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From Brunelleschi to Bilski

June 29, 2010 By Leave a Comment

Yesterday, the Supreme Court finally released its opinion in the case of Bilski v. Kappos, the decision that was expected to settle with some degree of finality whether business methods are patentable and under what conditions. It was a long wait — a recent commentator quipped a week before the opinion was issued that the “Supreme Court has unanimously decided to drive patent attorneys crazy.”

As patent attorneys study the Court’s ruling, which in very many ways leaves things pretty much as they were — but importantly now with the imprimatur of the highest court in the country — my own thoughts turn to the Tuscan city of Florence. And more specifically to the magnificent dome of the Santa Maria del Fiore, in many ways defining the cathedral that is the heart of that city.

The famous dome was the largest in the world for half a millennium, being surpassed only in 1928 when the Leipzig dome was finally constructed using a completely new technology — with reinforced concrete instead of traditional masonry techniques. Even today, the Florentine dome of the Santa Maria del Fiore remains larger than dome of the Capitol Building in Washington DC, just down the street from the Court in which the Bilski decision was handed down.

The Florentine dome was the masterpiece of Filippo Brunelleschi, who was also the first person to be granted a patent for a technical invention — a technique for transporting marble up the Arno river from the quarries at Carrara to Florence. His technique, which made use of a sort of barge called Il Badalone (“the monster”), very much simplified the process, but he refused to disclose to others how he did it. The Republic of Florence accordingly granted him a patent and in its grant recited the basic bargain that remains at the heart of every patent system in the world:

The admirable Filippo Brunelleschi, a man of the most perspicacious intellect, industry and invention, citizen of Florence, has invented some machine or kind of ship, by means of which he thinks he can easily, at any time, bring in any merchandise and load on the Arno and on any other river or water, for less money than usual, and with several other benefits to merchants…. [H]e refuses to make such machine available to the public, in order that the fruit of his genius and skill may not be reaped by another without his will and consent….. [I]f he enjoyed some prerogative concerning this, he would open up what he is hiding and would disclose it to all.

Governments do not issue patents out of the goodness of their hearts nor as some way of rewarding inventors. They issue patents for the purely practical objective of inducing inventors to disclose their inventions to the public, offering a state-backed right to exclude others from using their invention without permission for a limited time. In this way, innovation is spurred by having other inventors learn of the inventions and apply their own insight to develop further improvements. If patents fail to promote progress, then the system is not functioning as it should.

Should methods of doing business be patentable? This is a question that modern society has struggled with. Is there any real reason to suppose that the same bargain that was struck with Brunelleschi for “the monster” should not also be struck with those who invent new and efficient ways of engaging in financial transactions, providing insurance, holding auctions, or any of the other was of doing business? Bilski provides an implicit answer — while every justice agreed that Bilski’s method of financial hedging was not patentable, five of the justices came to that conclusion because it was expressed as an abstract idea, but acknowledged that “the Patent Act leaves open the possibility that there are at least some processes that can be fairly described as business methods that are within patentable subject matter.”

Four of the justices disagreed with the underlying reasoning. At the heart of their disagreement is a view that many share: “Business innovation … generally does not entail the same kinds of risk as does more traditional, technological innovation. It generally does not require the same ‘enormous costs in terms of time, research, and development.’… The primary concern is that patents on business methods may prohibit a wide swath of legitimate competition and innovation.”

Today, it is clear that business methods are patentable within the United States, provided they meet the other requirements set forth in the Patent Act. They must legitimately be novel, not obvious, and disclosed to the public with particularity.

Brunelleschi’s dome is an enduring edifice, a symbol to me of the achievements of the Renaissance and of the wonder that people create when their inventive capacity is encouraged. What all the justices in Bilski want — what we all want — is to foster that same kind of innovation in the sphere of business. Time will tell whether they have achieved that.

The full Bilski opinion can be read here.

Filed Under: Legal, Patent Law

Ill Seed, Ill Weed

June 23, 2010 By Leave a Comment

Ever since Justice Stevens announced his retirement several weeks ago, I have been trying to think of the perfect subject to talk about in this blog — some pivotal case, perhaps, where Stevens wrote the opinion and addressed some scientific issue. There have been several, of course. It is difficult for there not to have been many scientific issues that have come before the court during his 34-year tenure, the third longest in the history of the Supreme Court. There was, perhaps, his majority opinion in Massachusetts v. Environmental Protection Agency, the only Supreme Court case really to address an issue related to global climate change. Or maybe his majority opinion in Reno v. ACLU, the case that held the Communications Decency Act unconstitutional, having a great impact on the content that is available on the Internet. Or I could have written a speculative blog about In re Bilski, the case that is expected any day now to decide once and for all whether business methods are patentable; there is widespread speculation that Stevens will author a unanimous opinion of the court in that case.

But Monday, the court released its ruling in Monsanto Co. v. Geertson Seed Farms, a case that considers deregulation of a genetically engineered variety of alfalfa produced by Monsanto. The case is interesting to me in talking about Justice Stevens for several reasons. First, it is related to an important scientific issue — the release of genetically modified plants into the environment. It is the first time the Supreme Court has considered a controversy over a genetically modified organism. Second, Justice Stevens is highlighted by the case because he was the only one to dissent from the court’s ruling. One is naturally led to the question: Is Stevens simply out of touch with scientific issues or is the court about to lose a lone voice of reason about scientific issues?

“Roundup Ready Alfalfa” has been genetically engineered to be tolerant of glyphosate, which is the active ingredient in the herbicide Roundup. In 2005, the Animal and Plant Health Inspection Service (APHIS) deregulated Roundup Ready Alfalfa and some 220,000 acres were planted in 48 of the U.S. states, forming part of the crops raised by some 3000 farmers. But the deregulation occurred without an Environmental Impact Statement being completed.

The concern is that the introduction of a genetically modified plant into the environment allows the engineered genes to contaminate other plants. In particular, weeds may acquire the gene and also become resistant to Roundup, requiring the use of other, more powerful, herbicides to produce a viable crop. To guard against negative environmental impacts, the National Environmental Policy Act of 1969 (NEPA) requires that agencies prepare a detailed “environmental impact statement” that can be considered by the public. If the agency finds, based on an abbreviated statement called an “environmental assessment” that the proposed action will not have a significant environmental impact, it may take that action without completion of the environmental impact statement.

In 2004, APHIS prepared the abbreviated environmental assessment and received 663 public comments, of which 520 opposed deregulation of Roundup Ready Alfalfa. In addition to concerns about contamination of other plants, concerns were expressed by farmers and scientists that the engineered gene could contaminate nonengineered alfalfa, thereby impacting the export market for alfalfa because of restrictions imposed on the sale of genetically modified food in other countries. Nevertheless, APHIS concluded that there would be no significant impact and proceeded with deregulation.

In 2007, in response to a challenge brought by farmers and environmental groups, the district court determined that APHIS’s reasons for concluding that the risk of genetic contamination was low were “not convincing.” It enjoined further planting of Roundup Ready Alfalfa until the full environmental impact statement could be prepared and evaluated. The injunction was fashioned to take account of the fact that many farmers had already planted the seeds, permitting those who had already done so to harvest, use, and sell the resulting crops and to permit those who had already purchased seeds to proceed with planting.

But the district court rejected APHIS’s proposal to proceed with a partial deregulation in which some Roundup Ready Alfalfa could be planted under conditions that would isolate it from the greater environment at the same time that the detailed environmental impact statement was being prepared. This was the central issue before the Supreme Court — should such a partial deregulation be permitted under those conditions or should there be a complete ban on the planting of Roundup Ready Alfalfa until the full procedure for deregulation has been completed?

Only Justice Stevens sided with the district court, with the other members of the court accepting the partial-deregulation scheme. I admit to some sympathy with Justice Stevens’s position. The Court admits that voluminous evidence was presented both that the risk of gene flow would be insignificant under the proposed partial-deregulation scheme and that suggested the opposite, highlighting the very real disagreement that exists among scientific experts on the issue. The dissent’s view is one that would afford the district court discretion to take the more cautious approach in light of the scientific disagreement.

It seems unlikely that Justice Steven’s dissent in Monsanto will ultimately be viewed as little more than a footnote when historians examine his career on the Supreme Court. He is more likely to be remembered for the opinions he wrote in cases addressing social issues — such as his majority opinion in Wallace v. Jaffree striking down an Alabama statute mandating a minute of silence in public schools “for mediation and prayer” or for his majority opinions in Rasul v. Bush and Hamdan v. Rumsfeld that constrained executive treatment of detainees in the so-called “war on terror.”

But sometimes there is meaty stuff also in the footnotes.

Filed Under: Biology, Environmental Law, Legal, Scientific

Can You Hear Me Now?

June 18, 2010 By 1 Comment

Perhaps the name David Reynard is unfamiliar.  But it is his appearance on the Larry King Live show almost twenty years ago — in 1993 — that launched an uproar that simply will not settle down no matter how much scientific evidence is brought to bear.  On that show, Reynard discussed his lawsuit against a well-known cell-phone operator, claiming that it had caused a brain tumor that killed his wife.  His lawsuit was dismissed in 1995, but the idea that cell phones cause cancer is one that has persisted.  Just a couple of days ago, even, the city of San Francisco stated its approval for a bill that would require retailers of cell phones to display information regarding the level of radiation emitted by each cell phone sold. 

The idea that cell phones could cause cancer goes against every scientific understanding of the mechanism by which cancer is caused.  Cancer is caused by some agent — and there are very many that are known — breaking chemical bonds to produce mutant strands of DNA in cells that reproduce to form a tumor.  Known agents include radiation, some chemicals, and a small number of viruses, but they all act to create cancer in this same basic way.

 But not all viruses cause cancer.  Not all chemicals cause cancer.  And most certainly not all radiation causes cancer.  For radiation to break chemical bonds, each of the photons must have a certain energy, and the radiation emitted by cell phones does not reach that threshold.  It does not even come close to reaching that threshold. 

Cell phones emit electromagnetic radiation, which has a whole range of energies.  Once the electromagnetic energy is into the ultraviolet region of the spectrum, it is energetic enough to break chemical bonds.  This is why the ultraviolet radiation from the sun causes skin cancer.  It is why the even higher-energy X rays that may be received during medical exams are even more dangerous.  And why the yet higher-energy gamma rays released during nuclear blasts can be extremely dangerous. 

But cell phones emit radiation at the microwave range of the spectrum, even lower than visible light.  Their energies are about a million times lower than the energies needed to break chemical bonds.  It is fair to say that a person is more likely to develop a tumor from light from a reading lamp that he is from cell-phone radiation. 

Study after study has confirmed this basic physical result by finding no conclusive link between cell-phone use and cancer.  The most important study to date, the so-called INTERPHONE study, was released in May, stating that “[a]n increased risk of brain cancer is not established from the data.”  This was a 10-year study that cost some $14 million and analyzed cell-phone usage in 13 countries.  And still there are claims that the study was “biased” or that “just because no link is established doesn’t mean that it isn’t there.” 

If the epidemiological studies were all that there were, maybe — maybe — those claims might be justified.  But that is not all there is.  There is also the basic science of radiation and its effect on chemical bonds, and that science is extremely well understood.  In light of that fundamental understanding, ordinances like those proposed in San Francisco seem at best misguided.  And at worst alarmist.

Filed Under: Biology, Legal, Local Regulations, Physics, Scientific

Wonder Drug

June 17, 2010 By Leave a Comment

Perspective can be everything.

A few years ago, after alarmist reports about the dangers of the compound dihydrogen monoxide, many people responded and called for government regulation.  The reports noted such dangers as severe tissue damage after prolonged exposure to its solid form, its corrosive effects on metals, its presence in tumor biopsies, and numerous reports of death associated with its accidental inhalation.  But even in the face of such dangers, there was no prohibition on its use in numerous household products, including as an additive to baby food, in cough medicines, shampoos, shaving creams, and in all the coffee served at coffee houses throughout the United States.

Dihydrogen monoxide — H2O — is, of course, simply water, and the list of its possible hazards, while accurate, was deliberately couched in a way that made it sound more dangerous than it really is.

What if people were told of the amazing properties of a drug that is currently being investigated by researchers?  One that has the ability to fight multiple sclerosis, Crohn’s disease, and other forms of inflammatory disease.  It is also known to alleviate pain, reduce nausea in some patients, and to ease the impact of many sleep and mood disorders like stress, anxiety, and depression.  Researchers are currently testing its effectiveness on rheumatoid arthritis, Tourette syndrome, epilepsy, and schizophrenia, among others.  There are even recent reports suggesting that it shows promise as a cancer treatment by killing malignant brain, skin, and pancreatic cells without harming surrounding healthy cells.  Wouldn’t they be outraged that the government continues to ban this drug merely because it also has some psychoactive properties?

The drugs that seem to have all of these wonderful properties are derived from marijuana, which remains banned throughout most of the U.S.  Currently, only fourteen U.S. states allow medical uses of marijuana, but the medical-marijuana movement is active in seeking decriminalization in the other states.

The perception among many — and the perception is accurate to a large degree — is that those who actively seek decriminalization of marijuana do so mainly because they want to experience its psychoactive effects.  Its “medical” uses are used as a cover to argue for legalization so that, quite simply, they can get high legally.  But even if that is a motivation among many, it does not diminish the fact that there are legitimate medical treatments that use marijuana and that an understanding of those treatments is critical in deciding at what level the government should regulate its use.

Filed Under: Drug Regulation, Legal, Medical science, Scientific

Come On! Jesus Murphy!

June 1, 2010 By 1 Comment

The National Hurricane Center sets the “official” start of the hurricane season as today, June 1.  At the moment, all eyes are on the Gulf of Mexico and the failure of “top kill” to stop oil from spilling into the sea.  There will undoubtedly be many legal actions developing from that oil spill, and there is no doubt that the possibility of hurricanes developing in the Gulf during the next several months that the spill may continue is on people’s minds. 

In that case, though, there are very definite parties to identify as having potential culpability:  the oil company BP, certainly; perhaps some subcontractors of BP; at a stretch, maybe certain officials in the current government Administration. 

But consider the case of Comer v. Murphy Oil, which arose from Hurricane Katrina’s devastation five years ago, the memory of which is still fresh in people’s minds.  Canal-levee breaches that flooded more than 80% of New Orleans.  Thousands housed in barely livable conditions in the Superdome, with reports of fighting and rapes.  Widespread looting and a breakdown of law enforcement, communications, and transportation infrastructures. 

In Comer, a class of a dozen Mississippi property owners sued a range of about 30 corporate defendants involved in the energy and chemical industries for compensation for the damage caused to them by Hurricane Katrina.  Incidentally, one of the defendants was BP, the company struggling to control the Gulf of Mexico’s current oil spill.  Their liability theory is essentially as follows:  the defendants’ operation of their industries caused the emission of greenhouse gases, which in turn contributed to the climate change that is currently underway on the Earth, which in turn caused the hurricane to be more ferocious and devastating, which resulted in the destruction of their property. 

That the Earth’s temperature is increasing as a result of human activity is not seriously disputed.  It is, in fact, one of the most widely accepted conclusions that science has reached, certainly among those scientists who have examined and evaluated the evidence directly.  But any discussion of the Earth’s climate is necessarily a complex one and the Earth is sufficiently large that the impact of human activities on its climate proceeds relatively slowly.  These two factors — the complexity of the system and the slowness of its response — make it difficult to point to any particular event and establish the precise link to what human beings have done or are doing. 

The lower court in Comer dismissed the case.  One of its bases for doing so was that the issue was a “political question.”  This doctrine is one that courts use in implementing the separation of powers that defines the government structure in the United States.  Just as there are issues decided by the judiciary that the legislative and executive branches of government cannot interfere with, so too there are questions that are beyond the purview of the courts.  Such “political questions” require resolution by the other branches of government. 

It is difficult to fault the district court’s determination.  Fossil fuels provide a critically important source of energy that drives the national economy and alternative sources of energy are not as well developed at this point in time.  There are consequences to limiting the use of such energy sources that are significant and far-reaching.  And there are consequences to failing to limit the use of such energy sources that are equally significant and far-reaching.  Furthermore, the United States does not even have control itself over the level of greenhouses gases within its borders — the use of fossil fuels elsewhere on the planet also raises the concentration of such gases in the United States so that even if the U.S. did take some action unilaterally, the positive impact on its own atmosphere may be far less than the negative impact on its economy. 

It seems very much that the appropriate way to reach a solution to the issue is through the democratic mechanism of government.  It is through that structure that the collective thinking of the many different groups impacted by any approach may at least be considered, even if any solution will garner criticism.

But the panel on the appellate court for the Fifth Circuit disagreed with the district court, reversing its dismissal, and essentially telling the plaintiffs that they are at least entitled to present their evidence in a court to determine whether there is liability on the part of the defendants for the damage to their property. 

Where things became especially interesting procedurally in Comer was when the full court decided to hear the case en banc.  Each of the federal appeals courts has a relatively large number of judges — somewhere around 15 — and most appeals are heard by three-judge panels of the court.  When an issue is of significant importance, it is possible for the entire court to hear the case and render a decision.  There was considerable interest in Comer because of its potential in bringing some clarity to the ability of plaintiffs to sue oil companies and other large emitters of greenhouse gases for damage to property caused by severe weather. 

But several of the judges recused themselves from the case.  While the specific reasons for the recusals are not publicly known, the likelihood is that each of those judges had some investment in one of the defendant corporations so that he or she could not ethically participate in a decision.  Initially, seven of the sixteen judges of the court recused themselves.  This left a quorum that vacated the panel decision when the court agreed to rehear the case en banc.  But then an eighth judge also recused himself, leaving only eight judges on the court — a number insufficient to establish a quorum.

 On Friday, just before the Memorial Day weekend began, the court issued its order, dismissing the appeal and refusing to hear oral arguments or decide the case on its merits because of the lack of a quorum.  This leaves the case in a sort of limbo.  The original district court decision stands, meaning that the plaintiffs are not entitled to have their case heard on the merits unless an appeal to the Supreme Court of the U.S. is heard. 

In a strongly worded dissent, one of the judges of the Fifth Circuit described the action of the court as “shockingly unwarranted” and “deeply lamentable,” providing a number of reasons why the court should hear the case.  Options such as having the Chief Justice appoint another judge from another circuit to hear the appeal or of applying the so-called Rule of Necessity to allow the judges who recused themselves to set aside their recusals, were options that he felt should have been taken. 

The dissent argued that the court has “an absolute duty to hear and decide the appeal,” a position that is difficult to disagree with.  The issue of climate change and its legal ramifications is a critically important one.  What is at issue at the moment is not so much whether oil companies should be liable for damage caused by our changing climate — although that could potentially be the issue that ultimately arises — but whether the courts should be involved in hearing such cases at all.  Clarity is needed, and a clear decision by the full court would have had impressive weight in moving towards such clarity. 

The idea that the effects of climate change do indeed represent a “political question” is a compelling one.  While the plaintiffs in Comer may have suffered from an especially dramatic storm, all of us feel the effects of global climate change — and all of us contribute to it by using fossil fuels to power our automobiles and trucks or to heat our homes.  Can someone sue his neighbor for hail damage to his roof because the neighbor drives a car?  When severe weather damages a home in Hawaii, can a salmon cannery in Alaska be sued because it emits greenhouse gases?  These questions appear silly at first blush, and the havoc that could result if such suits were entertained is plain.  But they differ from the argument in Comer only by a matter of scale and degree, not in underlying principle.

The time is soon coming when the Supreme Court of the U.S. will need to step in and provide some clarification, particularly if intermediate courts are going to punt.  It feels instinctively right that authoritative clarification is deserved.

Filed Under: Climate change, Constitutional Law, Environmental Law, Legal, Scientific