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Patents for Medical Devices and Avoiding Infringement

It can be difficult to protect inventions through patents, particularly in the crowded field of medical devices. Yet it is essential for a company to become and remain competitive. Receiving a patent, however, is just a first step. It does not provide the patent owner with the right to sell the patented invention, only the right to prevent competitors from selling that invention.

One of the requirements for getting a patent is novelty. This requires that an invention be new in the sense that it is not already disclosed and part of the public domain. An invention is novel when it has not appeared in “prior art,” which means other patents, publications, trade brochures, and advertisements. If a medical-device designer comes up with an invention which is in the prior art, the invention is not novel. Also, depending on where patent protection is sought, novel means the inventor may not disclose the invention to others outside of his or her company before filing a patent application.

Novelty can be lost by an inventor's actions, that of his company's, or through actions completely outside his control. A prior-art publication not written by the inventor which discloses the invention is outside his control. So is another's patent or published patent application. Prior-art patents in the U.S. can be located by searching the U.S. Patent and Trademark Office's Website (www.uspto.gov). A simple keyword search in the abstract and title fields returns a list of patent documents that may be worth studying. The USPTO uses an elaborate patent classification system. Patents are grouped into categories, known as classes and subclasses. These are based on the patent subject matter. Relevant classes and subclasses can be identified on the front page of patents with similar subject matter, such as patents from competitors. Locating a patent which discloses your invention means it is not novel, and patent protection is not available.

Within inventors' control is the public use or display of an invention, such as at a trade show, public forum, or publication of a technical paper discussing the invention. These can cause an invention to lose its novelty if the display or publication is prior to the filing of a patent application. The U.S. gives inventors a full year to file a patent application after any such public disclosure or publication. Most foreign countries do not. For this reason it is important to promptly file a U.S. patent application prior to public disclosure because foreign patent rights will be lost.

Patent rights can also be lost if the inventor and his company abandon the invention. Abandonment may occur when work on an invention is completed, such as building a prototype, but the invention is put on hold for a length of time without promptly filing a patent application. There are different reasons for abandonment, but usually in the context of a large company, someone decides the invention is not feasible because of cost, consumer disinterest, or production concerns. If a competitor then files a patent application to the same invention, he will get the patent even though he conceived of the invention later. Abandonment of a patent application also happens by not meeting deadlines set by the USPTO.

An inventor's prior-filed foreign patent application can also result in the loss of U.S. patent rights. This happens when a U.S. patent application is filed more than twelve months after the foreign application or if the foreign application becomes a patent or is published before the U.S. application is filed.

Obtaining a patent does not give the patentee the right to sell the patented product. It only allows the patentee to stop others from making or using the patented invention. This rule is easy to remember if one considers that patents are often improvements on other inventions and the improved product can only be made by including the underlying invention. Designers should perform a freedom-to-operate study prior to marketing a new product, regardless of whether the new product is covered by its own patent. Freedom-to-operate studies involve locating relevant U.S. patents which are still in force and then determining whether those patents cover the new product. U.S. patents are valid for twenty years from their application filing dates. Thus, the study generally needs to look at relevant patents filed less than twenty years earlier.

As engineers, it is important to file U.S. patent applications as soon as an invention is fully developed, so potentially valuable patent rights are not lost. Patents owned by the competition should also be carefully checked before investing heavily in developing and marketing a new product.

Edward Weisz is a partner at Cohen Pontani Lieberman & Pavane, an intellectual property firm serving companies from a diverse range of industries including pharmaceuticals, electronics, heavy machinery, biotechnology, and telecommunications.

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© 2012 Penton Media Inc.


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