Saturday, February 10, 2007

Virtual Women: Patents

Panel 3, She Blinded Me with Science: Gender Issues in Patent Law

Moderated by Deven Desai, Thomas Jefferson

Dan Burk, University of Minnesota, Do Patents Have Gender?

Although women in the life sciences don’t patent as often as men, their patents are cited more often. In some cultures, patents on women’s work have been taken out by men to avoid the stigma for a woman of publicly claiming patent rights.

PHOSITA shows up in lots of areas of patentability. S/he is a legal fiction, but tells us whether you’re an “inventor” – whether you’ve come up with something that counts as an invention. Compare to the “reasonably prudent person” in tort law; many scholars have analyzed the extent to which s/he is really the “reasonable man” even after a change in label. A feminist reasonable person might be concerned more with connections to the community rather than separation or freedom from its constraints.

What about PHOSITA? One court has stated that the proper test is to imagine PHOSITA working alone in his shop, with the prior art around him. Masculine, isolated, incorporeal – he is thinking and not tinkering in the court’s description – and his relationship to the prior art is oppositional in that prior art is something for him to overcome.

Ways of knowing – Burk defends the idea of situated knowledge, knowledge in context and community. Case study: Edison drew on prior art for the lightbulb, and was enmeshed in a matrix of other inventors, financiers, his patent attorney, members of his scientific team, prior art looking for a cost-effective lightbulb. All of those coalesced in the invention; inventors can’t be divorced from context in the way that PHOSITA pretends.

Michele Goodwin, DePaul, Xerox Babies: Race, Power, Private Ordering and Procreative Freedom

There’s huge demand for biological resources and we haven’t answered many open questions, especially when the donors are still alive. Now living donations outpace cadaveric donations, e.g. ova and sperm. The federal government has only dealt with organ sales, not with altruism. We tend to attribute to altruism all sorts of characteristics that may obscure its actual content.

Here, a story of forgotten people: Marion Sims, the father of gynecology. He wrote about having epiphanies at 2 am and going into the hospital so that he could wake up his slaves and continue to experiment on them. Sims was able to patent the equipment he developed through his experimentation. Sims has statues and hospitals named after him, but we don’t know the names of the women who also, unwillingly, helped us get the benefits he did provide.

Today, there are concerns about the use of preimplantation screening and manipulation to create “superbabies.” The darker side of choice isn’t recent, but dates back to parents using their children to engage in “reproductive altruism” – parents who want to create and use a child to satisfy the needs of another child. Strunk v. Strunk: two siblings, Tom and Jerry, from Kentucky. 27-year-old Jerry, with the capacity of a 6-year-old, was confined to the state mental institution. 28-year-old Tom suffered from deadly kidney disease. Their mother wanted Jerry to give Tom a kidney. In the 1969 court of appeals ruling in Kentucky, the judges ruled that Tom had a good quality of life, was married, and was in college, so it would be good for him to get Jerry’s organ, and Jerry would receive a psychological benefit, so the court ordered the removal of Jerry’s kidney.

Goodwin identifies Buck v. Bell as the genesis of the state’s authority to intervene in this way. Almost all of the similar cases come out in favor of the parents’ authority to invoke state power on their behalf. Being outside the market does not mean being free.

Eileen Kane, Penn State Dickinson, Molecules and Conflict: Cancer, Patents and Women’s Health

Does IP limit access to the advances it was supposed to bring us? Cancer research today looks for targeted approaches identified through molecular biology. Four relevant molecules: taxol, tamoxifen, and herceptin, which disrupt cancerous processes, and BRCA1 & BRCA2, which can identify genetic risks for breast and ovarian cancer.

Taxol’s history involves attempts to monopolize the molecule past legitimate patent rights, eventually resolved by antitrust claims that spotlighted loopholes in Hatch-Waxman. Patents can be used to delay true competition with “evergreen” patenting techniques.

Tamoxifen also involved a patent invalidity fight with a generic competitor, resolved by settlement that vacated the judgment of patent invalidity. This led to a class action suit alleging Sherman Act violations, given that this reverse payment settlement blocked generic Tamoxifen for almost 10 years. There’s a circuit split, but the Second Circuit held that the reverse payment didn’t violate the law; a petition for cert is pending.

Herceptin: a protein that targets another protein, used for women whose tumors have a particular molecular signature. Genentech holds patents to the antibody and to treatment methods. It costs $48,000 per year, which not all insurance companies will pay, creating significant access issues. The FDA doesn’t have a formal regulatory procedure for biotech generics, but it’s under increasing pressure to expedite the introduction of generic biologics. This is a key pressure point for women’s health advocates.

BRCA1 & 2: The patent holder’s strategy is to market a commercial genetic test sent to the patentee’s labs for analysis. There is scientific criticism about the technical shortcomings ensue when only one lab does the tests – there may be significant false negatives. This has caused concern with the use of the patent, especially in Europe.

Lesson: Women’s health must pay attention to paradigmatic patent conflicts.

Malla Pollack, American Justice School of Law, Towards a Feminist Theory of the Public Domain, or the Gendered Scope of United States’ Copyrightable and Patentable Subject Matter

Basic question for social movements: Should we focus on short-term goals of improving living conditions or long-term goals of basic social change? The risks are wasted effort at impossible change versus entrenching the status quo by assimilating into an unworthy society. Many of IP’s exclusions are gendered, but does that mean we want in or out? Should we choose to help women make more money with IP, or to strengthen the public domain?

She chooses the public domain, because women are not alone in the public domain. Powerless people get rights when the interests of the powerful align with those of the powerless. And many people – consumers, producers – have interests in a robust public domain who aren’t feminists.

An example: The lack of protection for the feminine arts. Liberal feminism would argue: women are entitled to what men are entitled to. Essentialist feminism revalues women’s asserted differences as superiority. Both approaches could easily lead to claims for IP rights too – we want the master’s tools.

Instead, we should reject the male concept of ownership and put more in the public domain. The structure of individual ownership in intangible creations is male. In most so-called communitarian societies, however, status actually controls a lot of distribution and women are low-status. A big public domain therefore isn’t enough; we need structures that support an “owned” public domain, where we have a Lockean idea – you can’t be excluded without your permission.

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