can you patent a combination of existing products

However, if the combination results in an unpredictable function/structure/benefit, satisfies a long-felt need, or benefits from a certain amount of commercial success, it may be patentable. Ann. 287, 856862 (1972). Nearly 24 months after KEYNOTE-426 publication, in March 2021, the CheckMate 9ER trial of cabozantinibnivolumab was published, demonstrating modest PFS and OS benefits44; FDA approval had occurred 6 weeks earlier45. Lancet Oncol. Once an example of patent activity meeting these criteria for one of the 54 drug combinations was identified, we proceeded to the subsequent drug combination. Combining two active drugs with different mechanisms of action will likely confer statistically and clinically significant PFS and OS benefit when compared to the third drug. Finally, disclosure of the shortcomings of clinical trial design is an absolutely necessary component in the desired goal of clinical care shared clinical decision-making. Obtaining a combination patent used to be more simplistic. Complicating interpretation of the mRCC VEGFIO trials still further, nearly all enrolled a substantial number of patients from countries where access to IO only occurs through clinical trials, increasing the likelihood that patients randomized to the sunitinib arms of these studies would never receive standard-of-care, second-line IO in the event of disease progression, and thereby overestimating the OS benefit of VEGFIO48. In truth, encouraging combination patents and RCTs that do not aim to identify unexpected results carries societal costs. 1 Answer Sorted by: 2 For the current rules governing Design Patents, refer to MPEP Chapter 16, Section 171: Whoever invents any new, original and ornamental design for an article of manufacture may obtain a patent therefor, subject to the conditions and requirements of this title. Pfizer v. Apotex. The work of examining patent applications is divided among various technology centers (TCs), each overseeing assigned fields of technology. In general, a design patent is obtained for the aesthetically appealing features of a product. Reasons Patent Your Invention in a Bad Economic? Oncol. Due to these issues, LEAP-008 cannot demonstrate an unexpected result. For the combination invention to be rewarded with a patent, the invention must alter or enhance the functionality of the two existing patents. Can you patent a product that is the combination of two existing items So too were sensors for computer-controlled throttles, and even sensors located on the pedal assembly rather than in the engine compartment. Let us examine an emerging combination therapy in oncology as a case example. Atkins, M. B. et al. *Note: for each of the 15 combinations where initial analysis did not yield any patents or patent applications meeting our criteria for inclusion, it remains possible that, within the thousands of claims in these patents or others, there exist ones that could be asserted for the purpose of evergreening the combination therapy. Patent process overview | USPTO Rini, B. I. et al. 2106-Patent Subject Matter Eligibility - United States Patent and Here is excerpt from an old article that sums up the basic requirements for a Design Patent. Novartis Pharms. Approach a patent agent or lawyer to learn more about combination patents in Canada and the patent application process. Importantly, none of the 24 eligible RCTs possess the three criteria needed to demonstrate an unexpected result that were derived above: randomization, sequential treatment with A and B as a comparator, and OS as the primary or co-primary endpoint. Incorporating review of the relative amounts of industry- versus non-industry-sponsored research activity occurring at a given cancer center in the NCI P30 grant renewal process may help to promote truly innovative research. Use of our services are governed by our Terms of Use and Privacy Policy. Clin. Is it appropriate to ask for an hourly compensation for take-home tasks which exceed a certain time limit? First, despite the publication of evidence demonstrating modest OS benefit with the addition of ramucirumab to docetaxel four years before its opening64, LEAP-008 fails to incorporate VEGF-inhibiting therapy in the comparator arm. The basic question remains whether an innovation is sufficiently novel and nonobvious to qualify for a patent, or is merely a combination of two existing patented inventions. "novel" and "non-obvious") use, then the combination of these patents can itself be patented. 11-CV-1846, May 14, 2012. which is from the ruling on the Apple vs. Samsung Electronics design patent infringement case. Thus, it is not eligible for a patent. Improvement Patent | Everything you Need to Know - UpCounsel Frei, E. III Cancer 18, 15801584 (1965). Courts have determined that for a result to be unexpected, it must differ from the POSITAs expected results in kind rather than degree16. ISSN 1546-1696 (online) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-plus-cabozantinib-advanced-renal-cell-carcinoma (2021). Basics of writing a patent claim for a patent application, Patent Marking: Everything you wanted to know, Can I Copy My Competitors Product? How to solve the coordinates containing points and vectors in the equation. How can this counterintiutive result with the Mahalanobis distance be explained? Specifically, if a product has been on the market for twenty years without modification, can an unrelated company obtain a design patent describing part of that product (or even exactly that product)? Such guidance for the USPTO is in the interests of both drug developers (by providing a measure of certainty) and the public (by enhancing the riskbenefit calculus of biomedical research). If the invention was obvious, it was not worthy of a patent. But a ruling from the U.S. Supreme Court altered that practice, making it slightly more difficult to obtain such a "combination patent." While all inventions start with an idea, not every idea can be called an invention. Med. Note, however, that each of the elements combined, if individually patented themselves, may prevent the combination from being practiced without a license. Now, I'm not claiming that this is an official test for novelty of a design patent, but if this is how infringement is tested, then it makes sense that the phrase would also apply to novelty tests of new designs. Only two of the lenvatinibpembrolizumab RCTs fail to utilize OS as a co-primary endpoint58,59. https://www.nccn.org/guidelines/category_1 (2020). There are two scenarios where you may try to patent something that already exists. This is a very interesting example, though extending it into a more general answer would help. Many are combinations of multiple existing inventions, all used to create something new. How do precise garbage collectors find roots in the stack? (15 May 2019); https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-avelumab-plus-axitinib-renal-cell-carcinoma. Can you patent the combination of two existing products? A majority of patents being granted today are improvements over an existing patent. Second, even if VEGFIO patents were to be invalidated in court, the time and expense required to challenge them often deters competitors from entering the market, interfering with the natural competitive forces expected to discipline high prices4. Site design / logo 2023 Stack Exchange Inc; user contributions licensed under CC BY-SA. TKI, tyrosine kinase inhibitor; IO, immunotherapy. US Food and Drug Administration. Thirteen of the 24 eligible RCTs employ comparator arms that include at least one drug from the VEGFIO combination. When is a patent extension application submitted and where is it submitted? In re: Soni. However, obtaining a combination patent isnt straightforward, for the reasons we have listed below. LEAP-008, however, incorporates a 4-week washout period, reducing the probability of observing this phenomenon in a sequential administration paradigm. 122, 718727 (2003). Does Prior Art apply to Design Patents, and can they be invalidated based on Prior Art? A determination of obviousness basically boils down to whether or not there is a sufficient difference from the previous invention and how it was crafted and whether the technology has been used prior and if the owner of the original patent would not find that new use predictable. Step 1 - Identify the new use or combination There are two scenarios where you may try to patent something that already exists. 36, 142145 (2018). Oncol. Take for example the iPhone. Importantly, the term invention goes beyond the notion of tinkering. Given the decades-long approach in oncology of combining drugs with different mechanisms of action, it would be obvious for a POSITA to consider combining these two therapies. As the most commonly used objective indicium for overcoming obviousness concerns is demonstration of an unexpected result, we asked whether the RCTs in the VEGFIO development space have the capacity to demonstrate an unexpected result, if one were to exist. United States Court of Appeals for the Federal Circuit, Case No. N. Engl. https://www.cancer.gov/about-nci/budget/fact-book/extramural-programs/cancer-centers (2019). Despite stratification on whether IO was a remote therapy or the immediate prior therapy, LEAP-008s ability to disentangle lenvatinibs relative contribution to the efficacy of lenvatinibpembrolizumab is likely to be limited due to only 45 patients receiving lenvatinib monotherapy. Design or utility patent? The FDA has the capacity to provide information about all registered clinical trials, fully informing the prior art and context that the USPTO requires to make its determinations. The content and materials presented on this site are for informational purposes only and should not be construed as legal advice. Combination therapy patents: a new front in evergreening, $${{{\mathrm{PFS}}}}_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{PFS}}}}_{{{\mathrm{A}}}}$$, $$PFS_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{PFS}}}}_{{{\mathrm{B}}}}$$, $${{{\mathrm{OS}}}}_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{OS}}}}_{{{\mathrm{A}}}}$$, $${{{\mathrm{OS}}}}_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{OS}}}}_{{{\mathrm{B}}}}$$, $${{{\mathrm{PFS}}}}_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{PFS}}}}_{{{{\mathrm{A}}}} \to {{{\mathrm{B}}}}}$$, $${{{\mathrm{PFS}}}}_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{PFS}}}}_{{{{\mathrm{B}}}} \to {{{\mathrm{A}}}}}$$, $${{{\mathrm{PFS}}}}_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{PFS}}}}_{{{\mathrm{C}}}}$$, $${{{\mathrm{PFS}}}}_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{PFS}}}}_{{{\mathrm{D}}}}$$, $${{{\mathrm{OS}}}}_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{OS}}}}_{{{\mathrm{C}}}}$$, $${{{\mathrm{OS}}}}_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{OS}}}}_{{{\mathrm{D}}}}$$, $${{{\mathrm{PFS}}}}_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{PFS}}}}_{{{\mathrm{E}}}}$$, $${{{\mathrm{PFS}}}}_{{{{\mathrm{A}}}} + {{{\mathrm{B}}}}} > {{{\mathrm{OS}}}}_{{{\mathrm{E}}}}$$, https://doi.org/10.1038/s41587-021-01137-6. Arranging existing things in a new way which provides a new benefit is patentable. Patent law gives inventors the ability to maintain exclusive control over their inventions for a certain period, typically 20 years, if they successfully obtain a patent from the U.S. Patent and Trademark Office (USPTO). Many a times, a great invention is a combination of two (or more) existing products. Obviousness, however, is determined by several other factors. The information on this site may be considered a lawyer referral service in some states. Resource for anyone trying to get a patent, product research or get a prototype for an idea. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvatinib-plus-pembrolizumab-advanced-renal-cell-carcinoma (2021). Combining a combination of two existing patents alone doesnt guarantee you a patent. Nat Biotechnol 39, 15041510 (2021). Motzer, R. J. et al. How to exactly find shift beween two functions? All Rights Reserved. The best answers are voted up and rise to the top, Not the answer you're looking for? Is your new use different than what the old invention was accomplishing? Consequently, the resulting patent claims may be entirely unpatentable, as the combination approach has long existed in the prior art and was obvious to try. Oncol. https://oncologypro.esmo.org/meeting-resources/esmo-virtual-congress-2020/leap-005-phase-ii-study-of-lenvatinib-len-plus-pembrolizumab-pembro-in-patients-pts-with-previously-treated-advanced-solid-tumours (2020). If A + B confers 12 months of survival while A B confers 6 months of survival, then combining A and B is clearly advantageous. What is the utility, function, or use of this patent? is an employee of the US Federal Government; the views expressed in this manuscript do not reflect the views of the US Federal Government and are his personal views. KSR Intl Co. v. Teleflex Inc. 550 US 398 (Justia, 2007).

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