Biotech and patents: Prior art and freedom-to-operate searches

For biotech companies, prior art searching includes not only the search of patent databases, but also the search of scientific literature and conference proceedings for potential public disclosures of the intellectual property (IP) subject matter. A related consideration is a freedom-to-operate search, which may be necessary if a biotech company is using patented materials or processes.
Entrepreneurs coming from a research lab may find that material and procedures used freely in a research lab have restrictions for use in a “for-profit” company.

Patents for inventions will require prior art searches

If you are seeking a patent on an invention, at some point you will need to do a prior art search. A prior art search determines whether your invention has already been publicly disclosed. If it has been publicly disclosed, it may not be patentable, as it has lost the criteria of being “novel.”
The prior art search can also facilitate how to prepare your patent application so as to distinguish your innovations from prior art.

Steps to a thorough prior art search

Step 1: The first place to search is in patent files, since this is where the record of most devices and processes exist and the patent examiners who review your patent application will comb these files.
Because a patent involves claims, it is a good idea to have a patent agent or patent lawyer do the search. A patent agent or lawyer can also conduct a search using patent classifications.
Step 2: Search the useful and free patent databases of the following organizations: European Patent Office, United States Patent and Trademark Office (USPTO) and Google patents.
Go through the databases using keywords that describe your invention. Remember to check the status of patents that your search uncovers. These searches can be laborious, because often the title and the abstract of patents in the search results are extremely vague or general.
To understand clearly whether the patent overlaps your invention, you will need to examine the claims and description.
Step 3: Search the scientific literature by using PubMed. Again, use keywords to investigate whether your invention has already been published or disclosed.
If you discover that someone has published something that presages your invention, look further for public presentations, such as conference abstracts.
Step 4: To find out what has been disclosed publicly, Google keywords related to your invention. The results may turn up products or articles that report something overlapping your invention.

When to conduct a freedom-to-operate search

If you intend to sell a product or service, conduct a freedom-to-operate search, regardless of whether you are patenting your invention or relying on a trade secret.
A freedom-to-operate search is often confused with a prior art search, but it is actually a more extensive search to determine whether your product or your production of it infringes other patents. The difference between the two searches is illustrated below. A prior art search will determine if the final version has already been publicly disclosed. A freedom-to-operate search will investigate whether any of the steps or processes used to make your product infringe another patent.
Comparison of freedom-to-operate and prior art searches. Patented property plus not patented property equals product.
If a freedom-to-operate search reveals that some component or process is already patented, you have the option either to contact the patent holder and discuss licensing or cross-licensing their IP, or to use a workaround.
If you do not undertake a freedom-to-operate search, you may find out that you are infringing someone else’s patent when you receive a letter telling you to stop and to pay a fine or license fee.
Note: The content in this article is for purposes of general information only. It is not legal advice.