Innovation Fact of the Week: US Leads World in Period of Data Exclusivity For Biologic Medicine Innovators
(Editor’s Note: ITIF features an “Innovation Fact of the Week” in each edition of its weekly email newsletter and on Innovation Files.)
In addition to awarding patents to creators of novel biologic medicines, countries also mandate varying periods of intellectual property protection for the clinical test data on the drugs. This “data exclusivity,” as it is commonly known, helps ensure that creators of biologic medicines have sole rights for a certain period to all of the underlying IP necessary to make and market the drugs. Once the patent on the original compound expires, other manufacturers are free to produce similar drugs—and they are free to generate their own clinical trial data in the process—but, until the period of data exclusivity expires, they cannot use the original patent holder’s clinical trial data to prove the safety and efficacy of their new “biosimilar.”
This additional period of data exclusivity is important because it makes the economics of drug development work. It gives the innovator more time to market the drug and recoup the costs of developing it, which today can approach $3 billion for innovative biologics. The United States offers 12 full
A new NBER paper from Columbia University economist Frank Lichtenberg examines how pharmaceutical innovation correlates to fewer deaths among people with certain types of cancers. Fewer cancer patients died before the age of 75 if their particular type of cancer had experienced more medical innovation.
The basic message here is intuitive—new drugs and treatments save lives—but Lichtenberg does a good job of breaking down the costs and benefits. He estimates that medical innovation saved more than 100,000 years of aggregate life in Canada alone, at a cost of $2,730 per year based on the total spending for drugs to treat those forms of cancer.
Unfortunately, Lichtenberg does not factor in R&D costs for the discovery and development of these drugs. He does estimate the cost if the drugs had been brand name (versus the generics they are assumed to be), which comes out to $11,000. This is still significantly below estimates for the value of a year of life, and it is possible to assume that prices would be set by private companies high enough to recoup their research investments. This leaves only the question of public investments in R&D;
Today, the International Agency for Research on Cancer (IARC) has departed from the scientific consensus to declare glyphosate, the active ingredient in Roundup®, to be a class 2A “probable human carcinogen”. This contradicts a strong and long standing consensus supported by a vast array of data and real world experience, and comes from an organization that rarely addresses potential pesticide carcinogenicity, perhaps because the real concerns in this area are minimal, and lie elsewhere. The IARC statement is not the result of a thorough, considered and critical review of all the relevant data. It is beyond the pale.
A vast body of relevant information, including dozens of detailed genotoxicity, studies, animal bioassays, peer-reviewed publications and regulatory assessments, that show no evidence of carcinogenicity, and confirm its safety were presented to the IARC, but seem to have been ignored. On the other hand, witnesses report one paper so severely criticized and discredited that it was condemned by the scientific community and withdrawn by the publisher was actually taken on board by IARC.
That the IARC seems to have even considered such a fatally flawed and withdrawn paper
It appears that the global club of those who do not adequately appreciate intellectual property (IP) has gotten a new member: Ecuador. In the past few years the IP environment inside that small South American nation has deteriorated quite significantly, especially with regard to the protection of pharmaceuticals and biologics. And as the situation continues to worsen, those of us around the world paying attention are probably all thinking the same thing: You’re ruining it for everyone else.
Indeed, Ecuador’s weakening life sciences IP situation is just one of a long line of countries doing so around the world, including Canada, India, Nigeria, the Philippines, and South Africa. Ecuador’s decision to weaken its environment for life sciences IP risks perpetuating this global contagion effect. For example, since 2010 the nation’s main IP agency (responsible for ensuring IP rights, including enforcement and promotion) the Ecuadorian Intellectual Property Institute, has granted nine compulsory licenses (CLs) with 12 applications still pending. Six of those nine CLs were issued in 2014 alone, including one for Pfizer’s kidney and gastrointestinal cancer medication, Sutent. According to the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights
Intellectual property rights (IPRs) attempt to balance static and dynamic efficiency. By allowing innovators to appropriate a greater share of the value generated from their ideas, IPRs can create incentives for investment in research and development (R&D). With regard to pharmaceuticals for developing countries, incentives for drug development are critical, since many diseases prevalent in developing countries lack appropriate treatments. However, those in the global health community often allege that prices of new innovative drugs under patent make them unaffordable to most people in developing countries because of the absence of generic competition.
Thus, understanding the effects of IPRs on access and affordability are important for researchers, policymakers, and firms. In December 2014, Margaret Kyle and Yi Qian published a new paper investigating this with the National Bureau of Economic Research. Titled Intellectual Property Rights and Access to Innovation: Evidence from TRIPS, the authors examine the effect of pharmaceutical patent protection on the speed of drug launch, price, and quantity in 60 countries from 2000-2013.
The paper begins by noting that though the introduction of IPRs is an endogenous decision taken by policy makers, developing countries were required by
In 1997, the late Carl Sagan published a book titled “The Demon-Haunted World: Science as a Candle in the Dark.” It is an eloquent paen to the power of science and critical thinking to free humans from the demons of darkness and superstition. In it, he described one of his greatest fears:
I have a foreboding of an America in my children’s or grandchildren’s time — when the United States is a service and information economy; when nearly all the manufacturing industries have slipped away to other countries; when awesome technological powers are in the hands of a very few, and no one representing the public interest can even grasp the issues… when, clutching our crystals and nervously consulting our horoscopes, our critical faculties in decline, unable to distinguish between what feels good and what’s true, we slide, almost without noticing, back into superstition and darkness…
That day may be upon us.
According to the Los Angeles Times, “The Los Angeles City Council voted in late October to draft an ordinance that would prohibit the sale or planting of GM seeds and plants.
One individual in Los Angeles who
Consumers Union Makes False Claims Against the Safety of Genetically Modified Foods Based On Ideology Not Science
The ideologically driven, anti-technology campaign to restrict access to safe, sustainable and affordable foods improved through biotechnology got a boost when Vermont Governor Pete Shumlin signed into law a new measure that mandates the labeling of foods modified through genetic engineering sold in Vermont.
This campaign in support of the law is based on financial self interest and fear, not on reasoned policy designed to inform and protect consumers. Since other states are considering similar laws based on the same faulty reasoning, a detailed consideration of the argument is timely. To test the misleading statements and mischaracterizations of the labling campaigners I present testimony below from Michael Hansen, Ph.D., Senior Scientist with the Consumers Union. This testimony was presented as part of the New York State Assembly Standing Committee on Consumer Affairs and Protection’s Public Hearing on the Use of Biotechnology in Foods and the Effects on Consumers at Lehman College, on Tuesday, July 30, 2013. I include Hansen’s statements on GMOs and provide a factual analysis with documentation correcting his false and inaccurate claims.
The italicized portions below are statements by Assembly Members or by Michael Hansen. Some of
A March 3, 2014 story from Reuters by Carey Gillam presents claims by organic farmers that the federal government needs to step in to prevent “contamination” of their fields. So what is the problem that has organic growers hunting for help?
According to the press release uncritically recycled by Reuters, “Growing crops free from contamination by genetically modified crops and the pesticides used on those biotech versions is getting more difficult and more costly for U.S. farmers, and new government rules to control contamination are needed, according to [sic] report… by an environmental organization and an organic food group.”
The first problem with the story is the use of the term “contamination.” What does it mean to “contaminate” something? According to Merriam-Webster, to “contaminate” means “to make something dangerous, dirty, or impure by adding something harmful or undesirable to it.” So is it the right word to use in this context?
Farming is not a sterile endeavor. Farmers literally work in the dirt, and try as they might, it can be a very messy business. Harvests invariably reflect this truth, and nobody who’s ever spent any time on
“This is a peer-reviewed study!”
In the increasingly heated battles waged lately by crusaders against innovation in agriculture, such assertions are increasingly thrown down like a gauntlet. The intent is to negate findings by regulators and scientists around the world that crops and foods improved through biotechnology are safe. These advocates argue passionately that “paper X”, published in a scientific journal after being reviewed by anonymous scientists and an editor, is sufficient to overturn the findings of hundreds of previously published reports (see http://www.biofortified.org/genera/guide/) to say nothing of the vast experience accumulated through the consumption of trillions of meals derived from biotech improved crops since they first entered the marketplace in the mid 1990s. When these papers are criticized by scientists post-publication, cries of censorship and persecution inevitably arise, and are routinely coupled with claims that the critics are bought and paid for by vested corporate interests (see http://www.infiniteunknown.net/2012/12/17/smelling-a-corporate-rat-%E2%80%93-the-move-to-suppress-seralini-gmo-study/ and http://www.globalresearch.ca/gmo-researchers-attacked-evidence-denied-and-a-population-at-risk/5305324). But the noisemakers overlook something fundamental about the culture of science: where they thought peer review ended -is really where it gets going.
Peer Review – What is it?
Like so much of Western thought, the idea
Budget proposals – Presidential or Congressional – too often are more political Kabuki than serious policy, and the risk of smoke and mirrors is directly proportional to budget pressure. It is therefore a pleasant surprise to find in the President’s most recent budget proposal for the U.S. Department of Agriculture less theater than past experience would predict, as well as some genuinely sound policy.
ITIF has pointed out the sizeable discrepancy between present levels of support for agricultural research and development and those that would be commensurate to addressing the challenges facing agriculture over the next 40 years. We estimate that to meet the dual stresses of population growth and climate change on food production, existing agricultural research budgets should be tripled and focused on basic research and innovation that can drastically improve crop productivity and resiliency. This is the only way we will be able to meet food demand, which is expected to double by 2050.
The President’s budget proposal takes a significant step in the right direction by increasing funds for competitive grants in agricultural research by 45% over 2012 levels. In a time when the overall budget