Behold the Prior Art: A (Patentable) Solution to the COVID-19 Pandemic?

In his (perhaps, what will one day be a) seminal report on the results of a clinical trial, Dr. Didier Raoult and colleagues reported that after six days of administering hydroxychloroquine combined with azithromycin, 100% of patients infected with COVID-19 were “virologicaly cured,” compared with 57.1% who were treated with hydroxychloroquine only. In the control group (those not receiving the treatment), only 12.5% of patients did not show signs of the disease after Day 6.[1] The report stated that preliminary results suggested a “synergistic effect of the combination of hydroxychloroquine and azithromycin.”

Like many inventors before him, Dr. Raoult may have found that certain elements in the “prior art,” when combined, result in an ingenious (and maybe patentable) solution to a problem – – in this case, an enormous worldwide problem. So let’s look at some of the uses of hydroxychloroquine (“HCQ”) and azithromycin (“AZM”) in the prior art.

U.S. Patent No. 5,314,894 (“the ‘894 Patent”) recognizes that HCQ was used as an antimalarial agent, and also to treat rheumatoid arthritis and lupus. The ‘894 Patent discovered a safer method for HCQ to treat these diseases by removing from it a constituent that was found to cause adverse reactions. The ‘894 Patent issued with claims to the “composition of matter,” that is, to HCQ without the constituent causing the adverse reactions, and with claims to the method of treating these diseases with the “new and improved” HCQ.

U.S. Patent No. 8,575,195 (“the ‘195 Patent”) took the use of HCQ for treating disease one step further – – it claimed a method of treating the hepatitis C virus. The HCQ identified in the method of treatment claims drew from the prior art – – they included use of the HCQ composition claimed in the ‘894 Patent.

AZM, as noted in U.S. Patent No.7,067,493 (“the ‘493 Patent”), is an antimicrobial compound derived from erythromycin. AZM was discovered by the inventors of U.S. Patent Nos. 4,474,768 and 4,517,359, which disclose that AZM and certain derivatives have antibacterial properties and are used as antibiotics. In particular, as the ‘493 Patent notes, AZM is administered for the treatment of infections, particularly, respiratory infections and more particularly, respiratory infections of the bronchial tract, lungs, sinus, and the middle ear. The ‘493 Patent claims a method of treatment of middle ear infection.

A companion to the ‘493 Patent, U.S. Reissued Patent No. RE39,149 claims a method for treating a microbial infection.

Section 101 of the Patent Act (35 U.S.C. §101) provides, among other things, that whoever invents or discovers “any new and useful process,” or “any new and useful improvement thereof,” may obtain a patent subject to meeting the conditions of patentability.

A “process” includes a method of treatment of a disease, and a method of treatment is patent-eligible. Illumina, Inc. v. Ariosa Diagnostics, Inc., 2020 U.S. App. LEXIS 8327 at *9 (Fed. Cir. March 17, 2020). And it is well recognized in patent law that two or more things existing in the prior art, when combined, may qualify as “new” (one of the conditions of Section 101) and “non-obvious” (a condition of Section 103). See In re Kahn, 441 F.3d 977, 986 (Fed. Cir. 2006) (“Most inventions arise from a combination of old elements and each element may often be found in the prior art.”).

To be sure, the question of the patentability of the combination of HCQ and AZM to formulate a method of treatment of COVID-19 patients is quite secondary to the question of the combination’s efficacy in treating the disease. But if the “synergistic effect” found by Dr. Raoult in the combination of prior art HCQ with prior art AZM is the solution the world waits for, it is just one more example of how our patent system encourages inventors to look to yesterday’s experience to solve today’s problems.

[1] See Gautret, et. al. (2020) Hydroxychloroquine and azithromycin as a treatment of COVID-19; results of an open-label non-randomized clinical trial, International Journal of Antimicrobial Agents – in Press 17 March 2020 – DOI; 10.1016/j.ijantimicag.2020.105949.