Bargain Junta-ing

Developing countries often use the rhetoric of "breaking patents" as a bargaining device to encourage Western pharma- ceutical companies to cut the prices they charge for patented drugs. However, very rarely does the rhetoric lead to actual compulsory licenses. High profile patent fights, such as Brazil's 2005 threat to break Abbott Laboratories' patent covering Kaletra, an antiretroviral useful against HIV, usually result in negotiated settlement; to avoid a compulsory license, Abbott Laboratories agreed drastically to reduce the price it charged Brazil for Kaletra. Similar threats in south and east Africa have yielded similar discounts without resort to compulsory licensing.

Enter Thailand's latest military junta. Rather than waste time negotiating, it simply announced that it will issue a compulsory license on Merck's Efavirenz, another drug used to treat HIV. Such decisive action, though likely to praised by health advocacy groups, would appear to violate the spirit, if not the letter, of both the Paris Convention for the Protection of Intellectual Property (Article 5) and the Agreement on Trade Related Aspects of Intellectual Property (Article 31). Given that the AIDS crisis in Thailand was already severe prior to this year's overthrough of democracy, the explanation for the drastic change in policy resulting in the compulsory license appears to be the military. In response, Abbott Laboratories immediately offered to cut the price it charges for Efavirenz if Thailand agrees to reverse its decision. Perhaps Thailand's soldiers prefer the ease of issuing orders to drug companies to the civilian messiness of negotiation.

The compulsory license does place human rights campaigners on the horns of a dilemma: can they praise the result - cheaper drugs for the ill - without seeming to support a military dictatorship? Thailand's junta may have chosen well to pick on a western pharmaceutical company, one of the few parties even lower down the totem pole of popularity in the developing world.

The Supremes In The Greenhouse

This morning, November 29, 2006, the United States Supreme Court heard oral arguments in Massachusetts, et al. v. Environmental Protection Agency, et al. (No. 05-1120). The case arose from a challenge by Massachusetts and a number of other states and nongovernmental environmental groups to the refusal of the Environmental Protection Agency ("EPA") to regulate emissions of greenhouse gases under the Clean Air Act. Today's oral arguments yielded a number of revealing exchanges, some highlights of which are reproduced below.

Chief Justice Roberts seemed to limit reduction in harm from lower U.S. greenhouse gas emissions to situations in which global emissions declined in absolute, rather than relative, terms. By constrast, Massachusetts Assistant Attorney General James Milkey argued the importance of taking into account harm endured but for successful EPA regulation, and repeatedly cited the threat global climate change posed to at least 200 miles of his state's coastline.

MR. MILKEY: ...For example, if we're able to save only a small fraction of the hundreds of millions of dollars that Massachusetts parks agencies are projected to lose, that reduction is itself significant.

CHIEF JUSTICE ROBERTS: That assumes everything else is going to remain constant, though, right? It assumes there isn't going to be a greater contribution of greenhouse gases from economic development in China and other places that's going to displace whatever marginal benefit you get here.

MR. MILKEY: Yes, Your Honor. But reducing domestic emissions will reduce our harm, the harm we would otherwise face regardless of what--

CHIEF JUSTICE ROBERTS: Not if your harm is the alleged loss of coastline. Not necessarily. It depends upon what happens across the globe with respect to greenhouse emissions.

MR. MILKEY: Your Honor, we would still lose coastline but we would not lose as much because these harms are cumulative, and while reducing U.S. emissions will not eliminate all the harm we face, it can reduce the harm that these emissions are causing. So it will necessarily reduce our harm and satisfy redressibility.

Justice Scalia made it clear that neither "spheres" nor science are his strong suits.

JUSTICE SCALIA: ...your assertion is that after the pollutant leaves the air and goes up into the stratosphere it is contributing to global warming.

MR. MILKEY: Respectfully, Your Honor, it is not the stratosphere. It's the troposphere.

JUSTICE SCALIA: Troposphere, whatever. I told you before I'm not a scientist.

(Laughter.)

JUSTICE SCALIA: That's why I don't want to have to deal with global warming, to tell you the truth.

Later, Chief Justice Roberts and Milkey disagreed about whether the EPA had refused to regulate because it lacked authority to do so or because it judged there to be too much scientific uncertainty as of yet to embark upon regulation.

CHIEF JUSTICE ROBERTS: What they said was until more is understood about causes, extent and significance of climate change and the potential options for addressing it, we believe it's inappropriate to regulate these emissions.

MR. MILKEY: Your Honor.

CHIEF JUSTICE ROBERTS: That strikes me as saying they think there is too much uncertainty for them to act.

MR. MILKEY: Your Honor, they did not say there is too much uncertainty for them to form a judgment, which is the key issue. They said they preferred more certainty, but because of the nature of the endangerment standard, which emphasizes the important of regulating in the face of uncertainty, they have to at least explain why the uncertainty matters. And that is -- what they did here is particularly troubling in the fact that they ignored all of the indications pointing toward endangerment. They looked at what we don't know without ever looking at what we do know.

My reading of the tea leaves is that Chief Justice Roberts and Justices Scalia and Alito doubt that Massachusetts et al. possess even standing, while Justices Souter, Breyer, Stevens, and Ginsburg are less troubled by standing and more concerned with, and doubtful of, the EPA's reasons for refusing to regulate. Justice Kennedy seemed alternately sympathetic to each party, but may have shown a bit of his hand with his reference to State of Georgia v. Tennessee Copper Company, 206 U.S. 230 (1907), a case in which the Supreme Court found that Georgia was entitled to injunctive relief from out-of-state sulphur dioxide pollution damaging its forests. Justice Thomas did not participate in the discussion.

Whatever the Supreme Court's decision, a very different Congress will be waiting to respond.

Patents In The Enzone

Enzo Biochem ("Enzo") has made a habit of befuddling the U.S. patent system. Enzo is the assignee of U.S. Patent No. 4,900,659, which claims nucleic acids that preferentially hybridize to complementary nucleotide sequences found in Neisseria gonorrhoeae, the causative agent of gonorrhea. On April 2nd, 2002, in Enzo Biochem, Inc. v. Gen-Probe Incorporated, 285 F.3d 1013("Enzo No"), the Court of Appeals for the Federal Circuit ("Federal Circuit") held that these claims lacked written description support in the patent specification despite the fact that Enzo had placed copies of the claimed nucleic acids in a biological depository approved by the U.S. Patent and Trademark Office ("USPTO"). Then, in a remarkable change of heart, the same Federal Circuit panel reversed itself on July 15th, 2002, in Enzo Biochem, Inc. v. Gen-Probe Incorporated, 2002 WL 1540813, No. 01-1230 ("Enzo Oops I Meant Yes"), this time holding that the nucleic acid deposits did satisfy the written description requirement after all.


Ever prone to upset the patent applecart, Enzo is now creating a stir at the USPTO. A mere 24 years after it first filed a patent application claiming automated DNA sequencing, Enzo has convinced the USPTO to declare an interference involving U.S. Patent No. 5,821,058 ("'058 patent"), entitled "Automated DNA Sequencing Technique". Leroy Hood was one of the inventors of the '058 patent, which has generated handsome profits for its owner, the California Institute of Technology ("CalTech"). Automated sequencing using gel electrophoresis, one of the inventions claimed by Enzo's patent application, is one of the fundamental techniques depended on by biotechnology researchers in both industry and academia. If, after the interference proceedings and appeals that will likely ensue, Enzo's patent is finally determined to have priority over the '058 patent, then Enzo can expect an extremely lucrative payday as companies and universities engaged in biotechnology are compelled to purchase licenses.

However, given the glacial rate at which interferences proceedings progress, CalTech and the biotechnology community will have plenty of time to worry because a final determination on who controls automated DNA sequencing will likely take years.

Abigail Alliance - Drugs, Liberty, And Safety

In 2003 the Abigail Alliance For Better Access To Developmental Drugs ("Abigail Alliance") and the Washington Legal Foundation proposed that the Food and Drug Administration ("FDA") issue regulations allowing terminally ill patients excluded from FDA clinical trials to gain access to investigational new drugs. The Abigail Alliance then filed a Citizen Petition according to 21 C.F.R. §10.30. When the FDA failed to respond to the Petition within 180 days, the Abigail Alliance sued in the D.C. District Court to challenge the FDA's drug approval policy, arguing that the court should recognize the right to life under the Due Process Clause of the United States Constitution as allowing terminally ill patients access to drugs that have completed Phase I (dosage) trials. The District Court dismissed the suit under F.R.C.P. 12(b)(6), finding that the plaintiffs had failed to state a claim upon which relief could be granted.

In a 2 to 1 decision, the Court of Appeals for the D.C. Circuit reversed, concluding that

where there are no alternative government-approved treatment options, a terminally ill, mentally competent adult patient's informed access to potentially life-saving investigational new drugs determined by the FDA after Phase I trials to be sufficiently safe for expanded human trials, warrants protection under the Due Process Clause.

The Court of Appeals also remanded so that the District Court could consider whether the FDA's policy of refusing drug access violates the "protected liberty interest" of terminally ill patients "is narrowly tailored to serve a compelling governmental interest."

It is difficult to imagine this case not ending up in the Supreme Court. If the D.C. Circuit's decision stands, then FDA's role of guarantor of drug safety and efficacy may be significantly diminished, at least with respect to the terminally ill. Meanwhile, public health and patients' rights hang in the balance.

More later on this watershed case from Elizabeth Weeks and Andrew Torrance.

Burning up

Laura Hannon maintains the Global Warming Center, a blog sponsored by AccuWeather.Com. Among Laura's recent posts are discussions of the impact of climate change on droughts and fires and of predicted impacts of climate change on agricultural production, crime rates, and overall mortality, as offered by Stephen Dubner and Steven Levitt, the authors of Freakonomics.

Hat tip to Climate Change Elucidated, a relentless, RSS-powered compiler of blog posts related to climate change.

Antarctica

There is such a thing as a United States Antarctic Program. It's part of the National Science Foundation's Office of Polar Programs. The USAP has awarded sculptor David Ruth an "artists and writers" grant to study ice textures and forms at Palmer Station, Antarctica, from November 16 through December 23, 2006. David is keeping a log of his days way down south. Jurisdynamics and BioLaw recommend this visual record of the Antarctic, before global climate change erases its grandeur.

Medical dressing

Blame it on Grey's Anatomy. Or perhaps, unbeknownst even to Gil Grantmore, the classic law review article, Lex and the City, has surreptitiously snuck onto medical school reading lists. Whatever the cause, Dr. Erin N. Marcus ponders the ethical issues that arise when "young doctors strut too much of their stuff," in an essay in the New York Times.

Celling Short

In the dying days of summer, biologists from a small biotechnology company in Massachusetts, Advanced Cell Technology ("ACT"), made a startling revelation. In a letter published in Nature, they announced that they had discovered a technique to derive embryonic stem cells ("ESCs") from a single "blastomere" cell removed from an eight-cell zygote by micromanipulation. Beyond the elegance of the biology involved, ACT's new technique for generating ESCs seemed to provide a way to sidestep some of the ethical misgivings attending ESC research - notably the need to destroy embryos.

In a cautiously worded "ADDENDUM" published in this week's issue of Nature, the authors of the original paper now provide some additional details of their technique:

At the request of the Editors at Nature, we wish to clarify some questions that have arisen since the advance online publication (AOP) of our Letter on 23 August 2006. In our Letter, we showed that human embryonic stem-cell lines can be generated from a single cell after its removal from an 8–10-cell embryo. To minimize the number of embryos used, we removed multiple cells from each embryo, and none of the biopsied embryos were allowed to develop in culture.

In our experiments, the isolated blastomeres from each embryo were cultured together in the same medium that was used to culture the parent embryo, and were arranged to avoid contact with each other. Diffusible factors from the other blastomeres present in the media may assist recovery and growth of the blastomere. We have not excluded the possibility that only a subset of blastomeres of an 8–10-cell embryo are capable of forming human embryonic stem cells. These caveats are worth considering for future studies, but do not negate our central finding that blastomeres extracted from an 8–10-cell embryo by mechanical micromanipulation can form human embryonic stem-cell cultures.

Given the significance of the additional details, and the "request of the Editors of Nature", one wonders how how close the clarification came to characterization as "CORRIGENDUM" or "ERRATUM" instead of the far more forgiving "ADDENDUM".

Bioethicists who viewed the new technique as vitiating the claim that embryos must be destroyed to generate ESCs now face renewed disappointment. As the authors clarify, "we removed multiple cells from each embryo, and none of the biopsied embryos were allowed to develop in culture". In other words, ACT has not yet, in fact, demonstrated that ESCs can be generated from embryos that survive the loss of a blastomere. Though ACT's original claims may still be proven at some point, this reversal of scientific fortune should embolden opponents of ESC research to renew their criticisms.

Effectiveness And Enablement

The Court of Appeals for the Federal Circuit ("Federal Circuit") just published its decision in Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc. ("Impax v. Aventis")(November 20, 2006; 05-1313), which involves a drug, riluzole, effective in treating amyotrophic lateral sclerosis (“ALS”; also known as Lou Gehrig's disease). Aventis owns a patent that claims methods of treating ALS using riluzole. Impax filed an Abbreviated New Drug Application ("ANDA") to manufacture and sell generic riluzole, also for purpose of treating of ALS. The district court (District of Delaware) sided with Aventis, declining to find unenforceability or invalidity of Aventis' U.S. Patent No. 5,527,814 (“’814 patent”).

On appeal by Impax, the Federal Circuit affirmed the district court's decisions on enforceability and validity in light of one prior art patent. However, with respect to another prior art patent, the Federal Circuit vacated the finding of validity on the grounds that the district court had applied the wrong legal standard in assessing anticipation, and remanded the case for a reassessment using the proper legal standard. The Federal Circuit's discussion of the proper legal standard clarifies a subtlety of patent law: whether or not a prior art reference must be "effective" to be enabled.

The Federal Circuit distinguished the enablement standard under 35 U.S.C. 112 from that used to judge the sufficiency of allegedly anticipatory prior art references under 35 U.S.C. 102, and emphasized that the standard of enablement is indeed different between these two sections. The district court had judged an allegedly anticipating prior art reference not to anticipate because "there was no evidence that [what it taught] would be 'effective'" in practice. The Federal Circuit rejected this interpretation, stating, instead, that "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Rather, to be anticipatory, a prior art reference must only "[describe] the claimed invention sufficiently to enable a person of ordinary skill in the art to carry out the invention".

An inconsistent standard of enablement is one of many subtleties in U.S. patent law. In Impax v. Aventis, the prior art references under consideration were U.S. patents, which carry with them a strong presumption of validity upon issue. One wonders if the Federal Circuit would have accorded equal treatment to non-patent prior art, all other facts being unchanged. The same "effectiveness" standard in 35 U.S.C. 112 and 102 would make the law easier for courts to apply, and either increase or decrease the probability of claims issuing, depending on which of the two standards were chosen. However, as far as the Federal Circuit is currently concerned, vive la différence.

Priceless

Readers who have followed Kitzmiller v. Dover Area School District, 400 F. Supp. 2d 707 (M.D. Pa. 2005), and BioLaw's coverage of that case (Andrew Torrance; Kristi Bowman) will enjoy this video by Ed Brayton of Dispatches from the Culture Wars and Louis Shackleton of UDreamOfJanie:

Hat tip to John "Catshark" Pieret of Thoughts in a Haystack, a.k.a. Dododreams.

Kofi Annan Meets Mary Shelley

On November 18, 2006, Kofi Annan received the The Max Schmid- heiny Freedom Prize at the University of Saint Gallen, Switzerland. In his acceptance address, Annan focused on the dangers of biotechnology. The dangers he foresees are numerous and serious. Here is an excerpt of his speech:

But if [biotechnology] falls into the wrong hands, [the results] could be catastrophic.

When used negligently, or misused deliberately, biotechnology could inflict the most profound human suffering -- ranging from the accidental release of disease agents into the environment, to intentional disease outbreaks caused by State or non-State actors.

As biological research expands, and technologies become increasingly accessible, this potential for accidental or intentional harm grows exponentially. Soon, tens of thousands of laboratories worldwide will be operating, in a multi-billion dollar industry. Even novices working in small laboratories will be able to carry out gene manipulation. And the more laboratories there are with inadequate biosafety standards, the greater will be the number of mistakes and accidents waiting to happen.

Currently, we lack an international system of safeguards to manage those risks. Scientists may do their best to follow rules for responsible conduct of research. But efforts to harmonize these rules on a global level are outpaced by the galloping advance of science itself, and by changes in the way it is practised.

That is why, in recent months, I have raised the idea of a global forum for debate. Such a forum could discuss how to ensure that biotechnology’s advances are used by all for the public good; how to ensure that the efforts of countries to harness biotechnology are not hampered by unnecessary impediments; and how we can learn to manage the potential risks. The forum would bring together the various stakeholders -- industry, science, public health, Governments, and the public writ large -- to work out a common programme, built from the bottom up.

Some view the dangers posed by biotechnology as relatively minor and manageable. These biotechnophiles are most common in the United States, China, and some others parts of southeast Asia. Here biotechnology flourishes.

Biotechnophobes, especially in continental western Europe, see biotechnology through the prism of Frankenstein's monster. Here biotechnology struggles.

Annan appears to have considerable sympathy for the latter perspective. His call for increased legal control over biotechnological research, international harmonization, and a focus on perceived risks will be influential. Whether or not his proposal is grounded in biological reality is a crucial threshold question, and one that he should address before he embarks on his grand international regulatory scheme for biotechnology. As with the creature in Mary Shelley's literary masterpiece, biotechnology may well be in as dire need of understanding as of control.

Pa faut mwen

The Conference of the Parties to the Kyoto Protocol has ended in Nairobi. The New York Times all but excoriates the meeting as a failure on account of the parties' inability to agree "how to move beyond the Kyoto Protocol, which requires cuts in emissions by most industrialized countries but expires in 2012." The United States' exclusion from the existing international framework is a serious stumbling block. Also emerging as an obstacle to further progress is the recalcitrance of China and India. Kyoto imposed no sanctions on these two countries, which claimed some sort of "developing world" discount but have emerged as two of the world's fastest-growing generators of greenhouse gases.

More details will follow at Jurisdynamics and at BioLaw. In the meanwhile, this observation by the Times is worth quoting -- and contemplating -- in full:

Many African communities are already feeling the effects of a shifting climate, from increased droughts to more desertification to spreading malaria, one of the continent’s biggest killers. The irony is that these countries most vulnerable to climate change are the least responsible for it, because they have little industry and produce a relatively small amount of pollution.

Pa faut mwen is Haitian Creole rather than west African French, but the sentiment is entirely appropriate. It's not my fault.

Editor's note: This item is being posted simultaneously on Jurisdynamics and at BioLaw.

Interpretating Biotechnology Patent Claims After Phillips

On November 15, 2006, a panel (consisting of Judges Lourie, Rader, and Rader) of the United States Court of Appeals for the Federal Circuit ("CAFC") decided Abraxis Bioscience, Inc. v. Mayne Pharma (USA) Inc. (06-1118), a patent infringement case involving, among other issues, the construction of the term "edetate". In its 2005 decision, the district court below (S.D.N.Y.) found that an anaesthetic pharmaceutical composition for which Mayne Pharma (USA) Inc. ("Mayne") had sought regulatory approval in an Abbreviate New Drug Application, or "ANDA", infringed claims to patents owned by Abraxis Bioscience, Inc. ("Abraxis"), both literally and under the doctrine of equivalents. Mayne appealed the district court's findings of infringement to the CAFC.

Since the CAFC decided Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), there has been much speculation about how claim terms would be interpreted. In Phillips, the CAFC had the opportunity to clarify the principles of claim construction. Many were disappointed when the CAFC opted for flexibility and nuance over bright line rules when interpreting the meanings of claim terms. Whether or not hopes for easy clarity were naive, claim construction post-Phillips continues to rely on the divination of general patterns from CAFC decisions grounded in highly specific patterns of fact.

Even viewed through this prism of caution, Abraxis v. Mayne may may argue for narrower claim interpretations of chemical compounds. The CAFC reversed the district court's broad construction of the meaning of "edetate", along with a finding of literal infringement dependent on this broad construction. Professing to follow the interpretive principles explained in Phillips, the CAFC arrived at a relatively narrow definition of "edetate" as "ethylenediaminetetraacetic acid (EDTA) and derivatives thereof".

The district court had adopted an interpretation of edetate "derivatives" that encompassed not just salts of EDTA (that is, a relatively narrow category of chemical compounds derivable in a relatively direct manner from EDTA), but also structural analogs (that is, an expansive category of structurally similar chemical compounds, some of which are less easily derived from EDTA). By contrast, the CAFC, relying on evidence from the claim language itself and the specification of the patent, rejected the inclusion of structural analogs as impermissibly broad. The fact that the specification mentions only EDTA and specific salts of EDTA, but no structural analogs of EDTA, appears to have been particularly persuasive to the CAFC.

After reversing the district court on literal infringement, the CAFC went on to affirm the finding of infringement under the doctrine of equivalents - a notable outcome itself, given the declining vitality of the latter doctrine in recent years. Thus, the reversal of literal infringement was not decisive in the patent infringement dispute. Nevertheless, Abraxis v. Mayne may still provide valuable insight into the evolution of the CAFC's approach to claim construction, particularly in biotechnology cases.

Growing Dominance

This year marked the tenth anniversary of the first field-testing of biotech crops (better known as "genetically modified") with an arbitrary, though still impressive, milestone: almost 100 million hectares (ha) of approved biotech crops are currently growing around the world. According to its report, Global Status of Commercialized Biotech/GM Crops: 2005, the International Service for the Acquisition of Agri-Biotechnology Applications views almost all current trends in biotech crops as bullish.

Here are a few highlights:

The areal growth rate of biotech crops is currently at 11% per annum.

Twenty-one countries, spanning all continents but Antarctica, host 8.5 million farmers who engage in commercial biotech agriculture.

The champion growing countries (in decreasing order by area planted) are the United States (49.8 million ha), Argentina (17.1 million ha), Brazil (9.4 million ha), Canada (5.8 million ha), and China (3.3 million ha).

Soybean is the dominant biotech crop (54.4 million ha), then maize (21.2 million ha), cotton (9.8 million ha), and canola (4.6 million ha).

Herbicide tolerance is the most popular genetically engineered trait (63.7 million ha), followed by insect resistance (16.2 million ha), and "stacked" genes for both traits (10.1 million ha). Of these categories, gene stacking is growing most rapidly.

Though the science of biotech crops is often complex, the landscape of commercial control is quite simple: Monsanto bestrides the world of biotech crops like a colossus.

From Roundup Ready to Bt to "Terminator" seeds, Monsanto develops it, patents it, and then grows it around the world. Biotech crops engineered by Monsanto grow on more than 90% of the world's biotech crop fields. Syngenta, Monsanto's nearest rival, occupies just 4%. Monsanto possesses market power in biotech agriculture to rival Microsoft's dominance in operating systems.

Monsanto works hard to protect its investments in biotech crops. It is an enthusiastic patent applicant. In the United States alone, Monsanto holds at least 3,872 patents and 281 published patent applications. By comparison, "rival", Syngenta, holds only about one tenth the patents and 104 published patent applications.

Antitrust concerns about Monsanto's dominance of biotech crops should be quite severe if the relevant market is considered to be biotech crops alone. However, the current preference is to view the relevant market as including all crops, biotech or otherwise. Given the current rapid growth in adoption of biotech crops, Monsanto's days as big fish in a small pond will probably soon given way to the new role of very big fish in a large pond.

Climate Change Virtue And Vice

In honor of the second Meeting of the Parties ("MOP2") of the Kyoto Protocol a consortium of environmental groups have sponsored a league table of the heroes and zeros of global climate change. Germanwatch, an environmental and sustainability group focusing on North-South issues, compiled the data, weighted it based on greenhouse gas emissions levels, national climate policy, and trend indicators, and published the rankings.

Wearing the laurels is Sweden, where, for example, an astounding one quarter of all energy is generated from renewable sources. The worst of the worst is Saudi Arabia, whose energy policies deliberately oppose efforts to reduce greenhouse gas emissions.

Here are the top ten climate change heroes:

1. Sweden
2. United Kingdom
3. Denmark
4. Malta
5. Germany
6. Argentina
7. Hungary
8. Brazil
9. India
10. Switzerland

And, here are ten worst climate change offenders:

47. Australia
48. South Korea
49. Iran
50. Thailand
51. Canada
52. Kazakhstan
53. U.S.A.
54. China
55. Malaysia
56. Saudi Arabia

Interestingly, poor, but rapidly developing Brazil and India are both among the most virtuous on the list, while rich, but complacent Canada, Australia, and the United States share the basement. Perhaps the latter should learn some lessons from their former colonial master, Britain, whose climate change virtues are exceeded only by the Swedes. Germanwatch has noted that the United States could rise 30 places in the rankings by adopting British climate change policies.

No Holiday For Monsieur Hulot

France has created the biggest stir so far at the second Meeting of the Parties ("MPO2") to the Kyoto Protocol, in Nairobi, Kenya. The emissions limits in the Kyoto Protocol expire in 2012. Even the most hopeful technological optimists do not expect the global climate change problem to have been solved by then. So, the parties to the Framework Convention on Climate Change are currently debating what the successor regime to the Kyoto Protocol will look like.

France's prime minister, Dominique de Villepin, whose hopes of being elected the next president of France are in desperate need of rejuvenation, has proposed that the European Union impose a carbon tax on products imported from countries who remain outside the next emissions regime. de Villepin made a point of mentioning China by name; lately, competition from a flood of inexpensive imports from China has been sowing panic among many members of the European Union. The issue has allowed de Villepin to appear vert while simultaneously offering relief to beleaguered European manufacturers:

Il n’est pas normal que l’Europe fasse des efforts considérables et pas les autres grands ensembles. La Chine est en passé de rattraper l’Europe en matière de haute technologie, elle doit aussi faire des efforts en matière écologique. (It’s not right that Europe make considerable efforts and not other major players. As China is quickly catching up to Europe in high technology, it must also make an effort to do so on environmental issues.)

With the real contenders for the French presidency, Nicolas Sarkozy and Ségolène Royal, falling all over themselves to praise the Stern Review on the Economics of Climate Change, the latest sensation from across La Manche, de Villepin is also trying to establish his environmental credentials. Famous French environmentalist, Nicolas Hulot, has challenged all candidates for president to agree to his Pacte écologique to combat global climate change and other environmental challenges. So influential is Monsieur Hulot that presidential candidate, Laurent Fabius, has promised to make him his deputy, if elected.

Nevertheless, even with Monsieur Hulot leading the charge, solving the global climate change problem will be no seaside holiday.

New Studies on Renewable Energy and Biofuels

Governing the Eco-Commons
By J.B. Ruhl

Two reports issued this week suggest a dynamic energy future lies ahead for domestic policy:

Biofuels: The Council for Agriculture, Science, and Technology (CAST) issued a commentary on Convergence of Energy and Agriculture: Implications for Research and Policy (available for free here), discussing the use of energy in agriculture and the food industry in light of current federal and state policies. Energy production from bio-sources also is addressed.

“Because grain-based ethanol is currently the USA’s only major source of biofuels, and because the magnitude of increase in grain-ethanol production is expected to have a large impact on commodity prices, agricultural profitability, and global food security, this Commentary focuses on the key issues concerning corn-based ethanol production systems over the next 5 to 10 years,” says Task Force Chair Dr. Kenneth G. Cassman, Director of the Nebraska Center for Energy Sciences, University of Nebraska, Lincoln. “Much of the discussion also is relevant to fostering development and sustainability of other biofuels systems, including ethanol from sugar crops and ligno-cellulosic biomass, and biodiesel from oilseed crops.”

(CAST is a nonprofit organization established in 1972 as a result of a 1970 meeting sponsored by the National Academy of Sciences, National Research Council. It is composed of scientific societies and many individual, student, company, nonprofit, and associate society members.)

Renewable Sources: A RAND Corporation study (summarized here) finds that renewable resources could produce 25 percent of the electricity and motor vehicle fuels used in the United States by 2025 at little or no additional cost. Renewable sources currently provide about six percent of all U.S. energy supplies. Using a computer model, RAND researchers assessed the possible impact that a 25 percent renewable energy target for electricity and motor vehicle ground transportation could have on total national energy expenditures and on emissions of local air pollutants and carbon dioxide by the year 2025. They found that if renewable energy production costs decline by at least 20 percent between now and 2025, which is consistent with recent experience, the 25 percent figure can be reached unless long-term oil prices fall far below the range currently projected by the federal Energy Information Administration.

Seems like a lot of extrapolations with "ifs" and "unless x happens" loaded in both reports. Would anyone in 1975 have imagined our energy policy would be where it is today? Indeed, in the summer of 1979, during the second OPEC oil crunch, I worked for the Bureau of Economic Analysis, and just for fun we modeled the economy based on the then-insane assumption of $40/barrel. What a hoot!

One billion trees

Having been informed of the initiative through a post by Terri Windling of the Endicott Studio for Mythic Arts, I am happy to endorse the United Nations Environment Programme's Billion Tree Campaign. The idea is simple: Planting no fewer than one billion trees around the world during 2007 represents a small step toward reforesting the planet. Those trees, in addition to improving soil and water resources, will begin to mitigate the accumulation of atmospheric carbon dioxide, a leading contributor to global climate change.

When you've finished making your pledge to the Billion Tree Campaign, be sure to read the Endicott Studio's follow-up posts on spherical treehouses and the art of trees and wood.

Editor's note: This item is being posted simultaneously at Jurisdynamics and at BioLaw.

Biolawmakers

November 7, 2006, did more than change the political color of Congress from faintly red to faintly blue. Some biolaw issues will be significantly affected by the elections' results. Here are a few of the headliners.

Evolution. Rick Santorum (R-Pennsylvania), one of the most powerful cheerleaders of "intelligent design", lost his Senate seat in the wake of the Tammy Kitzmiller v. Dover Area School District decision. State schoolboards in both Kansas and Ohio shifted towards the pro-evolution position. Darwin's theory seems to be outcompeting "intelligent design" in the struggle for curricular existence.

Stem Cell Research. A Missouri ballot initiative constitutionally limiting legal restrictions on embryonic stem cell research succeeded. Nancy Pelosi (D-California), who earlier this year declared that "Every family in American is one phone call or one diagnosis away from needing the benefits of stem cell research... This research has the biblical power to cure", assumes the reins of power in the House of Representatives.

Global Climate Change. The party of Al Gore is likely to try to ride the new wave of enthusiasm for the global climate change issue.

The Arctic National Wildlife Refuge ("ANWR"). Maria Cantwell (D-Washington), the champion of ANWR, was reelected by an unexpectedly large margin. Without new drilling for oil, the caribou, muskox, and polar bears will all be able to sleep more soundly at night.

The Endangered Species Act. Richard Pombo (R-California), the scourge of endangered creatures everywhere, was defeated by Jerry McNerney (soon D-California), an alternative energy entrepreneur. The Delhi Sands Flower-Loving Fly, the Northern Spotted Owl, and even the Virgin Islands Tree Boa will feel more loved than they have for years.

The Pharmaceutical Industry. With Henry Waxman (D-California), of Hatch-Waxman Act fame, about to become chairman of the House Government Reform Committee, generic drug companies will cheer while big pharma will fear. Generic biologics may move a step closer to reality as well.

Beyond the guarantee of voluminous quantities of hot air emanating from both parties, the next Congress is sure to be an especially exciting one for issues of biology and law.

The Ups And Downs Of Greenhouse Gases

The second Meeting of the Parties ("MOP2") to the Kyoto Protocol of the United Nations Framework Convention on Climate Change ("FCCC") is currently underway in Nairobi, Kenya. In honor of MOP2, a quick look at the actual data on emissions of greenhouse gases ("GHG") by the Annex I parties to the Kyoto Protocol is in order.


Notice the striking differences in emissions changes from 1990-2004 by developed countries (mostly occupying the upper half of bar graph: increases in GHG emissions) and former members of the Warsaw Pact (mostly occupying the lower half of bar graph: decreases in GHG emissions). The increases of the developed countries (pink line) are roughly balanced (blue line) by the decreases of the former Warsaw Pact countries (red line).


These data strongly suggest that, if a GHG-trading system incorporating all Annex I countries were ever established, the former Warsaw Pact countries could benefit handsomely from the economic travails they have suffered since the fall of the Berlin Wall by selling unused GHG-emission credits to developed countries that emit more GHG than they should.

The COP2 is currently discussing just such an emissions trading system, in part because the potential gains from trade are so tantalizing.

Brandeis' Stem Cell Laboratory

Missouri passes Amendment 2. The impact of the Missouri Stem Cell Research and Cures Initiative will be felt in the laboratories of the Stowers Institute For Medical Research.

In his dissent in New State Ice Co. v. Liebmann (U.S. 1932), Supreme Court Justice Louis Brandeis famously stated that

To stay experimentation in things social and economic is a grave responsibility. Denial of the right to experiment may be fraught with serious consequences to the Nation. It is one of the happy incidents of the federal system that a single courageous State may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country.

Though embryonic stem research may be stalled at the federal level, Missouri has now grasped the opportunity to "serve as a laboratory" for embryonic stem cell research.

By a narrow margin, on November 7, 2006, Missouri's voters approved Constitutional Amendment 2. Article III of the Missouri state constitution will now be amended to add Section 38(d), entitled "Missouri Stem Cell Research and Cures Initiative". The core of proposed Section 38(d), Subsection 2, states

To ensure that Missouri patients have access to stem cell therapies and cures, that Missouri researchers can conduct stem cell research in the state, and that all such research is conducted safely and ethically, any stem cell research permitted under federal law may be conducted in Missouri, and any stem cell therapies and cures permitted under federal law may be provided to patients in Missouri, subject to the requirements of federal law and only [several additional limitations and requirements]

Now that Missouri's voters have chosen to place their state in the vanguard of stem cell law, Brandeis' metaphorical "laboratory" assures the literal laboratories at the Stowers Institute For Medical Research their place as leading-edge centers of embryonic stem cell research.

That was then, this is now

No, this isn't a celebration of the literary legacy of S.E. Hinton. This is just a short item highlighting two New York Times articles on global climate change.

That was then

Computer-aided analysis of CO₂ levels throughout the Phanerozoic eon is introducing half a billion years of atmospheric data into discussions of global climate change.

This is now

The International Energy Agency projects that China will surpass the United States in CO₂ emissions in 2009, nearly a decade ahead of ealier estimates.

A Gene By Any Other Name

The Human Genome Nomenclature Committee ("HGNC") is charged with a vital mission: to name genes. Recently, controversy has begun to bubble up over the names given to Drosophila (fruit fly) genes that have homologues (genes with similar nucleotide sequences derived from a common ancestor) in humans.

So what has given rise to this effort to abridge the freedom of scientific speech? The problem stems from the fact that Drosophila geneticists often give their fruit flies' genes names like "lunatic fringe homolog" ("LFNG"), "manic fringe homolog" (MFNG), "radical fringe homolog" ("RFNG"), "sonic hedgehog homolog" ("SHH"), and "Indian Hedgehog homolog" ("IHH"). As yet, no scientific evidence suggests that fruit flies themselves are offended by their genes' names. Though first discovered in Drosophila, these genes (and many others) have homologues in humans.

Currently the HGNC is worried that humans - a species that may possess genes for political lobbying for which fruit flies have no homologues - might react more negatively than do fruit flies to such gene names. As the HGNC's website soliciting comments on politically correcting gene names asks, "How would you feel if you were told you carried a mutation in the gene ‘Lunatic Fringe homolog (Drosophila)'?"

Perhaps the fruit flies will thank us one day for sparing them the indignity of injudicious gene names. Or maybe they will demonstrate a greater genetic potential for humor than we do, and just laugh at us.

American Public Health Association Annual Meeting

The 134th American Public Health Association (APHA) Annual Meeting began this past weekend in Boston and will be held November 4 - 8, 2006. The meeting, which anticipates 13,000 attendees, will focus on "Public Health and Human Rights." The conference is a massive affair, featuring hundreds of scientific and educational sessions -- including roundtables, poster sessions, and panel discussions -- and thousands of scientific papers on the latest public health issues. Featured speakers include Helene Gayle, of CARE USA, John McDonough, of Health Care for All, Massachusetts's leading consumer health advocacy organization, and Paul Famer, of Partners in Health, an international direct-care charity.

I join Ross Silverman, Robert Field, and Patricia Sweeney for a scientific panel session on "Vaccinations, Human Rights, and Public Health Interventions," tomorrow afternoon. The scope and size of the Annual Meeting is a testament to APHA's presence, the importance of the public health policy, and the breadth of issues bearing on the field.

Sorry Charlie--You're Dead

Governing the Eco-commons
By J.B. Ruhl

I can't help piggy-backing on Rebecca's post about the research just out in Science predicting the loss of marine biodiversity, to emphasize how real this threat is from the standpoint of complex adaptive systems theory. Perhaps I'm dating myself, but I remember the "Sorry, Charlie" TV ads for the Star Kist brand of tuna that showed a tuna named Charlie (yes, he wore a hat and glasses) saddend because Star Kist refused to catch him--he just wasn't up to their standards. Well, according to the research, Charlie probably would have no problem getting hooked these days, as he is likely to be part of a "global collapse of all taxa currently fished by the mid–21st century."

The research team analyzed local experiments, long-term regional time series, and global fisheries data to test how biodiversity loss affects marine ecosystem services across temporal and spatial scales. They found that, overall, rates of resource collapse increased and recovery potential, stability, and water quality decreased exponentially with declining diversity. Restoration of biodiversity, in contrast, increased productivity fourfold and decreased variability significantly. The researchers concluded that marine biodiversity loss is increasingly impairing the ocean's capacity to provide food, maintain water quality, and recover from perturbations. They also believe, however, that conditions have not crossed the threshold of irreversibility, and they call for measures to restore marine biodiversity through sustainable fisheries management, pollution control, maintenance of essential habitats, and the creation of marine reserves.

I am sure the report, which was picked up by media around the globe, will attract many smug assertions that the conclusion is absurd, that there is no way we will see the extinction of the world's marine species by 2050, or ever. Well, I'd be happy to have someone convince me it is not possible. To be sure, linear extrapolations from trend data are unreliable, particularly in the world of ecology, but if anything my guess is that it is more likely that any nonlinearity in the dynamic between "business as usual" and marine life will cut against sustainability.

So chalk this up as another high-stakes Type I Error/Type II Error bet we'll have to make on the scale of global climate change in a context of a highly complex system. Do we invest in the measures the researchers recommend on the belief they may be right, in which case if they are wrong we spent a lot of money and left a lot of fish in the sea we could have eaten. Or do we continue with business as usual on the belief that they are wrong, in which case if they are right...well, if they are right, it's not just Charlie who's going to be feeling a lot of pain.

Alex P. Keaton - Stem Cell Supporter

A few weeks ago, in Big Effects Of Little Stem Cells, I highlighted the heated Senate race in Missouri between Democrat Claire McCaskill (pro-stem cell research) and incumbant Republican Jim Talent (anti-stem cell research). Earlier, in Ev'rythin's Up To Date In Kansas City, I shared the results of a highly informal, completely unscientific poll of signs indicating support or opposition to proposed Amendment 2 to the Missouri state constitution: 25 in support and 3 opposed. Amendment 2, which is being pushed not just by Democrats, but also by Republicans like Missouri's governor, Matt Blunt, would limit legal restrictions on stem cell research and particular forms of cloning needed to conduct such research.

Much has happened over the past few weeks. After Michael J. Fox appeared in a television commercial urging voters to elect Claire McCaskill because of her pro-stem cell stance, that sultan of subtlety, Rush Limbaugh, mocked Fox for allegedly exaggerating the symptoms of his Parkinson's Disease. Limbaugh subsequently apologized, but his criticism appears to have strengthened support for stem cell research across the country. In Missouri, Claire McCaskill pulled even with Jim Talent in a number of post-Fox/Limbaugh polls. In what may be an indication that Talent's campaign - and the campaign against Amendment 2 - is flagging, both President Bush and Rudolph Giuliani have flown to Missouri hoping to conduct some last-minute damage control. Awkwardly for Talent, Giuliani did mention his own support for early stem cell research.

Unwilling to settle for rigorous and scientific polls alone, I conducted my own second, highly unscientific poll on the stem cell issue today (November 3, 2006) by again counting Kansas City lawn-signs favoring or opposing Amendment 2. The current tally: 42 signs in favor and 12 signs opposed.

Things look favorable for passage of Amendment 2. But then, when even Alex P. Keaton speaks out in favor of stem cell research, it's safe to conclude that the winds of change are blowing.

no more fish in the sea

There is a looming crisis in fisheries. Most experts agree that capture fisheries around the world have reached or exceeded sustainable limits. As a result, despite increased fishing effort and more effective equipment, total catch levels have remained stable or decreased every year since the mid-1990s. In 2004, the United Nations’ Food and Agriculture Organization (FAO) reports that 75% of the world’s fisheries were overfished, threatened or fully exploited.

Today's edition of Science published the most disturbing report yet. According to a meta-analysis study done by a team of researchers from the US and Canada, marine fish stocks are in more immediate jeopardy than has been previously reported. The research team, led by Boris Worms from Dalhousie University, concluded that the rate of fishery resource collapse is accelerating, and is undermining the stability of marine ecosystems as a whole, as well as negatively affecting water quality. Their analysis indicates that at current rates of diversity loss, there will be no more viable fish or invertebrate species available to fisheries by 2050.

2050 is the same year that world population is expected to reach 9 billion! Read together, these trends are extremely ominous--at the very moment that more and more people will need to turn to fish as a primary food source, fish stocks will be collapsing. Not only are the potential environmental consequences horrible, but so are the immediate human costs. Fish provides almost half the world's population (2.6 billion people) with at least 20 percent of their protein. The world already suffers from growing food insecurity, with 823 million people chronically malnourished. Despite World Food Summit and UN Millenium Development Goal commitments to halve the number of undernourished people by 2015, the trends look extremely discouraging.

The myth of plenty--that there is always another fish in the sea--is destroying the ocean.

Poller Opposites

The U.S. electoral silly season is upon us. And, most polls indicate a strong shift in the political winds. Those same polls also suggest that the issue of legal protection of the environment elicits seemingly conflicting responses from voters.

The latest New York Times/CBS News poll, conducted from October 27-30, 2006, posed two questions about environmental protection.

The first, Question 11, asked "Of all the problems facing this country today, which one do you most want the new Congress to concentrate on first?" Only 2% of voters chose "Environment". Eleven other issues were deemed more pressing. On the bright side, this is a marked improvment, because "Environment" did not even appear in the poll in 1998.

The second, Question 78, asked "Do you agree or disagree with the following statement: Protecting the environment is so important that requirements and standards cannot be too high and continuing environmental improvements must be made regardless of cost." Here, more people agreed (66%) and fewer disagreed (33%) than in any poll conducted since 1992.

So, to summarize, once Congress solves those first eleven pesky little issues - the war in Iraq, immigration, healthcare, the economy, defense/military, terrorism, education, jobs, poverty, foreign policy, and same-sex marriage - American voters will enthusiastically support efforts to protect the environment.

A Snake Mystery Resolved

A few weeks ago, in A Snake Mystery, I described the desperate plight of the Virgin Islands Tree Boa, a federally-listed endangered species found in the United States Virgin Islands. I noted then that "its last stronghold, in the dry, coastal forest of eastern Saint Thomas, is now the site of a planned major subdivision of luxury vacation homes." That was on Thursday, October 19, 2006.

I just received confirmation from several independent sources on Saint Thomas that on Friday, October 20, 2006, the developers, Dolphin Cove Development LLC, announced they would scale back their development considerably to set aside the core of the Virgin Island Tree Boa's habitat. What's more, after several years of singing a very different tune to those of us interested in the snake's survival, the developers appear to be sincere in their newfound desire to help save the snake. I applaud the folks at Dolphin Cove Development, and hope to meet with them soon to discuss their revised plans.

Although I do not for a moment suggest that the timing of Dolphin Cove Development's decision was more than a coincidence, I am delighted with the difference a single day has made for the future survival of this wonderful little snake.