Recent Developments in Medical Device Patent and FDA Law

Patent litigation in the medical device area continues. Along with pharmaceutical patent litigation, medical device patent litigation continues to provide important rulings and case law precedent. Because of the large-scale investment needed to bring medical devices to the market, device sponsors need certainty about the law and its application to ensure a return on the investment. Unlike pharmaceuticals in which the patent portfolio may include claims to the bare-naked compound/molecule and to formulations using that compound, medical device patent claims are usually related to the mechanical aspects of the invention. That is, most medical device claims are to parts and pieces put together into a patent claim. For example, an implantable pacemaker may include claims to wires, power supply, leads, attachments, etc. These tend to be medical grade but off the shelf parts or pieces. Medical device patents can also be claimed as method steps. 

In this article we describe a few areas where medical device patent law is implicated. 

Means Plus Function Claims

Means plus function claim structure is often used in medical devices. Under “old” patent law, means plus function claims were governed under old Section 112, paragraph 6. After the AIA, it is now governed under Section 112(f). It states: 

(f) Element in Claim for a Combination.—

An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

As can be seen from the statute’s plain language, the means plus function claim is in the form of a combination of elements, it is expressed as a means or step for performing a specified function, but lacks specific structural features in the claim itself. The claim construction process is to determine the scope of the means plus function claim. That entails construing the specified function recited and the means for doing so, including corresponding structures. The devil is in the details of course. For example, suppose the invention is to a hand-held imaging probe that collects electrical impulses on the patient’s skin and sonar of the deeper tissue, analyzes the data received to correlate the electrical impulses and sonar, and then displays the resulting image of what lies beneath the skin. The doctor can then “see” on the display what is there. The means plus function analysis may involve whether the structural means includes just the tip of the probe itself (and not any hand-held portion like the handle), the hand-held probe (but not any wiring connected to the display unit), or to just the display unit. In another example, if the invention is claimed as a means for stapling an incision or closing an opening, would the claim construction focus narrowly on the actual staple and the staple driver, or to the unit more broadly speaking. 

Practical Tip: In means plus function, it is important that the patent drafter understand how a competitor may seek to narrow a claim construction so as to avoid infringement later on. The drafter should incorporate as much needed details in the specification to correlate the functions and the means for doing so. Also, drafters should also consider adding more traditional claim sets to the elements in the parts/pieces style. 

Safe Harbor Exemption Under Section 271(e)(1)

Congress enacted the Hatch Waxman Act in 1984. It provided for the modern structure of brand and generic drug development. It also provided for the so-called “Bolar” exemption that legislatively overruled the pre-1984 Roche v. Bolar case. Briefly, before the Hatch Waxman Act, competitor companies could be sued for patent infringement for any development activities undertaken during the life a certain patent. Many times, the developers were engaging in initial prototype development, R&D, and clinical work to get ready for FDA approval and commercial marketing once the relevant patent expired. The patentees sued for infringement because that initial work often was in fact, infringing the patent. The HW Act created a new safe harbor exemption that allowed for certain activities to be undertaken without fear of patent infringement suits. This safe harbor is enacted in Section 271(e)(1), which states:

  1. It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

First, though the plain text of the statute seems to apply just to drugs and not devices, the Supreme Court in Eli Lilly and Co. v. Medtronic, Inc., 496 U.S. 661, 679 (1990) ruled that the safe harbor does apply to medical devices. Second, the safe harbor does not just apply to medical devices undergoing the PMA process, but it also applies to devices undergoing the 510(k) process. Third, much of the focus on the scope of the exemption involves the language, “…solely for uses reasonably related to the development and submission of information under a Federal law which regulates [the medical device].”

There are many cases on how expansive or narrow the “solely for uses reasonably related” phrase is interpreted in view of the underlying complained of activity. Many activities, such as sales of prototypes, demonstrations at conferences, clinical trial investigator recruitment, are discussed here: Shashank Upadhye, Understanding Patent Infringement Under 35 U.S.C.A. §271(e): The Collision Between Patent, Medical Device, and Drug Laws, 17 Santa Clara Computer & High Tech. L.J. 1, 10 (2000) (available here: )

The Federal Circuit recently issued another safe harbor exemption case, in which a dissent called into question its scope. In Edwards Life Sciences v. Meril Life Sciences (2024 WL 1243032, March 25, 2024), the Federal Circuit affirmed, over a dissent, the safe harbor exemption applied. Here, Meril developed a prototype of a transcatheter heart valve system. Meril traveled to the USA for a conference. But the prototypes never really saw the light of day. It was undisputed the devices sat in a bag in a closet in the hotel room, then in a storage room. Even at a dinner with doctors to recruit them into clinical trials, the devices were never shown or displayed. Other paper documentation stated that the devices were prototypes, not to be sold, not to offered for sale, etc. Edwards sued based on the “import into the USA” provision of the patent infringement law; i.e., the infringement exists simply because the devices were brought into the USA. 

The Federal Circuit affirmed that based on these facts, the safe harbor exemption applied and hence the importation was not deemed as infringement. The Court reaffirmed that the safe harbor had broad application. In short, Meril’s activities, under the broad interpretation, were shielded. Edwards argued that despite today’s activities of limited display and no sales, today’s activities would support tomorrow’s infringement. The dissent, however, focused on the word “solely” and would have held that the activities were not “solely” focused on developing information for the FDA dossier submission. The dissent grudgingly accepted that the Court followed the law and suggested that the fundamental law was incorrectly decided ab initio and hence all caselaw thereafter was suspect. The dissent did not state that Meril’s activities were infringing and unshielded. Rather that the dissenting judge would have remanded back to the trial court for full trial instead of disposition by summary judgment. 

Are Method Steps Performed Sequentially Or In Parallel?

Medtronic v. Teleflex, 2024 WL 1208642 (Fed. Cir. March 21, 2024) discussed how to interpret method claims. Medtronic filed IPR petitions to invalidate Teleflex’s patent claims. It argued that the broad claim scope rendered the claim invalid as obvious. More particularly, Medtronic argued that the claim was broad because the method steps did not require the steps to be sequential (that is, in order) but could be performed in any order. The Federal Circuit affirmed the PTAB’s findings that the claims were valid. 

Method claim interpretation raises several questions. First, are the method steps performed in sequence or can they be done in any order. Second, whether the order matters, does a step require full completion before the next step can begin. For example, a typical chocolate chip cookie recipe involves adding and blending some flour, water, sugar, butter, chocolate chips, and salt. Cooks know that eventually this mixture of ingredients will be blended and baked into cookies. In the absence of specific instructions, a cook may mix all the ingredients together, blend the mixed ingredients, then bake the cookies. Another cook may mix the sugar and butter together to get a paste, then once fully pasted the cook will slowly add flour into the mixer, and slowly add water, then fully blend that mixture. Then the chips are added. So, as can be seen some steps may not require the previous step to be fully completed before the next steps begins. Other cooks may work with wet and semi-solid ingredients first and then work with the dry ones. Now in baking cookies we know the last step is to bake the cookie so no mixing or blending can happen after the baking. 

In Medtronic, the Federal Circuit restated that unless specified, the method steps need not be performed sequentially. If the method steps though imply some sequence or order as a matter of logic or grammar, then those steps will be construed that way. Further, if a later step refers to a previous step using the word “the” as an antecedent, then an order can be implied at least as to those two steps. 

Practical Tip: The Medtronic case reaffirms that patent drafters need to be careful about method step claim construction. Drafters should explain in the written description if sequence or order matters. Different embodiments showing different orders of the steps should be included. 

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Our firm specializes in patent strategy and litigation. We help clients analyze the portfolio of patents. For investors, we provide the deep dive due diligence to find any problems in the patent portfolio or vet out the accuracy of pitch-decks. We help clients in patent litigation, appeals, counseling, opinions of counsel, and PTAB proceedings. When your current firm needs help or the client needs a change of counsel, we can help. 

About Upadhye Tang LLP

Upadhye Tang LLP is an IP and FDA boutique firm concentrating on the pharmaceutical, life sciences, and medical device spaces. We help clients with navigating the legal landscape by helping on counseling and litigation. Clients call us to help move drug and device approvals along and to represent them in IP and commercial litigation. Call Shashank Upadhye, 312-327-3326, or by email:, for more information. 

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