By: Shane Percival
Pharmaceutical companies are now in a global marathon to find an effective Coronavirus cure as soon as possible, one which can be quickly mass-produced and globally distributed. The questions on everyone’s minds seem to be:
- What happens if a COVID-19 vaccine is too expensive for most people to afford?
- If the vaccine is too expensive, can the U.S. Government intervene?
- If taxpayer money helped to fund research for a vaccine, does the public have any rights to the vaccine?
- Would a pharmaceutical company sell a Coronavirus cure at cost?
- How long will FDA & patent approval take for a Coronavirus cure or vaccine?
What Happens if the Winning Pharma Company Makes the Potential Coronavirus Cure Too Expensive for Most People to Afford?
Luckily, the United States laws allow the government to make sure those living within its borders can access patented technologies needed for the public good; for example, a patented vaccination or Coronavirus cure.
During the anthrax scare of 2001 to 2002, the U.S. government threatened to override the German pharmaceutical giant Bayer’s patent on its anthrax treatment drug Cipro. This would have allowed other pharmaceutical companies to produce generic copies of the drug and provide the U.S. government with the needed dosages of the treatment. Pressure from the U.S. government, coupled with bad global publicity forced Bayer to lower Cipro’s price and ramp up production to 200 million tablets over three months.
If the Vaccine is Too Expensive, Can the U.S. Government Intervene?
Yes. 28 USC § 1498 is frequently cited to enable federal agencies and third party government contractors to manufacture and/or use any invention without authorization from the patent holder without an obligation for prior negotiation with the patent holder. Many overseas governments have similar laws. So, if a company in possession of a COVID-19 vaccine fails to provide the vaccine for a reasonable cost, the U.S. & other governments could assert these laws to enable the use of the patented technology without recourse from the patent holder.
Given that the current administration is staunchly pro-corporation and anti-government interference in corporate responsibility, it remains to be seen whether this law would be implemented in the United States. Doing so would take the lawful right to manufacture a patent vaccine away from the company that validly obtained this right. It’s also unsure whether such a taking would be constitutional. If the U.S. government threatened to assert 28 USC § 1498 against a company that failed to lower the cost of a high-priced Coronavirus treatment drug or vaccine to ensure broad availability, something similar to the Bayer matter, above, may occur.
Related: New Injunction Policy Boosts Power Of Essential Patents
If Taxpayer Money Helped Fund Research for a Vaccine, Does the Public Have Any Rights to the Vaccine?
The Bayh–Dole Act from 1980 created a uniform patent policy among the many federal agencies that fund research, enabling small businesses and non-profit organizations, including universities, to retain title to inventions made under federally-funded research programs. One caveat of this system is that the government can obtain the rights to those patents. Specifically, the Bayh-Dole Act states that “the Government obtains sufficient rights in federally supported inventions to meet the Government’s needs and protect the public against nonuse or unreasonable use of inventions.” Under this law, if a company uses a federal grant to develop a successful Coronavirus drug or vaccine, the government can use such a drug or vaccine to benefit the public.
Would a Pharmaceutical Company Sell a Coronavirus Cure at Cost?
Johnson & Johnson, BARDA, and others have announced that, should they develop a Coronavirus vaccine or treatment medication, they intend to deliver such a product at a non-profit level.
Even with the potential billions of dollars that some of these companies are spending on the R&D for a vaccine, this makes sense. Wealthier nations can pay a reasonable price for the vaccine to recoup the cost, and countries that are unable to shoulder such a burden could obtain the treatment at a price they are also able to afford. Such a company could establish a worldwide brand affinity within a generation that would be difficult to detach.
Luckily, to help in this effort, there are patent pools that enable multiple parties to access COVID-19 vaccine research and access information related to individual experiments and drug trials. One such body is the International Federation of Pharmaceutical Manufacturers & Associations – a trade body where companies share their intellectual property with developing nations. These groups will help enable wealthy nations and emerging countries to access a successful COVID-19 vaccine for their populations.
How Long Will FDA & Patent Approval Take for a Coronavirus Cure or Vaccine?
The rapid pace of development and worldwide distribution of a Coronavirus cure or vaccination conflicts directly with the speed that typically occurs for FDA approval and obtaining an issued patent. For example, it now takes around an average of 22 months from the filing of a U.S. patent application to issuance of a U.S. patent. Furthermore, it can take up to eight years for a pharmaceutical company to do enough testing for complete approval from the U.S. Food and Drug Administration (FDA), as the FDA can ask for multiple tests, studies, and experiments to ensure that a drug is effective and safe for human use.
Given the above is in direct conflict with the speed in which a cure for the Coronavirus is needed, the United States Patent Office issued new rules prioritizing the examination of COVID-19 patent applications for small and micro-entities. Similar prioritization requests are available for large entities as well. Even with this prioritized examination, the time to obtain an issued patent for a prioritized application is around eight months to allowance and around 9-10 months to issuance.
Even with this prioritized process, a vaccine will likely begin distribution without the protection of an issued patent. Since only an issued patent can be enforced, even if the creator of a vaccine failed to provide the vaccine for a reasonable cost, it is likely that the owner of the vaccine would be initially unable to prevent others from making, using, offering to sell, and selling the vaccine under 35 USC § 271, which defines infringement of an issued patent under federal law.
As it remains to be seen who will win the race to the Coronavirus cure or vaccine, the laws surrounding the ability to prevent others from copying the developed product will play a large role in how and who develops and distributes the medication or vaccine.