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6 August 2020BiotechnologyRory O'Neill

LSPN Connect: micro-managing with Pendulum Therapeutics

With any rapidly-developing field, particularly the life sciences, the importance of a coherent IP strategy cannot be ignored.

That’s why  Pendulum Therapeutics recruited Ypsita Demunshi as its first in-house patent attorney in 2018. Pendulum is a biotechnology start-up focused on developing healthcare products that target the human microbiome.

Speaking to  LSPN Connect yesterday, August 5, Demunshi described how IP is closely interlinked with the scientific arm of the company. “We’re involved in all lab meetings,” she said, keeping on top of scientific developments as she develops the company’s patent strategy.

But it’s a small company and Demunshi regularly calls on outside counsel in various jurisdictions. “Having an attorney in-house definitely makes a difference … but this can’t be a one-man show, I need my army of people to help,” she said.

How does she go about selecting who to work with, particularly in foreign jurisdictions? “I keep my options open,” she said, continuing: “It’s a huge decision even to say we will file patents abroad.”

The process is a combination of referrals from trusted US counsel and careful searching on Demunshi’s part. Ultimately, these are business decisions, as well as legal ones. Her job is to “present options to management”.

This is particularly true when budgets are tighter than ever. “To save costs, I draft everything in-house,” Demunshi said. “It’s a management decision at that point whether they want me to file it with my registration number, or whether they want to involve outside counsel”.

Working with outside counsel, especially at renowned firms, can have its advantages: “They have partners with lots of experiences, and it brings in another advantage to have their name on the patent application—it definitely gives it some weight,” she said.

Demunshi continued: “It’s entirely based on foresight—how valuable is this patent going to be to us, and what names do we want to be associated with this patent application and the subsequent grant?”

Patent eligibility

This is how the business organises its patent prosecution, but what are the actual legal issues facing a company in Pendulum’s field? As with many sectors in the life sciences, it’s patent eligibility.

US patent law says that “naturally occurring” processes are not eligible for protection—it has to be something “significantly more”.

But what has not been clearly defined is what is “significantly more” than what occurs in nature, and where the threshold for an inventive step is.

This is particularly pressing for companies developing microbiome products, Demunshi said, since these products are essentially a “combination of bugs”.

To date, Pendulum has nine granted patents, with a “lot of pending applications worldwide”. Overall, Demunshi said, examiners have been “friendly” to the company’s innovations.

While greater clarity on patent eligibility would be welcome for virtually all working in the life sciences industry, the company has still enjoyed plenty of success with its IP strategy to date.

LSPN Connect is the membership programme for the Life Sciences—to watch on this session and for more information on joining, visit  www.lspnconnect.com

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