Reducing patent risk requires addressing all three powerful figures ruling the intellectual property landscape:

In ancient Rome, the Triumvirate was a group of three powerful figures who ostensibly ruled with equal power. In reality, the Triumvirate was an uneasy alliance formed to maintain power and order. Allegiance to one would not necessarily appease all.

The Triumvirate of Patent Risk includes Patent Prosecution Risk, Patent Value Risk, and Freedom to Operate Risk.

• Patent Prosecution Risk is the risk that a patent applications will be rejected and not issue.
• Patent Value Risk is the risk that issued patents will be recognized and upheld as valid, and that the scope of the patent claims is sufficient to keep out competitors in the US and elsewhere.
• Freedom to Operate Risk is the risk that company’s products and activities infringe the valid patent rights of a third party.

Patent owners often confuse the members of the Triumvirate, and believe if they have addressed one, they have addressed them all. Reducing patent risk requires addressing all three powerful figures ruling the intellectual property landscape.

Analysis of one member of the triumvirate can inform strategy related to the others...

Patent Prosecution Risk

Will your patent application issue in the U.S. and around the world? The back-and-forth between the patent office and the applicant, known as patent prosecution, has an uncertain outcome. The merits of an application are, of course, important. Is the invention new and nonobvious? Did the applicant disclose enough to show possession of the invention and to disclose how to make and use the invention? Is the patent disclosure sufficient to meet the requirements of patent offices throughout the world (e.g., the European Patent Office, China Patent Office)?

But patent prosecution is also a process that involves decisions made by Patent Examiners, Art Units, and Technology Centers at the patent office. Understanding how Examiners make decisions is important. For example, do you know how often your Examiner allows a case after an Examiner Interview? What percentage of the time the Examiner wins an appeal to the Patent Trial and Appeal Board? What your Examiner’s allowance rate is? This information can help you make important strategic decisions during prosecution that may be as important as the substance of your application to the desired outcome — a valid, enforceable, issued patent.

Patent Value Risk

While the patent office has the first say regarding whether a patent is valid and enforceable, they are not the last word. A court has the power to invalidate a patent or limit the scope of the claims in a way that permits a competitor to take market share away. After a patent issues, prior art may come to light that may impact the validity of your patent claims. Changes in the law may impact the validity and enforceability of your patent. Therefore, it is important to periodically evaluate Patent Value Risk to determine the likelihood your patent portfolio can effectively keep out competitors.

Patent owners may have a false sense of security if they carefully evaluate this risk before beginning product development and assume the circumstances have not changed when they are finally on the market.

Freedom To Operate

Patent owners primarily focus on Freedom To Operate risk. This is not surprising given numerous stories of companies hit with patent lawsuits out of the blue that can completely shut them down. In some industries, litigating patents is integrated into the product development and approval process (e.g., pharmaceuticals, biologics). In other industries, pejorative names for patent owners who sue large numbers of defendants have become popular and well-known — so-called patent “trolls.”

However, as with Patent Value Risk, a patent owner cannot assume that obtaining a Freedom To Operate clearance opinion when beginning product development will necessarily be helpful at product launch. Why? First, products frequently change during product development. Design and process changes, for example, can have a significant impact on whether or not the product or service will infringe a patent. Any changes in a product or service should be vetted by patent counsel. Second, patents may emerge after the initial search and analysis has been completed.

Conclusion

Investors and patent owners should carefully consider the Patent Triumvirate throughout the commercial development process and beyond — especially as changes or modifications to products and services are made over time.

Analysis of one member of the triumvirate can inform strategy related to the others. For example, understanding Patent Value Risk can inform patent prosecution strategy to shore up weaknesses. Avoiding Freedom To Operate Risk can result in new inventions that decrease Patent Value Risk.

Keeping these principles in mind will convert a three-headed triumvirate into a tool for enhancing the value of your intellectual property portfolios.

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[Jeremy A. Cubert is a partner at VLP Law Group and is a member of the firm’s Intellectual Property practice group. He writes about strategies to simplify the way inventors and investors evaluate and protect biotechnology and pharmaceutical inventions.]