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An Introduction to Patent Opinions

Whenever a medical device company develops a new product, process or technology, the topic of getting an “opinion” inevitably arises. Many different types of patent or Intellectual Property (IP) opinions exist, each one with a specific purpose.

If one were to follow the typical product development pathway, a patentability opinion would usually be the first type of patent opinion that is obtained. This kind of opinion is based on the results of a prior art search that are used to evaluate the likelihood of obtaining a patent on a specific invention. Moving further down the product development pathway, the next type of patent opinion a company will typically seek is a freedom to operate or clearance opinion. This looks broadly at the proposed technology/product/process and focuses on whether such invention may infringe on any in effect patents.

In the event a company has identified a specific patent or patents that they feel may impact their products/technology/process, a slightly different patent opinion may be obtained. This is called a non-infringement opinion and focuses upon the identified patent. The purpose is to closely examine it to see if the company’s invention “reads” on the identified patent or patents. Finally, if a company determines that their product/technology/process may actually infringe, then a fourth type of opinion, a validity opinion, may be obtained. The validity opinion will focus on whether the target patent is actually valid and enforceable.

Many legal and business reasons exist for obtaining one of these four patent opinions. Typical business reasons may include: whether to spend money on filing a patent application; evaluating the infringement risks of offering a new product for sale; determining the need to license technology before releasing a product and calculating the strength and corresponding value of the patent.

The chief legal reason for obtaining a clearance and/or a non-infringement opinion is to avoid infringing another party’s patent and the possible allegation of willful infringement. Remember, if a party is found to have willfully infringed another’s patent, the amount of damages awarded may be tripled!

Patentability Opinions

Before a company decides to invest money in filing a patent application on a product/technology/process, it may be advisable to obtain a patentability opinion from a registered patent attorney. The process begins with a comprehensive search of public records (e.g., USPTO patent/published application database, Google, etc.) for any public disclosures that may relate to the invention to determine whether it is new, useful and not obvious. One must understand that in addition to patent and published patent applications, non-patent references (e.g., scientific articles, journals, etc.) need to be searched, as these too may be used by the patent examiner to show that someone else has thought of the invention.

Once the prior art search is completed and the results reviewed, the patent attorney should be able to provide the company with an opinion on whether it will be able to obtain a patent or not. The opinion should evaluate the relevant references that may show that the invention is not new. Further, the opinion should discuss references that could be combined to render the invention as being obvious, and therefore unpatentable. One must be cautioned that some pertinent references may not be discovered during the search because of the 18-month lag in publication of filed applications. Obtaining a patentability opinion before filing an application will often save a company money, because the opinion will provide them with important information on the likelihood of success for actually getting a patent issued. In addition, patentability opinions can provide insight as to the existence of similar inventions (either patented and/or described in a pending application) which may impact their product’s continuing development.


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