Innovation Incentives Part 3: Combining Innovation Index and Product Cluster Models

Understanding the Consequences of Linking Market and Regulatory Incentives for Drug Development: Part 3

Editor's note: This is the third installment of a three-part series.

In Parts 1 and 2, we learned that it is both possible and valuable to import empirical scientific methods typically used in the hard sciences to the study of law. In fact, in our analysis of patent law and policy we can move beyond patent valuation to assess how and indeed whether a given piece of law or policy is working in conjunction to its so-called original policy intent. This includes the assessment of innovation within the context of the patent bargain, and whether governments that have accepted linkage laws are being rewarded in their twin policy goals of producing more new and innovative drugs and facilitating timely generic entry. Put another way, can we assess using the new tools of empirical legal research whether, as Senator Hatch put it at the time the U.S. linkage legislation came into force, the public is in fact “receiving the best of both worlds - cheaper drugs today and better drugs tomorrow.”

We can attempt to address this possibility using the innovation index discussed in Part 2 in combination with 3-D spatiotemporal models such as those used in the medical sciences. Over the last few decades, these models have been used increasingly for studying protein, DNA, RNA, and other structure-function relationships, including using x-ray and other crystallography techniques. Consistent with their use in medicine, 3-D legal models can be used to construct data for both descriptive (structural) and prescriptive (functional) law-making and law-reform purposes.

Read the rest of this post . . . .For example, in our Northwestern study, we developed a 2-D model of identifying patents in relation to “new and innovative” drugs and “follow-on” drugs that tracked the functional and temporal evolution of drug forms and associated patents over time. The example below is for the combination of Salmeterol and Fluticasone into one of several available forms of Advair®. We referred to this technique as a “patent tree” method and used it specifically to identify legally-related drug forms, associated patents, and patent types.

Fig. 1. Example of Convergent Patent Tree Analysis for Forth Generation Product Advair Diskus.®Patents were identified using the specific and general search strings described in our Berkeley study. In addition to quantifying patents per drug, the patent tree method allows assessment of how specific drugs evolve into related drug forms or (in this case) drug products representing combinations of known drugs. In addition, the patent tree analysis allows for identification of relevant patent types based on the classification nomenclature described in the Northwestern study. Finally, the patent tree analysis provides data relating to drug development, but also on the type of patents selected by pharmaceutical companies for listing on the patent register in order to prevent generic entry.

This method can be extended, as shown below, to identify “product clusters.” In particular, the patent tree method can easily be expanded to include patents listed on the patent register under linkage law, and a diagonally increasing axis of cumulative spatiotemporal growth. The resulting model represents a constellation of legally and functionally related new and follow-on drug forms and regulatory approvals, patents associated with these drug forms, the fraction of total patents listed on the patent register in order to slow down generic entry under linkage laws, and how each of the data classes relate to one another over time.

Fig. 2 Product Cluster-Based Model of Drug Development.Product clusters begin at some point in time with the first new and innovative drug (●; NCE) and associated originating patent (●). With time, and vetting by the market and regulators, further follow-on drug approvals (●) and patents (●) are granted within the cluster, and an increasing number of these patents are listed on the patent register (●). Listed patents can be used increasingly over time to prohibit generic entry not only on the originating new and innovative drug, but also on all drugs in the cluster that are deemed under law to be relevant to the originating drug.

We are now in a position to take our 2-D product cluster model above, first reported in 2011, and combine it with the innovation index depicted in Part 2 of this series, reproduced below for convenience.

Fig. 3. Innovation Index Data for Total Approval Cohort. Bar graphs showing the number of total approvals expressed as a function of the level of innovation (LOI) before (a) and after (b) of generic approval data. c Brand approvals expressed as a function of LOI. Solid line is a fit of the data to a single exponential function. d Cumulative normalized brand approvals expressed as a function of LOI. Solid line is fit using a sigmoidal function.

The combination of the drug nomenclature, product cluster and innovation index described in Fig. 4 yields a potentially new way of looking at the impact of regulatory and market incentives on drug development by multinational firms, As shown clearly by the data in the Boston study, this clearly includes both brand-name firms and generic firms, as both are pursuing cluster-based models of drug development. The resulting analytical model focuses on drug development driven by purposeful policy, and cumulative vetting of serial products by regulators and the market.

Described in detail in a forthcoming book, drug clusters denoted ‘on deck’, ‘at bat’, and ‘home run’ represent a theoretical mock-up of how drug clusters grow in time from a spatiotemporal perspective. In this model, product-patent clusters begin their life as single-drug products or small groupings at the most innovative end of the index and, with increased vetting of products in the cluster over time by regulators and the market grow in scope to encompass an increasing number of products and patents. As this occurs, the cluster may be anticipated to ‘swing up and to the left’ of the innovation index, moving from a high level of innovation with a low number of patents and listed patents to first a moderate and then a much lower level of innovation but with greater spatiotemporal characteristics. The model shown here is for 2,087 drug approvals over an eight year study period; similar results have been obtained using patents and chemical components.

Fig. 4. Combining Innovation Index and Product Cluster Models to Study Portfolio-Based Drug Development and Hedging.Product clusters are hypothesized to begin life at the most innovative end of the spectrum, with few patents and a small or negligible number of listed patents. Over time, and increased vetting by regulators and the market, the cluster expands to include more products, patents and listed patents but, as a whole becomes less and less innovative. The desired end point (the “home run”) is a substantial but low level cluster with numerous products, patents and listed patents, and the widest scope of market exclusivity and cumulative patent protection. Prior to this point, clusters are “at bat”, as they reach a critical state prior to moving into an expanded spatiotemporal state or merely “on deck” as firms await critical regulator and market vetting.

An important observation with regard to product-patent drug clusters is that as a given cluster grows spatiotemporally over time, it grows not only in scope but also in the scale of the interrelatedness of its functional components over time.

As noted in 2001 by Kingston and later by Polk & Parchomovsky and, notably, the EC Pharmaceutical Sector Inquiry, the strength of patent portfolios and related product clusters from an intellectual property law perspective is “greater than the sum of its parts”. This “more is different” element, originally described in 1972 by PW Anderson, is characteristic of complex systems, including complex legal systems such as those described by JB Ruhl and many others in the mid-1990s. As noted in Part 1, we have referred to the complex multidirectional interrelationships and interdependencies between drug development, drug regulation and intellectual property law in our previous McGill and Berkeley studies as a regulated Therapeutic Product Lifecycle, or rTPL.

Of interest, our data show that the profit of a given molecule is strongly related to the number of patents, regulatory approvals, the number of patents listed on the register, and the range of drugs and regulatory approvals that are legally related but separated by only very minimal changes to existing uses and chemistry. This is true even for drugs thought be innovative such as those with First in Class and New Active Substance (New Chemical Entities), owing to regulatory loopholes.

Somewhat surprisingly, in light of global innovation policy over the last 50 years, the greater the number and scope of these metrics the lower is the calculated level of innovation of a basket of drugs in a product cluster. As market and regulator vetting increases with time, one sees generally (1) more patents, regulatory approvals, fractional patent listing, patent classifications per marketed drug, (2) a greater follow-on-to-new drug ratio in the cohorts studied, and (3) greater profitability for less innovative drugs.

Indeed, drug clusters driven by line extension, or follow-on, drugs are proving to be very profitable. For example, we found that the vast majority of approval, patenting and chemical development activity associated with brand pharmaceutical products is directed to the development of Me Too drugs, in particular follow-on Me Too drugs. Of the top 25 most profitable drugs in 2006, 48% (12) were line extension Me Too drugs. The combined sales of these drugs were US $45.7 billion dollars. Follow-on First in Class drugs represented 28% of the top 25 selling drugs, and 7 of the top 15 selling drugs. Profit on this group of drugs was US $39.7 billion dollars in 2006.

Combined, follow-on Me Too and First in Class drugs accounted for 19 of 25 of the most profitable drugs, with total sales of US $85.5 billion in a single year.

From a "science of law" perspective, a major advantage of the rTPL and product cluster models is that there is, in fact, considerable empirical evidence available for study for all interested parties. This includes the various types of new and follow-on drugs, patents, patent classifications, listed patents, related litigation, as well as the relation of these metrics to one another over time. This wide array of empirically observable metrics and the observation that they change over time sets up the possibility that, akin to protein folding and X-ray crystallography models, the data can be expressed in 3-D spatiotemporal form.

Indeed, the goal of our empirical work over the last four years involving new and follow-on drugs, patent trees, patent types, WHO Anatomical Therapeutic Classification (ATC) data, litigation data, the innovation index, and product cluster model is to convert the cumulative data into 3-D formats used in the medical sciences. For example, the protein-RNA model presented below underscores the utility of 3-D “rotational” models to both identify and quantify the complex structural and functional characteristics in a given network of biological components, here those between an RNA strand and protein components in the context of Multiple Sclerosis.

Fig. 5. Medical Sciences Template for Rotational 3-D Spatiotemporal Models of Cluster-Based Drug Development. From: Joint Evolutionary Tree Method for Study of MS.

As discussed previously, rotational 3-D drug product-drug patent cluster models would be particularly useful to policy-makers and law-makers in order to enable visual and numerical quantification of the impact of intellectual property law on drug development, generic entry, and access to essential medications in the same manner that one might look at a car from behind (highlighting the ‘gas tank,’ or original drug product and associated patent tandems) as well as from the side (from the rear to the front of the vehicle, underscoring how and when approvals, patents, and listed patents increase over time with market and regulator vetting).

In this manner, extrapolating the empirical techniques conventionally used in the hard sciences to the study of law, including patent law and innovation policy, offers an important opportunity to not only quantify the effect of a given piece of law or policy, but also to help determine the vires of such laws after they have been put in motion and to guide law reform efforts in light of objective arm’s length evidence.

It is hoped this series of articles has shed some light on the utility of traditional scientific methods for quantitative and qualitative assessment of patent value, and whether laws made decades ago to enhance innovation in the pharmaceutical sector and to facilitate timely generic entry are producing intended effects, unintended effects, or some combination of both. A second consideration is whether empirical legal research can be a valuable tool to assess the convergence of public health law and industrial law such as that which has evolved in most developed nations over the last three decades.

In any event, it will be interesting to see whether, as in other fields such as medicine and engineering that are accustomed to taking an “evidence-based” approach to problem identification and problem solving, whether we in the legal field may also include empirical evidence in our expanding toolkit of legal assessment and interpretation methods.

Innovation Incentives Part 2: Patent Valuation

Understanding the Consequences of Linking Market and Regulatory Incentives for Drug Development: Part 2

Editor's note: This is the second installment of a three-part series.

In new work by our group, we have outlined a tandem of new methodological tools to identify and quantify new and follow-on drugs and patent valuation. The first is a harmonized method to quantify drug approvals, patents and associated chemical components that summarizes and extends our previous work on topic. The second provides a new “innovation index” that incrementally grades the value, not only for patents in the life sciences and other technology-intensive sectors, but also for associated regulatory approvals, chemical components, patent characteristics, etc. The innovation index values are based on evidentiary hurdles and prioritizations for several classes of “new” and “follow-on” drugs disclosed by drug regulators. As indicated by the titles of the articles, one focuses on the quantitative side while the other focuses on the qualitative side of the analysis.

The Boston Article presents a harmonized method to collect, compare, and quantify regulatory approval data from multiple cohorts of new and follow-on drugs. We looked in some detail at about 2,000 regulatory approvals, 5,000 patents, and 130 chemical components. The analysis encompasses all drug classes enumerated, described and prioritized by domestic drug regulators. The drug classes were gleaned from the usual literature reviews, supplemented by several hours of consultation with Health Canada regulators and review of Health Canada Guidance Documents on topic. A second purpose of this work was to go beyond simplified descriptors of new and follow-on drugs found in the literature, to categorize classes of new, line extension and generic approvals according to the nomenclature used by regulators themselves. This latter point is relevant is relevant, as we found different scholars use different approaches and nomenclatures, sometimes very different, and that these approaches were not always the same as those used by regulators themselves.

Read the rest of this post . . . .The innovation index work described in the companion Santa Clara Article was driven by the fact that almost all published patent assessment methods measure innovation using primarily quantitative methods, otherwise referred to as ‘counting methods.’ For reasons discussed in work on topic by Kingston at Trinity, Lemley at Stanford and Polk and Parchomovsky at Penn, and the sources cited therein, while quantitative models are widely considered to be problematic, a model that assesses patent value using qualitative methods that track, or are at least designed to track social benefits, has not yet emerged. A second reason for developing the two methods is that is that even when many scholars and commentators do look at the “innovative” aspect of the data, they simply accept data provided by regulators in their respective annual reports in a per se manner.

While developing a novel scientific method for either obtaining or analyzing legal data is fraught with its own problems, this step nevertheless forms a necessary component of the “trial and error” heuristic typical in the hard sciences. As more individuals with prior experience in medical science enter law and legal scholarship, we will undoubtedly see more and more scientific studies of law, including importing of fundamental mathematical, statistical, curve fitting, modeling, and graphing methods. In the Santa Clara paper, a qualitative innovation index is reported that we hope may fill some of the gaps in patent valuation. One of the figures from this work, relating to regulatory approvals, is shown below.

Fig. 1. Innovation Index Data for Total Approval Cohort. Bar graphs showing the number of total approvals expressed as a function of the level of innovation (LOI) before (a) and after (b) of generic approval data. c Brand approvals expressed as a function of LOI. Solid line is a fit of the data to a single exponential function. d Cumulative normalized brand approvals expressed as a function of LOI. Solid line is fit using a sigmoidal function.

The figure presents data for many classes of new and follow-on drugs and categorizes these classes using a linear scheme. Raw data values are given in the Y axis of Fig. 1a and 1b, the difference being generic data were subtracted in Fig. 1b to isolate data only from ‘innovator’ firms. The X axis in both panels represents the innovation index data. The innovation index data are referred to as transformed data, because the raw data pertaining to drug approvals, drug patents, and chemical components are transformed into qualitative values on a linear scale (0-15) using the methods outlined in the Santa Clara paper.

The strengths and weaknesses of the hybrid “subjective-objective” nature of data transformation, and the similarities to subjective-objective hybrid models that are already widely accepted for use in the fields of drug approval, patent grant, and the adjudication of patent claims by the courts are discussed more fully there.

Data can, of course, be fit to many types of numerical functions, linear or non-linear; increasing or decreasing. Fig. 1c above shows that the data in the bar graph of Fig. 1b fit to a declining exponential function. As can be seen by the close fit of the data to the function, the choice of an exponential relationship was well founded. The data are interesting as they demonstrate an exponential decline in the numbers of drugs in classes with relatively high innovation index values. In other words, the vast majority of drugs approved in Canada have a very low index value, and indeed are primarily follow-on Me Too drugs.

Fig. 1d represents the normalized cumulative data fit to a sigmoid (S-shaped log) function, which is a numerical approximation of “how fast” the innovation index data rise to their maximal peak. A fast rise, as we see here, suggests that most of the drugs approved over nearly a decade are in the low index bins and that the data in the low index bins accumulate much more rapidly than do the data in the higher index bins. Similar, though not identical, results were obtained with several indicator Cohorts studied, including a wide Cohort of 2,087 drugs, a narrower Cohort of 95 of the most profitable drugs, and a similar Cohort of associated patents and chemical components.

The innovation index provides a means of weighing legitimate patent protection against perceived societal benefit. As such, it affords a qualitative measure of the innovative nature of drug patents that, when compared to counting methods, may more adequately reveal the outcome of development incentives for firms and regulating bodies insofar as these parties have conflicting interests.

The results from our analysis indicate that it is not the most innovative or even strongly innovative drugs that are attracting the greatest firm patenting effort. Rather, when gauged against development priorities publicly disclosed by regulators and governments, including specifically in the United States and Canada where linkage first came into force, it is the least innovative drugs of all classes investigated that display the strongest regulatory approval and patenting efforts. This issue is touched on in more detail in Part 3 of the series.

In this manner, our data are contrary to the established dogma that the strength of patent protection is proportional to the "strength" of innovation of a given product. As discussed more fully in Part 3, the data obtained also support the conclusion that cluster-based, or portfolio-based, drug development has become the dominant innovation strategy for both brand and generic firms. Indeed, data from our Boston study demonstrates conclusively that generic firms are accruing more patents than their brand counter-parts, especially in the new drug approval category.

Finally, the data suggest that the perception on the part of governments and the public to the effect that societal benefit comes as a kind of “natural consequence” of patenting may need to be reconsidered.

Innovation Incentives Part 1: Regulated Therapeutic Product Lifecycle

Understanding the Consequences of Linking Market and Regulatory Incentives for Drug Development: Part 1

This is a three-part series by guest blogger Ron A. Bouchard.

Dr Ron A. Bouchard is an intellectual property lawyer and scholar, specializing in biomedical products. He began his career as a medical scientist, completing a PhD and Postdoctoral Fellowship in the field of ion channel biophysics and Ca2+ imaging. He shifted focus to obtain a law degree specializing in pharmaceutical and biotechnology law and has been involved in the prosecution, acquisition, financing, distribution, and litigation of intellectual property rights. Dr Bouchard has appeared before the Federal Court of Canada and the Supreme Court of Canada. He is a Professor of Law and Medicine, and is the recipient of a Canadian Institutes for Health Research (CIHR) New Investigator Award. He is currently on sabbatical.

Patent valuation has become a hot button issue of late, particularly in the area of pharmaceuticals. In the effort to win the global innovation race, substantial policy and economic efforts are being made by developed and developing nations alike in support of innovation, both in terms of understanding it and making more of it when innovation does occur.

The issue of patent valuation presents to an increasingly educated lay audience as a kind of titanic contest of wills between those who prefer big incentives for innovation and those who focus of the social benefits, or outcomes, of innovation.

Many studies of innovation and patent valuation use economic models to assess the business value associated with patents at a given point in time, as well as ways of maximizing value from those patents. Although there are certainly many skeptics, innovation and patenting have nevertheless become synonymous in economic discussions of national productivity and prosperity in a wide variety of debates, including scholarly, political, civil service, and in the media.

Read the rest of this post . . . .In the world of life sciences products, a distinction can be made between an economic analysis - even one cast in a law and economics light - and a patent law analysis. This is because one is primarily (though not exclusively) in service of utilitarian benefit and the other is primarily (though not exclusively) in service of equity, equality and the terms of the traditional patent bargain. As instructed by the courts when pharmaceutical patents are at issue, the patent bargain is itself to be interpreted through the public health mandate as it is bound by the unique trifecta of patent law, food and drug law and linkage law.

This places patent valuation front and center of any discussion of law reform focused on pharmaceutical innovation, as well as discussions and law reform aimed at reducing drug costs and expenditures. The fact that, unlike in many other industries, follow-on products may offer little benefit compared to existing products raises the bar on this discussion, as does the fact that patents associated with these products can be used as more of a sword than a shield to evergreen older product lines and keep drug prices high.

Because the availability, costs and expenditures of drugs are regulated by such a complex array of legal, policy and political vehicles, their analysis is quite amenable to “complexity”-based frameworks, which by design place significant emphasis on feedback loops between multiple interrelated nodes.

In this case the nodes, or spheres to use the nomenclature of Walzer, are industrial, economic, public health, and political in nature but also play out in numerous intersecting ways in statutory, regulatory, policy, and judicial terms. In our Berkeley study, we presented the model below for the development, consumption and regulation of drug products, referring to it as a regulated Therapeutic Product Lifecycle (rTPL).

Fig. 1. rTPL Innovation Ecology Model for Drug Development. Innovation is represented as an iterative process over time involving several functional groupings, including national science and technology (S&T) policy, clinical research, university and firm commercialization, innovation by private firms, drug regulation by national governments, and intellectual property and regulatory (IPR) rights covering both drug submissions and marketed products. Large red nodes represent functional groupings, and include sub-functions enumerated in the figure. Red lines are multi-directional between nodes and sub-functions and are independent of time (acknowledging that the process generally moves clockwise).

Through diagrams such as these, one can see that patent rights and incentives permeate all stages of the rTPL. As we have noted elsewhere, even assuming a relatively linear innovation process, because of regulatory incentives that allow the public to gain access to therapeutic products prior to conventional Phase 3 trials, and because linkage laws allow for the development of clusters of interrelated new and follow-on drugs and associated patents, the regulatory lifecycle for drugs has become at once increasingly complex, intertwined, and collapsed. Linkage laws in particular complicate the picture as they are intended to both facilitate industrial development in the form of new drugs and to satisfy the public health mandate by yielding cost savings on generic entry.

One might argue that the convergence of public health and industrial policy of this nature calls for a clear and concise set of policy levers governing the complex innovation ecology for therapeutic products, particularly in jurisdictions where the availability of both brand and generic drugs are regulated by linkage laws.

Yet, as noted in the recent decision of the High Court of Delhi in India, where (like the E.U.) linkage was rejected, the court held that worldwide there is a "raging debate on whether patent linkage should be permitted," concluding there is "no uniformity in the policy of different countries."

In North America, the birthplace of linkage, the Supreme Court of Canada held in its seminal decisions in Biolyse and AstraZeneca that linkage regulations tying generic entry to brand-name patents must be made in a patent-specific manner. The court's pronouncement highlights the importance of the qualitative and quantitative nature of the balance inherent to the patent bargain, especially when read in light of the so-called “special provisions” of linkage laws when parsing pharmaceutical patents.

As pointed out by the Global Consortium on Pharmaceutical Linkage in a recent article, patent law is also antecedent to linkage in the United States, which was the first jurisdiction globally to promulgate linkage laws. This was made clear by the seminal reports of the Committee on the Judiciary (COJ) and the Committee on Energy and Commerce (CEC) prior to the coming into force of Hatch Waxman. Both the COJ and CEC made it clear that the twin policy goals of linkage laws were to encourage the development of “new and innovative” drugs and to facilitate the “timely” entry of generic drugs.

Both of these competing policy goals depend on patents, and so again we arrive at a pivotal role for patent valuation in determining outcomes related to the twin policy goals at issue.

So, what evidence is there to assess whether these two policy goals have been met by patent, food and drug, and linkage laws? What evidence is there to determine the role of “strong” and “weak” patents in producing outcomes, including unintended consequences that may have been completely unanticipated by law-makers at the time pharmaceutical law and policy came to the fore in the early 1980s and 1990s?

This will be the subject of Parts2 and Part 3 of the series.

Secret Salmon Science

As one of the brothers in Lewis Carroll's The Two Brothers laments,

Take my friends and my home - as an outcast I'll roam: Take the money I have in the bank: It is just what I wish, but deprive me of fish, And my life would indeed be blank.

This ichthyophile brother would surely be alarmed at the crisis now facing wild salmon stocks on the Pacific coast of North America.


Salmon can contract an influenza-related virus that causes infectious salmon anemia ("ISA").  For the past few decades ISA has been devastating salmon populations from Norway and Scotland to the Canadian Maritimes and Chile, sometimes killing more than 9 out of every 10 fish.  Critics of salmon farming have blamed the spread of ISA on the high densities of fish kept together in ocean-borne cages, along with frequent piscine jailbreaks into the wild.

In October, 2011, ISA was diagnosed among wild pacific salmon in British Columbia by the ISA Reference Laboratory at the Atlantic Veterninary College, in Prince Edward Island.  Although these diagnoses were quickly disputed by the Canadian Food Inspection Agency, it now appears that Canada may have made similar diagnoses as long ago as 2002.  If so, it seems that Canada failed in its obligations to inform the United States and the World Organization for Animal Health.

Salmon farming is especially controversial on the Pacific coast of North America, because of the existence of a thriving wild salmon fishery.  Fears that escapees from fish farms there could spread diseases to these wild populations have generally been dismissed by fish farmers.

If ISA has indeed infected wild Pacific salmon populations, Carroll's other, ichthyophobic, brother would surely be delighted:

What? a higher delight to be drawn from the sight of fish full of life and of glee? What a noodle you are! ‘Tis delightfuller far to kill them than let them go free!

Too bad Dudley Do-Right did not do right by the salmon.

More biolaw at LEXVIVO.

IPAT Baby Seven Billion

With the seven billionth living human being imminent, it is important to consider that numbers of people alone do not explain the environmental impact Homo sapiens have on the earth.  Developed by Stanford biologist Paul Ehrlich, Assistant to the President for Science and Technology John Holdren, and others back in the 1970s, the IPAT formula provides a useful lens through which to view Mr. or Ms. Seven Billion ("Giga Septem").

The I=PAT formula is an identity.  I represents environmental impact, P population, A affluence, and T technology.  While human population (that is, number of people) and affluence (that is, wealth per person) have tended to push I upwards over the last few thousand years, the technology factor (impact per wealth) has tended to decrease I by providing increasingly efficient means for accomplishing tasks.  Because I is calculated as the product of P, A, and T, each factor is equally important.

Thus, while population growth certainly contributes to environmental impact, so do affluence growth and technological improvement.  Welcome, G. Septem.  Now that you have joined us, we will watch with fascination how wealthy you become, and how quickly technology improves during your lifetime.

More biolaw at LEXVIVO.

"We eat animals because they taste good"

. . . and other arguments in a spirited debate over the ethics of killing animals for food, fur, and/or leather.

Weldon Amendment Welded Onto The Patent Act

In 2004, the Consolidated Appropriations Act (Public Law Number 108-199, Section 199) was passed with the "Weldon Amendment" (named for its sponsor, former Republican Congressman Dr. Dave Weldon), a rider stipulating that "[n]one of the funds appropriated or otherwise made available under this Act may be used to issue patents on claims directed to or encompassing a human organism."  On September 16, 2011, when President Barack Obama signed into the law the America Invents Act, the Weldon Amendment became an integral part of the Patent Act.  Effective immediately, here is what this new patent law requires:

SEC. 33. LIMITATIONS ON ISSUANCE OF PATENTS
(a) LIMITATION.-Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
(b) EFFECTIVE DATE.-
(1) IN GENERAL.-Subsection (a) shall apply to any application for patent that is pending on, or filed on or after, the date of the enactment of this Act.
(2) PRIOR APPLICATIONS.-Subsection (a) shall not affect the validity of any patent issued on an application to which paragraph (1) does not apply.

No one yet knows what "directed to or encompassing a human organism" means.  The United States Patent and Trademark Office will have the first opportunity to apply this restriction as the initial arbiter of patent applications.  Inevitably, the federal courts will weigh in to provide more authoritative interpretations.  Eventually, Congress may have to amend this provision to clarify it.  Meanwhile, the inclusion of this restriction on patenting "a human organism" directly within the patent statute strongly signals that at least some biotechnological advances have unsettled both Congress and the President.

Polycentrism, Fragmentation, and the Role of Linkages in the Decade on Biodiversity

The United Nations has declared 2011-2020 the Decade on Biodiversity and the Convention on Biological Diversity has adopted a Strategic Plan for this period. The plan suggests an emphasis on national and regional action with support from the international level. The approach fits generally within the concept of polycentric governance that is receiving increased attention as an approach to climate change (for legal literature advocating this approach, see here and here).

Polycentric governance, a concept that grows out of social science studies of municipal governance in the mid-twentieth century, provides a useful framework for thinking about how to address complex global collective action problems at a time when the chances of agreement on an overarching top-down treaty are nearly nonexistent. It proposes that governance can be more effective by creating multiple nodes of authority, and urges that trust among participants is among the most important factors for success in addressing collective action problems.

The existing structure of international environmental law is highly fragmented and, thus, might lend itself to a more polycentric approach. However, the issues addressed by international environmental law are often closely linked to each other in an ecological sense. Thus, one of the challenges for developing a more effective approach to biodiversity preservation over the Decade of Biodiversity is to ensure that efforts give appropriate attention to these linkages among issues. One way to do this will be to target program development, under CBD or elsewhere, and funding to programs that make progress on multiple fronts. I develop this idea further in an article recently posted to SSRN. This issue linkage based approach to new initiatives can compliment the diffusion of authority characterizing polycentric governance by countering the negative impacts of institutional fragmentation while enhancing the overall effectiveness of internationally financed or initiated programs.

Myriad Genes To Patent

The United States Supreme Court must be despairing of how many patent appeals are coming its way.  After all, patent law is few people's cup of tea.  As one old, though obscure, joke puts it:

Question:  What's the difference between a patent attorney and a tax attorney?

Answer:  Patent attorneys are like tax attorneys, but without the scintillating personalities!

Watch out, Supremes, because the Court of Appeals for the Federal Circuit may have just teed you up to grant yet another writ of certiorari in a patent case.

Like Prometheus v. Mayo, a dispute focused on the patentability of methods of medical diagnosis and treatment, Association for Molecular Patholody v. Myriad raises fundamental questions of patentable subject matter and the interpretation of 35 U.S.C. 101.  On July 29, 2011, the Court of Appeals for the Federal Circuit largely overturned a decision on summary judgment by Judge Sweet of the Southern District of New York that rendered unpatentable claims to isolated DNA molecules per se and methods of diagnosis relying on comparisons of mutated DNA molecules with corresponding patient DNA samples.

It would be natural for the Supreme Court to combine the appeals of Prometheus v. Mayo and Association for Molecular Pathology v. Myriad because they both probe similar and related issues of patentable subject matter.  Such a combined appeal would have the potential to settle fundamental issues of patent eligibility surrounding many biotechnology inventions for a generation.

The eyes of biologists, the biotechnology industry, and patient advocacy groups are now firmly fixed upon the Supremes.

More biolaw at LEXVIVO.

When Patents Attack

This American Life, a quirky and wonderful weekly radio program on National Public Radio, has featured stories on comedians, how to speak to kids, psychopaths, unconditional love, and mind games.  On July 22, 2011, TAL investigated a special breed of trolls:  patent trolls.  Here is how TAL describes the program:

Why would a company rent an office in a tiny town in East Texas, put a nameplate on the door, and leave it completely empty for a year? The answer involves a controversial billionaire physicist in Seattle, a 40 pound cookbook, and a war waging right now, all across the software and tech industries.  We take you inside this war, and tell the fascinating story of how an idea enshrined in the US constitution to promote progress and innovation, is now being used to do the opposite.

This patent who dunnit is fascinating and entertaining.  Moreover, it transforms a field of law often viewed - even by other, non-patent, attorneys - as dry, technical, and inaccessible, into something that, like Lord Byron, seems mad, bad, and dangerous to know.  Listen to the program here.

Hear it before you go infringing. You'll never go in the patent pool again!

More biolaw at LEXVIVO.

Toxodebtosis

Toxoplasmosis is a fascinatingly tragic condition.  A mouse infected by the protoctistan, Toxoplasma gondii, behaves strangely.  Instead of scampering away at the first whiff of feline scent, as an uninfected murine certainly would, the mouse is dangerously attracted to eau de chat.  As its predator steadily approaches, the unfortunate mouse simply awaits, even welcomes, its catastrophic end.

Humans may also be infected by T. gondii.  Those with toxoplasmosis often exhibit an unreasonable penchant for obviously risky behavior.  Neurally transfixed by the parasite, an infected person may not only stare danger in the eyes, but willingly step within its opened jaws.

Though many metaphors, some more purple and florid than others, have been offered to describe the debt ceiling crisis currently threatening the United States, toxoplasmosis may be as good as any.  Like a parasitized mouse, the American economy and polity seem to be marching steadily and willingly towards a possible August 2, 2011, default.  Unlike the mouse, however, if the United States is consumed by default, it will likely take the rest of the world with it.  The weird serenity currently infecting the political classes in the District of Columbia, some of whom appear not simply to have accepted default, but positively to welcome it, suggests a debilitating political disease capable of leading to much economic pain.

While it remains unlikely that the United States will actually default next week, equity, bond, gold, and even food markets, as well as credit rating agencies, have already begun to price in significant economic damage.

Can a treatment be found in time?  If so, will it merely control the symptoms, or cure the disease?  Whatever the result, the current debt ceiling crisis amounts to the largest and most dangerous game of cat and mouse ever played.

More biolaw at LEXVIVO.

Prometheus Rebound To The Supreme Court

On its second opportunity, the United States Supreme Court has granted a writ of certiorari to hear an appeal of Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Mayo Clinic Rochester ("Prometheus v. Mayo"), a decision by the Court of Appeals for the Federal Circuit ("Federal Circuit") that ratified - for the second time - the patentability of methods to determine optimal drug dosage levels in therapeutic treatments.  This bodes ill for the patentability of inventions involving methods of medical diagnosis and therapy.
As discussed previously on LEXVIVO, on December 17, 2010, Prometheus, Inc., a San Diego-based biotechnology company, prevailed in appealing a district court's grant of summary judgment that had found claims in Prometheus' exclusively licensed patents (U.S. Pat. Nos. 6,355,623 and 6,680,302) invalid as drawn to non-statutory subject matter under 35 U.S.C. §101.  In Prometheus v. Mayo, a unanimous panel of the Federal Circuit "again [held] that Prometheus' method claims recite patentable subject matter under §101."  The court's previous finding that Prometheus' claims constituted statutory subject matter was successfully appealed by defendants-appellees Mayo Collaborative Services and Mayo Clinic Rochester (hereafter, "Mayo") to the Supreme Court, which vacated and remanded the Federal Circuit's decision on April 29, 2010, "for further consideration in light of Bilski v. Kappos," a business method patent case the Supreme Court had decided the day before.  It would appear that the Supreme Court has now called two strikes on the Federal Circuit on this issue.

The claims at issue cover methods for determining the optimal dosage of thiopurine drugs, such as 6-mercaptopurine and azathiopurine, used to treat inflammatory bowel diseases that include Crohn's disease and ulcerative colitis.  For example, claim 1 of the '623 patent involves (1) administering a drug capable of producing 6-thioguanine inside a patient suffering from a gastrointestinal disorder, (2) determining the concentration of 6-thioguanine in the patient's blood, and (3) indicating the need to increase or decrease the drug's dosage depending on whether the drug's blood concentration is outside of the therapeutically desired range of 230-400 pmol per 80,000,000 red blood cells.

Now, the Supreme Court will have an opportunity to clarify the patentability of inventions directed to methods of diagnosing medical conditions, as well as those that combine such diagnostic methods with methods of treatment.  Any optimism the biotechnology industry might have derived from the Federal Circuit's December 17, 2010, decision in Prometheus v. Mayo may now be tempered by the specter of the Supreme Court adopting the argument that Justice Stephen Breyer (joined by now-retired Justices John Paul Stephens and David Souter) made in his vigorous dissent to the dismissal of the writ of certiorari of a kindred case, Laboratory Corporation v. Metabolite Laboratories, Inc..  In his dissent, Breyer described the medical diagnostic method contested in that case as follows:

At most, respondents have simply described the natural

law at issue in the abstract patent language of a "process." But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge.

A similar conclusion in Prometheus v. Mayo by a majority of the Supreme Court could redraw the boundaries of patentable biological subject matter in United States patent law.

See more biolaw at LEXVIVO.

These geese will be cooked

Canada geese represent a serious urban menace. Their molting season presents local governments a short, annual window of opportunity to respond by culling geese en masse. After an outcry over the failure in 2010 to convert culled geese into low-cost, high-protein food, New York officials will not consign this year's harvest to the landfill. Instead, geese from Brooklyn's Prospect Park are destined for slaughter and distribution to food banks.

Response to Pesticide Concerns Neglects Water Quality

The following is a guest post by Sonya Ziaja, J.D. Ms. Ziaja is a California attorney and MSc candidate at the University of Oxford, School of Geography and the Environment. She writes regularly for LegalMatch's Law Blog, Shark. Laser. Blawg. and First Movers.

* * *

The Environmental Working Group published this year's “Dirty Dozen” list of the most pesticide laden fruits and vegetables. The conventional produce industry characterizes the list as fear-mongering. They propose that if you are concerned about the dangers of ingesting pesticides, then “just wash your fruits and vegetables.” This is a specious argument.

Washing pesticides off of your produce only moves the problem from your plate to your glass. Of course, compared with the giant quantity of pesticides that are washed into rivers, creeks, and groundwater, the addition of pesticide residue washed away in your kitchen is small. But, either way, the pesticides end up in the same place—in our water. Once there, waste water treatment plants do not detoxify pesticides. Bottled water won't necessary help the situation either, considering that much bottled water is simply bottled tap water.

Pesticides can and do contaminate water sources, causing harm to wildlife and to human beings. This fact is leading to lawsuits against the agencies that regulate pesticide use. One lawsuit, brought by the Center for Biological Diversity and the Pesticide Action Network, seeks to limit the use of pesticides in order to protect humans and over 100 endangered species.

We cannot “wash away” pesticides. Nor can the conventional produce industry wish away responsibility. If we are serious about having safe food to eat and clean water to drink, industry needs to abandon specious arguments. Absent that and corresponding changes in behavior, agencies and industry will likely to face more lawsuits.

Big Dilemma Over Smallpox

Smallpox virus (Variola vera) has been one of the most horrific diseases to afflict humanity.  Fortunately, worldwide vaccination programs appear to have eradicated it among humans.  However, both the United States and Russia maintain carefully-guarded stocks of the virus for research purposes.  Over the years, international pressure to destroy these last laboratory stocks of smallpox virus has been building.  Many assumed that the World Health Assembly, the decision making body of the United Nations World Health Organization, which held its 64th conference from May 16th to 24th, 2011, would vote to do just that, thus consigning Variola vera to the dustbin of disease history.  Instead, the Assembly granted the virus a stay of execution until at least 2014: 

Reaffirmed that the remaining stock of smallpox virus should be destroyed 

The Health Assembly strongly reaffirmed the decision of previous Assemblies that the remaining stock of smallpox (variola) virus should be destroyed when crucial research based on the virus has been completed. The state of variola virus research will be reviewed at the 67th World Health Assembly in 2014 and in light of that, determining a date for destruction of the remaining virus stocks will be discussed.

Bioethicists disagree about whether or not to destroy the virus.  As long as it survives, the risk of its release - either accidental or deliberate - will persist.  If it is destroyed, the best opportunity to derive future insights into its, and other disease organisms', biology may be forgone forever.  In the meantime, the virus that has taken about half a billion lives in recent history will continue to hang, like the Sword of Damocles, over the future health of humanity.


More biolaw at LEXVIVO.  

More on Brazilian Deforestation

The European environmental law group ClientEarth has also done some blogging on the moves to open forest land for agriculture in Brazil (see post here). Their post highlights the reason that REDD, which I've written about here (among other places), seems to generate so much hope where prior international forestry efforts have fallen flat: money. When it comes to legal changes that promote or discourage deforestation, the potential economic impact of REDD could turn the tide. Brazil may be a testing ground . . .

Brazil Debates Easing Curbs on Developing Amazon Forest

NYT reports that the Brazilian Congress is considering legislation to exempt small farms from current requirements to maintain forest on property within the Amazon, which would allow significantly more deforestation than current law. Along with the traditional concerns about deforestation, the effort to relax deforestation restrictions comes at a time when large sections of the Amazon appear to be approaching a tipping point. Recent droughts and predicted climate changes suggest that at least parts of the Amazon are on the edge of flipping to another ecosystem type from forest dieback. Such an event would likely have major biodiversity and climate implications -- reducing or eliminating large swaths of habitat and releasing vast quantities of carbon dioxide. (A 2005 Amazon dieback caused by drought, for example, is a suspected cause of a notable spike in global GHG concentrations that year). With the ecosystem already teetering, now is not the time to relax forest protection law.

Tilapia: The flip side of the perfect factory fish

Tilapia is traditionally regarded as the fish in the biblical story of Jesus feeding a multitude of five thousand. The question is the price we pay for farmed tilapia as part of the contemporary food supply. It is fish, to be sure, but it doesn't offer the same nutritional value as species far richer in omega 3 fatty acids. Tilapia is also one of the world's most destructively invasive fish species. What makes tilapia so destructive is its rapid feeding and growth cycle and its adaptability to a wide variety of habitats. Those are also the perfect traits for a factory fish.

As global aquaculture in tilapia booms, the words of Danilo Sosa, a technician with Nicanor Fish Farms in Nicaragua, bear remembering: “Nature is for maintaining species; what we do is make fillets.”

Osama Bin Laden - Pioneer Of Bioterrorism

It appears that Osama bin Laden was killed on May 1, 2011.  Among his nefarious "accomplishments", bin Laden was the first internationally prominent proponent of bioterrorism. Worries about the deliberate misuse of biological agents have prompted the United States Federal government to set up new anti-bioterrorism facilities, such as the Center for Excellence for Emerging and Zoonotic Animal Disease, to be located in Kansas.  Despite the demise of bin Laden, the threat of bioterrorism is likely to remain firmly fixed both in the public consciousness and in the wishlists of terrorists.


More biolaw at LEXVIVO.

On Fast Track, Patent Office Run Over By Budget Deal

As LEXVIVO previously reported, the United States Patent and Trademark Office ("USPTO") entered 2011 by proposing several significant reforms designed to improve the efficiency and quality of the patent application process.  Included in these proposed changes were a new fast-track patent pathway and new satellite Patent Offices.  The Federal budget compromise recently agreed between Congress and President Obama, the Full-Year Continuing Appropriations Act, 2011 (Pub. Law 112-10), brings this brief patent office perestroika to a halt.  Here is an email USPTO Director David Kappos sent to his employees last week:

As you may know, the FY 2011 budget was signed by the president on April 15, 2011 and contains the USPTO’s appropriation through the end of this fiscal year, September 30, 2011. With the enactment of the Full-Year Continuing Appropriations Act, 2011 (Pub. Law 112-10), USPTO spending authority for FY 2011 has been limited to $2.09 billion. In view of the funding cuts reflected in the final budget and affecting the U.S. government as a whole, we will be unable to expend the additional $85-100 million in fees that we will be collecting during this fiscal year—funds that we had anticipated being able to use to fund operations this year.

In short, the Continuing Appropriations Act for FY 2011 does not allow us to maintain spending at the levels planned for this year. Further, I am mindful of the fact that we may very well be operating at the FY 2011 level for the foreseeable future. As a result, we have had to make some difficult decisions in order to ensure the responsible stewardship of the agency. It is against that backdrop that I must reluctantly announce, effective immediately, that:

• All overtime is suspended until further notice;

• Hiring—both for new positions and for backfills—is frozen for the rest of the year unless an exemption is given by the Office of the Under Secretary;

• Funding for employee training will be limited to mandatory training for the remainder of the year;

• Funding for contracting of Patent Cooperation Treaty (PCT) search is significantly reduced;

• The opening of the planned Nationwide Workforce satellite office in Detroit and any consideration of other satellite locations are postponed until further notice;

• Only limited funding will be available for mission-critical IT capital investments;

• The Track One expedited patent examination program, scheduled to go into effect on May 4, 2011, is postponed until further notice.

In addition, all business units will be required to reduce all other non-compensation-related expenses, including travel, conferences and contracts.

Trademark activities are unaffected and will maintain normal operations.

I want each of you to know that we have not come by these decisions easily. I recognize that these measures will place additional burdens on your offices, your staff, and your ability to carry out the agency’s mission. However, I believe that they are absolutely necessary to ensuring that the agency can continue to operate through the remainder of this fiscal year and into FY 2012.

I thank you for continuing cooperation and patience, and I appreciate your dedication and service during this challenging time.

David Kappos

Under Secretary of Commerce for Intellectual Property and Director of the USPTO

Ironically, the USPTO does not contribute materially to the Federal deficit.  Instead, it is financially self-supporting, covering its operations through the collection of fees from patent and trademark applicants.  However, Congress has traditionally appropriated these fees for other governmental purposes, leaving the USPTO continually short of money to pay for improvements, such as skilled new patent examiners to help alleviate the huge backlog of patent applications.  In an age of austerity, the USPTO might be celebrated as a governmental exemplar of financial self-sufficiency.  Instead, it continues to act as a piggy bank continually filled by inventors, only to be raided by Congress.  It is difficult to see how this strategy benefits technological innovation.

More biolaw at LEXVIVO.

Opening The Closed While Closing The Open

The Public Patent Foundation describes its mission as "Representing the Public's Interests in the Patent System."  As its website explains,

Undeserved Patents and Unsound Patent Policy Harm the Public
... by making things more expensive, if not impossible to afford;
... by preventing scientists from advancing technology;
... by unfairly prejudicing small businesses; and
... by restraining civil liberties and individual freedoms.
PUBPAT Represents the Public's Interests Against Undeserved Patents and Unsound Patent Policy

Patent Attorney David Garrod, who has served as Senior Litigation Counsel for the Public Patent Foundation, assisted the Public Patent Foundation in its campaign against false patent marking, and authored several free claim construction dictionaries.  Meanwhile, his company, Bedrock Computer Technologies, LLC, asserted its own patent (United States Patent No. 5,893,120, entitled  "Methods and Apparatus for Information Storage and Retrieval Using a Hashing Technique with External Chaining and On-The-Fly Removal of Expired Data") against software giants such as Google, Amazon, and PayPal.  On April 21, 2011, Bedrock won a $5 million jury award against Google, whose use of open source Linux software code allegedly infringed claims of the '120 patent.

The result is a fascinating and apparently quixotic juxtaposition of opening the closed while simultaneously closing the open, and is as clear as mud.

More biolaw at LEXVIVO.

The Patent Conference

Early in A Connecticut Yankee In King Arthur's Court, the titular Yankee, Hank Morgan, upon becoming King Arthur's "perpectual minister and executive", explains the importance he places on patents:

the very first official thing I did, in my administration—and it was on the very first day of it, too—was to start a patent office; for I knew that a country without a patent office and good patent laws was just a crab, and couldn't travel any way but sideways or backways.

Although this sentiment appears in a work of humor, many earnestly share Morgan's views on the importance of patents.  The recent explosion of patent scholarship reflects the growing perception that patents and patent systems are crucial instruments of public policy - instruments capable of generating benefits and costs for society.  Now, the increasingly important field of patent research has its own annual home:  The Patent Conference.

On April 8, 2011, the inaugural Patent Conference will be held at the University of Kansas School of Law.  The Patent Conference will be an annual event featuring the bleeding edge of patent scholarship.  This year, The Patent Conference schedule features research on patent infringement, patent damages, patent courts, empirical patent analysis, patent litigation, interdisciplinary patent studies, and Asian patent law.  Here is a press release from the inaugural host institution, the University of Kansas School of Law, describing the event:

Conference to bring world’s top patent scholars to School of Law

LAWRENCE — A critical mass of the world’s foremost patent scholars will present their latest research at the inaugural Patent Conference at the University of Kansas School of Law. 

The Patent Conference, or PatCon, will run from 8 a.m. to 6 p.m. Friday, April 8, in the Stinson Morrison Hecker Lecture Hall, 104 Green Hall. The event is free and open to the public.

The conference is a cooperative effort between the KU School of Law, the Chicago-Kent College of Law, the University of San Diego School of Law and Boston College Law School to hold an annual conference at which patent scholars in law, economics, management science and other disciplines can share their research. After this year’s inaugural conference, future gatherings will rotate among the four schools, returning to KU in 2015. 

“The scholarly study of patents has exploded in importance over the last decade,” said Andrew Torrance, a KU associate professor of law and an internationally known scholar in patent law, intellectual property law, food and drug law, and biodiversity law. “It has undergone a rapid transformation from a small niche field within intellectual property, largely overshadowed by copyright and trademark law, to an academic discipline that now attracts the enthusiastic attention of schools of law, business, public policy, engineering and medicine, as well as departments of economics, history, science and technology studies — and even science and mathematics.

“Clearly, the time has arrived for the field to have a permanent academic home, which is why we decided to found The Patent Conference.”

Torrance cofounded the conference with his colleagues David Schwartz, Chicago-Kent College of Law; Ted Sichelman, University of San Diego School of Law; and David Olson, Boston College Law School.

Nearly 40 patent scholars will make presentations in a series of panel discussions. Broad themes will include patent infringement, patent damages, patent courts, empirical patent analysis, patent litigation, interdisciplinary patent studies and Asian patent law. A complete schedule is available on the law school website.

“We are delighted that the response to the inaugural Patent Conference has been so positive,” Torrance said. “With almost 40 confirmed speakers from dozens of institutions in attendance, many of the finest patent scholars in the world will be presenting their work right here at KU School of Law. In a world that depends on technological innovation more than ever before, the cofounders and I hope this event will help spur the field of patent research to even greater success.”

The Patent Conference is sponsored by Shook, Hardy & Bacon LLP and the KU School of Law.

Patent law has attracted considerable controversy of late.  Patents are capable of inspiring both passionate support from those who believe they are necessary to spur technological innovation, on the one hand, and grave concern from those who oppose the monopoly rights to exclude others they confer upon their owners and favor more open models of innovation, on the other.  The importance of these and other issues has led to the founding of The Patent Conference, which will provide an annual venue for the free exchange of ideas and research about patents.

More biolaw at LEXVIVO.

Thomas Eisner: Chemistry, Ecology, and Conservation

Thomas Eisner, a professor of entomology at Cornell University, died on March 25, 2011.  Eisner was both a scientific and a conservation pioneer.   He helped found the field of chemical ecology, which studies how organisms use the natural chemicals they synthesize, whether in communication, defense, or predation.  Later, he helped the National Biodiversity Institute of Costa Rica ("INBio") negotiate an agreement with pharmaceutical company Merck & Co., Inc., under which INBio received a $1,000,000 payment and $135,000 in scientific laboratory equipment in exchange for bioprospecting for, and preparing chemical extracts of, promising natural chemicals from Costa Rican rainforest organisms.  In addition, the agreement promises Costa Rica a modest royalty should any of these natural chemicals form the basis for a commercially successful drug.

Although no such drug has yet emerged from this relationship, the Merck-INBio agreement established a new paradigm in bioprospecting, in which developing countries with abundant biodiversity control access to that valuable natural resource through negotiated agreements.  Subsequent biodiversity access agreements increased both in ambition and legal sophistication.  For example, the multinational pharmaceutical company Novartis AG entered into an access agreement with the Brazilian Association for the Sustainable Use of the Biodiversity of Amazonia ("BIOAMAZONIA") under whose terms BIOAMAZONIA received an upfront payment of $4,000,000 in return for supplying Novartis with 30,000 promising biological samples over a three-year period;  furthermore, should any of these samples lead to a drug that receives both patent protection from the United States Patent and Trademark Office and regulatory approval from the United States Food and Drug Administration, Novartis will pay BIOAMAZONIA a one-percent royalty on any profits.

Professor Eisner embodied a rare dual genius that combined pure scientific study of biodiversity with creative, practical, and effective actions to conserve the sources of that biodiversity.  Many in the fields of biology and conservation mourn his death.

More biolaw at LEXVIVO.

Après Loi Le Déluge

Preparing for rare natural disasters, such as the massive earthquake and tsunami that hit Japan on March 11, 2011, is vitally important, if human tragedies are to be minimized.  The invention of technologies useful in disasters, such as earthquake-resilient buildings, pharmaceutical drugs to treat outbreaks of disease, and even logistical methods, may be spurred by policy tools as diverse as patents, innovation prizes, and protection for open, user, and collaborative innovation.  Thus far, patents have received the most attention.  Here is the abstract an article entitled Patents to the Rescue - Disasters and Patent Law:

The patent system can play a vital role in preparing for, mitigating, reacting to, and preventing disasters. In the far term, it ensures that society continually improves its technological capacity to deal with disasters. In the near term, the patent system includes a diversity of legal options for ensuring access to patented inventions needed in disasters. Foreseeable and surprise disasters require different legal approaches to ensure timely access to patented inventions while ensuring that society is able to continue enhancing both its general and specific technological capacities. Accomplishing optimal results requires careful balancing of far term and near term interests, respect for both international and United States patent law, a clear understanding of the interrelation of different aspects of patent law, insight into the incentives that drive technological innovation, and appreciation of the disparate challenges posed by different kinds of disasters. When employed wisely, the patent system can offer society powerful assistance to prevent, prepare for, and mitigate disasters.

The entire article is available here for free download.  Once the immediate crisis passes, in Japan and its Pacific neighbors, policy makers should reevaluate how best to promote technological innovations useful in preventing and responding to natural disasters.  The more natural disaster-related innovation can be encouraged, the more likely it is that the next natural disaster will take fewer lives than the disaster that preceded it.

More biolaw at LEXVIVO.