The patent protection landscape’s been turned on its head in the past couple years, ever since the Leahy-Smith America Invents Act went into effect. A discussion at trade group Biocom’s DeviceFest in San Diego this week addressed some of these changes and subtleties as they apply to medical device companies:
“Gone are the days of storing the notes of your inventions in a lab notebook – we’ve aligned ourselves with the rest of the world,” said Laura Johnson, vice president of intellectual property at continuous glucose monitor maker DexCom. She added:
“Every company has a different challenge. For ours, where we have more complex IP that runs the gamut of technologies – all the way from the chemistry to the device design to the software – it’s difficult to capture that all as quickly as we want to.
From a practical standpoint, if you can’t file as quickly as possible, what’s the key? Before public disclosure. Now, if you’re giving a quick speech at a conference somewhere, for example, and at the 3:15 mark you disclose something, that’s public disclosure. It could give someone else in the room an idea.
And that will bar you from getting patent protection in the U.S. Before you disclose anything publicly, you need to file.”
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One example of public disclosure that can bar an early startup from getting intellectual property rights is crowdfunding, said Salil Bali, an associate at Stradling Yocca Carlson & Rauth.
“Crowdfunding is a great way for early startups to get funding, but it’s a landmine when it comes to IP rights,” Bali said, adding:
“I’ve had a couple of clients sadly come to me too late in the process, saying “Now we’re running.” But they can’t get protection, because they publicly disclosed it through Kickstarter or IndieGoGo, and lost the ability to get patent protection. That’s why it’s very key, and an important element to think of early the process – when and where do I engage with patent attorneys?”
The choice to file for a patent or hold a trade secret is a delicate one. Jonathan Spangler, vice president and chief patent counsel at surgical device maker Nuvasive, cited the Coca-Cola “secret sauce” and elaborated:
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“It’s a perennial question we get. To me, it depends on how subject your technology is to trade secret protection. Can people reverse engineer when it’s out in the open? It’s important to patent the technologies that can be reverse-engineered as best as you can.
Coca-Cola’s trade secret has become an actual urban legend – the actual recipe and components are divvied up, and known by only three or four people in the whole company. They’ve maintained that trade secret in a vault in Atlanta.
If you can keep that secret sauce close to the chest, where no one can figure it out, then trade secrets are the way to go. But as soon as it can be reverse-engineered, it’s perfectly allowable to take what you’re doing without a patent.”
Every company at some point gets a cease and desist letter. Tom McClenahan, executive vice president and general counsel at Masimo Corp., said the first thing to really consider is who sent it, because the response level will always vary.
“If it’s a competitor, you just need to dig in,” he said.
Other cease and desists are from individuals in the medical device space, such as doctors who see the product and realize they published an article on something quite similar.
“In those cases, my experience has been that these people are operating in good faith,” he said. “Explain why you don’t infringe, but be reasonable about it, and you should be fine.”
The third category, however, is the “patent troll” – a company whose main business is enforcing patents, rather than selling products. In this infrequent case, the best course of action is to do an analysis, check its validity and purported infringement, and then typically just not respond.”
Printed publications, public disclosures and public uses of an idea or an invention are all considered “prior art” in patent law, meaning if you disclose something publicly you have one year to follow up with a patent application. So if a competitor makes a presentation on something related to your technology, it’s very likely your patent application will be blocked by that disclosure. Spangler elaborated:
“A provisional patent is your initial toehold with the USPTO – your line in the sand. You want to file fast, but you have to not have too spartan a disclosure so that if someone comes with a developed, well-vetted concept, you may have priority relative to certain aspects, but not all of them, because they preempt that.”
Made it down here? You’re a champ. Patent law is dense.
