University Patent Shield Goes To Supreme Court?

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patents1.jpgLast October, a federal appeals court in Washington reignited a heated debate over patent infringement that may now be headed to the US Supreme Court. At issue is sovereign immunity, which protects states - including state universities - from being sued for patent infringement in the federal court system. Yet, state universities can sue others for patent infringement. In other words, they can have it both ways.

And so a little-known company, Biomedical Patent Management, is hoping the Supremes will hear its argument that such immunity is not only unwarranted, but unfair. The company’s lawyers recently filed a request, known as a petition for writ of certiorari, for the court to hear its case, which has potentially far-reaching ramifications for industries, notably drugmakers and biotechs, that invest large sums to create and defend their inventions.

“The judgements these universities win raise the cost of research and development, and manufacturing and more,” says Andrew Dhuey, one of Biomedical’s attorneys, who notes that private universities, for example, have no right to sovereign immunity. “They’re very big patent litigators. And the University of California is the biggest of them all. And for them, it’s sue, but never be sued.”

supremecourt.jpgIndeed, California has successfully alleged some sizeable patent infringement claims - between 2000 and 2006, there were more than $900 million in judgments and settlements in patent-infringement actions, according to the company’s Supreme Court filing. Genentech, for instance, paid a $200 million settlement. Over the last 20 years, however, sovereign immunity was cited by the university to dismiss a half dozen patent challenges.

That brings us to Biomedical, which sought royalties on a patented method of screening birth defects, but lost after the University of California raised its patent shield. The patent is Biomedical’s only asset, so a great deal is at stake. PhRMA and BIO, meanwhile, are considering filing friend-of-the-court briefs. Whether the Supreme Court agrees to hear the case, or seek the opinion of the US Solicitor General, remains to be seen, but Dhuey and his colleagues make a compelling argument:

“A state has no right simultaneously to use the federal courts to extract revenue from industry competitors and to avoid any responsibility in those same courts for its own actions,” they write. “The Eleventh Amendment (which grants states sovereign immunity) is not a license to print money, and those who drafted (the amendment) would never have embraced California’s exploitative interpretation, which has little to with sovereignty and everything to do with unjust financial enrichment.

“All (Biomedical) has ever sought is a level playing field for enforcing patent rights. When a state can enter and exit the judicial arena at its pleasure, non-state actors are severely handicapped. And when states manipulate the courts to gain a competitive edge in the patent market, they jeopardize the balance struck by Congress in creating incentives for inventors to innovate by giving them a time-limited monopoly.”

It’s hard not to agree with such logic. Even US District Court Judge Marilyn Hall Patel, who dismissed the case two years ago, appeared to sympathize: “The court is indeed troubled by the University of California’s ability to reap the benefits of the patent system without being exposed to liability for infringement. Similarly situated private universities enjoy no such advantage.” The law, however, remains the law. Unless the Supreme Court is willing to restore some balance to the system.

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  1. Universities have already raised clinical development costs exponentially with their obscene demands for payment well above UCR to conduct studies, rising overhead, delays in study initiation (when’s the last time you were able to negotiate new clinical trial agreement language in less than 6 months?) accompanied by demands that they be allowed to enroll patients past end of recruitment (or that a set # of subjects for them to be able to enroll) because they started so late and didn’t think that competitive enrollment was fair to them.

    Ironically, the academic centers with their KOLs tend to overpromise and underperform despite the additional cost & delays. Clinical Trial Management is generally forced to use the centers and meet they’re demands because these guys are KOLs, friends to the company who will be speaking about the drug. . .

    They’re Universities so, of course, they also want IP rights to anything observed at their center, so this little bit of hypocrisy is rich.

  2. You state: They’re Universities so, of course, they also want IP rights to anything observed at their center, so this little bit of hypocrisy is rich.

    I share your view of university hypocrisy. From the perception of a lowly taxpayer, I would not be perhaps quite so resentful if money garnered from IP licensing and clinical trial participation had a ROI–like IMPROVED quality of education, more scholarship/grants for students, or reduced taxpayer-burden. But if these things are occurring, I don’t see them. What we, as taxpayers DO see (and perhaps quite wrongly since athletic budgets are oftentimes separate from the general budget) are head coaches who make 2-3x the amount of academic leaders; IP-generators who profit (individually) from taxpayer-funded research; and headlines (here in Florida) that scream budget cuts for higher education.

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