Companies face many hurdles when bringing a new product to market, including technical problems, regulatory requirements and changing market forces. Introducing a new drug or medical device to the market introduces additional regulatory hurdles before both the Food and Drug Administration (FDA) and the US Patent and Trademark Office (USPTO). The strategies for meeting these regulatory requirements may often seem contradictory, and can be a trap for the unwary. This ultimately doomed the Belcher Pharmaceutical patent as will be explained in detail below.
When filing a patent application with the USPTO, an invention must be novel and non-obvious over "prior art," which includes prior patent applications and public documents and prior uses of the technology. As part of the review process, an applicant also has the duty to disclose all relevant art or background information that they are aware of that may be relevant, or material, to the patentability of the invention. This is also known as an information disclosure statement (IDS).
The FDA has a separate set of requirements for inventors planning on pursuing expedited approval of their inventions by the FDA. This is known as the 510(k) route and requires inventors to demonstrate their new devices are "substantially equivalent" to a predicate device. The FDA considers a device "substantially equivalent" if it has the same intended use and the same technological characteristics as a legally marketed device.
At times, the requirements of the USPTO and the 510(k) requirements of the FDA can appear to be contradictory and may pose a challenge to inventors. On one hand, the inventor needs to demonstrate to the FDA that the device has the same technological characteristics as a predicate device that has been commercially available prior to the 510(k) in order to be eligible for expedited approval. On the other hand, the patent applicant needs to demonstrate that the device is novel and non-obvious in light of the available prior art. Accordingly, applicants seeking an expedited 510(k) approval need to ensure that the information they are disclosing to the FDA and USPTO is accurate, but also satisfies the requirements of each agency.
In the recent case of Belcher Pharmaceuticals v. Hospira, the Federal Circuit held Belcher's patent ('197 Patent) unenforceable for inequitable conduct after they presented conflicting information to the USPTO and FDA in an attempt to obtain 510(k) approval process for its patent. The '197 patent covered an epinephrine formulation with a pH range of 2.8 to 3.3 with a certain impurity level limitation. In the new drug application submitted to the FDA, Belcher named as a reference product Sintetica's epinephrine formulation with a pH range of 3.1 to 3.3, a range that overlapped with the range specified in its patent. Belcher explained to the FDA that the pH range of 2.8 to 3.3 was "old" and that it was necessary to reduce the range to a pH of 2.4 to 2.6 to reduce racemization. However, Belcher was advised that seeking FDA approval for a pH range of 2.4 to 2.6 would delay approval so they reverted back to the pH range of 2.8 to 3.3 shown in the Sintetica product.
Belcher also filed a patent application for its epinephrine product. The prosecution of the '197 patent involved only a single office action after the examiner rejected the claims as obvious based on a Canadian Patent Application ("Helenek") that disclosed an epinephrine product with a pH range of 2.2 to 5.5. However, Belcher successfully argued that the Helenek patent failed to render obvious the claimed range of 2.8 to 3.3 because "the claimed range was unexpectedly found to be critical ... to reduce the racemization of epinephrine." Not only did Belcher fail to disclose the Sintetica product to the USPTO, but this statement directly contradicts the statement to the FDA that 2.8 to 3.3 is the "old" range and needed to be lowered. Once this information came to light in the patent infringement case initiated by Belcher, the court found the '197 patent to be unenforceable for inequitable conduct.
While District Courts have ruled that 510(k) equivalency statements made to the FDA to compare a new device to a predicate device are potentially relevant, an equivalency statement is not sufficient to establish infringement. Instead, the courts will often exclude the 510(k) evidence in a patent infringement case so as to not confuse the jury because the term "equivalent" has a different meaning before the USPTO and FDA.
Given the costly consequences that can result from missteps, it is critical for patent applicants seeking an expedited 510(k) approval from the FDA to ensure that they carefully strike a balance regarding the disclosure requirements to ensure they satisfy the requirements of both the FDA and USPTO while avoiding the fate of Belcher's '197 patent.
Jay Halt is co-author of FDA and Intellectual Property Strategies for Medical Device Technologies which provides comprehensive, easy to understand guidance for medical device technology innovators on how to work through the U.S. FDA regulatory review process while also providing insight on intellectual property concerns.
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