It was an honor to be invited to speak at the Personalized Medicine World Conference(PMWC2014) on the subject of “Intellectual Property: Ten Things a Personalized Medicine Company Should Know.”
The most important of those ten things takes me back to my studies of evolutionary fitness functions – mathematical constructs intended to show the fitness of phenotypes or strategies as a function of features in the world, and often used to predict their relative success as well as the evolution of the underlying landscape. The IP landscape is just like that—a dynamic system where the IP strategies of today may change the landscape and not work so well tomorrow.
Surviving in such a system requires knowing not only the current landscape, but also anticipating how that landscape may change, and developing IP that works for the landscape of today as well as that of tomorrow.
Here are nine other things a personalized medicine company should know:
Nos. 2 and 3: The U.S. has moved to a first-inventor-to-file system, which changes the incentives to file and introduces certain risks of collaboration. Inventors who do not file promptly for a patent may lose their rights to later inventors who are more expeditious in their filing efforts. And collaborators that have access to information about an invention may, whether intentional or not, file for a patent on those inventions. With proper planning, such situations can be corrected in the newly devised derivation proceedings.
Nos. 4 and 5: The Supreme Court has changed, and may further change, the rules on patents. In its 2012 Mayo v. Prometheus decision, the Court found that certain claims to diagnostic methods were not patent eligible subject matter. Then, in its 2013 Myriad decision, the Court found that naturally occurring DNA sequences are not patent eligible subject matter. The Supreme Court may be changing the rules on three additional patent issues in 2014, including the patent eligibility of computer-implemented methods (Alice Corporation Pty. Ltd. v. CLS Bank International), the potential invalidity of ambiguous claims (Nautilus, Inc. v. Biosig Instruments, Inc.), and liability for induced infringement where multiple parties perform the steps of a method claim (Limelight Networks, Inc. v. Akamai Technologies, Inc.).
No. 6. There are several new procedures for challenging patents, including Post Grant Review (PGR) and Inter Partes Review (IPR). PGR is available for any patent that claims priority to an application filed on or after March 16, 2013, and must be instituted within nine months of the patent’s issuance. Validity can be challenged on any grounds. IPR is available for any patent, and must be instituted more than nine months after the patent’s issuance and within one year of any allegation involving the patent—such as a lawsuit alleging its infringement. A party that institutes a PGR or IPR proceeding will be estopped from later raising any issues that reasonably could have been raised in the proceeding, so be careful.
Nos. 7 and 8. There are viable alternatives to patent protection, and intellectual property can also be shared. Intellectual property can be protected as a trade secret, like coke or the software underlying proprietary computer operating systems. It can be protected with the use of trademarks, which become positively associated with the company’s products. Copyright cannot protect information itself, but it may be a useful tool in protecting software and promotional materials. In addition, both patents and copyright provide a basis for sharing of IP rights, for example, through pooling and/or cross-licensing, which may facilitate growth and development in personalized medicine.
No. 9. The legislative and executive branches are working to institute legislation that would curtail litigation by non-practicing entities (NPEs). Several bills are currently pending. They include provisions that would impose costs of the litigation, such as attorney fees and discovery expenses, on the NPE, and also provide for higher standards of pleading and potential sanctions for abusive litigation.
No. 10. It’s important to hire a smart IP attorney. That person should be someone who knows your technology, business, and goal. That person should also know the protocols and procedures of the PTO, courts, and agencies, as well as the applicable law. And that someone should be willing to work with you and provide timely and excellent service to achieve your goals.