Maximizing The Term Of Patent Protection For Medical Devices

Patent term extensions (PTE) are crucial for medical device innovators to recover patent life lost during lengthy FDA regulatory reviews.  While more common in pharmaceuticals, recent cases show significant PTE benefits for medical device patents relating to class III devices requiring FDA Section 515 premarket approval.

Patent Term Extension Background and Application

35 U.S.C. § 156 permits a patent owner to request a PTE when (1) the launch of a product is delayed by regulatory review, and (2) the delay erodes the owner’s patent term.  Products eligible for a PTE include human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products.  Not all medical devices are eligible for PTE.  Only class III medical devices subject to review under Section 515 of the Federal Food, Drug, and Cosmetic Act are eligible, meaning class II devices regulated under Section 510(k) are not eligible for PTE. 

However, there are several criteria the patent owner must satisfy in order to receive a PTE.  As a threshold matter, the patentee must file a PTE application within sixty days of the first grant of regulatory permission for commercial marketing or use of the product.  The application must identify the approved product and the federal statute under which regulatory review occurred.  Additional “eligibility” information includes the term of the patent, the nature of the product, details about the regulatory review the product underwent and the activities the applicant took to get the product approved, and the approved uses for the product.  This narrative is to ensure the patent owner acted diligently throughout the regulatory review period.

Enforcement Considerations in PTE Applications

The PTE application must include a showing which lists (1) “each applicable patent claim” and (2) “demonstrates the manner in which at least one such patent claim reads on … [the] approved product.”  In making these showings, the patentee should carefully consider whether its interpretation of the applicable patent claims and its reading on the approved product may impact any patent enforcement strategy.  For example, selecting a broad patent claim may be enticing from an assertion perspective.  However, the patentee may want to consider whether mapping its approved product to a broad claim in the PTE application could be used against the patentee to support an allegation that its approved product infringes a third party’s patent.

Patent enforcement strategy must also be considered when a patentee holds multiple patents protecting a single approved medical device.  A particular regulatory review period may serve as the basis to extend the term of only one patent.  Accordingly, where there are multiple applicable patents that might be the subject of a PTE application, the patentee should evaluate which patent provides the greatest advantages from an enforcement perspective.

Given the time constraints and strategic considerations associated with seeking a PTE, medical device patentees should promptly seek advice from patent counsel when they anticipate receiving regulatory approval for a medical device.

Recent Examples Of Patent Term Extension Success     

In one recent example, Intrinsic Therapeutics, Inc., extended the term of its U.S. Patent No. 9,610,106 from an expiration date of April 19, 2027, to a PTE-adjusted expiration date of February 22, 2029.  The covered product subject to FDA review was Intrinsic’s Barricaid® Annular Closure Device, which included a titanium bone anchor and a barrier that closes an annular defect in tissue.  The FDA’s review of Intrinsic’s product extended over a period of approximately four years and Intrinsic was able to recover almost half of the patent term that it lost during the review period.

In another example, Intact Vascular, Inc. recently received a PTE of 621 days for its U.S. Patent No. 9,375,327, titled Endovascular Implant, which claims an expanding vascular implant used in repairing blood vessels.  Intact Vascular’s PTE application showed its Tack Endovascular System® was the subject of an FDA review that extended over approximately three years.  The PTE application also identified selected claims of the patent as reading on the approved Tack Endovascular System.  Intact Vascular was able to recover more than half of the patent term it lost during the FDA review period.

Lastly, W.L. Gore & Associates, Inc. succeeded in extending the term of its U.S. Patent No. 9,474,517 by 556 days.  The patent, titled Heart Occlusion Devices, relates to an implantable device that closes a defect in the septum.  W.L. Gore’s PTE application explained that its Gore® Cardioform® ASD Occluder product was subject to an FDA review lasting 751 days and identified five claims that were applicable to the approved product.  W.L. Gore was successful in clawing back almost 75% of the patent term it lost during the FDA’s review.

Takeaways

1. The foregoing recent examples illustrate that substantial portions of patent term lost during an FDA review can be recovered with a PTE application.
2. Timing is critical. Given the sixty-day window of time to apply for a PTE after receiving the first grant of regulatory permission, patentees should keep their patent counsel informed of the progress of any regulatory reviews that may provide a basis for requesting a PTE.
3. Additionally, the patentee’s PTE application must be filed with the USPTO before the original patent term expires.
4. Patent enforcement strategy may be implicated by the patentee’s selection of particular patents for PTE as well as statements in the PTE application about the applicable patent claims. Accordingly, patent litigation counsel should be consulted when evaluating PTE options.