Companies generally have two options when deciding what product to pursue and patent: develop a novel product from scratch or find an existing one and repurpose it. Repurposing existing technologies can offer viable opportunities for companies looking to expand their product portfolios since it eliminates many of the costs, time, and risk associated with developing de novo products.
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 drug 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.
New indications: To overcome the novelty hurdle, composition claims including pre-existing drugs need to include new elements not anticipated by the earlier disclosure. Such new elements could be, for instance, reciting new uses, such as a new indication. If the original claims were directed to a cancer indication, for instance, a novel use would be to claim a cardiovascular one. Such method claims are often difficult for competitors to design around, and they are also available in many foreign jurisdictions, although in slightly different formats. Other uses could include new dosage amounts, different formulations, better safety, better tolerability, new way of administration, and so forth.
New dosage forms: Another way to claim a previously-known drug is to claim novel pharmaceutical dosage forms. Pharmaceutical dosage forms can be, for instance, 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.
New combinations: Yet another 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. The combination product expired in 2018, about seven years after the expiration of one of its products.
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.”
Commercial success: 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.
Prior problems: 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.
Unexpected results: 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.
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.
Overall, overcoming novelty and obviousness rejections for repurposed products 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 for 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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BioPharma Law Blog posts updates and analyses on IP topics, FDA regulatory issues, emerging legal developments, and other news in the constantly evolving world of biotech, pharma, and medical devices.