Patent Primer for Medical Devices
Physicians who develop medical device inventions often encounter patent law before they have had reason to think much about intellectual property at all. Terms such as patent rights, patentability, and patent costs are frequently discussed in general terms, but their practical meaning is not always clear, particularly in the context of medical devices. Before considering whether an invention should be protected or how a patent strategy should be structured, it is helpful to understand what a patent actually provides, what is required to obtain one, and what is involved in the process. This section provides a brief overview of these foundational concepts and links to more detailed discussions elsewhere on Bitlaw for readers who wish to explore them in greater depth.
This page is divided into these parts:
Protections Granted by a Patent
Patents are a type of intellectual property. Some types of intellectual property, such as copyright, come into existence automatically. As you soon as you enter your new novel in your word processor, or capture your video image, or even write your software program, you have rights under the Copyright Act to prevent others from copying your works. Patent rights are different, in that you only obtain a patent after having an application for patent protection examined and approved by a national patent office, such as the United States Patent and Trademark Office (USPTO).
The reason patent rights are more difficult to obtain is that a patent provides a much broader form of protection than copyright. Copyright law protects against copying, so a copyright owner generally must show that the accused work was derived from the original expression rather than created independently. Patent law is different. A patent gives its owner the right to exclude others from making, using, selling, offering to sell, or importing the claimed invention, even if those others developed the same invention on their own without any knowledge of the earlier inventor. Because patent rights can reach independent inventors in this way, the law requires examination by a patent office before those rights are granted.
In the context of a medical device invention, an issued patent will prevent device manufacturers from making the invention without permission of the patent owner. The patent will also prevent others from using that device without permission. Thus, if an improvement to a medical device can improve patient outcomes better or cheaper than other devices, then a patent owner should be able to receive reasonably royalties for granting others the right to make or use the device.
When a patent issues, the scope of its ability to exclude others is determined by its claims. If someone makes, sells, uses, or imports a medical device that is covered by the claims of a valid patent, they are liable under the Patent Act for infringement. Unfortunately, the cost for suing someone for patent infringement can be very, very high, frequently costing multiple millions of dollars. The cost can make the idea of enforcing a patent seem out of reach for a small medical device company or an individual physician. However, lawyers are sometimes willing to pursue a patent infringement action on a contingency basis, and entities known as litigation funders are sometimes willing to help fund litigation in exchange for a percentage of any recovery. See our Guidance on What if You Cannot Afford to Enforce Your Patent Rights for more information.
These rights are granted only when the patent office has approved a patent. After the application is filed, one can tell the world that there is a "patent pending" on an invention. No legal rights to exclude others are granted just for filing the application, so the patent pending status does not allow you to stop others from using your invention. However, as explained in our Guidance section on Patent Pending Benefits, filing for patent protection can still help deter competitors, can assist in marketing your products, and can make your company or idea more appealing to potential investors and acquiring companies.
Requirements to Obtain a Patent
Before the patent office will grant a patent application, the office will determine whether the invention meets the general requirements for protection. As explained in more detail in the Bitlaw section on Patent Requirements, inventions are patentable if they are new, useful, non-obvious, and statutory.
The requirement that an invention be new before a patent is granted has two, somewhat separate meanings. The first meaning is that the medical device improvement that is the subject of the patent application cannot have be described in a published document, or have been put into use or offered for sale anywhere in the word before the filing date of the patent application. Thus, if a physician in Japan describes a modification to a medical device in a journal article, no one can file for patent protection on that same invention after the publication data of that article.
The second meaning relates to the activities of the inventor. Section 102 of the Patent Act grants inventors up to one year to file their patent application after they have made their invention public through a publication, public use, or an offer to sell. However, if the patent application is not filed within one year of the inventor's own public disclosure of the invention, the patent application is barred. This is referred to as a "statutory bar," and there is no way to recover the right to file for patent protection after this one year period. For physicians developing an improved medical device, this requirement is especially important as there is frequently a need to test an idea before knowing whether the invention is going to work as expected. During this testing period, it is important to maintain the confidentiality of the invention as much as possible. Non-disclosure agreements, for example, should be used with colleagues participating in the testing and with manufacturers that are requested to manufacture prototypes.
The usefulness requirement means that the patent office will only grant patents on medical devices that have a useful purpose. It is usually sufficient to specify in the patent application how a medical device could be used to satisfy this requirement.
As mentioned above, the new-ness requirement says that if anyone else has made the invention public before the filing date of the patent application, then no patent will be granted. The obviousness requirement effectively adds that the difference between the invention and what has been done before cannot be an obvious difference. Thus, if a competitor has offered a medical imaging apparatus that uses software to create an image on a Linux workstation, a new patent will not be granted on the same apparatus and same programming that functions on a Apple Mac computer. Moving the same software from one computing platform to another would be considered obvious, and the patent office would reject this application.
Typically, a patent examiner at the USPTO will reject a patent application for being obvious by looking at multiple examples of what people were doing before the patent application was filed. These examples are typically previously filed patents and patent applications, and are frequently referred to by patent attorneys as "prior art" or "prior art references." The examiner will note, for example, that the invention in the patent application relates to a catheter with features A, B, and C. While no other catheter ever combined all three features, the examiner may note that one prior art reference shows a catheter with features A & B, while the second prior art reference shows a catheter with features A & C. The examiner may then state that a person of ordinary skill in the art would have found it obvious to combine the two references to know that a catheter will all three features would be possible and beneficial. The examiner would then reject the application and find that the invention does not meet the non-obviousness requirement of Section 103 of the Patent Act.
The last requirement is the statutory subject matter requirement. This requirement, which is actually not spelled out in the statute, states that a patent should not be granted on an invention if it is not the right kind or type of invention. This is true even if the invention is new, useful, and non-obvious, and even if it could save millions of lives and be worth a fortune. This complex issue is frequently referred to as the Section 101 issue, or the non-statutory subject matter issue, and is described in detail elsewhere Bitlaw (see, for example, the Section 101 Index).
Costs for Obtaining a Patent and Conducting a Patent Search
The cost of filing a patent application varies, depending on factors like complexity, attorney fees, and additional expenses. The primary cost is that of hiring a patent attorney to draft your application. The application itself is a dense legal document, one that the Supreme Court had once called among the most complex legal documents to draft with accuracy. Your attorney will be tasked with fully disclosing your invention, designing figures that illustrate your invention along with the description, and drafting claims that are designed to be as broad as possible without being so broad as to be unpatentable. Medical device applications will generally cost between $9,000 and $16,000 to draft, depending upon their complexity. In addition to this cost, the application will require the payment of various filing and issue fees, and an issued patent will incur periodic maintenance fees. For more detailed information these cost, please visit BitLaw's Guidance on patent application costs.
In addition to the costs for filing a patent application, a medical device inventor would frequently be wise to pay for a patentability search. Our firm charges a flat $2,500 to have the search performed and to provide a brief summary of the results. However, not all of our clients choose to have us perform a patentability search. Please see our guidance on such searches to see if a patentability search would make sense for you.
Medical Device Patent Attorney
For physicians encountering patent law for the first time, the process of protecting a medical device invention can feel unfamiliar and opaque. Medical device patents raise issues that differ from those encountered in many other technologies, including how clinical practice translates into patentable subject matter and how incremental improvements are treated under patent law. An attorney with experience in medical devices can help explain what patents can and cannot protect, how the patent process works in practice, and what considerations are most important at an early stage. This type of guidance can provide clarity and context before any decisions are made about whether or how to pursue patent protection.
If you are developing a medical device and are looking for assistance with patent protection, you may wish to contact James Urzedowski. James focuses his practice on patent law with an emphasis on medical devices and related technologies, and he regularly works with physicians and early-stage teams developing new medical innovations.