The Anatomy of Patents and Intellectual Property

Summary:

Medicine is ripe for new ideas, and plastic surgeons are some of the most capable innovators. Some may choose to pursue the development and entrepreneurship of their idea. In these cases, obtaining a form of intellectual property such as a patent, copyright, or trademark can be a wise decision. Doing so can provide the inventor with the exclusive and legal right to their invention. Unfortunately, the process to acquire these forms of intellectual property, especially patents, can be a confusing and time-consuming process. This article provides a primer on patents and intellectual property for the aspiring inventor.

Takeaways

Question: What are the critical considerations and steps for plastic surgeons to secure patents and intellectual property rights?

Findings: The article provides a comprehensive overview of intellectual property. It covers the types of patents relevant to medical professionals, the process for applying, and the importance of novelty and documentation.

Meaning: Understanding the importance of intellectual property, particularly patents, enables medical innovators to safeguard and bring their inventions to market successfully, fostering both professional growth and advancements in healthcare.

INTRODUCTION

In the world of entrepreneurship, collaboration, and technology, surgeons may find themselves with an invention, software, or product of their own creation. The next steps of production, marketing, and distribution are likely unfamiliar after the generation of this initial idea. However, before any of these actions should be pursued, one of the first steps to any novel idea is to consider patenting, the process of claiming and protecting your novel idea as your own. This article will highlight the purpose and terminology of a patent, a brief history of patent law, the process of turning an idea into a patent, and the marketing of a patent for practical use by prospective surgeon-innovators (Fig. 1).

Fig. 1.

Understanding patents and intellectual property: from concept to commercialization.

WHAT IS A PATENT?

A patent grants the exclusive right for an invention. As a form of intellectual property, a patent provides legal protection to its inventor to decide who may or may not use the invention for the period while it is protected. In other words, commercialization, distribution, or usage of the patented invention cannot occur without the owner’s permission. A patent also grants the owner the ability to sell the rights to the invention. If a third-party copies a patented idea, the patent owner can pursue litigation against the third party for infringement. The US Patent and Trademark Office (USPTO) is responsible for approving and managing patents.

TYPES OF PATENTS

There are 3 types of patents: utility, design, and plant. Surgeons are likely to pursue either a utility or design patent; a plant patent is for new varieties of plants and therefore likely of less value to surgeons. A utility patent is for a new or improved, useful product, process, machine, or technology, and it is the most common type of patent.¹ Once approved, a utility patent provides the patent holder with 20 years of full ownership rights.²

DISTINGUISHING PATENTS FROM OTHER FORMS OF INTELLECTUAL PROPERTY

Patents differ from copyrights, trademarks, and trade secrets, which are all also forms of intellectual property. Although patents protect tangible inventions, copyrights protect the expression of ideas. Examples of such expression include literature, music, art, and pictorial works.³ The purpose of copyright law is to provide financial incentives for creativity that benefits the public.⁴ In the United States, a copyright lasts much longer than a patent with a duration of the creator’s lifetime plus 70 years.⁵ Individuals can apply to register a copyright through the US Copyright Office for a fee.⁴ A standard application is $65.⁶

Trademarks are a tool that companies use to identify their products with the purpose of promoting its reputation. The trademark is intended to simultaneously prevent other companies from copying their product or advertising that a lower-quality product is associated with a different manufacturer’s name.⁷ A company may license their trademark to other businesses, which, if the trademark is recognizable, could serve as beneficial advertising. Like patents, they are filed with the USPTO. The cost to file a trademark starts at $250.⁸ Trademarks can last forever as long as the trademark is regularly filed with evidence of use.⁹ A trade secret is considered economically valuable information that is not available publicly. Trade secrets may be more effective in slowing down competition but have practically no protection once they are publicly disclosed, which can inadvertently happen.¹⁰ Even though trade secrets are not applied for, granted, or registered, laws exist to provide legal protection for trade secret owners.¹¹ Table 1 summarizes the different forms of intellectual property.

Table 1.

Different Types of Intellectual Property

	Patent	Trademark	Copyright	Trade Secret
Protection purpose	Tangible inventions	Unique symbol or word(s) representing a business	Expression of ideas	Valuable information not publicly known
Application fee*	$300 for provisional; $220 for nonprovisional	$250	$65	n/a
Duration of Protection	20 y	Forever, if maintained (requires regular renewal with USPTO)	Creator’s lifetime plus 70 y	Forever, if maintained

^*Not representative of total fees associated with intellectual property type (excludes, ie, issue, extension, renewal fees, or fines).

A BRIEF HISTORY OF PATENT LAW

Patent law in the United States has been active since 1790, when Congress established the Patent Board for reviewing and issuing patents. The first US patent was granted the same year to Samuel Hopkins for a process of making potash, an ingredient used in fertilizer.¹² Throughout the late 18th and early to mid-19th centuries, patent law was refined to emphasize the necessity of novelty in inventions receiving patents and detail the timeline for filing and protection. In 1880, Thomas Edison received patent no. 223,898 for the invention of the “electric lamp,” or lightbulb—just one of the 1093 patented inventions he created.¹³ In 1959, Jack Kilby and Texas Instruments filed a patent for the first microchip. Robert Noyce and Fairchild Semiconductor Corporation also filed for a similar patent just four months later, albeit with greater detail in their application regarding the manufacturing process, thus differentiating his application from Kilby’s. Although Kilby filed first, Noyce was awarded a patent first.¹⁴ Kilby was also eventually granted a patent, resulting in a decade-long legal battle. Ultimately, both decided to cross-license each other’s patents and share credit for the invention of the microchip.¹⁵ It was not until 2011 that the America Invents Act implemented the standard of “first inventor to file” for distributing patents.¹²

Plastic surgery is a field full of innovators. Notable patents in plastic surgery include the microsurgery suture needle, hybrid arch bars, and the wound vacuum assisted closure device. In 1971, Werner P. Schulz, working with Dr. Harry Buncke, received patent no. 3,556,953 for the microsurgery suture needle and its method of manufacture, which were critical to the development of the new specialty.^16,17 In 1997, Drs. Louis Argenta and Michael Moryk received patent no. 5,636,643 for their negative pressure device, also known as the wound vac, which has changed the course of wound care.^18,19 In 2012, Dr. Jeffrey Marcus received patent no. 8,118,850 for hybrid arch bars, which have been safer for surgeon use and have provided patients with a cost-beneficial alternative to traditional Erich arch bars (Table 2).^20,22,23 New ideas and their associated patents play an important role in advancing the future of plastic surgery.

Table 2.

Examples of Significant Patented Inventions in Plastic Surgery

Invention	Inventor(s)	Patent No.	Year	Description of Invention
Microsurgery suture needle	Werner P. Schulz Dr. Harry Buncke	3,556,953	1971	Suture needle with cross-sectional diameters of 5–8 µm19
Wound vacuum assisted closure	Dr. Louis Argenta Dr. Michael Morykwas	5,636,643	1997	Vacuum pump to apply controlled negative pressure under a sealed cover with a porous screen. Facilitates tissue migration and closure of various wounds20
Hybrid arch bars	Dr. Jeffrey Marcus	8,118,850	2012	Arch bar for intermaxillary fixation with adjustable attachment loops and hooks. Helps facilitate secure attachment to the jaw or prosthetic21

TAKING AN IDEA TO PATENT

Documenting an Invention

The first step in pursuing a patent is filling out an invention disclosure report form. This form serves as a useful outline for intellectual property professionals to understand the purpose, ownership, and novelty of an invention, in detail.²¹ Typically, academic institution patent offices or patent attorneys will require an invention disclosure report form to assist them with determining an invention’s patentability.^21,24 Importantly, inventors have one year after public disclosure of an invention—such as via a poster, oral presentation, or published article—to have filed for a patent. After 1 year, the invention is no longer patentable and will be considered “prior art.”²⁴

Assessing for Novelty

An invention must meet four conditions for it to be considered for a patent: (1) able to be used (ie, it cannot just be a theory), (2) has clear instructions on production and use, (3) is a new or “novel” idea (ie, something not done before), and (4) is “not obvious,” as related to a change to something already invented.³ Although the search through “prior art,” or previously patented ideas, can be done manually, third parties can be used for a fee. Google and the USPTO both have patent databases individuals can use to find potentially similar, preexisting patents.^25,26 Assessing for novelty should give a comprehensive understanding of where one’s invention stands in the industry.²⁷

Structure of a Patent

The actual structure of a patent consists of several components, with four major sections. The patent starts with a cover page, which includes the title of the invention, an abstract describing the invention, and a patent number to provide a unique identifier.²⁸ The cover page will also include an International Patent Class, which is a classification system that was established in 1971 to categorize patents based on different areas of technology to simplify patent searching.^28,29 Following the cover page, there is a drawing sheet, which visually depicts the invention. This is typically a black and white image documenting the features that are detailed in the claims section.²⁸ After the claims section is the description, which provides a summary of the invention, a background illustrating the need for the device, and any related applications—for example, provisional patent applications.²⁸ Finally, is the claims section, which describes the scope of the patent in a very detailed manner. This is considered to be the most important section of the patent and affords legalistic protection with respect to specific aspects of an invention.²⁸

The Patent Application

For a utility patent, the process begins by submitting a patent application. There are two types of applications for a utility patent: provisional and nonprovisional. A provisional utility application provides inventors with legal protection of their idea for 12 months from date of application filing, provided that they are eventually issued a formal patent. Once an individual submits a provisional application, they can label their invention as “patent pending.” However, an individual cannot sue for any instances of patent infringement during these 12 months or the time their invention has “patent pending” status until they hold a nonprovisional patent.³⁰ The provisional application is meant to provide inventors with the opportunity to lay claim to their idea first, as well as time to test and refine their concept and prepare their nonprovisional application, which must be submitted by the time their provisional application protection ends.³¹

Submitting a provisional application is relatively inexpensive and quick. The standard cost is $300, although discounts exist for applicants who qualify as either small or micro entities.⁸ On the other hand, a nonprovisional utility application is a more complicated and expensive process, but it is the formal way to receive an actual patent. Nonprovisional applications start at $220; small and micro entity discounts are available.⁸ Individuals can choose to submit a nonprovisional application without submitting a prior provisional application. Once the application is submitted, the invention receives “patent pending” status. It should be noted that other costs, including legal fees, can make a patent application more expensive than just the application fee.

Once all documents are gathered, patents can be submitted online to the USPTO. The current average wait time for a decision or “first office action” is 20 months.³² If an application is rejected, one can request reconsideration with a thorough response to all examiner comments. Second office action rejections can still be appealed, but with more restrictions. If no response is received from the applicant by the set deadline, the application will be considered abandoned after six months from the mailing of the final rejection.³³

Patent Approval and Issue

If the USPTO determines an application to justify a patent, a patent will be issued. The issue fee starts at $740 for design patents going up to $1200 for utility patents. Again, discounts exist for small or microentities. The issued patent only provides rights to an invention in the United States; if an inventor wishes to patent their invention in other countries, they will need to file in the country of interest.³³ For utility patents, the USPTO requires maintenance fees paid at years 3.5 ($2000), 7.5 ($3760), and 11.5 ($7700).⁸ Design patents, however, do not require maintenance fees. Figure 2 summarizes the process of obtaining a patent.

Fig. 2.

Patent process.

THE ROLE OF LEGAL ASSISTANCE

For the busy surgeon, enlisting third party help can be beneficial to complete the steps necessary to file for and manage a patent. Some law firms have patent attorneys, who can offer expert advice on navigating the complexities of patenting, licensing, due diligence, and/or patent protection for a fee. The USPTO has a searchable registry of qualified patent attorneys available online.³⁴ For academic surgeons, institutions of higher education often have offices of research translation and commercialization who can assist. It is important for individuals interested in pursuing this route to be aware of the rights they will retain if they engage this type of help. Although some institutions will file on your behalf, it is also reasonable to inquire if they provide support for self-filing. Companies also exist to help individuals patent, which can offer services similar to law firms and academic institutions. For inventors who would like to try pursuing a patent without assistance, there are free resources available to learn more from the USPTO and the Michelson Institute for Intellectual Property.^35,36 The USPTO’s Law School Clinic Program and Patent Pro Bono Program offer services for inventors with limited resources.

PROFITING FROM A PATENT

There are several ways to earn a profit from a patented invention. Inventors may elect to use their patented invention to start a company and produce earnings from the traditional sale of their invention to consumers. In contrast, inventors may rather pursue licensing their patent to an already established firm, allowing the business to obtain the right to use the invention claimed in the patent.³⁷ This transaction allows a company to acquire a new technology and the inventor is often paid a royalty based on the gross sale of the invention, in addition to the payment for the license.³⁷ Alternatively, an inventor has the option to simply sell their patent. The inventor will not receive any royalties from the use or sale of their invention to customers in this process. Companies may be wary of purchasing patents for devices that have not yet been shown to be profitable, but the sale of a patent can be a mechanism for inventors to quickly profit from their patent.³⁸

LIMITATIONS OF A PATENT

Although patents can be used for a broad range of inventions, there are limitations to what can be patented. Although surgical devices and medicines can be patented, methods of medical treatment or surgical techniques for the benefit of humans or animals cannot be patented.³⁹ In addition, laws of nature, natural phenomena, and mathematical equations cannot be patented. Moreover, abstract ideas, suggestions, or inventions related to nuclear and atomic weapons cannot be patented.^3,39 Patents also cannot be used for what is considered common knowledge, which was the basis for a legal battle which India won over an American university attempting to patent turmeric as a wound healing agent, given that turmeric has been used in Indian wound care for generations.^40,41

CONCLUSIONS

Patents, copyrights, and trademarks are all forms of intellectual property that allow an inventor to be legally credited for their work and to have the exclusive right to pursue commercialization. The process for obtaining any form of intellectual property, especially patents, can be complex, although a variety of free and paid resources exist to help.

DISCLOSURE

The authors have no financial interest to declare in relation to the content of this article.