Educational Research Retreat: When to Publish, Patent or Protect a “Trade Secret” P. Gunnar Brolinson, DO, FAOASM, FACOFP, FAAFP Vice Provost for Research Discipline Chair for Sports Medicine Team Physician Virginia Tech Director of Primary Care Sports Medicine Fellowship

What is Intellectual Property? Article I, Section 8 “The Congress shall have power to…promote the progress of science and useful arts, by securing for a limited time to authors and inventors the exclusive right to their respective writings and discoveries”

Intellectual Property Distinct from tangible items…. ▪ More abstract than other types of property ▪ Products of the mind ▪ Types: Patents (Title 35, U.S. Code) Trademarks (Title 37, U.S. Code) Copyrights (Title 17, U.S. Code) Trade Secrets (State law)

Intellectual Property ▪ Patents – inventions of functional and ornamental design design, plant and utility provisional applications ▪ Trademarks – identifies source or origin of product words, brand names, slogans, graphics/logos e.g., Nike logo, “We bring good things to life”, VIOXX should seek federal registration (®) use ™ for non-registered marks

Intellectual Property ▪ Copyrights – literary and artistic impressions or arrangement protects medium from copying by others identifies author’s specific expression e.g., articles, videos, computer programs protection is automatic; use © with year and name of owner ▪ Trade Secret – protection from unfair appropriation of information any information (e.g., software, formulas) that: provides competitive advantage; not available to public; and treated as confidential

Patents ▪ Utility demonstrated use or proposed use one of “ordinary skill in the art” would believe ▪ Novelty not fully described in one patent or publication > 1 year before you filed (the “prior art”) ▪ Non-obviousness whether one skilled in the art at the time of the invention would have had a rational basis to combine prior art to reach the claimed invention

Patents ▪ Enablement one of ordinary skill can carry out the invention without “undue experimentation” ▪ Best mode provides best known way of making and using the invention when application was filed

Patents Patents are not technical publications, they are legal documents…

US Patent 5,433,036 Method exercising a cat

US Patent 5,255,452 Method and means for creating anti-gravity illusion

Patenting Nonprovisional Application Filed: $7-10K US Patent Issued Provisional Application Filed: $2-4K Office Action #1 Received: Response Filed: $2-4K Notice of Allowance Received: Issue Fee Paid: $2K Continuation Application Filed (?) Office Action #2 Received: Response Filed: $2-4K National Phase Applications Filed: $25-30K Regionalized In EP PCT International Application Filed $4-5K National Phase 1 st Office Action Received: Response Filed $3-4K Notice of Allowance Received: Issue Fee Paid: $4K National Phase 2 nd Office Action Received: Response Filed $3-4K Foreign Patent Issued 12 Months20-30 Months6 Months 3 Months 18 Months Months12 Months 6 Months EP, JP, AU, CA

Two Different and Conflicting ways to protect IP and Technology Patent Protection –The inventor strikes a bargain with the government for a limited period of exclusivity in exchange for full disclosure of the idea or technology Trade Secret –Can protect any form of confidential information that has business value –Trade Secret protection can last forever as long as the IP owner maintains confidentiality Can only prevent the use of the information if someone has misappropriated it “Reverse Engineering” is allowed So must carefully consider which way to go….

Some Cases are Clear Cut…some not so much The US FDA requires full disclosure on any new medication brought to market so the “trade secret” approach is not an option. Variables to consider include the length of time and difficulty a competitor would have in “reverse engineering” your idea Patent protection and trade secret protection have two very different statutory frameworks

Is there a “defensive” strategy? For scientists and technologists the defensive strategy is to publish in trade journals Inventions must have these characteristics –Utility –Novelty –Non-obviousness The invention or IP must be sufficiently different from what is found in the literature, in public use or for sale A “defensive” publication establishes “prior art” –Potentially disabling a patent or preventing it from issuing

Publish or Protect…the thought process Is public disclosure necessary? Is the idea easy to reverse engineer or discover independently? Is the technology area evolving rapidly? Is this a new area of technology? Are you potentially interested in licensing the invention? Do the potential market revenues out weigh the costs associated with patent protection?

General Approach….

VCOM Process IDEA DISCLOSURE FORM EVALUATION ACTION PLAN Potential Protection? Requires further research Marketing/Licensing Abandon

Cleveland Clinic Healthcare Innovation Alliance The Healthcare Innovation Alliance is a program to manage the innovation and commercialization functions for hospital systems, academic institutions and corporate partners across the country. We leverage the size and capabilities of the collective Alliance to improve the visibility of innovative products and to expedite commercialization.

IP Policy 1. Inventor discloses Ideas and assigns to VCOM 2. IP Office manages protection and marketing 3. License revenues split 50/50 between Inventor(s) and VCOM The IP Office will do all the heavy lifting

In Conclusion… Working together, we can make sure VCOM innovations are managed so they have the best chance to make a difference in art of teaching or the practice of medicine!