When deciding what product to pursue and patent, companies generally have two options: start from scratch and develop a truly novel product or find one that has already been around and repurpose it for another use. Repurposing technologies can offer viable opportunities for companies looking to expand their product portfolios since working with pre-existing technologies eliminates many of the hurdles associated with developing de novo products. This is especially true of therapeutics since the discovery of effective, safe therapeutics remains costly, time-consuming, and risky.
We are seeing this dynamic unfold in the current COVID-19 pandemic. Companies and universities are working to see if existing pharmaceuticals, vaccines, treatments, and diagnostics can be used to fight against the novel virus. Several U.S. companies have already announced that their research into COVID-19 has resulted in the filling of patent applications covering coronavirus treatment. For instance, Texas-based Moleculin Biotech took their existing inhibitor compound WP1122 and tested it to see if it could limit coronavirus replication by depriving the host cells of energy.
There are two main hurdles when it comes to IP issues involving a pre-existing technology: novelty under 35 U.S.C. Section 102 (“Section 102”) and obviousness under 35 U.S.C. Section 103 (“Section 103”). We will address these in turn.
Section 102: Novelty
One of the main hurdles to overcome when patenting a pre-existing technology is novelty, or Section 102. As applied to a pre-existing drug, Section 102 requires that it not be previously patented, described in a printed publication, in public use, on sale, or otherwise available to the public before the patent application is filed. In other words, a claim to the pre-existing technology must recite something not previously known to the public. For drug patents, most composition of matter claims reciting only the pre-existing drug will run afoul of Section 102 because the drug was previously known to the public, and thus, would be considered prior art to any subsequent patent application. Accordingly, composition claims including pre-existing drugs need to include new elements not anticipated by the earlier disclosure.
Below are ways to overcome Section 102 hurdles to obtain claims directed to previously-known technologies.
Reciting new uses
One way to obtain claims directed to previously-known technologies that overcome a Section 102 challenge is to draft claims reciting a novel use for that technology, such as a new indication in the case of a drug. If the original claims were directed to a cancer indication, for instance, a novel use would be to claim a cardiovascular indication. We are seeing this play out with existing drugs, such as AbbVie’s HIV drug, Kaletra®, being tested on COVID-19 patients. Such method claims are often difficult for competitors to design around, and they are also available in many foreign jurisdictions, although they may be drafted in slightly different formats. Other uses could include new dosage amounts, different formulations, better safety, better tolerability, new way of administration, and so forth.
Recite new dosage forms
For drugs, specifically, another way to claim a previously-known drug is to claim novel pharmaceutical dosage forms. Pharmaceutical dosage forms can be, for example, gels, solids, liquids, or sustained or extended-release forms. Other examples of dosage forms can be for a specific type of administration including oral, parenteral, intramuscular, and the like. Many variations of pharmaceutical dosage forms are available and lend themselves to drafting novel claims that overcome Section 102 rejections.
Develop new combinations
A final approach for overcoming a Section 102 hurdle is to combine two pre-existing technologies into one product. In the case of drugs, one can incorporate the pre-existing drug into a composition including one or more other compounds to form a novel combination. For instance, Pfizer’s drug, Caduet®, is the combination of the calcium channel blocker, Norvasc®, and the cholesterol-lowering agent, Lipitor®, which expired in 2007 and 2011, respectively. As a side note, combining more than one product into one overall product can have the added benefit of extending the patent term. Caduet®, for instance, expired in 2018 which is about seven years after the last expiration of one of their products.
To overcome novelty objections with combination products, applicants should be prepared to focus on new uses of their products and to draft their patent applications with sufficient disclosure to address these new uses. Such combination claims should include additional features, such as specific drug amounts or ratios between the drugs to increase their likelihood of being found patentable over what was previously known in the prior art. Nevertheless, combinations of one or more products can be patentable.
While the repurposed technology can be any new use, new form, or even new combination that is novel for the purpose of overcoming Section 102, such modifications to the pre-existing technology may nevertheless encounter Section 103 obviousness hurdles as the modification may be obvious to one skilled in the art. Below we explore Section 103 and provide suggestions for overcoming rejections to pre-existing technologies.
Section 103: Obviousness
Obviousness rejections under Section 103 for pre-existing technologies can be based on a combination of several prior art references, each of them teaching one or more aspects of the rejected claims. Overcoming an obviousness rejection can, therefore, be complex. Overcoming obviousness rejections often turns on arguments that focus on the context for the inventive process rather than on the technical features of an invention. These arguments, which include the invention’s commercial success, satisfying a long felt but unsolved needs, failure of others where the invention succeeds, and the appearance of unexpected results are often referred to as “secondary considerations.” The most effective way of overcoming obviousness rejections employing these secondary considerations requires early planning and foresight. Before the patent application directed to the new use of the pre-existing technology is drafted and filed, one should think about possible obviousness rejections the application might face and, when possible, design and conduct experiments to generate data that will help overcome these rejections.
Showing commercial success of an invention is one way of overcoming an obviousness rejection. In theory, if a product that is commercially successful was obvious to invent, then competitors likely would have already developed it. Therefore, if a product is commercially successful, one argument in overcoming obviousness is that others also recognized the product’s potential for commercial success but failed in their commercial attempts to develop a solution to the same problem. Including information showing a connection between the novel aspects of the patent claim(s) and the commercial success is often required in demonstrating non-obviousness based on commercial success.
Discussing complex hurdles
Another possible argument against obviousness is disclosing a prior, unappreciated problem or complex hurdle the inventors overcame in a non-obvious manner. In this situation, the inventors could point to wide-spread skepticism that a hurdle could not be overcome using known methodologies. Showing that the methodology for overcoming the hurdle or problem was unique can be a successful strategy when overcoming an obviousness challenge.
Failure of others
Yet another possible argument in overcoming an obviousness rejection is to show that previous studies either failed at developing the claimed invention or indicated the claimed invention would not work. In this situation, it is necessary to have a clear understanding of research in the space and point to any shortcomings. Including such shortcomings in a patent application can greatly help overcome obviousness rejections down the road.
Another strong argument in overcoming an obviousness rejection is by showing unexpected results. This can include data showing that the pre-existing drug has a surprising effect—that it works at the higher/lower dose used, that a combination of drugs demonstrates synergy when used together, or that it has a different mechanism of action for a new use—that would not have been expected based on what was known at the time. Such examples of unexpected results can greatly help to overcome obviousness rejections, and as such, designing experiments to help generate this data is important.
If the experiments to generate the above argument are not planned before the application is drafted and filed, they could still be conducted while the application is being prosecuted. Some countries, including the U.S., allow post-filing data to be submitted during prosecution. Post-filing data is that which is generated after the application is filed and thus not part of the originally-submitted application. Generating post-filing data is often worthwhile, especially when you cannot predict the kind of experiments or data that will be necessary to overcome a rejection.
Overall, overcoming novelty and obviousness rejections for repurposed technologies is not only possible, it can also offer a faster and more efficient way of bringing potentially valuable products to the market. To successfully obtain patent protection to the new product, be prepared to provide a lot of information. The more information you have about how the repurposed product was generated and how it differs from the previously-known versions, the better the chances are of overcoming possible rejections.
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