Thank you for sharing!

Your article was successfully shared with the contacts you provided.
Christmas 1994 was just a couple of days away, and Sharon Terry felt miserable. She had driven her daughter to the doctor expecting to be told that cheap detergent had caused the girl’s persistent neck rash. Instead, Terry learned that she and her husband, Patrick, had passed on a rare genetic disease to their two young children. Elizabeth and Ian, ages 7 and 5, were oblivious to the diagnosis. Santa had brought them every toy they had requested. The older Terrys, however, needed more substantial consoling. They spent that weekend shuffling around a medical library near their Massachusetts home, reading studies of the connective tissue disorder known as PXE, pseudoxanthoma elasticum. They found little to reassure them. The medical texts forecast that the Terry children’s lives, beginning in early adulthood, would be marked by deteriorating blood vessels in their stomachs and hearts, blindness from the cracking of blood vessels in the eyes, and increasingly saggy, plucked-chicken skin. The family received confirmation of the disease’s severity within a week. A researcher from a university laboratory called the Terrys, requesting permission to draw a sample of the siblings’ blood. The children’s pediatrician had phoned around for more information on the disease, and word of the double diagnosis had spread. The caller stressed that the blood was to be used for research purposes only. The Terrys’ mood hadn’t much improved three weeks later, when another researcher called. He, too, asked for samples. “Why can’t you just get the blood from the other researchers?” asked Sharon Terry. “They said, ‘Oh no, scientists don’t share samples.’ “ Terry was unnerved. “We quickly realized the research community was not set up to work together,” she says. “We said, ‘We’re not giving our kids’ blood.’ My kids were whatever age they were, little kids, and I wasn’t interested in having them stuck multiple times.” The Terrys started a Web site and began receiving calls from families affected by the disease. As more parents checked in, the Terrys saw the potential for a better study than any they had read; they researched what a person needed to start a blood and tissue bank. By the start of 1996, they had mailed blood kits to a couple of dozen PXE patients and collected a handful of specimens. A neighbor who researched food chemistry at Tufts University offered a corner of his laboratory freezer as storage space. Some PXE families, including the Terrys, felt exploited by researchers. Their reflections tumbled out — when they weren’t fretting about the condition itself: If the medical investigators saw patients as just an assortment of molecules, they clearly weren’t motivated to call with updates about the search for the PXE gene. Would the doctors even protect family privacy? The parents concluded that researchers had other interests that trumped those of the patients. Academics wanted to publish in journals, win rights to important patents, and attract funding, while their administrators were focused on trading those patents for some of the roughly $850 million that U.S. universities receive annually from licensing their professors’ inventions. Pharmaceutical companies provided researchers no incentive to pay attention to the families. The group itself estimated that PXE affects only one in 25,000 births, far too few customers for any big-league drug, even should the patients need to take the drug every day for the rest of their lives. Patients had to find a way to make research serve their needs. “Only we would have the understanding needed to keep it flowing in the right direction,” says Terry. Kimberly Collins’ children had played with the Terry kids. Collins lives several woodsy streets away from the Sharon, Mass., split-level where the Terry family resides, and she works as an employee benefits attorney at Boston’s Testa, Hurwitz & Thibeault. In 1996 she arranged for firm colleagues to incorporate the Terrys’ support group as PXE International Inc., a nonprofit organization, and to provide counsel about acquiring specimens for their new bank. Soon, though, the Terrys would need more advice. Necessity had inspired them to create a device that gives patients control over the intellectual property at the center of disease research. Their tool? Do-it-yourself patenting. Or, literally, patenting yourself. In the feverish race among biomedical researchers to acquire gene patents, the Terrys are unlikely players. When they started the PXE group, he was a construction manager; she had a master’s in religious studies and was teaching home-schooled students part-time at a science museum. But in an age when companies extract, assess, and convert tissue into products with great potential for gain, the Terrys had a simple insight: They could steer researchers towards their family’s own diseased blood and tissue by controlling the PXE gene itself. The Terrys decided to act like many property owners — building a fence around their property and granting access only in exchange for something of value. The property in question is the blood of a thousand PXE patients and their families, moved a few years ago from Tufts to a 1-by-3-by-3-foot freezer in an Arizona laboratory. Five research teams have studied the organization’s collection of DNA. All signed a contract giving PXE International co-ownership of any patent that ensues from study of their tissues. “No one’s objected to the intellectual property conditions,” says Terry, in her kitchen. “People are concerned that they not look bad in this climate, with all the Canavan publicity.” Canavan disease is at the center of a lawsuit that shows what can happen to a patient group that doesn’t take the precautions that PXE International has. A Chicago parent of a child with the degenerative (usually fatal) condition procured tissue specimens from patients and handed those over to a researcher, who, in 1993, made a breakthrough in isolating the gene. His then-employer, Miami Children’s Hospital, received the patent that claims all methods for detecting the gene for Canavan. Subsequently, the hospital imposed a royalty for each test, and restricted which laboratories could offer it. Four so-called Canavan families have since asserted that they donated their blood under the assumption that the test would be available to all. The families have sued for breach of contract and lack of informed consent to the use of their tissues in a study that resulted in a disease gene patent. In February 2000, PXE International received good news from the University of Hawaii. Pathobiologist Charles Boyd, who had been working with the organization for nearly six years, stretching back to when he had been at Rutgers University in New Jersey, had isolated the crucial gene. Now, he was also happy to tell Sharon Terry that, splitting with scientific tradition, he had listed her as part of the research team when the patent application was filed. He views her as the catalyst for the gene search’s success — through her marshaling of the patients’ medical information, maintenance of confidentiality, and the recruiting of scientists. Terry tipped off the lab guys to scientific developments reported in journals, and traveled to prestigious scientific conferences to scout for fresh ideas about proteins that might apply to PXE. She made house calls to fellow patients when the lab results raised questions. “She’d call up and say, ‘We need to talk about the genetics in the family, why don’t you come over for dinner?’ ” says Boyd. Boyd (who hasn’t been funded by PXE International) agreed with Terry’s morally driven, but practical, view that the laws of this market left patients no choice but to seek control of the intellectual property. “This was a way to ensure that that the test isn’t going to cost an arm and a leg,” notes the scientist. The university still stood in the way of PXE International having any say about access to the gene and the access fees. Boyd’s contract gives his university the rights to his inventions. University technology transfer offices typically don’t have many patents, so they often try to milk what they have for all they can. “It would be very unusual for the university to agree, we’ll give you a patent if you give us the starting material,” says Q. Todd Dickinson, who headed the U.S. Patent and Trademark Office until January, when he left for Washington, D.C.’s Howrey Simon Arnold & White. A few years ago, however, when the University of Hawaii gained access to the specimens in the PXE group’s bank, no one thought twice about implications for intellectual property when another nonprofit was involved. Neither Boyd nor Ann Park of the university technology licensing group know of any agreement from that time contemplating dual ownership of a patent. When talks did begin at the end of 2000 over how to share the patent, Hawaii was reluctant to give up control over licensing, even though the PXE group’s focus is on broad access. According to Terry, “They wanted to recoup the cost of filing the patent and to get some licensing fees. We told them that we would take care of all those costs,” using the $150,000 PXE International budget — built up by swim-a-thons and bake sales — and the pro bono services of Testa Hurwitz. PXE International offered to share the royalties equally if Hawaii would allow them to decide on licensing deals. A good licensing deal for PXE International would yield lower medication costs for PXE patients. A good licensing deal for Hawaii would add to its coffers. PXE’s designation under food and drug law as a so-called orphan disease, with little prospect of blockbuster revenues, weakened the university’s incentive to hold a tight grip on the patent. In early spring it agreed to the patient group’s request to make the licensing decisions, accepting 50 percent of the royalties from any diagnostic test or marketable product. Although the deal was unsigned as of late spring, it seemed imminent for another reason. PXE International has an unusual asset: In 1998 Terry had joined the board of the Genetic Alliance Inc., a national organization of disease-related support groups. As the Alliance’s vice president for consumers, she has had growing contacts with industry officials. She was more likely to score a licensing deal than Boyd would by taking a break as his laboratory’s principal investigator (PI), and creating a road show. “If I really want to make money on PXE, I would have to get out of the lab,” says Boyd, who holds two other patents. “That is a fantasy. PIs don’t have the communications skills. It’s an entirely different set of skills that allows one to reach out with passion and sensitivity.” Terry brought an even more powerful bargaining chip to the table: the leverage of inventorship. Showing her growing command of biology, on top of law and citizen organizing, she actually made molecular-level insights that accelerated gene discovery. The Testa Hurwitz patent lawyers (and Boyd) have deemed her an intellectual contributor, and under patent law, any co-inventor has full right to sell access to the invention. “If you are joint inventors,” says Chicago patent lawyer Daniel Boehnen of McDonnell Boehnen Hulbert & Berghoff, “then that means that you have complete undivided right to it. Just like two roommates who might be sharing an apartment. They both can invite friends over; both can do with it what they want.” (As of late spring, the patent had yet to be issued.) When it’s time for PXE International to license access to the gene — within biotechnology, that often is arranged long before a patent ever issues — the Terrys say the group will recognize that they can’t do anything with this patent by themselves. And they promise not to be as tenacious as most universities. “If you’re a pharmaceutical person, we’re an easier mark — we’re not as hard-nosed about profits. We’re more interested in the search for treatments and patient support and research,” says Sharon. Like any savvy patent holder, the PXE group wants to broaden its market. Patrick Terry notes that the PXE gene may be helpful for hypertension and cardiovascular research because PXE-caused mineralization of the midsize arteries mimics general aging of arteries. Although macular degeneration of the eye prematurely threatens the relatively small number of PXE patients, Patrick Terry notes that 60 million Americans eventually risk the condition because of ordinary aging. If the gene becomes important to other researchers, Sharon Terry says their group will resist patient profiteering. “It’s been suggested that we could make a killing because who cares if we’re making the cost of cardiovascular treatment huge. We always say, we don’t just represent people with PXE, we represent anybody who has anything,” says Terry. Still, she concedes the group would only seek a deal that would maximize patient access to a future PXE diagnostic test or PXE treatment — one that provides a guarantee of access, a guaranteed supply, or a low cost. The Testa Hurwitz technology specialist who drafted the patent application, Patrick Waller, says the rewards of group ownership could include dividends from royalties, despite risking the appearance of getting paid for their disease. After all, he says, the costs of a lifetime of treating a chronic disease add up. PXE patients are not alone in pursuing a way to keep their disease within the public domain. Cure Autism Now, the Juvenile Diabetes Research Foundation International, and other groups have pooled members’ specimens. Vicky Whittemore, a Genetic Alliance vice president, says organizations tell her that the terms for access to any biorepository will include IP conditions: “Oh, absolutely.” The patient groups have the advantage that demand for tissue is generally strong. Scientists by nature insist on access to a better research tool — particularly one they have spotted in a competitor’s hand, says Ross Oehler, vice president of U.S. patent operations for Aventis Pharmaceuticals. More than 300 million specimens are stored in the United States, says Elisa Eiseman, an analyst with RAND’s Science and Technology Policy Institute, but most of what’s already collected doesn’t impress researchers. They want individual health histories and symptom descriptions, too. No matter how entrepreneurial patient groups are, they now will have to outgather and outsell newly launched commercial DNA brokers, who have more funds, plus the pledged patronage of pharmaceutical companies. “It’s unlikely we’d be willing to give up any intellectual property rights to obtain tissue if it could be gotten elsewhere,” even for more money, says Nancy Linck, a lawyer for Guilford Pharmaceuticals Inc. The commercial tissue businesses could also co-opt groups’ efforts. The Terrys say that private companies are asking to buy groups’ mailing lists and proposing to take over the gathering of tissues. The Terrys say pharmaceutical companies should see advocates less as moralists and more as potential customers. The demand is great enough now that some commercial tissue providers have felt bold enough to act like PXE International, and ask for payment in intellectual property. Pharmaceutical lawyers aren’t so confident anymore that they can avoid that steep price. “We’re in active negotiations right now with some groups about this very topic,” says Jack Douglas, general counsel of Cambridge, Mass.’ Millennium Pharmaceuticals Inc. If the market grows sufficiently ferocious, little would stop already organized AIDS and cancer groups from trying to lock up their diseased tissues in self-run banks. Any group with family histories of diseases conceivably could create a tissue bank. Though efforts to develop the value of tissues are intensifying, they rest on an unstable property framework. The California Supreme Court judges in Moore v. The Regents of the University of California held in 1990 that one cannot assert ownership of freely given tissues once they are outside the body. If the patient comes to the operating room with a cooler, she can’t assume she’ll be able to take the tumor home. The law is a muddle, colored by inconsistent health and privacy statutes, says Dr. M. Sharon Webb, a Foley, Hoag & Eliot attorney in Boston. She is currently representing one of the parties in a dispute between university administrators who want tissues to be sent elsewhere for commerce, and a medical researcher who believes she has the right to stop that transport. Patients viewing tissues as their property, and theirs alone, could face lawsuits from other family members, suggests Dr. Victor Weedn, a pathologist and lawyer who directs biotechnology and health initiatives at Carnegie Mellon University. Relatives might fight relatives over extracted DNA that tells all of their genetic stories — potentially to insurance companies, law enforcement, and employers. Weedn contends that society, and families, should leave the decision to the pathologist, who is bound by both the patient-physician relationship and professional duty. PXE International, though, can take solace in other courts’ rulings that a patient’s family has a property interest in a loved one’s corpse. Judges have overturned laws that say hospitals can presume they have the right to harvest corneas from the deceased. Instead, permission must be obtained from the family. Meanwhile, PXE International’s call for responsible development of genomic property is likely to be heard widely. Patrick Terry is no longer in the construction business — the entrepreneur behind Incyte Genomics, Randal Scott, has hired him to be director of consumer advocacy for his new company, Genomic Health Inc. On a recent Friday morning, one hour at the Terry house included Patrick arriving back from the company’s headquarters in Palo Alto, Calif., and Sharon excusing herself to field a phone call from a U.S. congressional staffer, who wanted to confirm that she would still be available to testify on human cloning (she supports a ban) in between her other speeches. In the sunroom, the PXE International intern was entering data a few feet in front of a desktop ready for dealmaking with power brokers: On it was a copy of “Negotiating at an Uneven Table: A Practical Approach to Working With Difference and Diversity” by Phyllis Beck Kritek. By laying legal claim to their bodies, the Terrys have advanced research enough that doctors genuinely may be able to arrest the progress of PXE before their children go blind, which often happens to patients in their late 30s. Ian Terry, now 11, already has initial signs of eye trouble. At the very least, the parents’ organizing has inspired Elizabeth Terry, now 13, to say she’ll become a patent lawyer — though her mother says she’s also flirting with criminal law. No doubt, Elizabeth should pursue what she wants: By the time she graduates from law school, the patient advocacy movement should have plenty of patent attorneys on its side.

This content has been archived. It is available exclusively through our partner LexisNexis®.

To view this content, please continue to Lexis Advance®.

Not a Lexis Advance® Subscriber? Subscribe Now

Why am I seeing this?

LexisNexis® is now the exclusive third party online distributor of the broad collection of current and archived versions of ALM's legal news publications. LexisNexis® customers will be able to access and use ALM's content by subscribing to the LexisNexis® services via Lexis Advance®. This includes content from the National Law Journal®, The American Lawyer®, Law Technology News®, The New York Law Journal® and Corporate Counsel®, as well as ALM's other newspapers, directories, legal treatises, published and unpublished court opinions, and other sources of legal information.

ALM's content plays a significant role in your work and research, and now through this alliance LexisNexis® will bring you access to an even more comprehensive collection of legal content.

For questions call 1-877-256-2472 or contact us at [email protected]


ALM Legal Publication Newsletters

Sign Up Today and Never Miss Another Story.

As part of your digital membership, you can sign up for an unlimited number of a wide range of complimentary newsletters. Visit your My Account page to make your selections. Get the timely legal news and critical analysis you cannot afford to miss. Tailored just for you. In your inbox. Every day.

Copyright © 2020 ALM Media Properties, LLC. All Rights Reserved.