Jackie Harlow
From Cyberlaw
Contents |
3.Apr
Refreshing voices
Tonight, I listened intently as Nick Groombridge, co-chair of Weil Gotshal's New York Patent Litigation group, discussed the un-inevitability of the U.S. patent system. He pointed out the absence of any serious studies indicating that the current patent system is the best possible driver of invention, or even that the current system is an important contributor to the technological advancement witnessed in recent years. Just as likely, he suggested, is that the record number of individuals alive today - the record number of knowledge workers in particular - is the basis for the boon we've seen. Hearing a private lawyer take this stance, one whose clients include BigTechnology and BigPharma was encouraging.
Yesterday, flipping through an old Economist I had previously neglected to read, I stumbled across an article discussing "advance purchase commitments" that could be made by industrialized countries (i.e., the G8) to spur development of much needed vaccines against diseases that plague developing countries (i.e., malaria and TB). The article explores the potential for such a program to improve world health, in addition to addressing some of the drawbacks and disincentives it might create.
These voices give me hope. When enough voices whisper in unison, it sounds like a shout. And even if the patent system is never overhauled, or advance purchase commitments never gain traction, the mere discussion of these ideas is bound to yield new, perhaps better, perhaps more practical, ideas.
21.Mar
It’s always been that way
Justice Scalia is unquestionably one of the most acute legal minds of our time. The opinions he authors are typically bullet proof in their logic. The questions he asks during oral argument incisive. For the most part, his interpretation and application of the law is consistent across fact patterns. Yet, I often question exactly what Justice Scalia is doing for American law. His commitment to the intentions of our founding fathers gives me pause. I often find myself questioning the practice of looking back so many years – to a time long since gone – for solutions to modern problems. Certainly, appeal to precedent and to the distant past has its place in law. I submit, however, that the past should guide us, not shackle us. It should not keep us from searching for innovative answers to hard and important questions.
While the wisdom of applying of innovative solutions to legal questions is debatable, the wisdom of applying innovative solutions to business problems is not. Examples of creative business models are the stuff of business school case studies nationwide. The success of Silicon Valley companies, which have little in common with the staid and hierarchical organizations that dot the East Coast, is but one example. Accordingly, the defense of the patent system – the patentability of genes in particular – on the basis that “it’s always been that way, and that way works for investors,” rings hollow to me. To me, that stance evinces entrenchment in and over commitment to the current system.
The incentive system for scientific research has remained essentially unchanged from its inception. Sure, there have been important tweaks and modifications to patent law. At the end of the day, however, patents carry with them roughly the same exclusionary rights as they always have. Patents have not been tailored to the needs of different industries, nor have they been tailored to reflect modern economic and governmental realities.
The patent grant could be tailored to account for the needs of different industries and the priorities of the public. Longer terms for pharmaceutical and shorter terms for semi-conductors, for example. In addition to tweaking the patent term, the scope of patents might be varied to suit both corporate and social interests. Instead of granting a full patent on a gene, it might be feasible to grant a patent on a process for synthesizing a gene product and another for the particular use that product will be put to, in addition to extending the term of that limited patent grant. The potential reduction in revenues brought on by the limited grant would be evened out with a longer patent term (it is uncertain there would be any reduction in revenues, since many genes will only have one practical application). This scheme would preserve investment incentives, and leave genes themselves in the public domain.
Beyond simply changing the patent grant, we might also consider exploiting other mechanisms to spur investment. Tax breaks and other subsidies might offer incentives sufficient to permit the reduction of patent terms on pharmaceuticals. We might also consider revamping the regulatory process. If FDA approval were less costly, or at least faster and more efficient, that might make a shorter patent period possible. These are just a few ideas “off the cuff” for ways to modernize our intellectual property protection system. Certainly brighter minds with more time could come up with far better.
In a country that prizes innovation so dearly, it is notable that we have not had much in the way of innovation in IP law or in the business models of bio/pharma companies. Instead of simply pointing to investments and profits made under the current system and proclaiming success, perhaps it is time for creative leaders in both the public and private sectors to innovate in the area of IP regulation. With the right mix of investment incentives, an internally consistent and socially beneficial IP system might be more than just the utopian dream of a naïve law student.
20.Mar
Benevolent Societies Can Develop Drugs
The assertion made in class today that no drugs would be developed in a benevolent society seems simplistic and inaccurate. Let’s start by taking a look at the NIH mission:
In realizing these goals, the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research:
* in the causes, diagnosis, prevention, and cure of human diseases;
* in the processes of human growth and development;
* in the biological effects of environmental contaminants;
* in the understanding of mental, addictive and physical disorders; and
* in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists.
The NIH provides funding for public and private drug research. Foundations and public interest organizations fund science. There is tremendous investment by non-shareholders in drug research. Although it would be equally short sighted for me to assert that we would have as many wonderful drugs as we do today in a benevolent world of government funded drug research, I think it is naïve and narrow minded to suggest that public interest groups would not pick up where private business leaves off to develop some percentage of socially beneficial products.
It troubles me to hear the representative of a “good corporate citizen” assert that there is no need to share scientific discoveries with the public because the public will not necessarily use them. Rather, I would challenge “good corporate citizens” to dedicate the IP that they are not going to use to the public domain, and to publish their results – clinical and pre-clinical – so that interested groups might uncover them and have the chance to do something with them. Our speaker today could not provide a colorable excuse for failing to do so. In the absence of harm to the corporation, the off chance that some good might come of sharing information seems sufficient justification for taking these simple steps.
21.Feb
Doctors and the Death Penalty
The New York Times reported today that the refusal of two anesthesiologists to oversee the execution of Michael Angelo Morales, convicted of rape and murder, resulted in postponement of the execution.
Last week, a federal judge ordered anesthesiologist oversight of the execution to minimize the pain of the inmate. The doctors assigned to this task refused to participate in the execution due to ethical concerns. The anesthesiologists cited concern about a requirement in the judge’s order that they intervene if Morales awakened or appeared in pain. The New York Times reported that the doctors stated, “Any such intervention would clearly be medically unethical.”
In addition to the individual anesthesiologists, the Times reported, “The American Medical Association, the American Society of Anesthesiologists and the California Medical Association all opposed the anesthesiologists' participation as unethical and unprofessional.”
The brave decision of these doctors not to participate in an execution - even under the guise of providing for the inmate's comfort - serves to reinforce my position that doctors have both a moral obligation to oppose practices that violate their duty to patient care, and the power to stand up to government institutions and force adaptation. Even though the execution of Mr. Morales will no doubt go forward, at least the public consciousness has been raised, and doctors now have precedent for refusing to participate in unethical activities. I applaud these California anesthesiologists.
16.Feb
Indulgence in the optimism and idealism of my biotech self…
Open Access Biotechnology
If it is true that pharmaceutical companies are not profiting from some drugs for ailments that plague the poor (especially the poor in the developing world), such as AIDs and malaria, why not make those compounds “open access” compounds? Why not permit generic and government subsidized manufacture of these desperately needed drugs, instead of leaving them unused? Better still, why not share orphaned or abandoned discoveries that hold promise for helping the poor, but offer no hope of turning a profit for the BigPharma firms behind them?
- Very good question. Companies may not be profitting from certain drugs but they may not be prepared, financially-speaking, to give them away either. They may lose what revenue, even if it is not enough to turn a profit, those drugs do generate or they may worry about allowing other companies to piggy-back on their research and develop profitable drugs of their own. I'm sure there are other concerns as well but none of the ones that I can think of are very compelling other than from an economic standpoint. Which, I think, brings us back to the question of whether biotech wouldn't be better off (or, rather, whether society wouldn't be better off) as a regulated industry...? DVorhaus 14:38, 20 February 2006 (EST)
- Your point is well taken, but I wonder, what if we found some middle ground or came up with a licensing strategy such that any IP rights from new discoveries went back to the original company? Or as a less ambitious step, just allowed for the manufacture of unprofitable drugs by governments and generics? What's the credible industry objection to the second option? --JHarlow 14:23, 21 February 2006 (EST)
Who is Biotechnology?
Essential to understanding biotechnology and the ethical quandaries that plague it is identification of “who” biotechnology is. Asking “who” instead of “what” presupposes that biotechnology has a character. That she is more than an area of endeavor. More than the patents that flow from research and capital investment. Asking who suggests that biotechnology has an ethic.
Her innate qualities are many, and their interrelationships are complex. At her core, biotechnology is discovery. She is made from ah-ha moments and eurekas. She is sustained by the hope and curiosity that drive experimentation. The cynic will argue that she is sustained by money. Certainly there is merit in that claim, as revealed by the cost of modern drug development. Yet, money alone is not enough. The passion of the scientists who innovate and their high hopes for eradicating disease, these are the nutrients that sustain biotechnology. One need only look to the academy to see that passion, not salary, bonus structure, or stock options, is the true incubator of innovation.
Biotechnology gives rather than takes. She promises a better future with more food, less disease, and longer life. We should hold this ethic in mind as we explore biotechnology throughout the semester. We must remember that fundamentally, biotechnology is a creator, not a destroyer. That she is a bearer of hope and promise for our wellbeing. Proceeding in that way will undoubtedly guide us toward the right answers when we ask hard questions about what experimentation should be allowed, who ought to profit from biotechnology, and what rights inhere in all human life.
