How to Protect Your Healthcare IP When Collaborating

For healthcare startups, collaboration is often the fastest way to gain expertise, share costs, and accelerate commercialization. But teaming up with another company, a CRO, or a university lab can also expose your intellectual property to risk. Without clear agreements, disputes over ownership or disclosure can derail partnerships and jeopardize future fundraising or exits.

“Each party is coming to the dance with their own IP and knowledge. That’s the whole reason for the collaboration, so you need to have some ground rules,” said Anthony J. Fitzpatrick, Chair of the Patent Litigation Division at Duane Morris. “You don’t want to end up in a situation where everybody’s getting along, everything’s going great, and then one party decides to file a patent application and name themselves as the inventors and the other party finds out they weren’t included 18 months later.”

Cure spoke with Fitzpatrick about the most common pitfalls and the steps healthcare entrepreneurs should take to protect their IP before entering into collaborations. This conversation has been edited for length and clarity.

When collaborating, is it important to clarify ownership of existing IP?

Yes. There are really two pieces to address. First, the pre-existing IP that each party brings to the table. Usually, each side retains ownership of its own IP, but it’s critical to spell out what that IP is so everyone agrees on the baseline. That way, you can clearly separate what’s old from what’s newly developed in the collaboration.

Frequently in the life sciences, you may have situations where parties are collaborating in a way that involves trade secrets of one party. Or you might have a situation where party A has a pharmaceutical or a biologic, and they contract with party B to help develop that. You might also have a material transfer agreement where one party makes some material and then transfers it to the other party. It’s important to figure this all out thoroughly.

What about new IP that develops from the collaboration?

That’s the second piece. You need to decide upfront who will own the new IP, who will have rights to use it, and who will handle things like filing and maintaining patents. It’s not always possible to anticipate every scenario, but the more clarity you have upfront, the fewer disputes you’ll face down the road.

If the collaboration is between a company and, say, a university or CRO, does the contract need language about new IP?

Absolutely. If there’s any chance new IP will be created, the contract should address it. Without that, you might end up with both parties as co-owners of a patent, which legally gives each the full right to exploit it independently. That may not be what either side wants.

Can accidental disclosures cause problems?

Typically, in my experience, parties are pretty good about entering into non-disclosure agreements before they jump into collaborations. But that’s not always the case. Sometimes people jump into relationships and start collaborating before they’ve got an NDA in place.

This occurs more in the academic context, whether it’s at a university or a research institution, where the culture is to publish and present findings quickly to get the knowledge out into the world. Even a conference presentation can impact patentability down the line. That’s why NDAs and clear timing around patent filings are so important.

What should scientists think about before collaborating?

Don’t just dust off a five-year-old form agreement. Circumstances evolve, and a boilerplate contract may not fit. Not infrequently, I see disputes arise because you have a collaboration between two companies or a company and a research institution and the parties have signed an agreement that was developed years earlier. Things evolve and the agreement doesn’t really fully fit the circumstance, but they still go ahead and use it.

It’s better to tailor the agreement to the project. And definitely avoid relying on informal emails; they don’t offer the protection you’ll need if things go south.

Should scientists avoid signing agreements that grant “exclusive rights to all results?”

Usually, yes, but it depends on the context. Every situation is unique, so the key is to make sure the agreement reflects what both parties actually intend.

What if a collaboration breaks down?

That’s when the contract becomes the rulebook. If disputes arise, and they often do once the IP turns out to be valuable, you’ll be glad you invested in a well-drafted agreement at the start.

Any final advice?

I’ve seen several disputes over the years that arise after agreements were signed, and they often are because the development or invention is now more valuable than anticipated--someone wants to commercialize it, one of the parties involved is raising money or has raised money, or is going public.

Treat every collaboration as if it could yield something hugely valuable, because you never know which one will. A vague or outdated contract might feel “good enough” at the time, but years later, when the stakes are high, it’s often the source of costly disputes.