Harness IP patent attorney Bryan Wheelock was quoted in Law360 article by Ryan Davis about a pair of recent rulings from the Federal Circuit involving the written description requirement.
The cases related to Indivior UK Ltd’s Suboxone drug for treating opioid addiction and Biogen’s Tecfidera drug for treating multiple sclerosis. In both cases, the Federal Circuit invalidated the patents covering these drugs based on the patent owners’ failure to meet written description requirements.
More specifically, the dosage amounts or ranges where the drug is effective are not clearly supported by the written description in each of the patent applications.
Wheelock suggests the issue is likely a result of additional research that was performed after the application was filed. The new research allowed each patentee to move from a broader dosage range to a more narrow one, although, by that time, it was too late.
For Indivior, the patent claims say the invention is a film composed of 40% to 60% water-soluble polymeric matrix. In the original application, however, phrases like “at least 25%” are used. For Biogen, the patent claims describe treating MS with 480 mg of their drug. Somewhat controversially, there is a reference to this amount in the application, but the court found it was part of a wider range of doses that do not specifically call out 480 mg as the effective dose.
“It’s not a matter of staking out a claim and going prospecting: I figured out that someplace in here, there’s something good, and I’m going to go find it,” says Wheelock. “What they’re looking for is more like a treasure map, where X marks the spot.”
The cases offer a valuable lesson for patent attorneys: “Attorneys can’t just take what the client says. We have to investigate it, prod them into being more specific and keep a fire lit under them: ‘Look, this is a broad range. You need to get your work done really fast to actually have an invention here’” says Wheelock.
Patent applications need to be filed quickly, but “until you have that treasure map where it actually works, neither the inventor’s nor the attorney’s work is done,” he adds.