Ebola in America: The Double-Edged Sword of Government Patents and Vaccines
The Ebola outbreaks in Western Africa over the past few months have resulted in a lot of attention being paid to vaccination practices, in particular compulsory vaccinations for infectious diseases deemed to be the most dangerous. According to Robert Wolfe and Lisa Sharp (2002):
Vaccination is unique among de facto mandatory requirements in the modern era, requiring individuals to accept the injection of a medicine or medicinal agent into their bodies, and it has provoked a spirited opposition. This opposition began with the first vaccinations, has not ceased, and probably never will. …A passive reaction could be construed as endangering the health of society, whereas a heavy-handed approach can threaten the values of individual liberty and freedom of expression that we cherish.
This speaks to the debate that presents an ongoing conundrum for both the pharmaceutical industry and the U.S. Government. On one side are those who criticize the Government for its failure to provide public health services, vaccines and therapeutics to needed areas in foreign countries, and chide companies for not releasing unapproved medical countermeasures (MCMs) (or for charging hefty prices for those already commercialized). On the other side are those who claim that the Government is exploiting underdeveloped countries and harvesting bodies in order to profit (in partnership with “Big Pharma”) from MCM development, going as far as to accuse them of deliberately infecting populations and licensing “Little Pharma” to do so covertly. These scenarios paint a grim picture of our society and perpetual “damned if we do, damned if we don’t” situation, and do nothing to solve the problem at hand.
Mike Adams falls into the latter camp. ‘The Health Ranger,’ as he is known, often provides relevant insights into food, health and other issues through his own laboratory evaluations, but an article he recently posted on his blog entitled Why does the CDC own a patent on Ebola ‘invention?’ falls short.
The patent Adam’s refers to is No. CA2741523A1, only it is an application for a patent that was published in 2010, and not an award notice. According to the USPTO, the invention provides “compositions and methods including and related to the Ebola Bundibugyo virus (EboBun),” specifically those based upon the isolation and identification of this new human Ebola (hEbola) virus species, which “was isolated from the patients suffering from hemorrhagic fever in a recent outbreak in Uganda.” To note, this is not the same Ebola virus responsible for the current pandemic concern.
Adams’ failure to examine more deeply the issues and concerns regarding the control of highly infectious diseases fuels numerous faulty assertions. Some of these do contain facts. However, most are taken out of context to support an apparent belief that a conspiracy exists by the U.S. Government to harvest virus material in order to make shady deals with pharmaceutical companies it somehow stands to profit financially from when the specter of an outbreak is raised, during which time the public would be subject to mandatory vaccinations against the patented disease organism.
Regarding the Claim that the U.S. Government “Invented” an Ebola virus
There is first a misrepresentation of the facts based on the language used in the patent application as interpreted by Mr. Adams. As the patent summary states, “The invention provides the isolated human Ebola (hEbola) viruses …deposited with the Centers for Disease Control and Prevention.” The CDC does not claim to have literally invented the EboBun virus, which would imply that the CDC deliberately applied genetic engineering to make a new virus. Rather, the invention describes a combination of the discovered viral composition and methods created to enable its isolation and identification, along with a stock of the propagated EboBun itself from these processes.
Why does the CDC need a patent for the Ebola variant?
Adams is right to assert that to understand why the government is filing for patent protection on EboBun requires that one understand what a patent really is and why it exists. The problem is that Mr. Adams’ article conveys limited understanding of how the action applies to this particular circumstance. He notes that a patent allows its owner to “exclusively profit from the ‘invention’ or deny others the ability to exploit the invention for their own profit,” but incorrectly assumes exclusivity and does not recognize that “profit” refers as much to “benefit” in the broader context as it does financial gain. Moreover, Adams fails to examine the latter part of his own definition, which actually points to why the federal government might seek patent protection for an Ebola variant.
Ebola is considered a Category A priority pathogen by the U.S. Government, meaning that it is deemed to pose the greatest risk to national security and public health. As such, obtaining a patent for EboBun would allow the CDC and U.S. Government to exercise some degree of control over how a highly infectious disease agent like Ebola might be discovered and used by parties having malicious intent, and grant them some legal backing to enable them to take action against patent violators. Considering that the biggest criticism of the Biological Weapons Convention is its lack of an enforcement mechanism for non-compliance, one would think the CDC patent action is a rather prudent, even if imperfect, step toward a solution.
The allocation of patent rights funded by federal R&D funds among the government, government employees, universities, university employees and government contractors and subcontractors is a complex determination controlled by federal laws, executive orders, federal acquisition regulations, and the regulations and policies of over 25 government agencies. Executive Order 10096, recorded in 1950, provides the guidelines for allocating most of these patent rights. The actual process of allocation, however, requires the resolution of complicated issues, including when the invention was created, the official duties of a government employee inventor, and whether or not it is inequitable for the government to obtain title. The final determination of the government’s rights to inventions of its employees accordingly requires the factual circumstances of each case to be evaluated in view of EO 10096 as applied by the various agencies and as interpreted by the courts.
Click here to read a comprehensive summary of patent rights in federal funding of R&D.
In the above summary, Herbert Zeh of the law firm Eckert Seamans Cherin & Mellott notes an exception to the standard procurement contract terms for granting licenses, as several governmental agencies like the Department of Defense, the Department of Energy and NASA have statutory prohibitions against private business organizations (except small businesses) obtaining title to inventions developed with federal funds. Accordingly, the World Intellectual Property Organization (WIPO) notes that it is common for a government to allow third parties to exploit an invention on its behalf in the public interest, typically occurring in one of three fields: national defense, national economy and public health. Licenses for them are then granted under any number of conditions, for example: that they be exclusive; that the patent owner be paid adequate remuneration based on the circumstances; and that they only be granted for the duration of the requirement (e.g. a deemed emergency). [See the WIPO Intellectual Property Handbook: Policy, Law and Use sections 2.100, 2.155, and 2.160]
The “profit” or “benefit” that drives CDC patenting of EboBun and other Select Agents is thus primarily to the public, rather than “the Government” (except, for example, to recoup and/or re-invest federal funds into R&D). Mr. Adams might have had a worthy argument if he had instead been targeting a pharmaceutical company for attempting to create and patent the same.
Does the CDC hope to collect a royalty on Ebola vaccines?
Royalties are income generated from the licensing of Federal intellectual property, so even if the CDC did plan to collect a royalty on Ebola vaccines, it would be common practice.
With the exception of certain circumstances and agencies as highlighted by Zeh and according to the Technology Transfer Handbook of the United States Geological Survey, a scientific agency of the U.S. Government,
…if an inventor’s patent or intellectual property is licensed by the Department for use, manufacture or sale, a licensing agreement will be developed between the owner of the patent (the Government) and the licensee (usually a private company). The licensing agreement will outline royalty payments to be made by the licensee to the Department.
Royalty income from inventions under the USGS in particular are payable to the inventor(s) if the inventor was employed by the agency at the time of the invention. They continue for as long as payments from the license holder continue to be made, regardless of the eventual employment status of the employee. If an invention is licensed for commercial use and royalty or other income results, USGS inventors are entitled to the first $2,000 in royalties and a minimum of 15% of the income collected per year by the agency. Notably, these payments cannot exceed $150,000 per year without Presidential approval.
It is also worth noting that in 1980, the U.S. Congress passed the Bayh-Dole Act. Rather than support government manipulation of the economy, as Mr. Adams’ article might imply, it was actually passed to provide uniformity in the patent and licensing process among the various government agencies. Universities, nonprofit organizations and small businesses could now more easily obtain title to patents developed with federal funding.
While many in the R&D community enthusiastically welcomed this Act, its critics questioned how much benefit the economy received as opposed to individuals and shareholders. The exact numbers of products that made it to market based on government-held patents that been commercially licensed is unknown. Regardless, their low estimates relative to the actual number of patents held (nearly 30,000 at the time) leads to the reasonable conclusion that the government had seen little return on its investment of billions of dollars in public funds for R&D that went to non-public institutions.
Is the CDC looking to “invent” more variants and patent those too?
Again, the patent does not provide for invented “variants” of the EboBun virus, but rather for various nucleotide sequences and laboratory processes for isolating and identifying the virus. If the U.S. Government and its partners in the global public health sector are able to determine methods to successfully isolate, identify and develop medical countermeasures for other such viral variants in the public interest, then I am confident they will. Why wouldn’t they?
Why would the U.S. Government Risk Bringing Infected Patients into the U.S. if they did not intend to start an Outbreak?
The Government’s decision to bring Ebola patients to the U.S. was alarming to many, eliciting responses akin to that of Donald Trump in his 31 July ‘Tweet’. However, most of the general public’s knowledge of Ebola comes from popular culture, in particular from movies like Outbreak with Dustin Hoffman. What viewers may have missed, however, is that in that movie, the disease became most contagious after it mutated into a form of the virus that could remain viable outside of its host. Recall when Hoffman’s character traveled to Zaire with Cuba Gooding Jr.’s character to investigate the mysterious Motaba Virus? The latter ended up removing his mask after vomiting upon seeing the hemorrhaging bodies, only to be calmed by a local man, “Benjamin Iwabi,” who appeared proclaiming, “Don’t worry. It’s not airborne.”
The public health community’s understanding of Ebola and confidence in American medical resources relative to those available in Africa led the U.S. Government and officials at Emory University to conclude that they could safely bring Dr. Kent Brantly–the American scientist infected during the current outbreak–home. Regardless of whether people know the biomedical facts regarding Ebola, however, it is fear of the unknown that gives the public reason to be concerned about the transport of infected persons into the United States. Perhaps, as Dr. Howard Markel asserts in his 2013 article published in the New England Journal of Medicine, it’s time for Congress to re-calibrate Bayh–Dole.
Profits and patents can be powerful incentives for scientists, business people, and universities, but new and ongoing risks—including high prices that limit access to lifesaving technologies, reduced sharing of scientific data, marked shifts of focus from basic to applied research, and conflicts of interests for doctors and academic medical centers—should be mitigated or averted through revisions of the law.
More importantly, as ‘new’ risks include those associated with potential pandemic diseases like those that have emerged in recent years, it is prudent to consider other reasons to be concerned. For now, how do we address both the growing lack of public trust of the government when it comes to public health, and the ongoing lack of public knowledge about health science and their role in mitigating the spread of infectious disease?
In examining this issue, we must also consider how we control infectious disease knowledge and products to prevent their malicious exploitation, yet simultaneously refrain from limiting scientific and economic freedoms that benefit society. No single individual is ever 100% protected against a novel infectious disease, so it is in the best interest of all to work toward common solutions. Corporate greed and government secrecy surely don’t solve the problem, but neither does alarmism.
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