Patent claims are where it’s at if you are looking at freedom to operate. Keep in mind, however, that it’s really issued claims that are the worry.
I get a fair bit of concerns sent my way about patent applications. It comes in two flavors. Some concerns are for what is in the specification, and others are for the claims published with the application. I’ll take these on one at a time.
With regard to what is in the body of the application (the specification), if the subject matter of interest hasn’t made it into the claims, this is at best a worry for the future. Because the relevant elements are not in the claims, this is not what the applicants are currently pursuing for patent coverage. There is a possibility that this subject matter could provide the basis for claims in a future application (e.g., a continuation or divisional application filed from the parent application). But it is just as possible that the matter causing you worry is general background information, part of the prior art or a side issue that is not of interest to the applicant.
Now turning to the published claims of an application. This is what I call a “wish list.” Applicants generally file on a broad scope that if there were no prior art or other patentability hurdles, this would be the desired “land grab.” However, reality sets in during prosecution, and it is not unusual for claims to get significantly narrowed before a patent issues.
Another way of looking at this is a bit like “now you see it . . . And now you don’t.” Claims that look super broad or dangerous can lose their bite and be limited in ways that will take them completely off your radar.
Let’s look at some examples.
Claim as filed: A nucleic acid construct comprising a non-catabolite-repressed promoter operably linked upstream to a natively catabolite-repressed promoter.
Claim issued: A nucleic acid construct comprising two non-identical promoters in a tandem arrangement, wherein each promoter is responsive to an exogenously supplied compound, wherein the upstream promoter is set forth in nucleotides 1329-1369 of SEQ ID NO:13, wherein the downstream promoter in the tandem arrangement is the catabolite-repressed promoter set forth in nucleotides 1477-1509 of SEQ ID NO:13, and wherein induction of the upstream promoter in the tandem arrangement overcomes the catabolite repression of the downstream promoter.
As filed, the claim could be any promoter sequences as long as one was non-catabolite-repressed and the other catabolite-repressed. As issued, however, the claim is much narrower in the scope. The issued claim limits the promoter arrangement to one specific set of nucleic acid sequences in a specific functional arrangement.
Claim as filed: 1. A method for treating a melanoma tumor in a subject in need thereof comprising: (i) identifying a patient having a PD-L1-negative melanoma tumor; and (ii)administering to the patient: (a) an anti-PD-1 antibody or an antigen-binding portion thereof that binds specifically to a human PD-1; and (b) an anti-CTLA-4 antibody or an antigen-binding portion thereof that binds specifically to a human CTLA-4.
Claim as issued: 1. A method for treating a melanoma tumor in a human patient in need thereof comprising: (i) identifying a patient having a PD-L1-negative melanoma tumor; and (ii) administering to the patient: (a) about 1 mg/kg of an antibody or an antigen-binding portion thereof that binds specifically to a human PD-1 (“an anti-PD-1 antibody”) and a dose of an antibody or an antigen-binding portion thereof that binds specifically to a human CTLA-4 (“an anti-CTLA-4 antibody”) every three weeks for about 4 doses; followed by (b) a dose of the anti-PD-1 antibody, wherein the dose in (b) is a flat dose of about 240 mg or about 480 mg.
As filed, the two antibodies were not limited by dosage amount or timing, whereas the issued claim requires specific dosages of each antibody and a specific order and timing for the dosages.
Setting a course of action. Given these changes between filed claims and the state in which they issue, you may ask, do I just wait for this application to issue and assume the claims won’t then be a problem? That is one approach, but you can also monitor how things are progressing. Particularly for US and EP applications, the back and forth between the applicant and the patent office (referred to as the file history or file wrapper) is easily accessible from the patent offices’ websites. As the claims get amended, you can download the most recently filed claim set. For the US, this is accessible on PAIR and for Europe, Espace and its link therein to the EP register holds all of the file history docs.
Why do claims get narrowed? Typically, there are two major hurdles to claims. The most common is prior art. If the claimed composition or method is already disclosed in a publication, in a product on sale, or otherwise in use, then these items will be prior art and cannot be encompassed by the claims. The applicant must tailor the claims to exclude what is already out there. Similarly, if the claims describe an obvious variant to what is already known, this too must be excluded from the scope of the claims. Rather than negative disclaimers (e.g., A but not B), more typically claims are narrowed by adding features that distinguish them from the already known composition or method (e.g., A also having features C and D).
A second hurdle shaping claims is what is known as written description and enablement in the US, and referred to in Europe as sufficiency of disclosure. Basically, this runs along the premise that if you did not adequately describe certain aspects in your original application, you may not be entitled to claims covering those features. For example, when an applicant tries to distinguish the described invention from the prior art, these differences must be found somewhere in the original application or they will not provide a sound basis for tailoring the claims.
With these two forces at play, the starting point for claims if often just that. . . a starting position for negotiation with the patent office. When all is done, the claims may end up in a much different place. So, don’t panic when you see crazy broad claims and think, wow that’ll block everyone and everything. Keep a watch on it, but for the most part, what you see is not always what you get.
The content of this blog is for informational purposes only and does not offer legal advice. Circumstances are fact-specific and you should consult an attorney for legal advice concerning your individual issues.