It takes many years for new drugs and new medical devices to wind their way through the approval process of the Federal Food and Drug Administration (FDA). It can take anywhere from three to eight years on average for new medical devices to proceed from human trials to FDA approval. On the other hand, according to the USPTO’s statistics released for 2016, for biotechnology, drugs, and medical devices, the average pendency time of 24.9 months from patent application filing to patent issuance (assuming the application satisfied patentability requirements).
As can be seen from the discrepancy in the average pendency between these two government entities, many medical device companies must juggle their FDA regulatory review process and their patent procurement efforts. A patent might issue within just two years, but FDA approval might take another three to eight years. While a medical device company might secure patent protection on a new medical device, the company is not permitted to sell the new medical device until there is FDA approval. This scenario is typical in the medical device industry with regard to Class III devices, and it unfortunately has the ability to significantly reduces the profitability of new innovative devices.
But under the Hatch-Waxman Act, drug and medical device makers can apply for a patent term extension. Like the name implies, the term of a patent can be extended for up to a maximum of five years in certain circumstances where it can be shown that delays by the FDA lead to loss of a patent owner’s ability to exercise their patent rights.
Medical Devices: Patent Term Extensions
In 1984, Congress passed the Drug Price Competition and Patent Term Restoration Act — often called the Hatch-Waxman Act. The Act is now codified at 35 U.S.C. §§ 156, 271, 282. The Hatch-Waxman Act was aimed at addressing two problems. First, the patent holder lost part of its 20-year monopoly by virtue of needing regulatory approval and, second, generic drug makers were not allowed to seek approval from the FDA until the patent expired.
With respect to patent term extensions, 35 U.S.C. 156 enables the owners of patents on certain human drugs, medical devices, and other products to restore to the patent term some of the time lost while waiting on government approval.
What is the Process for Seeking Patent Term Extensions?
The application for patent term extension must be filed with the USPTO. The application must be filed within 60 days of the date the drug or medical device received permission for commercial marketing or use from the applicable governmental agency, like the FDA. The USPTO next conducts an internal review and if the patent is eligible for an extension, the USPTO requests information from the applicable governmental agency concerning how long it took to complete the regulatory approval process.
In general, this request goes to the Secretary of Health and Human Services, which oversees the FDA. Based on the information received, the USPTO issues a Certificate of Extension. In general, the patent term is extended by an amount of time equal to the regulatory review period for the drug or medical device product occurring after the date the patent is issued, but the extension cannot exceed a maximum of 5 years. Note that not all medical devices are eligible. Only Class III medical devices are eligible, i.e., high risk medical devices like pacemakers.
Medical Devices: Contact The Rapacke Law Group Today
If you need more information about patents term extension for your medical device, contact an experienced and skilled attorney at The Rapacke Law Group. RLG can be reached at 954-533-4396 or by completing this online contact form.