Overview of Intellectual Property Protections

If you’re here it’s because you are an innovator. You’re exploring how to solve meaningful medical problems with your ideas and projects. That means you are producing Intellectual Property (IP). These are valuable assets that can not only help you have Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant application success, but general commercial success as well. In this post, we’ll apply our years of experience working on SBIR/STTR grant applications to start navigating the overwhelming landscape of Intellectual Property protections.

Understanding Intellectual Property

Intellectual property (IP) can be defined as any creation of the mind that is expressed in some form. It includes inventions, literary and artistic works, designs, symbols, and names used in commerce. These can be incredibly valuable assets for businesses and individuals alike. The purpose of IP law is to provide legal protection to those who have created or own it.

As an applicant for an SBIR/STTR grant, you are mostly likely going to be dealing with patents. Patents protect inventors who come up with novel, useful and non-obvious ideas from having them copied by competitors for a set amount time - usually 20 years from date patent was filed in most countries around world. Patent owners have exclusive legal right over how they make use their invention as well prohibiting others from using it without authorization. Patents need to be registered with relevant government agency before they can receive full protection under IP law yet once registered typically remain valid for up 20 years.

Other forms of IP include trademarks, copyrights, and trade secrets. Trademarks protect words or logos used to identify a product or service; copyrights protect original works such as books or music; trade secrets are confidential information that gives a business a competitive advantage over its competitors.

Developing an IP Strategy

SBIR/STTR applications do not require that you already have patents or other IP in place, but you will need to demonstrate that you have an IP strategy and ideally a patent application filed (provisional or non-provisional). This will be particularly important for projects applying for Phase II SBIR/STTR grants.

1. Build a Defensible Patent Portfolio

At the heart of any successful IP strategy lies a comprehensive patent portfolio. Start by clearly defining and patenting the unique features of your medical devices. Prioritize strategic patents that offer broad protection, establishing formidable barriers to entry for potential competitors. Think of this as a strategic arsenal of intellectual property rights that serves as protective tools in the competitive business landscape. Building a robust patent portfolio is akin to fortifying your position in the market by securing exclusive rights to your innovations. Although these costs are not eligible to be covered by direct or indirect costs in your application budget, they are something you would be able to cover through the fee category once you have been awarded a SBIR/STTR grant.

Patentability

Part of your strategy will also include having a general understanding of what makes your innovation eligible for a patent. This will be something you will want to articulate in your application as well as clearly understanding the nature of your IP innovation.

Novelty:

Every patentable invention must possess a unique quality that meaningfully sets it apart from existing inventions and concepts.

Non-Obviousness:

Beyond novelty, an invention must also demonstrate a non-obvious quality. This means it shouldn't be an evident progression to someone with ordinary skill in the relevant field. To be eligible for a patent your would be adding an additional layer of ingenuity.

Useful or Industrial Applicability:

Practicality is key. A patentable invention must have a real-world application or industrial purpose. It should offer tangible benefits that are clearly articulated in the patent application.

Enablement:

The patent application should empower others in the field to replicate and use the invention. This requirement ensures that inventors disclose sufficient information to enable a skilled practitioner to understand and apply the innovation.

Written Description and Best Mode:

A thorough written description should accompany the patent application to guide readers through the intricacies of the invention. Additionally, the best mode of carrying out the invention must be disclosed.

Statutory Subject Matter:

Aligning statutory subject matter requirements is vital. In jurisdictions like the United States, the invention must fall into recognized categories such as processes, machines, manufactures, or compositions of matter.

2. Ensure Freedom-to-Operate (FTO)

Conducting a thorough Freedom-to-Operate analysis is imperative. This involves assessing the patent landscape to ensure your medical device doesn't inadvertently infringe on existing patents. An FTO analysis involves a thorough examination of existing patents and potential intellectual property obstacles that could hinder a company's ability to bring a product or technology to market. This analysis helps businesses identify and understand any third-party patents that might pose a risk of infringement.

 If risks are identified, consider licensing agreements or design modifications to navigate potential conflicts.

4. Fostering an IP-Aware Culture

Educate your team about the importance of IP and its alignment with the company's overall strategy. Involve employees in the innovation process, encouraging a proactive approach to identifying patentable inventions.

Additional Resources

Utilizing online resources can be a great way to get more information about intellectual property and its protections. Websites such as the United States Patent and Trademark Office site contain valuable resources related to IP law. Additionally, consulting with an attorney who specializes in intellectual property rights is another way to ensure that your rights are properly protected.

Blue Haven Grant Consultants has over a decade of experience working on SBIR/STTR grant applications. This experience includes working with companies that are developing IP or already hold IP, so we know how complex these questions and issues can be! When you use the BHGC Advantage, you’ll get personalized support that will help you understand how your IP strategy interacts with the other elements of your company, project, and grant application. We look forward to working with you, so schedule a free consultation!

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AAG Unplugged: Fundamentals of the NIH Grants Process