a pretty clear sign of which way the judge is leaning and I would expect that there would be some serious settlement negotiations going on right now.  Moral of the story – spend some time when determining inventorship: you don’t want the curse of Martha to show up now – would you?



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Posted by Douglas Sorocco at 12:12 PM.
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