Call Me Ishmael No Longer

The International Convention for the Regulation of Whaling ("ICRW") was intended to promote, not discourage, whaling.  Countries engaged in commercial whaling, concerned about precipitous declines of many whale populations negotiated, and, on December 2, 1946, signed, the ICRW to ensure the "proper conservation of whale stocks and thus make possible the orderly development of the whaling industry."  The governing body established under the ICRW, the International Whaling Commission ("IWC"), determines which species and populations of whales may be hunted, if at all, mandates where and when such hunting may or may not take place, and monitors the health of whale stocks.

Due largely to conservation measures implemented by the IWC, many whale stocks had begun to recover by the 1980s.  However, public attitudes towards whales had changed radically since the inception of the ICRW.  The discovery of complex Humpback Whale songs - first intercepted in Bermuda by a listening post for Russian submarines, and first studied by biologists Roger Payne and Scott McVay - transformed lethargic sources of ambergris, blubber, and ivory into hauntingly articulate, socially complex, and seemingly intelligent peers.  Conservation groups and even prominent bands, such as Yes and The Grateful Dead, promoted cetacean conservation.  As the Dead sang, in "Save the Whales," 

Lots of whales in the deep blue sea, we kill them for the companies.Drag 'em alongside and chop 'em in two, melt them down and sail it to you.

In 1986, anti-whaling sentiment prompted the IWC to declare a commercial moratorium on whaling.  The IWC expanded its protection of whales in 1994, when it created the huge Southern Whale Sanctuary.

Since then, a small hard-core of pro-whaling nations - Iceland, Norway, and Japan - have fought unsuccessfully to overturn the moratorium, and, despite growing widespread opposition to whaling among their own citizens, have resumed harpooning whales.  Since the moratorium came into effect, Japan has justified its annual whale hunt as "scientific permit whaling."  Its extensive whaling fleet has harpooned and killed thousands of whales, increasingly in the Southern oceans.

Sea Shepherd, an environmental group dedicated to ending whaling, has followed the whaling fleets for years, and interfered with its hunt, with increasingly effective results.  The profile of Sea Shepherd and its Canadian founder, Paul Watson, have risen to unprecedented heights with the airing of the Animal Planet television series, Whale Wars.  This week, their efforts prevailed:  the Japanese whaling fleet conceded defeat, for this season at least, and headed home.  As the Japanese newspaper, Yomiuri Shimbun, reported on February 20, 2011,

With this season's research whaling in the Antarctic Ocean called off due to harassment by the Sea Shepherd Conservation Society, Japan's whaling activities in the area may not see another year.  In addition to Sea Shepherd's acts of sabotage, low domestic demand for whale meat--which used to be a valuable source of protein during the food-scarce postwar years--also has made the prospect of continuing whaling extremely gloomy, officials said...[A Fisheries] ministry official said, "With the suspension of research whaling, there is no possibility of whaling continuing from next season as it has in the past."

While not yet saved, the whales may now be a lot safer.

More biolaw at LEXVIVO.

Expansion of the Government Provision of Health Care and Individual Rights: Panacea or Pandora’s Box?

“The proposal that promoting and protecting human rights is inextricably linked to the challenge of promoting and protecting health derives in part from ecognition that health and human rights are complementary approaches to the central problem of defending and advancing human well-being.” Jonathan Mann.

The Patient Protection and Affordable Care Act will create a much needed expansion of government supported health programs which will improve access to health care for many Americans. However, under current jurisprudence, if the policy makers who craft these new programs fail to proceed with great caution, the expansion of the government provision of health care could come at a significant cost to individual rights. Our country sits at a crossroads with the choice to either proceed to promote the health and well-being of the population while promoting and protecting individual rights or to enhance public health at the expense of these rights.

The threat to individual rights which lurks within the expansion of government supported health care programs originates with the body of jurisprudence built around Rust v. Sullivan. In Rust, the Supreme Court upheld legislation that barred health care providers who accepted government funds from engaging in abortion counseling, referral and activities. The Court held that:

[t]he Government can, without violating the Constitution, selectively fund a program to encourage certain activities it believes to be in the public interest, without at the same time funding an alternative program, which seeks to deal with the problem in another way. A legislature’s decision not to subsidize the exercise of a fundamental right does not infringe the right. There is a basic difference between direct state interference with a protected activity and state encouragement of an alternative activity consonant with legislative policy.

This body of jurisprudence opens the door for programs like the one being pilot tested in West Virginia that I blogged on last week over at the Health Law Prof Blog. In early 2007, the federal government approved the West Virginia Pilot Project which provides health care for low-income, Medicaid beneficiaries. This program, and ones like it, is an attempt to respond to the ‘obesity crisis’ and the overall rise in health care costs. The West Virginia Pilot Project punishes those who do not join, and religiously adhere to, weight-loss or anti-smoking programs, or who otherwise fail to strictly comply with doctor's orders or to comply with government mandates. The punishment for this failure to conform is the denial of important medical services. A recent study of the program indicates that it is, in fact, negatively impacting access to health care. This type of paternalistic program violates the harm principle as it reaches out to broadly regulate the behavior of low-income individuals that is self-regarding; in other words, conduct that impacts only the individual. It is the first step on a slippery slope of potentially ever-expanding limitations on freedom of choice and individual rights, all in the name of public health.

Advances in genetic testing and in the science of pharmacogenomics that presage a new world of individualized medicine elevate the seriousness of this concern. Will this mean, for example, that a person with a particular genetic code must take a medication that pharmacogenomics dictates as the recommended treatment to ameliorate the condition and the long-term costs associated with treatment of the condition in order to qualify for future treatment of that medical condition? Taking this to the hypothetical extreme, what about a woman who has a BRACA-1 or 2 mutation with a very high probability of the future development of breast/ovarian cancer? Will she be forced to undergo surgical removal of her breasts and ovaries in her 20s in order to maintain her health care coverage and obtain treatment later in life if she contracts cancer? Is there a principled way to draw a line between what is acceptable regulation of self-regarding behavior with relation to health and what is not?

As we move forward to develop public health programs that deal with the rising cost of health care, it is hoped that we are able to design programs that seek to both promote public health while protecting individual rights. Cross posted at Health Law Prof Blog.

Eight-Track Tape, Meet Three-Track Patent

A lot can happen in five years.  One could write a great novel - or two.  One could run around the world.  One could complete an MD degree, and begin saving lives.  One could get pregnant, have a baby, watch that baby learn to crawl, walk, talk, and read, and begin kindergarten.  Or, one could apply for, and receive a final determination about, a patent.  Enter the new "Three-Track" patent system being proposed by the United States Patent and Trademark Office ("USPTO").

Gary Locke, U.S. Secretary of Commerce, has described the Three-Track system as a strategy for shifting the speed of patent prosecution for higher quality patents from lentissimo to allegro:

“The Patent and Trademark Office plays a key role in promoting innovation and entrepreneurship,” Locke said. “This new system will bring the most valuable patents, as determined by inventors, to market faster and will help shrink the backlog by catering to the business needs of America’s innovators.”

The USPTO placed a notice of its prioritized "Track I" proposal in the Federal Register on February 4, 2011, describing this new fast track to patenting as follows:

Under Track I prioritized examination, an application would be accorded special status and placed on the examiner’s special docket throughout its entire course of prosecution before the examiner until a final disposition is reached in the application. The aggregate goal for handling applications under Track I prioritized examination would be to provide a final disposition within twelve months of prioritized status being granted.

The main elements of Track I would be (1) a very expensive examination fee of $4,800 (that is, almost five times more expensive than the filing, search, and examination fees currently paid by large entities (companies with more 500 employees), and almost ten times what small entities (with 500 or fewer employees) currently pay), (2) strict limits of 4 independent claims and 30 dependent claims per application, and (3) mandatory filing of patent applications using the USPTO's electronic filing system ("EFS-Web").

Track III would allow patent applicants request that docketing of an application be delayed, allowing the application to hibernate from prosecution for up to 30 months (corresponding to the Patent Cooperation Treaty ("PCT") deadline for taking a patent application national).  Unless a patent applicant specifically affirmatively opted for Track I or Track III, that applicant would be placed by default on Track II, the current patent prosecution pathway.

The USPTO has proposed that the Track I pathway would be limited to 10,000 patent applications during its first year, and the USPTO would hire "additional examiners above the number of planned hires...so that the non-prioritized applications would not be delayed due to resources being diverted to process the prioritized applications."  This may be somewhat optimistic given the U.S. Congress' penchant for diverting fees collected by the USPTO to other governmental purposes, and 10,000 expedited patent applications, yielding almost $50,000,000 in the first year of the program alone, would present an extremely tempting target in this dawning age of federal austerity.