Intellectual property attorney Daniel Scola Jr. remembers a time, early into his career, when his area of law “wasn’t seen as sexy.”
He can’t answer whether data-driven science and artificial intelligence technology is what you would call sexy. But it’s certainly making what he does a whole lot more interesting, important and difficult.
The managing partner at Parsippany-based Hoffmann & Baron LLP said attorneys in intellectual property are being asked to come up with the right approach to patent innovations that involve predictive analysis churned out quickly by the latest programs and software. Finding the best way to protect those innovations has attorneys treading a careful tightrope walk between offering enough information while also not giving too much away.
Scola portrayed the dilemma as one that often presents itself in New Jersey’s pharmaceutical space. As he explained it, companies in that sector might have just one compound. But their high-tech systems allow them to extrapolate many findings — and potential new drugs — from it in early experiments.
Protecting all those what-ifs … that’s not always easy, or even feasible.
“Even if you don’t have the time, nor interest, in attaching thousands of things to that compound, the patent office isn’t likely to say, ‘That’s good enough, and anyone who attaches anything infringes on your product,’” he said, adding, “That was the case in a recent U.S. Supreme Court case, which dealt with a patented method on which potentially millions of antibodies could be based. The (Supreme Court justices) just weren’t going to give that kind of land grab.”
Scola alluded to a Supreme Court ruling from May involving the biotech companies Amgen and Sanofi. Both companies had worked to develop drugs to reduce cholesterol through the manipulation of PCSK9, a protein that interacts with LDL cholesterol. In short, Amgen was claiming protections over the entire genus of antibodies that block or inhibit PCSK9, and the court rejected that.
Scola understands that companies want to get as much as they can out of research. But, as he sees it, there’s a whittling down of the type of protections companies are able to get through intellectual property claims. There’s a higher burden than there once was on patent applicants to get the scope of protections they want.
“The way to adjust to it is to not disclose more than you can actually support, and to save that extra portion for when you have data to support it,” he said.
The strategy in securing patents was once this: Get everything you can in your original application to make sure you’re fully covered. Pigeonholing everything into one patent application isn’t the suggested route now.
Giving an example from his work with a client, Scola described a well-known doctor and inventor at a university finding a unique way of processing human tissue from patients with serious burns. The method spared the cartilage of people by extracting and processing it in a way that didn’t kill the cells, and instead promoted new tissue growth.
“When it came to the patent, and how we were going to talk about how the tissue is being processed, the inventor wanted to put in all of this discussion about it,” he said. “We didn’t have the data at the time to know everything about that process. So, we described it in general terms in the original (patent) application.
“When the university, and the inventor, later had real results, we hadn’t set up that prior art against ourselves (when going for additional patents).”
The issue would be in securing more patents for uses that would be considered obvious in the first patent — they might not be granted if that original application was overly broad.
“That’s why it’s sometimes best to hold back (on an original patent application),” he said. “What you should disclose on those applications is a judgment call. Because you do want (to disclose) enough to get good coverage.”
Good coverage is also needed in a time of intense global business competition.
Count it as one more complexity of the work of an IP attorney today.
“There’s so much at stake,” Scola said.
Frier Levitt is a boutique law firm in Pine Brook that has worked to establish itself as health care law experts. Along the way, it made a name for itself on a specialty within that area …
And it’s one that’s aging well.
Daniel Frier, co-founder of Frier Levitt and chair of the firm’s health care practice, said there’s been more interest than ever in the anti-aging and wellness business, an area the firm considers itself as having a lot of experience advising clients in.
“That might be hormone replacement therapy, weight loss drugs or injectables such as Botox,” he said. “All around the country, we’re seeing entrepreneurialism, folks putting money into that, trying to put a regulatory-compliant structure together and selling these businesses.”
There’s not much explanation needed: These businesses are offering services, drugs or elective procedures that people have been — and are increasingly often — spending money on.
In fact, some so-called “longevity” or “rejuvenation” startups are raking in massive investments. Amazon’s billionaire Jeff Bezos reportedly invested in Altos Labs, a Silicon Valley venture that wants to develop a method of halting or reversing the aging process.
Even if not all businesses in the anti-aging and wellness space have the goal of actually turning back the biological clock, they generally share the need to navigate regulatory and legal issues.
“While it sounds like anti-aging and wellness can be owned by a businessperson — in fact, in most states, it’s considered a health care service,” Frier said. “What that means is the entity providing the service must be owned by a licensed physician.”
That’s true for New Jersey. And it means legal experts have to help these businesses set up business structures that allow investor dollars to flow through entities owned by physicians.
Along with that, there’s also Food and Drug Administration regulations to move clients through, as well as questions that arise around state-specific laws that determine what level of medical practitioner supervision is needed for providing these services.
Frier is going to be talking to entrepreneurs about these topics when he travels next month to a Las Vegas conference that’s known as the world’s largest anti-aging business conference.
“We’ve established a presence in this, especially on the web and through Google searches, in the region,” he said. “But because our market is national, we probably have an equal number of clients in this space outside New York and New Jersey. And it’s growing.”