Amgen submitted a
biologics license application (BLA) for evolocumab to the
FDA in August 2014. The FDA approved evolocumab injection on 27 August 2015, for some patients who are unable to get their LDL cholesterol under control with current treatment options. The European Commission approved it in July 2015. Evolocumab received approval from Health Canada on 10 September 2015. Amgen reported approval by Health Canada in a press release on 15 September 2015. Results of the FOURIER trial were published in March 2017. Results from FOURIER-OLE, an open-label follow-up study of 24% of the patients in the treatment arm of FOURIER, were published by Amgen in 2022. In 2022 a reanalysis of the FOURIER trial based on regulatory data found that cardiac mortality with evolocumab was higher than had been reported in the trial publication, with the authors calling for a full independent trial restoration of FOURIER. Overall cardiovascular mortality, which had been overreported, was found to be higher on evolocumab than on placebo, but the difference was not statistically significant.
Regeneron Pharmaceuticals and Amgen each filed for patent protection on their monoclonal antibodies against PCSK9 and the companies ended up in
patent litigation in the U.S. In March 2016, a
district court found that Regeneron's drug
alirocumab infringed Amgen's patents; Amgen then requested an
injunction barring Regeneron and Sanofi from marketing alirocumab, which was granted in January 2017. The judge gave Regeneron and Sanofi 30 days to appeal before the injunction went into effect. After several years of litigation, the patent dispute between Regeneron and Amgen was docketed by the
SCOTUS for March-April 2023 Other commentators believe that the
SCOTUS took the case because of the significance of the legal question, which was deemed comparable to the impact of
KSR v. Teleflex. Amgen's issued patents contained a so-called "functional genus claim," which defines an antibody by its
epitope, the specific target against which it binds. Although Amgen did discover the target
antigen, the antigen itself cannot be patented, because it is a product of nature (i.e. it was discovered rather than invented). However, Amgen was able to convince the USPTO to issue a patent that broadly claimed yet-unmade antibodies with a high affinity to the discovered antigen. Although there are many potential problems with such "functional genus" claims, the lower courts invalidated Amgen's broad claims based on the patent requirements for
sufficiency of disclosure. The
purposivism justification for disallowing such broad poorly-enabled claims is to allow other pharmaceutical companies to develop other (and potentially better) drugs that target the same antigen. However, the drawback of such narrow interpretation is the resulting reluctance of the antigen discoverers to share their findings with the world, because such early disclosure would prevent them from reaping the maximum profits from their discovery, which they could obtain by developing multiple medications and keeping them secret for many years. Such a dilemma is not unique to
biologics or to
pharmaceuticals, since the purpose of the patent system is to provide an incentive for earlier disclosure in the gambling game from discovery to market, that does not necessarily reward every participant according to their contribution, but encourages discoverers and inventors to play the gambling game nevertheless. == Society and culture ==