Tag: pharma

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Patent Law Pharma

CPIP Scholars Examine the Flaws in the Term “Evergreening”

scientist looking through a microscopeIn their new paper, Evergreening of Pharmaceutical Exclusivity: Sorting Fact from Misunderstanding and Fiction, Professors Kristina Acri née Lybecker and Mark Schultz, along with CPIP John F. Witherspoon Legal Fellow David Lund, analyze how the term “evergreening” is used in the context of pharmaceuticals.

After sorting through the vagaries and rhetorical excesses that restrict meaningful discussion, they identify seven categories that capture typical uses of the term:

  • The assertion that the duration of existing patents can generally be “renewed” or “extended,” for very long or indefinite periods;
  • Obtaining additional patents related to a particular pharmaceutical or treatment;
  • The use of laws that allow patent owners to restore some portion of their term lost due to governmental delays;
  • The use of laws that give companies a limited term of exclusive time to market a drug;
  • Regulatory barriers that frustrate potential generic competitors’ ability to enter a market;
  • Business practices that largely rely on marketing to advantage innovators; and
  • Settling lawsuits with generic manufacturers that seek to invalidate a patent.

In addition to identifying practices claimed to be “evergreening,” this paper also discusses the impact and value of these practices. For most situations, the practices reflect specific policies that are having their desired effect, such as the increase in studies of drug safety and efficacy in children brought about by pediatric exclusivity. In some cases, the practices are simply legal impossibilities. Only in a few specific situations related to regulatory requirements do the authors observe strategic opportunities that could plausibly be considered problematic.

Because of the number of practices and the diversity of value those practices bring to pharmaceutical commercialization, the term obscures far more than it illuminates. Discussions about patents, exclusivities, and public health would benefit greatly from discussing the practices and policies specifically, rather than attempting to use a nebulous term such as “evergreening.”

The paper, which started as part of Professor Acri’s work through CPIP’s Thomas Edison Innovation Fellowship, can be found here. The abstract is copied below.

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Evergreening of Pharmaceutical Exclusivity: Sorting Fact from Misunderstanding and Fiction

Abstract

When people use the term “evergreening” to describe pharmaceutical industry practices, they typically display an unwarranted confidence that they know exactly what they mean both descriptively and normatively. However, a consistent and coherent definition of “evergreening” does not appear to exist.

This article surveys legal, academic, trade, and popular sources that use the term “evergreening” to develop a taxonomy of the policies and actions to which the term is applied. We find that the term is used to cover roughly seven categories of circumstances. Our review finds that the use of the term, taken as a whole, is more typified by the diversity of practices to which it applies rather than any consistent meaning. There are some commonalties, but they exist mostly at a general level.

We then analyze these seven categories to determine if the rhetoric matches the reality. Evergreening is most frequently used as a pejorative term, with a common implication that the “evergreener” is engaged in some sort of strategic behavior at least, or perhaps an immoral if not illegal practice. However, the categorical application of a pejorative term such as “evergreening” to any of the general policies and types of actions we examine is unwarranted and inappropriate. Proponents often apply the term to ordinary use of legal rights as they were designed and the concept makes no meaningful distinction between beneficial and problematic actions.

Unfortunately, “Evergreening” is a key concept in health policy that obscures far more than it illuminates. Once the term is stripped of misunderstandings and loose rhetoric, little of value remains. This is not to say that all policies and actions that extend or preserve exclusive rights are prudent or defensible in individual cases. Rather, the discussion regarding patents and public health would gain much clarity and rationality from addressing the disparate things labeled as “evergreening” on their individual merits.

To read the paper, please click here.

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Biotech Commercialization Conferences Copyright Innovation Intellectual Property Theory Inventors Uncategorized

The Common Economic Case for Patents and Copyrights

This is the second in a series of posts summarizing CPIP’s 2014 Fall Conference, “Common Ground: How Intellectual Property Unites Creators and Innovators.” The Conference was held at George Mason University School of Law on October 9-10, 2014.  Videos of the conference panels and keynote will be available soon.

The opening panel of CPIP’s 2014 Fall Conference examined the common economic case for patents and copyrights. Unfortunately, IP policy discussions often include a false narrative that intellectual property produces monopolies that harm innovation and economic growth.  The panelists, Troy Dow (Disney), Professor Stan Leibowitz (University of Texas at Dallas), Jon Santamauro (Abbvie), and Professor Jay Kesan (University of Illinois College of Law), highlighted how this narrative, in fact, ignores the essential role that intellectual property serves in enabling the creation, development, and commercialization of both inventions and creative works.

Kesan explained how patents provide economic benefits from both an ex-ante and ex-post perspective. Ex-ante, a strong patent system provides incentives to create, invest in R&D, and finance further innovation. While there are other ex-ante motivations to invent (such as a first mover advantage, the ability to secure trade secrets, and reputational advantages), Kesan argued that innovation is best facilitated ex-ante by a combination of all of these incentives plus the incentives created by patents. The ideal system incorporates a heterogeneous mix of these incentives to invent—in the absence of patents the level of disclosure decreases and innovation slows down.

Patents also provide numerous ex-post benefits. Patents facilitate coordination with producers and perform important signaling functions. They additionally allow for important private ordering by giving inventors increased control over who uses their invention and under what circumstances. In many industries, this is essential to collaboration, interoperability of products, and the aggregation of complementary benefits.

Jon Santamauro discussed the role of patents in the pharmaceutical industry. The exclusive property rights created by patents encourage R&D and serve as a crucial catalyst for new discoveries and businesses.  Patent protection is particularly important in the pharmaceutical industry due to the high-risk, lengthy, and costly process necessary to develop new, safe, and effective drugs.

Pharmaceutical companies developing new drugs screen thousands of potential compounds over 6-7 years of testing to gain FDA approval, at an average cost of about $1.2 billion per drug. The reasons for the high R&D costs?  Out of 10,000 initial molecules tested, only 6 go to clinical trials, and of these, only 1 is approved by the FDA for use in the healthcare market.  Of the 1 out of 10,000 drugs that make it to market, only 2 out of every 10 medicines produce enough revenues to recoup the initial high costs of R&D and also provide revenue to invest in more R&D. In short, pharmaceutical and biotech firms face very high risk—high R&D expenditures and very few market successes.  Strong IP protection helps offset this risk and encourages further investment and research.

Leibowitz explained that one of the primary criticisms of copyright—that it grants a monopoly, and that monopolies are intrinsically bad for society—is utterly thoughtless. A property right is, by definition, a monopoly of sorts. This criticism is an indictment of property rights on the whole, including real property rights.  This is even more inapt to copyright, as copyright does not restrict entry and does not provide an economic monopoly.

Leibowitz also addressed the common argument that IP isn’t necessary because inventors and creators would continue inventing and creating even if they didn’t get to own the fruits of their productive labors.  While some innovative and creative activity would undoubtedly continue, many innovators and creators do not simply create for creations sake. They need salaries (like everyone else), and strong IP rights allow them to capture the value of what they produce.

Finally, Troy Dow highlighted the benefits of strong copyright protection in the movie industry. Bringing a film to market involves substantial risks that many people do not appreciate.  He explained that studios perform the same market function as venture capitalists: they invest in  films at the birth of the original idea and then provide financing all the way through the final showing in movie theaters. This financing comes from banks, other investors, or other studios in order to spread the risk. Dow analogized a new film project to a new startup company, as each new film has its equivalent of a CEO (producer), COO (director), and thousands of employees and independent contractors.  And just as with startup companies, everyone must be paid before the film makes a single cent in revenue.

A single film can cost over $200 million to produce. While a particularly big hit can gross over $350 million after long-term distribution (including on-demand and DVD sales), only 4 out of every 10 movies recoup their investment at the box office. Copyright thus serves the vital function of making it possible for studios to make substantial, upfront investments with the hope of a return on this investment and a sufficient profit to reinvest in further film projects.

Disney’s IP is enormously valuable and is the dominant driver of their business. Even though only $6 billion of Disney’s $45 billion in revenues last year came directly from movie revenue, the movies, including the stories they tell, are at the heart of the Disney experience.  The movies form the basis for other products, media networks, theme parks, and licensing. A strong copyright regime allows studios like Disney to keep producing both creative works and the myriad other products and experiences that so many of us enjoy.

Together, the four panelists illustrated that the economic foundations of IP are equally applicable to the creative industries as they are to the innovation industries.  By securing for inventors and creators the value of their productive labors, IP provides the economic bedrock of our creative and innovative economy.