MediPurpose® Blog

Over the past few months, the LinkedIn group discussion that I moderated on the Medical Device Inventors forum yielded some valuable information on best practices in safeguarding medical device IP. Now that ideas have been presented on what to do, let me address for a moment why it is so important to implement these measures. Besides protecting medical device ideas and product designs from theft or misuse, what other undesirable—and costly—circumstances might be avoided?

For those who have never been through a patent dispute, a centimeter of personal experience may equal a kilometer of knowledge for new medical device innovators who are not only unsure about the protections available, but also the immediate and long-term costs if one must ultimately go to court to protect their medical device IP interests.

Here are just a few of the issues that medical device innovators could face if a patent dispute makes it into a public forum:

• Legal Expenses: These are what everyone thinks of first when they hear the word “lawsuit.” Court costs, attorneys’ fees, travel costs to-and-from court proceedings, and expert witness compensation are just a few of the financial burdens associated with being involved in a medical device IP dispute.

• Public Relations: Simply being a party to a lawsuit can be damaging to your standing as a medical device innovator or IP owner, regardless of whether you are a designer or an unintentional infringer. If you have just started building your reputation in the medical device market or establishing a medical product brand, quick work may have to be done to repair any collateral damage and to even save your fledgling startup.

• Relationship Building: There could be temporary or irreparable harm done to your relationships with investors, distributors, manufacturers, strategic partners and customers when they evaluate the uncertainties that a patent dispute could impact their businesses.

• Development/Production/Sales: Even though you are the plaintiff, be prepared for counter suits by the defendant (read Apple vs. Samsung). Cases could result in a court-ordered cessation in development, production or sales that could sideline medical product product advancement for months or even years.

• Management Distraction: Cases may drag on for months and years, taking away valuable management time which could be better used on developing, manufacturing and selling your new medical product.

Although it is important to note that not all patent infringements are malicious, it can be quite costly to both your bottom line and your reputation. For this reason, it is best to shield your medical device IP during each stage of its journey to market. Based upon the results of the LinkedIn discussion, the following represents the offensive and defensive strategies to employ at the most critical stages of your medical product’s lifecycle.

Protect Your Medical Device IP From Inception

To ensure that your new medical product IP is protected from its first stage of development:

• File for both medical device patent and medical product trademark protection.

• Reverse-engineer your medical product: It is best to file for protection for each alternate design or improvement.

• Establish where the medical product will be manufactured, sold and distributed: It is recommended that you file for protection in countries where the cost/benefit ratio is balanced.

• Require non-disclosure agreements (NDA): Obtain these from all investment partners, developers, manufacturers and distributors, as well as any other individuals who will have access to proprietary information.

• Consider IP insurance, balancing the cost versus the protection you’ll get.

• Utilize Google Alerts: Keep track of your own trademark, company name and generic product identification.

• Enforce your rights without an infringement lawsuit: This can be accomplished by a) sending a warning letter to the offender, b) requesting an opinion on patent infringement from independent counsel, or c) filing a complaint with the U.S. International Trade Commission.

• Enforce your rights with an infringement lawsuit: When selecting your legal team, remember that the size of the law firm chosen is not as important as the experience and expertise of the attorneys. If you cannot afford representation, locate counsel who will take a patent case on a contingency basis.

• Negotiate a license and royalty agreement with a patent infringer: Higher royalties charged to an offender can offset their past infringement and keep them out of direct market competition.

Protect Your Medical Device IP From Your Suppliers and Partners

Now that you have a solid idea on paper and you have built some protections around your medical device IP, you are ready to contend with potential issues that could arise as you bring suppliers and partners into your development circle.

To ensure that your medical device IP is protected from misuse by suppliers and partners:

• Select the right partners: Get recommendations or referrals from trusted colleagues or networks.

• Select the right countries in which to do business: Consult with representation that specializes in IP management.

• Research each country’s legal infrastructure: Investigate the protections that are afforded to IP owners.

• Use experienced counsel to draft all agreements.

• Execute non-disclosure agreements (NDA): Require all suppliers and partners with whom you intend to discuss proprietary information to assert their commitment to confidentiality in writing.

• Prevent medical device IP dilution: Ensure that your agreements specifically address all additions made to the original design.

• Control access to information: Divide all proprietary components among several suppliers and limit the number of individuals who have internal or external access to sensitive information.

• Monitor partners’ and competitors’ activities: Subscribe to patent-listing Websites, or pay a firm to monitor for the appearance of similar medical device IP filings.

• Address any infringements swiftly and thoroughly: This will benefit both parties involved.

Protect Your Medical Product in the Marketplace

Once your new medical product is ready for market, you will need a new arsenal of tools to help you stay ahead of infringers and copycats. To ensure that your new product is protected from intentional or unintentional IP infringement or reverse engineering:

• Be the first one to market: Strive to expand the gap between your medical product and similar ones that may follow.

• Expedite regulatory clearancesfor your medical device.

• Develop the market: Make a concerted effort to establish benchmarks in medical product quality and customer service.

• Establish a broad network of medical product distributors: Ensure that your product is inserted into all corners of the market.

• Continue to improve your medical product: Stay abreast of advancing technologies in order to provide your customers with the best, most up-to-date product available.

• Build your brand: Establish your reputation by being consistent with medical product quality. Develop recognition by being persistent with marketing messages.

Knowing about the potential threats that exist in a competitive marketplace is only half of the battle for new medical device inventors. Understanding how to shield your medical device intellectual property is key to facilitating a secure environment for bringing your ideas to fruition. The three stages above highlight critical steps in protecting your medical device IP as your product moves from concept to market.

At MediPurpose, our commitment to medical device innovation stems from our proven success at every level of the medical product development process. We are pleased to provide supplemental information about topics like medical IP protection, in addition to offering more comprehensive support to medical device inventors and innovators. For more information or to submit an idea, please contact us.

Thank you to everyone from the LinkedIn Medical Device Inventors forum that contributed his or her comments and suggestions to this discussion. Your input has helped us to provide support to medical device inventors and innovators.

 

 

 

Tags: Medical Device Innovation, Medical Devices | Medical Products, Medical Device Intellectual Property (IP) Read More

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.’ 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?

Tags: Medical Device Intellectual Property (IP), Medical Product Manufacturing, Medical Devices | Medical Products, Medical Device Innovation, Medical Product Distribution Read More