Two views: Diagnostics firms may be worried but there are Prometheus write arounds

The biotech industry has moved swiftly to decry the Supreme Court’s Prometheus decision where the nine justices ruled unanimously  in favor of  Mayo Clinic that natural bodily responses to medical treatment are not patent eligible.

In an interview with MedCity News, Kevin Noonan, a partner with intellectual property law firm McDonnell Boehnen Hulbert & Berghoff, said that the reason that the biotech industry has found the decision troubling is because it is so broad.

“They just drew a very bright line saying that this is a law of nature, but if you read the decision you are like, ‘OK where is the bright line?'” Noonan said. “This is the thing that worries people because you know there is a bright line and it’s a law of nature, but boy it’s very easy to make something a law of nature.”

Innovation in the diagnostics field may also be challenged because of the ruling.


“If I am an investor, I will say that I am not sure my investment is worth what I thought it would be worth because the patent protection is now uncertain,” he said.

Noonan believes that the problem stems from the way the Supreme Court has historically viewed patents.

“The Supreme Courts sometimes treats patents, in my view, as something you need — you need a guard dog, but you want to make sure that you keep him in his cage because he bites and you don’t want him to take over,” Noonan said. “It’s a very mid-20th century kind of view. …”

He noted that the plethora of diagnostics companies out there with patent claims will now have a very tough time defending them.

“These companies spent the time, the money, and more importantly, disclosed their invention to the public,” he said.

And now the Supreme Court decision might prompt some people to work on their inventions in secret and later claim the “prior use” provision to practice their invention, thereby undermining the patent of someone else who disclosed their invention, he said.

“One of the dangers for the country is that patent lawyers will figure out how to help their clients practice their inventions without disclosing them,” he said.

Devan Padmanabhan, a patent litigator and partner at Minneapolis law firm Winthrope and Weinstine, said all is not lost for diagnostics companies. He pointed to preliminary guidelines the U.S. Patent Office has issued in the wake of the Supreme Court ruling as a practical road map that narrows the justices’ broad decision.

“Some people were predicting that the Patent Office would go to the extreme, which is to say diagnostics as a whole is kind of dead now,” Padmanabhan said. “But they left it to the patent drafters to craft claims so that you have an argument around the rules set in the Prometheus case.”

Padmanabhan added that it would be an overstatement to think that innovation in the diagnostics industry is going to suffer simply because of a single Supreme Court decision.

“Just take a page out of the history books,” he said. “If people think and look back to the software patent area, and all the things that patent attorneys had to do to protect software — a lot of the same issues are at play here. All patent attorneys did then was look at the rules and craft protection consistent with the rules. It’s not all doom and gloom.”


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