19 Jun How to Protect Medical Product IP from Suppliers and Partners

Last month, I wrote a blog that emerged from a question that I first posed in a LinkedIn discussion forum for members of the Medical Device Inventors group. In that blog, I digested suggestions for what you can do if somebody copies your medical device invention.

Since that time, the conversation has evolved to address other related issues, such as Ian. S.’s question about how to protect medical device IP from medical product suppliers and other partners in the manufacturing and distribution chain.

Coincidentally, I also discovered a SPRING Singapore white paper, Best Practices in Intellectual Property Protection: Are Your Asian Suppliers Protecting Your Interests?

So, as I did last month, I’m summarizing some key points from the LinkedIn discussion and the SPRING white paper.

The Best Defenses

Following the old saying “an ounce of prevention is your best defense” and using some common sense can go a long way in protecting your medical device IP:

• Have IP to protect: Firstly, if you haven’t taken the steps to establish your medical products’ IP, you don’t have anything to protect. Much of what was covered in the IP Protection section of my previous blog provides some crucial considerations related to establishing IP.
• Mitigate risks: Although legal systems are in place to assist in resolving medical product IP disputes, the best defense, according to SPRING, is to create systems that minimize the likelihood of IP being stolen. As mentioned in my previous blog, once IP is infringed, it can be very expensive to resolve matters.

Select the Right Partners in the Right Countries

It’s very difficult and often economically impossible to not outsource any part of your medical product’s manufacturing or distribution. But while having partners in some countries may yield economic advantages, this might expose you to greater IP infringement risk. So how do you select the right partners in the right countries?

• Consider a country’s legal infrastructure and protections: Select countries that are “reinforced by a highly ethical culture,” are signatories to key international IP protection conventions and practice an effective legal system.
• Seek expert advice: Another great point from SPRING is to find corporate counsel or a firm specializing in IP management in the selected region.
• Get recommendations and referrals: Trust is easy to lose and hard to get, so it’s worth the effort to seek trusted partners — whether through your own networks or by reaching out to LinkedIn members such as Ian S. who can vouch for “having a supplier for many years that would never consider ‘screwing me over.'”

Execute Effective Agreements

Once you’ve established your medical product IP and have found the right partners, ensure that the agreements that bind you go as far as they can to protect you.

• Execute non-disclosure agreements (NDA): According to SPRING, this should be done with ALL medical product suppliers before discussing ANY proprietary information. And don’t worry about offending them — if they have passed the recommendations and referral litmus tests, they know that NDAs are an SOP (standard operating procedure)
• Use experienced attorneys to draft agreements: Don’t just copy an NDA or manufacturing agreement that somebody else once had you sign or something that you downloaded from the Internet, especially if you are dealing with international partners. Use an attorney with experience in manufacturing practices in the countries you’ve selected.
• Clarify agreements to prevent IP dilution: As Nick W. pointed out, it can become very difficult to maintain IP identity and value, especially if a prototype gets additional development from manufacturers and partners. What started off as “your” unique and novel IP can ultimately end up as “their” IP if too much creative license is allowed.

Control Access to Key Information

• Diversify the information: As Jory T. suggested, medical device IP owners should “split the product patent, know-how, core software/firmware (if any), market control, key-component supplier agreement, and module product design with multiple suppliers.”
• Diversify access to the information: As with the different departments in your company, not every partner needs to know what every other partner knows in order to maintain an efficient, productive workflow. SPRING encourages medical product IP owners to both control internal access to sensitive documents and ensure that all external persons and suppliers handling sensitive information understand their responsibility to protect that information by restricting access only to those who need to know.

Monitor Partners and Competitors

• Keep an eye on patent filings: Just because you have a medical device patent, it doesn’t mean that everybody is aware of it, especially if others are filing medical device patents that unintentionally infringe upon yours, said Nick W. The sooner you discover such filings, the better.

Andy. R. mentioned two ways to monitor medical product patent filings. One is to subscribe to Websites such as Free Patents Online.com, or to even hire a search firm to monitor patent filings for you.

De-escalate Problems

Whether they occur intentionally or not, medical device IP infringements are unavoidable in the medical product industry. When preventative measures aren’t enough, Nick W. advised, “A key part of effective IP enforcement is diligence and speed. Help your infringers to cave in gracefully and cheaply. Save them money and bask in their gratitude.”

As before, these tips and suggestions are anything but an exhaustive list. Can you suggest others? How do you protect your medical product IP? Has your IP ever been infringed? How did you handle it? What did you learn?