Health Law Update

Home | Health Law Update

<a href="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2015/07/provisional-application-iStock_000054442194_Large.jpg"><img class=" size-medium wp-image-3249 alignright" src="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2015/07/provisional-application-iStock_000054442194_Large-300x200.jpg" alt="provisional application iStock_000054442194_Large" width="300" height="200"></a>In today’s world, there are a few things most people can agree on: Sean Connery was the best James Bond, ice cream is the perfect dessert for any season – and patent applications are expensive! Because even a run-of-the-mill patent application may, depending on the invention’s complexity, cost several thousand dollars, life science entities may elect to file an informal “provisional” patent application, which can cost less than a few hundred dollars and is not examined by the United States Patent and Trademark Office (USPTO). And although the decision to file a provisional patent application may hold a certain appeal, a provisional patent application that is insufficiently detailed can have significant and irreversible negative effects, especially for life sciences entities that protect any part of their market position with their intellectual property.

There can be good reasons for pursuing a provisional patent application. For example, filers receive an official filing receipt from the USPTO and maintain the option to file a “full” patent application within 12 months of the provisional filing. This provides the filer with a year’s “grace period” for gauging the market’s interest in their technology. Another reason, and one that is especially applicable to medical and biotechnology institutions with researchers who frequently publish and attend conferences, is to establish a filing date prior to the disclosure of the technology in a scientific journal or academic conference. This is especially critical because most countries and the U.S. do not grant patent protection for inventions that are disclosed prior to a filed patent application.

A provisional patent application, however, can provide the foregoing safeguards only when the application is sufficiently detailed.

An insufficiently detailed provisional patent application may destroy the ability to patent an invention.

Although provisional applications include some description of the invention, an insufficiently detailed provisional application may not satisfy the applicable portions of the Patent Act. A provisional application that does not satisfy the Patent Act does not establish a filing date, which in turn means that if the researcher publicly discloses the invention after filing a faulty provisional application, the researcher (and the institution) will have lost the ability to secure patent protection in a number of countries.

An insufficiently detailed provisional patent application may weaken the ability to patent an invention.

Even if a poorly drafted provisional patent application doesn’t destroy the ability to secure later patents, it can still adversely impact the strength of those later patents. More specifically, if an earlier provisional application insufficiently describes the technology, a full patent application that is related to that provisional application will be vulnerable to prior art references that a more detailed provisional application would have avoided. For example:
<blockquote>BioInstitute files in May 2015 an insufficiently detailed provisional application that describes synthetic molecule X in detail and describes synthetic molecule Y only in passing. In June 2015, a scientific article is published that describes molecule Y in full detail. BioInstitute then files a full application (related to the May 2015 application) in May 2016 that describes synthetic molecules X and Y. That May 2016 application could then be rejected (or limited) based on the intervening June 2015 scientific article that describes synthetic molecule Y. If, however, the May 2015 provisional application had described both X and Y in complete detail, then BioInstitute’s May 2016 full application would not be rejected based on the June 2015 article.</blockquote>
This scenario often arises in the medical and biotechnology fields, where researchers are constantly publishing their own work and seeking to improve upon the work of others.

An insufficiently detailed provisional patent application can provide competitors with an opportunity to secure crucial patent protection.

A provisional patent application that fails to adequately describe the subject matter technology can leave the filer of the provisional application vulnerable to patent applications filed by competitors during the filer’s pendency period. For example:
<blockquote>
BioCorp’s scientists develop molecules X, Y, and Z. BioCorp then files in May 2015 a provisional patent application that describes only molecules X and Y (and not Z). In June 2015, CompetitorBioCorp files an application that describes and claims molecule Z.

Although BioCorp also invented molecule Z, it was not described in BioCorp’s provisional application, and CompetitorBioCorp can then obtain a patent on molecule Z even though it was BioCorp that first invented molecule Z. This scenario could be especially damaging to BioCorp if molecule Z becomes a market-leading product, as BioCorp could have – but didn’t – secure patent protection to molecule Z.
</blockquote>
There are other ways in which a poorly drafted provisional application can create problems, but the foregoing scenarios – receiving a narrower-than-desired patent or even losing the ability to secure any patent protection at all – underscore the harm that an insufficiently detailed provisional patent application can inflict.

How an Insufficiently Detailed Provisional Patent Application Can Hurt You