Pros and Cons of Provisional Patent Applications
As of June 8, 1995, the USPTO has offered inventors the option of filing a provisional patent application, which was “designed to provide a lower-cost first patent filing in the United States.” One of the key benefits of this option is that filing a provisional patent does not trigger the start of the 20-year patent term.
What is a provisional patent application?
A provisional patent application is often described as a placeholder for a future, non-provisional application that is based on the invention described in the provisional application. In contrast with a non-provisional application, a provisional application is exempt from:
- an inventor’s oath or declaration;
- the duty to disclose information material to patentability (prior art); and
- formal patent claims.
A provisional patent application will not be examined or disclosed by the USPTO because a provisional application cannot become a granted patent.
Then why should I file a provisional patent application?
The filing date of a provisional patent application establishes the priority date for a non-provisional patent application that claims the benefit of the invention described in the provisional application – so long as the non-provisional application is filed within 12 months of the provisional filing date.
During the 12-month period, the inventor can file additional provisionals that further elaborate on the invention – all of which can be included in the non-provisional application (with the oldest providing the priority date).
Be the first to file
When the America Invents Act came into effect in March 2013, the US patent process shifted away from its historic “first to invent” approach and adopted the globally practiced “first to file” system. Being able to establish a priority date for an early-stage invention is probably the greatest benefit of a provisional patent application, especially since the provisional application has no impact on the future patent’s 20-year term.
The expense of preparing and filing a good provisional application is about half the cost of preparing and filing a non-provisional application. With the priority date secured, the inventor now has 12 months to further develop the invention and validate its market potential before incurring the expense of filing a non-provisional patent application and seeing it through the patent examination process.
In the meantime, the inventor can use “patent pending” to describe the invention, enhancing its perceived value in the eyes of potential investors and partners.
Things to watch out for
A non-provisional patent application that references a provisional application must be based on the invention as it is described in the provisional application. Thus it is important to write the provisional patent application with great care, anticipating as many ways as possible of practicing the invention so as not to restrict the future non-provisional patent application (which cannot be changed so easily after filing).
Provisionals are often filed because the inventor wants to share the inventive solution with potential investors or partners as quickly as possible and seeks to protect it before showing it to others. It is important, however, not to fall into a false sense of security. Even a non-provisional patent application’s claims cannot be enforced until the patent has been granted. A provisional patent application affords even less protection.
The graph below shows the number of provisional vs. non-provisional applications filed in the past decade (from 2009 to 2018), as taken from the USPTO’s annual workload tables. The number of provisional applications has increased 26% in that time, from just over 134,000 to just under 169,000. This upward trend indicates strong interest in leveraging provisional applications as part of an overall IP strategy.
An easy out
A final benefit of provisional applications is that they give the inventor a window of opportunity to further test the technological and commercial feasibility of an invention. If further testing yields poor or unprofitable results, the project can be dropped before committing to a long and potentially expensive non-provisional patent application process.
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Labeling requirements for medical devices in Israel
Regulatory requirements for the medical devices industry are constantly changing, which can be quite challenging for manufacturers and distributors that need to comply with a variety of country-specific registration requirements.
If you wish to sell a medical device in Israel, you’ll need to demonstrate compliance with the requirements of the Medical Device Division of the Israeli Ministry of Health (AMAR).
Israel does not have its own classification system for medical devices, but it accepts the classification method and the applicable regulatory requirements of the United States, EU, Australia and Canada. As such, products that are FDA approved or EU CE marked should already have the essential parts of the device dossier required to complete the registration process in Israel.
US Food & Drug Administration (FDA)
High quality labeling is necessary to ensure device performance as well as patient and user safety. As such, the use of FDA recognized labeling standards is highly recommended and can facilitate your approval/clearance process. FDA labeling requirements can be found in Title 21 (see Sec. 801.15). You may also refer to ISO 15223-1, an international standard recognized by the FDA for use of symbols on medical device labeling.
Note: The FDA constantly publishes new guidelines which can assist companies to better understand the regulatory requirements, so be sure to reference the most current information available.
EU CE marking
A CE mark is a specific certification demonstrating that a product meets EU health, safety and environmental requirements. In order to apply a CE mark on a medical device, you must demonstrate compliance with the EU Medical Device Regulation (MDR) which defines labels as “written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices.” The MDR requires that labeling will be provided in plain language that is clearly comprehensible to the end user.
As stated above, if a product is already in compliance with the FDA or EU MDR then it can be assumed that its labeling covers the regulatory requirements in Israel. Still, there are some specific requirements related to labeling translation in Israel. For example, the Israel Ministry of Health has different translation requirements for devices intended for professional use and devices intended for home use.
In Israel, when the device is intended for professional use in healthcare facilities, the labeling may be provided in English-only. When the device is intended for home use, labeling must be provided in three languages: Hebrew (Israel’s official language), Arabic and English.
The Medical Device Division of the Israeli Ministry of Health (AMAR) is the regulatory authority in Israel for medical devices. In order to register a device in Israel, you must submit a product dossier (including labeling and regulatory approvals from other recognized countries) to AMAR. In Israel, labeling of products for professional use can be provided in English-only, while labeling for home use devices should be provided in at least in 3 languages: Hebrew, Arabic and English.
About the author:
My Name is Dalia Givony and I am a regulatory and clinical affairs consultant with 20 years of experience in global regulatory and clinical studies of medical devices, including 7 years at Medtronic specializing in executive RA & Clinical management. I offer my customers professional support for FDA submissions, CE marking, Global Registration (including registration in Israel), as well as design and management of clinical studies. With proven experience in direct communication and negotiation with the FDA, CE and other regulatory authorities, I aim to reduce the regulatory burden and V&V requirements and specialize in innovative, creative and effective regulatory strategies that take your other business aspects into consideration. Trust me to plan and manage cost-effective pre & post market clinical studies that will support your local regulatory requirements, as well as expansion into new markets. If your company needs regulatory and clinical support in Israel, you are welcome to contact me at [email protected] or visit www.daliag.com