Macfie, McCain, and McPrizes

In late 19th Century Britain, a British Member of Parliament, Robert Macfie, vigorously advocated awarding governmental cash prizes to inventors whose inventions proved useful, and pressed for such a reward system to replace patents. Patents are usually justified on the grounds that they promote technological innovation. The United States Constitution is rather explicit about this, granting Congress the right to set up a patent system "To promote the Progress of...[the] useful Arts". However, the monopoly right to exclude that a patent confers to its owner can also create a deadweight loss to society. Macfie's system of government-funded rewards was intended to sidestep the deadweight loss from patent monopolies by making new inventions free for anyone to exploit.

Earlier this week, John McCain revealed that he shares more with Macfie than just most of the letters in his name. McCain proposed a version of Macfie's invention reward system to improve automobile fuel efficiency:

I further propose we inspire the ingenuity and resolve of the American people by offering a $300 million prize for the development of a battery package that has the size, capacity, cost and power to leapfrog the commercially available plug-in hybrids or electric cars...That’s one dollar, one dollar, for every man, woman and child in the U.S. — a small price to pay for helping to break the back of our oil dependency.

Though McCain's formula for deriving the size of the prize may seem unsophisticated, he shares the philosophy underlying his proposal with Steven Shavell, a professor of law and economics at Harvard Law School. Shavell has suggested the advantages of a reward system over a patent system for more than a decade. As he and coauthor Tanguy Van Ypersele observe in their 2001 paper, "Rewards Versus Intellectual Property Rights" (Journal of Law and Economics, Volume XLIV: 525-547):

We conclude in our model that intellectual property rights do not possess a fundamental social advantage over reward systems and that an optional reward system—under which innovators choose between rewards and intellectual property rights—is superior to intellectual property rights.

Technological optimists tend to view technological innovation as the key to solving the world's problems, and the patent system has traditionally been viewed as playing a pivotal role in spurring and advancing innovation in the "useful Arts". However, other legal models of promoting innovation exist. In the spirit of Robert Macfie, not to mention Shavell and Van Ypersele, perhaps John McCain's proposal is worth a try.

Biotechnology Goes Underground

Although advocates of comprehensive reform to the United States Patent Act have so far failed to shepherd any of their bills into statute, the next Congress is sure to take up the baton again. After all, the 2007 proposals actually passed the House before dying in the Senate. New regulations proposed by the United States Patent and Trademark Office ("USPTO") and decisions by U.S. Supreme Court have both added to a sense that patent protection is weakening.

There seems to be a near-consensus at the 2008 Biotechnology Industry Organization ("BIO") International Conference that erosion of patent protection will disproportionately affect the biotechnological innovation. As BIO President and CEO, James Greenwood, declared during a lunchtime plenary speech, BIO and others in the biotechnology and pharmaceutical industries have decided to dedicate themselves to sustaining strong patent rights in the U.S. and elsewhere.

Regardless of the outcome of this patent battle, the perception of risk to patent rights may already be changing intellectual property strategy in biotechnology. As patent rights lose some of their lustre, there may be increased reliance on trade secret protection. Generally, trade secret law is ill suited to protect drugs and other molecules because the structures of such compositions of matter are readily discernible once the composition itself has become available in the marketplace. Trade secret protection does not extend to reverse engineering if the product to be reverse engineered is itself public. However, inventive methods and best practices whose secrecy can be maintained are susceptible of protection.

The quid pro quo of the monopoly exclusions rights that patents confer is the requirement that patent applicants disclose detailed information enabling others to make and use the invention into the so-called "public storehouse" of knowledge. Without the prospect of patent protection, patent applicants may shift their efforts to protect their inventions towards secrecy, depriving the public storehouse of vital knowledge. In addition, such a decline in public disclosure may worry those who monitor biotechnologies for their potential dangers to society. Obviously, since products themselves are difficult to keep secret, such a change in protective strategy has limits. However, the sense among the biotechology community here at BIO 2008 is that current patent reform efforts are forcing them to become more guarded in what information to share with the public, and that this may harm future innovation. The consequences of a more cloak-and-pipette biotechnology industry could be significant, perhaps even profound.

Biotechnology's Unsettled Forecast

The global biotechnology industry came within a whisker of profitability in 2007. In the 35 years since Boyer and Cohen first produced recombinant DNA, the industry as a whole has suffered staggering losses. That may change in 2008, a cause for cheer among the more than 20 000 biotechnology aficionados attending this year's BIO International Conference. However, instead of celebration, and despite enthusiastic endorsements of biotechnology by conference keynote speakers, Craig Venter, Arnold Schwarzenegger, and Colin Powell, the overall mood at BIO 2008 appears to be one of growing fatalism, even gloom.

So, what is raining on biotechnology's parade? Three clouds have come up repeatedly in a variety of panels and plenaries: (1) risks of weakening patent protection, (2) a drastic deceleration in Food and Drug Administration ("FDA") drug approvals, and (3) the credit crisis.

Patent protection. After several years of aborted efforts, the House of Representatives finally managed to pass a significant patent reform bill, H.R. 1908. The Senate, by contrast, let its counterpart bill, S. 1145, die. Though aligned on many policy issues over the years, the high technology and biotechnology industries strongly disagree about Congress' patent reform bills. James Greenwood, President and CEO of BIO, defiantly told at a plenary lunchtime crowd that, although high technology has had the upper hand on promoting patent reform, the tide has now turned, and "We are going to win [the battle against weakening of patent protection]". Even so, the combined effects of KSR v. Teleflex (U.S. 2007), Congressional patent reform efforts, and proposed new rule changes at the United States Patent and Trademark Office ("USPTO") have sown uncertainty about what level of patent protection is, and will be, available for biotechnology inventions.

FDA regulation. With a modern record low of 24 approvals in 2007, the FDA has strongly signaled that the bar for drug and diagnostic approvals has now risen considerably. So, once they survive the USPTO frying pan, biotechnology companies developing drugs or diagnostics now face the prospect of the fire of the FDA approval process.

The credit crisis. Over the last decade, the funding required to sustain biotechnology companies through the billion dollar expense of drug development has become increasingly difficult to obtain. What began as a gradual decline became a precipitous fall last year, and has not improved much since then. With money for biotechnology companies so tight, failed ventures are accelerating.

Mixed with the gloom is a spirit of defiance. BIO is spearheading increasingly effective efforts to ensure that Congress does not weaken patent rights. USPTO efforts to limit continuation pratice have been permanently enjoined, providing a template for legal challenges to other proposed rule changes, such as heightened disclosure obligations and much more difficult procedures for appealing claim rejections to the Board of Patent Appeals and Interferences ("BPAI"). The biotechnology product pipeline appears to be healthy, with exciting progress in stem cells, gene therapy, genomics, proteomics, and synthetic biology. Biotechnology in Asia and Latin America is booming as never before. And, the biotechnology industry can, at least, enjoy Schadenfreude that the pharmaceutical industry is experiencing even harsher challenges, such as vigorous competition from generics companies and an approaching epidemic of patent expirations of blockbuster drugs.

Given the legal and financial challenges it faces, the biotechnology industry may be entering a new, less wildly optimistic, phase. The coming year may be one of tempered expectations. On the other hand, the biotechnology industry as a whole will almost certainly make a net profit in 2008, an unprecedented event that may allow at least some singing in the rain at BIO 2009.

The case for banana sex

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Social Contract On Drugs

Each year at BIO, Ernst & Young offer a numerically intensive update of the biotechnology industry, rich in charts, tables, graphs, pie charts, and Venn diagrams. However, this year's update managed several moments of philosophy as well. The most interesting involved several panel members discussing the "social contract" between the public and the bio/pharmaceutical industry.

According to the panel, this contract involves public tolerance of relatively strong patent protection for truly innovative new drugs in return for these new drugs to be abundant and,...well,...truly innovative. Apparently each party to this bargain has increasingly been shirking its obligations to the other.

Apparently, rather than ensure consistent, predictable, and strong patent protection for new drugs, public distrust has led to pressure on both Congress, the United States Patent and Trademark Office ("USPTO"), and even the courts to diminish patent rights. Why would this happen? Well, simultaneously, the public has apparently begun to feel cheated by trivial improvements in patent drugs, such as time-release or newly formulated versions, rather than the development of radically new drugs.

Who is to blame? The panel called for the bio/pharmaceutical industry to start developing truly new drugs in return for stronger, more reliable patent protection. Rather than allowing drug development to languish, industry was asked to embrace true innovation. True innovation would then be rewarded with stronger patent protection.

Perhaps a period of confidence-building is in order to convince both parties to renew their social contract. Without reconciliation with consumers, bio/pharma may continue to suffer a surfeit of trivially new patent applications claiming variations on previously patented molecules, not to mention a retreat to traditional therapeutic approaches, such as small molecules or monoclonal antibodies, while consumers may try to punish the industry by supporting patent weakening disguised as patent reform.

Of course, there is a chicken/egg challenge in avoiding this spiral of blame. Which needs to come first: - (1) renewed vigor in patent protection, thus creating an incentive for more truly innovative drugs, or (2) redoubled efforts to develop truly innovative drugs, thus justifying stronger patent protection? It will be interesting to watch efforts to renew the social contract surrounding drugs. If unsuccessful, the biotechnology industry and consumers may continue to play their current game of patent chicken, to the detriment of both.

Reporting From BIO 2008

BioLaw will be reporting live all week from the Biotechnology Industry Organization International Conference ("BIO 2008") in San Diego. BioLaw wishes to thank BIO 2008 for granting it official press status, and for providing excellent facilities in the Press Room.

BioLaw will report on every interesting biolaw issue it can during the week. However, BioLaw expects four issues in particular to attract disproportionate attention at presentations and among attendees at BIO 2008:

Follow-on biologics. Drug and patent law are both currently grappling with how to foster and effectively regulate a market for generic versions of biotechnological therapeutics. The existing model of generic pharmaceuticals may be useful, but the issues involved in more complex biologics tend to be more complicated.

Food and Drug Admistration ("FDA"). The past year has offered an unfortunate cornucopeia of regulatory disasters relating to food and drugs. Inadequate funding, ineffective management, political interference, and global trade have all been offered up as culprits responsible for such problems as tainted pet food, Salmonella tomatos, and unsafe pharmaceuticals.

Healthcare costs. Spending on healthcare and drugs by both government and consumers is reaching new heights. Presidential hopefuls, the Prescription Drug User Fee Act ("PDUFA"), the Medicare Modernization Act of 2003 ("MMA"), generic drugs, and follow-on biologics could each have significant effects on whether the escalating trajectory of healthcare costs can be altered.

Biotechnology patent law. The combined effects of KSR, Quanta, Seagate, and the trilogy of mental steps appeals considered by the Court of Appeals for the Federal Circuit will influence biotechnology patent law for years to come. Add to these cases both the continuing efforts in Congress to rewrite the Patent Act and the Patent and Trademark Office's proposed patent rule changes, and biotechnology patent law is undergoing considerable - perhaps even unprecedented - flux.

Stay tuned for regular biolaw updates from BIO 2008.

Exhaustion Reinvigorated

Quanta Computer, Inc. ("Quanta"), has two reasons to celebrate today. First, the new G3 iPhones that it builds for Apple have gone public. Second, the United States Supreme Court finally released its decision in Quanta Computer, Inc. v. LG Electronics, Inc. ("Quanta v. LGE"). Although not a biotechnology dispute per se, Quanta v. LGE will have significant implications for biotechnology patent law.

The main issue in dispute was the doctrine of patent exhaustion. As Justice Clarence Thomas, writing for a unanimous Court, explained,

The longstanding doctrine of patent exhaustion provides that the initial authorized sale of a patented item terminates all patent rights to that item.

LG Electronics, Inc. ("LGE"), licensed a portfolio of computer technology patents to Intel Corporation ("Intel"), but attempted to prevent Intel from selling products covered by those licensed patents that would be combined with non-Intel products. However, Intel sold some of these products to Quanta, which then combined the Intel products with other products of its own. LGE sued Quanta for patent infringement. Quanta argued that there could be no patent infringement because LGE's patent rights had been exhausted once Intel had sold the products covered by LGE's patent claims.

The Supremes sided with Quanta, and articulated a strong formulation of the patent exhaustion doctrine:

The authorized sale of an article that substantially embodies a patent exhausts the patent holder’s rights and prevents the patent holder from invoking patent law to control postsale use of the article. Here, LGE licensed Intel to practice any of its patents and to sell productspracticing those patents. Intel’s microprocessors and chipsets substantially embodied the LGE Patents because they had no reasonable noninfringing use and included all the inventive aspects of the patented methods. Nothing in the License Agreement limited Intel’s ability to sell itsproducts practicing the LGE Patents. Intel’s authorized sale to Quanta thus took its products outside the scope of the patent monopoly, and as a result, LGE can no longer assert its patent rights against Quanta.

Many biotechnological inventions are analogous to the products in Quanta v. LGE. Nucleic acids, polypeptides, and other biomolecules may be combined with other products or substances, such as incipients, carriers, or vectors. The Supremes appear to have made the preparation or sale of such combination products, if not independently covered by patent claims, more difficult to constrain through licensing of the initial product due to exhaustion of patent rights. One result could be even more creative attempts to license around patent exhaustion, although the Quanta v. LGE decision should make licensors even more careful to avoid patent misuse. Another result may be higher prices for the pre-combination products covered by patent claims to compensate for any loss of post-sale revenue.

The Supremes also clarified that patent exhaustion applies not just to product claims, but, despite LGE's protestations, to method claims as well. It is extremely common for biotechnology patents to claim methods. Consequently, efforts to constrain the use of claimed biotechnological methods in licenses may be effected by the renewed susceptibility of method claims to patent exhaustion.

Quanta v. LGE also focuses light on the continued unanimity with which the Supremes seem to view intellectual property law. Dissents and concurrences have become the exception over the past several years in such cases raising interesting questions about why intellectual property disputes are so easy for the Supremes to agree upon, while other areas of the law continue to inspire such division and acrimony among members of the Court. Of course, love for iPhones can conquer all.

Supreme Court decides Quanta

The Supreme Court just handed down its decision in Quanta Computer Inc. v. LG Electronics Inc., 06-937. The Court ruled 9-0 in favor of Quanta ruling that method patents are subject to exhaustion, and that the patents had been exhausted in this case. The opinion is here. It will be interesting to see how this decision plays out in the agbiotech context. Croplife International, BIO and the American Seed Trade Associations all filed amicus briefs urging the court to decide the case in a fashion that did not raise questions about the licensing agreements used in the agbiotech context. Given the Court's fairly sweeping language and unanimous opinion, I imagine there are some very anxious patent holders in agbiotech land this afternoon.

The greatest story ever told

Hear the rhapsody in cyan that cyanobacteria composed in bridging the Archaean and Proterozoic eons of geologic history. By "poisoning" the ancient earth's atmosphere through photosynthesis, cyanobacteria converted the reducing atmosphere of the Archaean into the aerobic atmosphere that has prevailed ever since and has supported a wide range of oxygen-loving (or at least oxygen-tolerant) organisms.
Once again, reports Rebecca Bratspies, politically potent forces of ignorance are trying to undermine the teaching of evolution in the United States. Comet West, as it appeared in 1976, was beautiful to behold. But did it presage yet another deadly bolide from the depths of transneptunian space, headed toward a fatal collision with earth? Enlightened voters and policymakers should fight back with precisely the emotional and rhetorical weapons that opponents of evolution have used to foist ignorance upon American children. As Brian Greene recently wrote in the New York Times, science — real science — "really matters" because: Science is a way of life. Science is a perspective. Science is the process that takes us from confusion to understanding in a manner that’s precise, predictive and reliable — a transformation, for those lucky enough to experience it, that is empowering and emotional. To be able to think through and grasp explanations — for everything from why the sky is blue to how life formed on earth — not because they are declared dogma but rather because they reveal patterns confirmed by experiment and observation, is one of the most precious of human experiences. Science empowers humanity — indeed, science morally impels humanity — to seek nothing less from life and to ask nothing less of the universe than the truth. In the poetic idiom of the Hebrew Bible — namely, chapter 38 of the Book of Job: 4 Where were you when I laid the foundation of the earth? Tell me, if you have understanding. . . . 16 Have you entered into the springs of the sea, or walked in the recesses of the deep? 17 Have the gates of death been revealed to you, or have you seen the gates of deep darkness? 18 Have you comprehended the expanse of the earth? Declare, if you know all this. Humanity, so it seems, demands a story of origins. If we need a creation myth, and the emotional reality of human existence evidently demands no less, then let's tell the greatest story ever told: the real story of earth, from its Hadean origins to the sixth great extinction spasm of the Phanerozoic. Evolution, the unifying theory of the life sciences, has a rigorous explanation for each of the phenomena illustrated here. It helps humanity unlock the mysteries behind the Book of Job, among other myths that have enchanted humanity throughout its history. In any of its guises, creationism offers no answers whatsoever. Teachers, parents, and citizens, go tell it on the mountain: You shall know the truth, and the truth shall set you free.
Govett's Leap in Australia's Blue Mountains is a spectacular instance of the Permian-Triassic boundary (250 million years ago), which marks the largest mass extinction of the Phanerozoic eon. Triassic sandstone overlies Permian coal; the boundary occurs roughly at the tree line near the base of the waterfall. Charles Darwin wrote about Govett's Leap in The Voyage of the Beagle: "Jan 18, 1836: Very early in the morning, I walked about three miles to see Govett's Leap . . . . These valleys . . . are most remarkable. Great arm-like bays . . . penetrate the sandstone platform; on the other hand, the platform often sends promontories into the valleys, and even leaves in them great, almost insulated, masses."	The Phanerozoic eon has witnessed five mass extinctions: the end Ordovician, the late Devonian, the end Permian, the end Triassic, and the end Cretaceous. Humanity is living through — and largely responsible for — for the sixth: the Holocene mass extinction. Amphibians, a clade 400 million years old, have lived through four mass extinctions. They may not survive a fifth. Will chytridiomycosis, caused by the chytrid fungus, ultimately be responsible for the extinction of evolutionarily distinct, globally endangered amphibians?

Biolaw Conference 2.0 (November 13-14, 2008)

The second annual Biolaw Conference 2.0 will be held on November 13th and 14th, 2008, at the University of Kansas School of Law. Biolaw 2.0 is being organized by the Kansas Journal of Law and Public Policy, and invited articles spanning the range of biolaw topics will be published in a special volume of the Journal. The inaugural Biolaw Conference featured such wonderful speakers as Hank Greely (Stanford Law School), Jim Chen (Dean, Louisville Law School/Mr. Jurisdynamics himself), Peter Barton Hutt (Harvard Law School/Covington & Burling), Jerry Menikoff (National Institutes of Health), Rudolf Beese (Sonnenschein Nath & Rosenthal), and Ken Lynn (KTEC). This "Biolaw 1.0" conference, generously sponsored by both Sonnenschein Nath & Rosenthal and KTEC, was so successful that it has now become an annual event whose mission is help elevate "biolaw" to the level of scholarly prominence achieved by technology-inspired cousin, cyberlaw.

Biolaw 2.0 will feature a number of speakers of national and international stature in the rapidly developing field of biolaw. An address by Professor Lee Silver, a leading geneticist at Princeton University who has also become a leading public policy scholar at the Woodrow Wilson School of Public and International Affairs, will deliver the conference's opening address. In addition to authoring several genetics textbooks, Prof. Silver has written two influential books on biotechnology and public policy: Remaking Eden - How Genetic Engineering and Cloning Will Transform the American Family and Challenging Nature: The Clash of Science and Spirituality at the New Frontiers of Life. In addition, he frequently comments on biotechnology and public policy for such other famous scholars as Stephen Colbert, Ted Koppel, and Charlie Rose.

In addition to Prof. Silver, senior scholars, such as Michele Goodwin and Peter Yu, and some of the most exciting and innovative junior biolaw scholars from the United States, Canada, Europe, and Africa will present their latest research in such areas as human enhancement, law and genetics, law and neuroscience, cloning, embryonic stem cells, organ transplantation, legal bioethics, biotechnology patent law, genetically modified food, climate change, and biodiversity law.

For anyone interested in attending Biolaw 2.0, admission to most of the presentations will be free and open to the public.

Stay tuned to Biolaw: Law and the Life Sciences for additional information on Biolaw 2.0, including a full schedule of speakers and their topics.

New Front on the Evolution Wars

The phrase seems innocuous enough: "strengths and weaknesses." In fact those three words are the latest salvo of those who were previously thwarted from forcing their personal religious beliefs on unsuspecting science students by court decisions rejecting creationism, creation "science" and "intelligent" design.


In today's NYT, Laura Beil ( article) writes about the latest attempt, using the language "strenths and weaknesses," to subvert Texas's state science curriculum. Because Texas law mandates that the "strengths and weaknesses" of evolution be taught, anti-evolution and anti-science forces are hoping to force their own religiously-inspired version of the origins of human life into the state-wide curriculum.


The website for the Orwellianly-named organization Texans for Better Science Education, a major booster of the effort, prominantly displays a link to Ben Stein's absurd anti-evolution screed Expelled (which Jim Chen and I have blogged about on this site previously). The site Expelled Exposed , put together by the National Center for Science Education, effectively documents Expelled for the inaccurate and deliberately deceptive nonsense that it is. If the choice to prominently feature the Stein screed didn't already tell me just about everything I need to know about Texans for "Better" Science Education (sorry, can't really type that with a straight face) except how to keep them out of the classroom, their frequent reference to "miltant" Darwinists would.


By the way, the url for Texans for Better Science Education is "strengths and weaknesses.org." Beil reports that these anti-science folks are only one vote shy of a majority on the Texas School Board. Phrases sure can be deceptive .

Where is the Flying Spaghetti Monster when we need him?

Patently Immoral Genes

It is not uncommon for patent attorneys in the United States to console themselves, especially when suffering from the stress of long workdays and endless due dates, deadlines, and statutory bars, that at least their branch of legal practice avoids the minefields of morality. Even if a patent attorney's judgment fails, none of her clients will be executed, jailed, or suffer public shaming as a consequence. As one patent attorney once "boasted" to a group of non-patent attorney colleagues, "Patent law is totally amoral."

Almost 200 years ago, in Lowell v. Lewis, F. Cas. 1018, 1019 (C.C.D. Mass. 1817), Justice Story proscribed certain inventions as too immoral for patenting if they would be "injurious to the well being, good policy, or sound morals of society." However, in the ensuing years this "moral utility" requirement has waned significantly, at least in U.S. patent law. In Juicy Whip, Inc. v. Orange Bang, Inc., 98-1379, 1999 U.S. App. LEXIS 18342, 51 U.S.P.Q.2D (BNA) 1700, (Fed. Cir. Aug. 6, 1999), the Court of Appeals for the Federal Circuit appeared to dismiss moral utility as a quaint historical practice, stating that "the principle that inventions are invalid if they are principaly designed to serve immoral or illegal purposes has not been applied broadly in recent years."

However, moral concerns about the patentability of biotechnology have retained their salience in Europe. In fact, Article 53(a) of the European Patent Convention ("EPC") explicitly excludes from patentability "inventions the publication or exploitation of which would be contrary to 'ordre public' or morality..."

Gene patents have been a special lightning rod in Europe for moral qualms about patenting. Now, the European Society of Human Genetics ("ESHG") has issued recommendations that would severely limit patents on genes in the European Patent Office ("EPO") and member states of the EPC. Specifically, the ESHG recommends that the EPO establish an "ethics committee" to police the patentability of controversial technological innovations, such as genes. As its report explains,

Many disputes between supporters of the patenting system and the public revolve around ethical issues. It is also felt that attorneys, patent applicants and patentees sometimes push the ethical limits of patentability, which damages the perception of the legitimacy of the patenting system as a whole. The ESHG urges EPO to find a way, together with the scientific community and the European institutions, to ensure that a morality issue, when it cannot be addressed under the morality article of EPC, can still be taken into account.

Along the same lines, the ESHG proposes EPO to consider the benefit of having an ethics committee to consider issues of major interest, such as patents applied to genes.

Enhanced ethical scrutiny, as well as other restrictions on gene patents proposed in the ESHG report, will not be greeted warmly by European biotechnology companies. On the other hand, the ESHG proposals will be viewed with interest by those in the U.S., such as Michael Crichton ("You, or someone you love, may die because of a gene patent that should never have been granted in the first place.") and California Democrat, Xavier Becerra (whose "Genomic Research and Accessibility Act" (H.R.-977) would ban gene patents), who are also pursuing strict limitations on gene patents justified largely on moral grounds.

As more and more gene-based drugs and diagnostic tests enter the market, and genetic testing for genetic traits and family ancestry become commonplace, this debate is likely to grow in importance.

Dealing with the Polar Bear

There has been a lot of hoopla and controversy focused on the Fish and Wildlife Service's (FWS) recent listing of the polar bear as a threatened species under the Endangered Species Act (ESA). The FWS is taking flak from all sides. Alaska, Canada, and many US industries argue that the agency used insufficient science to designate the bear as threatened, and that the listing will bring doom and gloom to our economies. Environmental groups argue the polar bear should have been listed as endangered, a more dire ESA designation, and that the agency should be clamping down on greenhouse gas (GHG) emissions that are causing the polar bear's decline.

In an article published in the Boston University Law Review a couple of months before the listing decision, I suggested that the agency do exactly what it did. The agency, of course, can argue its own case, but here are my three reasons why I believe it made the right move:

1. The Listing. Regardless of population numbers, industry has it wrong to say that the bear is not facing potential threats to its survival. If present trends are extrapolated, the species is in trouble. On the other hand, the agency is not required to extrapolate only one scenario. After all, the real problem for the polar bear is human political will--lack of it. But it seems two-faced for environmental groups to argue that legal measures are needed to alter GHG emission trends but that FWS cannot anticipate that possibility. Designating the species as threatened, but not yet endangered, fulfills the precautionary purpose of the threatened category. It's in the ESA for a reason, and the polar bear is a perfect case for its application.

2. Greenhouse Gases. One advantage of the threatened designation is that the ESA allows FWS to tailor protective measures for threatened species, whereas the full weight of the ESA's regulatory anvil lands when a species is designated as endangered. The concern is over how the ESA would treat GHG emissions were the polar bear listed as endangered. To suggest that the ESA is the way to accomplish a cogent, rational GHG policy is nothing short of ludicrous. As a practical matter, FWS and its ESA ocean species twin, the National Marine Fisheries Service (NMFS), have absolutely no capacity or expertise to regulate GHG emissions from industry or other sources. They are mainly habitat protection agencies, not pollution control agencies. More to the point, as a legal matter there is no principled way to identify which molecules of GHGs are harming the polar bear. Why would a coal-fired power plant in Kansas be the culprit, but not agriculture in California? If any source of GHGs is harming or jeopardizing the polar bear under the ESA, all sources are legally to blame. How would the agency choose which sources to go after without opening up a huge can of legal worms like this? Listing the polar bear as threatened avoided this problem in large part, and the agency has stated it will not pursue GHG emissions in contexts where the threatened designation nonetheless requires the agency to exercise its regulatory authority. That was the right position to take. Congress needs to belly up to the climate change bar and develop meaningful GHG legislation, not leave it to FWS to try to jam the huge square peg of GHG emissions into the small round hole of the ESA.

3. Helping Climate-Threatened Species. The polar bear is just one of the first species listed under the ESA based on climate change (NMFS had previously listed several coral species), but it won't be the last. FWS and NMFS should be focusing on what they do best--protect habitat. Many climate-threatened species can be helped along through habitat protection measures, given a bridge to what we hope will be a stabilized, albeit different, climate regime of the future. FWS and NMFS should focus their resources on this important component of our climate change policy.

JBR