What are some options if a sequence that you are working on is claimed in a patent or patent application?
A granted U.S. Patent gives a patentee the right to exclude others from making, using, selling, or offering to sell the claimed invention in the U.S. In addition, a patentee may exclude others from importing the claimed product or product of a claimed method, even if it is not patented in the originating country.
Patent applications are not the same as granted patents. If there is no granted patent, there is no infringement. If a patent owner has a good faith belief that you are infringing her patent, the patent owner may request that you “cease and desist”, demand licensing fees or royalties, or sue you in court.
So, what if you have discovered that a nucleotide or amino acid sequence that you are working on in your laboratory is claimed in a U.S. patent or pending application? Don’t panic! There are a number of options available to you.
First, take a careful look at the claim language to see if the sequence that you are concerned about is indeed claimed in a patent or patent application. Remember that a patent in the U.S. only applies to the U.S. If you are in another country, a U.S. patent or patent application does not apply to you (unless you plan to import the patented subject matter into the U.S.). Refer to the last section of the previous page in this landscape paper for examples of sequences that are simply recited in a claim as opposed to claimed as compositions of matter.
Options if it is a patent application in the U.S.:
- Submit prior art to the examiner as a “third party submission”. If the application is a U.S. application, and if you have evidence that the sequence was published prior to the patent filing date, and the application of interest was published less than two months prior, you (as a third party) may submit patents or publications for consideration in a pending published application, pursuant to 37 CFR 1.99 (rule 99). With these types of submissions, the third party is not allowed to comment or provide explanation as to what they are submitting. See section 1134.01 of the MPEP for more information about this option. The downside to this approach is that the examiner is not obligated to consider your submission.
- Submit prior art to the inventor or assignee. You, or a party on your behalf, can submit the publication in which the sequence is published to the applicant. If it is actually prior art, and the applicant hasn’t already submitted it to the examiner, applicant then has a duty to disclose it. The downside to this approach is that if you identify yourself in the submission, the patent applicant may be alerted that you are working on the sequence, and if the patent issues, may flag you for royalties or legal action.
- Do nothing. If you are at a university or non-profit institution, and if you are not using the sequence for commercial gain, it is unlikely that a patent applicant will take legal action against you when the patent issues. See the article by Nottenburg et al. “Accessing other people’s technology for non-profit research” (link is to a PDF) for more details. A downside to this is that if you use the subject matter of a patent application, and the patent later issues, and the claims in the granted patent are substantially identical to the claims in the application, the patentee has the option to collect royalties retroactively to the publication date of the patent. See 35 USC 154 for more details on information about “provisional patent rights”.
Options if it is a granted patent in the U.S.:
- Negotiate a license. Contact the patent holder and see if they would be willing to provide you with a license to use the sequence. Some companies grant different types of licenses depending on who’s seeking it. If you are a researcher at a university or non-profit organization, they may grant you an inexpensive or cost-free non-commercial license. The downsides to this is that the fee for the license may be more than you can afford to pay, or that they may refuse to grant you a license at all. In addition, you are alerting the patent holder to a potential infringer.
- Initiate a reexamination. If you have evidence that the patent is invalid due to prior art, you can initiate a patent reexamination. There are two types of patent reexamination; aninter partes reexamination, and an ex parte reexamination. For an inter partes reexamination, both the reexamination requester and the patent holder may file briefs with the USPTO. With an ex partes reexamination, only the requester files a brief. If the USPTO finds the claims unpatentable over the new prior, they will cancel them. The downside to this option is that affirmation rates of patents in reexamination proceedings is relatively high.
- Invent around the patent. Depending on the scope of the claims, and whether or not broadening language is used, you may be able to make minor substitutions in the nucleotide or amino acid sequence that will allow you to “work around” the patent claim without affecting the function of your sequence. The downsides are that re-engineering DNA or protein constructs can be expensive and time-consuming, and that broadening language may make this difficult or impossible to do.
- Do nothing. If you are at a university or non-profit institution, and if you are not using the sequence for commercial gain, it is unlikely that a patent applicant will take legal action against you. See the article by Nottenburg et al. “Accessing other people’s technology for non-profit research” (link is to a PDF) for more details. Another important fact to note is that due to 11th amendment to the U.S. Constitution, which deals with each State’s sovereign immunity in regards to federal lawsuits, state universities cannot be sued in federal court. The downside is that you may expose yourself to risk of legal action, particularly if you are using the sequence in collaboration with a for-profit company.
- Get a legal opinion. A legal opinion will protect you from willful infringement charges if you choose the “do nothing” option. The downside to this option is that legal opinions are generally quite costly and will not protect you from a lawsuit or being judged as an infringer.
The information contained in this page was believed to be correct at the time it was collated. New patents and patent applications, alter