Getting Started

Developing and maintaining an effective IP strategy is challenging but essential step in preparing to take an innovation to market. References and resources concerning strategies for patentability can be found in the Getting Started section in chapter 4.1. The following steps can be used to develop an overall IP strategy.

Understand the IP Landscape

What to Cover

A key part of assessing how one should define an IP strategy is knowing what patent references exist in the area of invention. Creating an assessment of IP landscape begins with patent searches to identify key patents and patent applications. Patent searches should be performed early in the biodesign innovation process to help an innovator understand the IP landscape and assess freedom to operate in the field. The output from these searches can help shape ways of thinking about the claims for the invention, developing strategies to work around prior art, challenging existing patents, obtaining licenses, or avoiding wasted investment. An explanation of how to perform these searches is included in 4.1 Intellectual Property Basics.Because new IP is published every week, and other prior art is published daily, keeping an IP landscape up-to-date is a constant challenge, but it is extremely important in understanding competitive IP.

Where to Look

Refer back to the resources and references listed in chapter 4.1 for more information.

Validate Freedom to Operate

What to Cover

The goal of an FTO analysis is to find any patent claims from another inventor that are currently in force and that explicitly cover the new invention, a component of it, or methods of making or using it. For any claim that appears to read on a feature of the new device, assess each word and clause of the claim carefully to make certain that it applies completely. Interpret words in the claim in the context of their definitions (and diagrams) in that patent. If you can show that even a single feature or element that is described in the claim, but that is not included in the device, then the device will likely not infringe that claim. If a claim does appear to block the new device, make sure to consult an IP attorney to confirm that there is in fact an FTO issue. If FTO is indeed in jeopardy, conduct brainstorms to see if there are ways that the troublesome feature can be circumvented. If not, consider options for licensing the patent at issue.

Where to Look

Use the USPTO databases, Google Patents, or another search engine. For keywords refer back to information collected through prior art searches and the assessment of the competitive landscape.

Hire IP Counsel

What to Cover

Invest early in hiring an IP attorney or patent agent. This person (or team of people) must have deep, first-hand experience with patent filings—ideally in the domain of the invention as well as with IP strategy and protection.

Where to Look

The best way to identify a qualified IP attorney is through a referral from a trusted source. Network with professionals in the field and ask for assistance in meeting and choosing an IP attorney. Other sources to consider include:

• IP Professional Societies – Associations such as the American Intellectual Property Law Association can be a resource for referrals.
• American Bar Association (ABA) Lawyer Locator – Another resource for finding IP attorneys in different areas of the U.S.
• USPTO Patent Attorneys/Agents Search – A searchable database of contact information for attorneys and agents with licenses to practice before the USPTO.
• University Office of Technology Licensing – If a company or entrepreneur is affiliated with a university, the on-campus office of technology licensing (OTL) should be able to provide information as well as referrals related to IP issues.

Devise Defensive and Offensive IP Strategies

What to Cover

The key to developing defensive and offensive strategies is to maintain an up-to-date understanding of how the technology is evolving within the team (internal monitoring) while continuing to evaluate the technology and IP of competitors (external monitoring).

Where to Look

• Internal – For internal monitoring, it is essential to calendar regular meetings between the technology group and IP counsel to assess any new technical directions that are underway (and how these may be creating new IP and/or moving away from the original coverage).
• External – External monitoring is time consuming and difficult, but critically important. Set up Google alerts for any news items or published IP relevant to the technology. Talk with physicians in the field. If possible, visit hospitals where competitive technologies are being used. Attend medical meetings, making sure to spend time in the exhibit halls, visiting competitors’ booths, attending evening sessions, and being alert to gleaning information in the hallways.

Develop a Comprehensive IP Strategy and Implementation Plan

What to Cover

Begin by specifically outlining what would constitute an ideal patent portfolio for the company. Formalize this vision into a comprehensive IP strategy that clearly lays out what the team needs to do in order to develop this portfolio. Work closely with an IP attorney in these first steps. Create a work plan that outlines the critical milestones for operationalizing the strategy, linking them to other important milestones (e.g., R&D accomplishments, funding needs). Use this strategy and work plan as a guide for continually strengthening the IP portfolio. Revisit the strategy and plan to keep it current. Make adjustments frequently, based on changes in the internal and external environments.

Where to Look

Work together as a team in collaboration with an IP attorney who truly understands the company’s business, strategy and plans for the future, as well as the timing of its operating milestones. Validate the company’s plan with the board of directors and/or other trusted advisors and experts in the field.