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Patent Docs: Copyright law threats to U.S. drug innovation
One of the powers of Congress conferred by the Constitution is to grant copyright and patent protection; these powers are enumerated in the same part of Article I, specifically in Section 8, Clause 8:
To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.
This coincidence of these powers has raised questions of whether development of the law in one area can affect the law in the other; for example, with regard to concepts such as exhaustion and extraterritoriality. Both of these issues arose in the copyright case of Kirtsaeng v John Wiley & Sons decided by the U.S. Supreme Court last term; while the immediate effect of this decision on patent law was unclear, recent developments may make the case very relevant and very dangerous for continued pharmaceutical innovation.
Briefly, the case involved a copyright infringement action brought by Wiley against a Thailand national, Supap Kirtsaeng, who was studying in the United States and arranged to have copies of textbooks sold in Thailand sent to him by his relatives for resale in the United States. Because Wiley (like many U.S. publishers) sells the same textbook at a much lower price in countries like Thailand than they cost in the states, Kirtsaeng was able to sell the books sent to him from abroad on eBay, ultimately making $1.2 million in revenues. Although Wiley prevailed in the lower courts, the Supreme Court reversed, on the grounds that the “first sale doctrine” permitted resale of legally obtained copyrighted works without obtaining the copyright owner's permission, and that U.S. copyright law, and the notice on the textbooks purchased in Thailand that they were only authorized for sale outside the U.S., did not mandate a different outcome. (Not unexpectedly, Wiley increased the cost of its textbooks sold abroad after this decision.)
This case has clear implications for branded drugs, which are often sold outside the U.S. for less than the same drugs costs at home; at least some of these cost differences are the result of foreign governments imposing price caps and otherwise regulating the cost of branded drugs. This is not a phenomenon limited to developing or Third World countries: many European countries having a nationalized healthcare system also have varying levels of cost controls for branded drugs, along with regimes for generic versions of these drugs after expiration of some term of exclusivity for the branded versions. And many countries, such as Brazil, China, India, Russia and Thailand, have relied upon international treaty provisions (such as the Doha Declaration under the auspices of the World Trade Organization) to provide government-subsidized generic versions of branded drugs at prices much lower than the prevailing price in Western countries. These differences in costs have not affected U.S. prices because, unlike textbooks, branded drugs cannot be reimported into the U.S. under FDA regulations and U.S. law.
That may be changing, however, in view of a New York Times report recently on bipartisan efforts to reduce drug prices by permitting reimportation. The Times reports, in an article by Elisabeth Rosenthal, that Sen. Amy Klobuchar (D-MN) is planning to revive a prior bill that would permit reimportation from Canada, a country whose national health service regulates the price of branded and generic drugs. She is supported in these efforts by Sen. John McCain (R-AZ), and undoubtedly other senators will join in the effort. The impetus for action now, according to Rosenthal, is not that branded drug prices are high (although there is certainly concern about the price of some drugs, particularly biologic drugs directed towards intractable diseases like cancer); rather, it is the rising price of generic drugs that has raised concerns.
A panel of the Senate Subcommittee on Primary Health and Aging chaired by Sen. Bernie Sanders (I-VT) investigated the issue, hearing from Prof. Stephen Schondelmeyer of the University of Minnesota, Dr. Aaron Kesselheim of the Harvard Medical School and Rob Frankil, who testified on behalf of the National Community Pharmacists Association who had requested congressional action. (Three generic drug company executives declined the panel's invitation to testify, according to the Times report.) The testimony included reports of generic drug costs increasing by about 8,000 percent (i.e., 80-fold, for doxycycline) and over 300 percent for 10 other generic drugs.
These increases are recent (over the past few months), and the causes attributed to the increases range from shortages in active pharmaceutical ingredient supplies, manufacturing problems and consolidation of drug companies by mergers and acquisitions. As can be expected, the Senate panel heard calls for greater government regulation and application of drug rebate requirements to Medicare and Medicaid to apply to generic drugs, just as they now apply to branded drugs.
More troubling in the long term is the solution proposed by Senator Klobuchar, allowing importation from Canada; Maine is already permitting its residents to purchase some drugs from Canada, Great Britain, Australia and New Zealand, in contravention of U.S. law. The crisis in the cost of generic drugs has made this solution particularly attractive, because paradoxically, the cost of a generic version of a drug in the United States can be higher than the cost of the branded drug in Canada. The Times article illustrated this situation for digoxin, where a 90-day supply of the generic drug costs $187 in New York while the same amount of the branded version, sold as Lanoxin, costs $24.30 in Canada. The comparisons are similar for an inflammatory bowel disease drug ($1,625 for the generic in the U.S., $155.70 for the branded version in Canada) and the cholesterol drug Pravachol ($230 U.S. generic/$31.50 branded Canadian). With these differential costs, plans permitting branded drug reimportation have begun to have political force, reinforced by the aging of the population where more people will be covered by Medicare and costs to the government will rise accordingly.
If successful, these efforts will create a situation akin to the consequences of the Kirtsaeng case in the copyright arena. Here, however, innovator drug companies will not have the option, exercised by Wiley, of increasing prices abroad to make reimportation less economically attractive. The prevalence of ANDA litigation in the U.S. over the past 30 years is one indication of the importance of exclusivity, and the attendant profits that result from exclusivity, to pharmaceutical innovation. Should those profits decrease significantly, the return on investment (ROI) for innovator drugs will fall, and the calculus of investment that supports new drug development will be affected unpredictably (but not positively; the unpredictability resides in how much the ROI will change and how that will affect investment decisions). A common criticism aimed at branded drugmakers is the frequency with which they develop “me too” and next-generation versions of already-marketed drugs rather than create innovative new treatments and therapies. The same uncertainties in drug development that make such behavior sound economically also impact the decision to develop new drugs, and policies that reduce ROI for such new drugs (which bear the greatest economic risk) are unlikely to promote innovation.
Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/.