08
JUN
2017

Medical Device Patents: an Introduction

By Tanner Jones, MS4, University of Nevada, Reno School of Medicine

Interventional Radiology (IR) is a field blooming with innovation and rapid advancements in technique, technology, and equipment. Since it’s early beginnings, IR has established a defining culture to seek out new solutions, improve efficiency, and optimize outcomes. Due to the novelty of the field, angiography supplies in the 50’s and 60’s were rudimentary and often constructed at home as there were no commercial vendors. Pioneers since then have worked to develop new devices. Medical device companies were born due to the increasing complexity of the tools and a need for consistency in manufacturing. While it is an important skill to be able to solve complex problems using the resources available, it is vital for future generations to develop alternative products to aid in navigating such situations with greater ease.

So what do you do if you find yourself daydreaming about a product you believe should be stocked on the shelf? Although there are increased quality standards in today’s product development, not all testing requires clinical/preclinical trials. A creative idea might make a difference in your field and lead to personal satisfaction and recognition. This article will discuss how to patent such ideas and protect the intellectual property rights of the “inventor.”

Starting with the basics:
Intellectual property (patent, trademark, copyright, trade secret), or IP, is an umbrella term that covers the legal rights granted to inventions and creations of the human mind. A patent protects original ideas. It is a fence granted to the inventor giving legal authority to prevent/exclude other individuals or companies from making or using the invention for a set period of time. A patent allows for product development and production in a controlled market without competition. A patent is a financial entity that can be sold, traded, or licensed (loaned). In exchange for the patent, the inventor must share the details of his/her idea with the public. After a patent expires, the product of the inventor’s work can be utilized by others. 1, 2

A product, idea, or improvement can be patented if it is “useful,” “novel,” and “non-obvious.” Sometimes patents are granted to big pioneering breakthroughs and other times they are for creative improvements to an existing product. “Non-obvious” denotes some level of innovation, that the product is not an obvious adjustment or combination of current practice.3

While our current legal and patent system isn’t perfect, the principle behind a patent is to promote the sharing of information and incentivize creativity and innovation. A patent allows the inventor to have a say in how his/her product is utilized while it is under a legal protection. This influences revenue of a company by protecting the market share of those with a patent and consequently may limit expansion into new markets that are patent protected. This market protection is one of the big intangible assets that increases the value of a company. In medical device companies, intangible assets often make up over half of the companies total worth. Considering that the medical device industry generates over $70 billion in sales annually in the United States, the impact of patents to the success/failure of a company is not inconsequential. Patents are a powerful influence on medical device companies and how healthcare is delivered.

So what happens without a patent?

Sharing information is an important part of the Hippocratic Oath. In most cases, widespread sharing of medical information leads to positive changes in the practice of medicine. However, because patents are granted in a “first to file- first to invent” manner, if an inventor shares information about a specific product or procedure idea without proper documentation, it is possible that another party could file for and be awarded a patent on the idea that they didn’t invent. Even when compensation is not important to the inventor, registering the invention without filing a patent application may lessen conflict by preventing the idea from being patented by someone else.

When is it safe to share my idea with others?

Sharing an idea after having filed a patent application offers the greatest protection to the inventor. A complete patent application contains a background as to why the invention is useful, invention summary, drawings, descriptions, claims, and an abstract. After a standard, full-length, nonprovisional, “final,” patent application is sent to the United States Patent and Trademark Office (USPTO), months pass before the application is reviewed and there could be additional years of deliberation between the USPTO and inventor before a patent is granted. The process of communication between the inventor and USPTO is referred to as a “patent prosecution.” Stipulations exist to expedite the process in cases of patent dispute. When the idea is patentable and there are no earlier filed applications for the same idea, a patent will eventually be awarded to the inventor. The backlog of patents in the USPTO determines the length of this process, however, two years of “patent pending,” before becoming “patent protected” is a reasonable estimation.1

Of note, part of the application includes a duty to disclose pertinent material for the patent examiner to review when deciding if an idea is patentable. This information consists of previous medical devices or publications called “prior art.” Even if a patent is awarded, it could be revoked in a patent infringement claim using the defense of “inequitable conduct” if it is determined that the inventor knowingly withheld pertinent information from their patent application which may have compromised the novelty of their idea.4

Often one may choose to file a “provisional” application as a first step before filing a standard, full-length, application. While both applications require the same level of detail in describing the invention, a provisional application is faster to file as it requires less background work. This step secures an earlier “filing date” to the inventor and grants a 12-month window to complete the standard application. Although not required, the inventor may choose during these 12 months to share their idea with others because they would have an earlier filing date compared to any new party if they were to apply for a similar patent. If the standard application is not received within 12 months of the provisional application, then the application is rejected and the inventor may lose the opportunity to patent their invention.5

In the United States, there is some protection to inventors who share their idea publicly without already having a patent application filed. There is a one-year grace period from the day an invention is publicly disclosed, before the patent application is required. Offering to sell your idea or pitching your idea to investors without first having them sign a non-disclosure agreement would constitute public disclosure. If an application, standard or provisional, is not filed within the 12-month grace period, the invention is forfeited into the public domain and can be used or manufactured by anyone.1

US patents are not international. To protect and encourage sharing of information internationally, most countries have contracted together in the Paris Convention. Participating countries grant an inventor a protected 12 months grace period from their original domestic file date to file international patent applications. Countries participating in the Patent Cooperation Treaty (PCT) take an additional step by offering an application that will extend the allowed time to file international patents from 12 months to 30 months. In non-participating countries, any public disclosure without a filed patent application can forfeit the invention into public domain. Because of this increased risk, it is encouraged to file a provisional application early and certainly before presenting at trade shows or soliciting investors.6

Who can I ask for more help?

For most in academics and research, visiting the institution’s technology transfer/commercialization office (TTO/TCO) is usually the first step towards obtaining a patent. Inventors start by filing a record of invention (ROI), which becomes the basis for a provisional patent application. Most institutions have resources for further developing the idea prior to filing and may pay for the cost of the provisional patent. They will also help explore funding, marketing, manufacturing, and licensing options to further develop the idea. In most cases, unless otherwise stated by contract, the university or hospital owns the intellectual property, but the inventor may benefit from royalties or milestones. The distribution of royalties (X% of profit) varies, but is generally subdivided among the inventor, institution, and inventor’s department. In other instances, the inventor might license the technology from the university itself.

Although time consuming, the patent application can be completed without having a technology transfer office or hiring professional assistance. Patent examiners at the USPTO do assist inventors through the process. The cost for the provisional application is typically less than $300. The standard application can range between $1000-$1500 in fees. If additional legal help is desired, there are a variety of options ranging from patent software, patent websites with legal chat support, local non-lawyer advice, and in person meetings with a patent lawyer. Contacting “invention” companies is generally discouraged. Hiring a lawyer will cost between $4k-$10k depending on the complexity of the application and their level of involvement ($200-$400/hr). If trying to enter a competitive market, inventors may want to spend extra money in order to obtain the best possible patent protection.7

Inventions must be developed before they are profitable and useful. Even after obtaining a functional prototype and patent, additional work from many people is needed to bring a product to market.

While lucrative brand name pharmaceuticals under patent protection may come to mind when thinking of patents, it should be acknowledged that the granting of a patent does not have any indication on whether or not the invention will be successful or widely used. Many patents generate less revenue than they cost to obtain. It is a personal decision as to whether or not to pursue a medical device patent. Many physicians work with a medical device company to develop an idea. The dynamics of such partnerships are complex, should only be entered into with caution after obtaining professional legal advice, and must include formal documentation defining the terms regarding the intellectual property of the project. Reiterated from above, if an inventor begins collaboration with others and does not have an active patent pending 12 months after their public disclosure, collaborators have the right to independently develop the invention.

Topics beyond this article include:

FDA approval- class I, II, III, 510(k), clinical trials.

What to do with the patent- sell or license the patent vs business startup.

Funding- seed funding, grants(NIH), venture capital, angel vs super angel investors.

Manufacturing/marketing- need for partnerships; accelerator, incubator, or science and technology park.

 

Special Thanks to Dr. Bhavraj Khalsa for contributions and editing.

 

Citations:

  1. http://euro.ecom.cmu.edu/program/law/08-732/Patents/LegalFAQ.pdf
  2. https://corecopyright.org/2009/12/03/copyright_ip/
  3. https://www.lotempiolaw.com/2010/06/articles/patents/what-is-nonobvious-and-can-be-patented/
  4. http://www.mddionline.com/article/how-510k-submission-can-affect-your-patent
  5. https://www.uspto.gov/patents-getting-started/patent-basics/types-patent-applications/provisional-application-patent
  6. https://www.inovia.com/2013/02/the-paris-convention-versus-the-pct/
  7. http://www.invents.com/how-much-does-a-patent-cost/

 

Related:

http://www.neustel.com/Provisional-Patent-Applications/Refile-Provisional-Patent-Application.aspx

License agreement example: https://www.autm.net/AUTMMain/media/About/Documents/RochesterModelExclusiveLicenseAgreement.pdf

 

Resources as listed from:

Intellectual Property and Technology Transfer

Chris Paschall, Ph.D., CLP, Ohio State University.

Presentation given at SIR 2017. Washington D.C. 3/7/17

 

US Patent and Trademark Office: (www.uspto.gov)

Patent Searching (patft.uspto.gov)

University Tech Transfer (www.autm.net)

IP Handbook (www.iphandbook.org)

Patents (www.patentlyo.com)

Stanford Biodesign (biodesign.stanford.edu)

 

Patent It Yourself by David Pressman (NOLO, 18th Edition)

Profit from your Idea by Richard Stim (NOLO, 8th Edition)

Invention Analysis and Claiming by Ronald Slusky (ABA)

 

673 total views, 1 views today

Leave a Reply