The Mayo v. Prometheus event hosted at George Washington School of Law with the Biotechnology Industry Organization created an opportunity for a panel of thought leaders to distill meaning from the case, the impact on personalized medicine, and possible solutions to the Court created problem.*

Is the decision a game-changer?

Photo Credit: www.zooboing.com

Judge Paul R. Michel, former Chief Judge of the Court of Appeals for the Federal Circuit handling patent cases, concluded that the Mayo v. Prometheus represents a “shift in attitude between the Supreme Court and Federal Circuit.  There’s a certain amount of trust, a certain amount of respect, a certain amount of suspicion that there might be some deeper immersion, deeper familiarity, harder thinking and greater exposure [to patent law] at the Federal Circuit than the Supreme Court itself can offer,” he said. “The game changer I see here is the Supreme Court is effectively saying ‘We’re done with the Federal Circuit.’ They don’t get any credit for greater immersion, greater expertise, harder thinking or anything of the sort.”  While many of the panelists disagreed on what exactly the Supreme Court concluded in the Mayo v. Prometheus decision, it was clear that all the panelists shared in the concern expressed by Judge Michel.

Some might think that a 9-0 decision represents a shared consensus of opinion on how to handle the “law of nature” exemption for patents.  Not so according to former Solicitor General to the United States, Seth Waxman.  Waxman asserted that when this Supreme Court rules unanimously “its language cannot be taken at face value.”  This court rarely suggests edits or withholds their votes unless certain language is included.  “But in the end, there is no way that all nine justices thought that this opinion has the broad consequences that people are catastrophizing.  I do not believe that every single justice on the Supreme Court thought that the entire field of molecular diagnostics, everything in personalized medicine, that’s over. There’s just no way that there was that level of consensus about how the patent laws have to be reasonably read.”

How will Prometheus affect the Myriad case?

The panelists expressed disagreement over how Prometheus would impact Myriad with some asserting a clear difference between the abstract idea claims in Mayo versus the tangible molecules in Myriad.  However, Donald Dunner from Finnegan indicated that future litigants are going to take Prometheus to the ultimate extreme until district courts agree and the federal circuits have to disagree and until the Supreme Court disagrees again.

However, all panelists agreed that the Courts and the Department of Justice were unclear on the science.  Professor Christopher Holman stated that no rigorous claim construction had occurred in the District Court.  As a result, there is as lot of misperception of what exactly the patent covers in the Myriad case.  Professor Holman argued that the Court created distinctions between isolated cDNA and gDNA that do not make any scientific sense.  Seth Waxman added that the considerable challenge for articulating the science and what the patent covers in the remand of Myriad is to correct the “unfortunate formulation conceived immaculately.”

How will these decisions affect businesses?

Paul Yasger, head of IP for Abbott Laboratories, stated that while the Prometheus decision may be good for litigators and patent office fees, it is not good for business because of the uncertainty it creates.  Phil Johnson, Chief Intellectual Property Counsel at Johnson & Johnson, pointed out that “capital is hard to come by these days and people are reluctant.”  Johnson and Johnson can invest money in R&D projects involving shampoo instead of biomarker research.  He said investors “have other things they can invest in but I don’t think we, and I mean mankind, can afford it.”

Michael Walker, Chief Intellectual Property Counsel at Dupont pointed out that these decisions have an impact beyond personalized medicine.  60% of Dupont’s R&D is in Ag and Food research and industrial biosciences such as biofuels.  Mr. Walker concluded that businesses have large settled business expectations in this technology and they look at Prometheus and Myriad and wonder if their technologies are just natural phenomena.

What are the solutions going forward?

Phil Johnson at J&J concluded that making it hard to get patent protection cannot help innovation because who will fund that work.  In this day and age, government sources of additional money are unlikely.  Chief Judge Michel pointed out that this is exactly the problem when the Court makes assumptions about patents stifling innovation without providing any convincing evidence that it was so.  Michel pointed out that the articles cited “don’t prove the point that the Court is assuming.  The preemption problem is all hypothesized as far as I can tell.”  Finally, Michel concluded it is dangerous to have unelected judges with no expertise in measuring the retarding effects compared to the beneficial effects make these kinds of decisions.

Hal Wagner, partner at Foley & Lardner, argued that in spite of the lack of evidence of the stifling effect of patents on research, the rest of the world allows for an exemption for experimental use.  It does not hurt the patent owners and it gets rid of the stifling argument.  Dr. Sauer pointed out that Judge Newman, among other Judges on the Federal Circuit has expressed frustration on the lack of cases on this issue as researchers are not being sued and so the court cannot explore the U.S. exemption.

Chief Judge Michel closed the meeting by suggesting that participants focus their energy and attention on the federal circuit panels and district courts dealing with 101 issues over the next 12 months.  If at the end of the year it is a terrible mess then go to Congress for a solution.

*Comments by the panelists should not be taken to bind the clients, companies, law firms, or other organizations with which they are affiliated.

The Subcommittee on Conservation, Energy, and Forestry held its final hearing today on the 2012 Farm Bill. Testimony focused on Formulation of the 2012 Farm Bill: Energy and Forestry Programs. BIO’s President & CEO Jim Greenwood joined the panel testifying about Farm Bill energy programs along with Ryan Stroschein, Agriculture Energy Coalition; Steve Reinford, Reinford Farms Inc.; Jerry Taylor, MFA Oil; and Gary Haer, National Biodiesel Board.

“Farm Bill energy programs are working and BIO member companies are beginning to put steel in the ground,” Greenwood said. He highlighted several companies that have biorefineries today as a result of these programs, including INEOS Bio New Planet Energy in Florida, Myriant in Louisiana, and ZeaChem in Oregon.

Greenwood urged the committee to reauthorize the Farm Bill energy programs, such as the Biorefinery Assistance Program, BCAP, and the Biobased Markets Program, with meaningful mandatory funding to allow them to continue to spur America’s energy and agricultural future.

Farm Bill energy programs have had a tremendous positive impact in revitalizing rural America, helping new agricultural markets emerge, and reducing the need for direct payments to farmers. These programs have unlocked private capital for construction of the nation’s first cellulosic and advanced biofuel biorefineries; put more than 150,000 acres of underutilized farmland in more than 150 counties into production raising next generation energy crops; and led to an explosion of renewable chemicals innovation, demonstration and early commercialization here in the United States. For a modest federal investment a high rate of return has been achieved in terms of viable projects funded and operating.

Renewable energy is cleaner, safer and healthier. We cannot afford to wait to fund renewable energy projects that can create permanent jobs in rural America. Now is not the time to abandon these forward-looking, high return programs.

Other panelists echoed Greenwood’s sentiments in their testimony that energy program funding is necessary to continue bringing these innovative technologies to market and are a vital component to the bipartisan all of the above energy strategy of the United States. Stroschein of the Agriculture Energy Coalition warned that not funding these programs leaves other countries poised to leap ahead in clean energy technologies undermining our national and economic security.

Greenwood added that these energy programs allow American farmers and foresters to play the role they can – and must – play in producing domestic energy and therefore improving national security and rural economic prosperity.

Celiac disease is one of the most common autoimmune conditions in the U.S. but frequently goes undiagnosed.  The cause is currently unknown and it can develop at any point in life.  People who have a relative with the disease are more likely to develop it, and women are more likely than men to have it.

When people with celiac disease eat food with gluten, their immune system reacts by damaging areas of the lining of their intestines. Symptoms can vary from patient to patient but can include abdominal pain, bloating, gas, indigestion, nausea, vomiting, decreased appetite and unexplained weight loss.  This variance in symptoms is one reason celiac disease can be difficult to diagnose.

There is currently no cure for celiac disease but it can be managed with a gluten-free diet.  Wheat, barley, and rye contain gluten but other grains (including quinoa, buckwheat, millet and amaranth) do not.

According to the International Service for the Acquisition of Agri-Biotech Applications, researchers are currently seeking to develop wheat that would be safe for celiac disease patients to consume.

Dr. Peter H.R. Green

Dr. Peter H.R. Green, Director of The Celiac Disease Center at Columbia University and Professor of Clinical Medicine at the College of Physicians and Surgeons at Columbia University in New York City, spoke with BIOtechNow to raise awareness of what celiac disease is, how it is diagnosed and the treatment options.

In recent weeks, there’s been a lot of new discussion around the biotech labeling debate.  On May 10, the International Food Information Council (IFIC) released its latest “Consumer Perceptions of Food Technology” survey, which showed that very few Americans cite biotechnology as an information need on food labels.

Earlier this month, the California Right to Know initiative announced at various rallies held around the state that it had collected the prerequisite number of signatures to get its proposal on the November ballot. The initiative would require biotech foods (also known as Genetically Modified Organisms, or GMOs) and foods containing GMO ingredients to be labeled.

A number of mainstream media outlets reported on the California activity. Andrea Billups’ piece in the Washington Times and Jack Kaskey’s article for Bloomberg nicely sum up why the broader agriculture and food manufacturing community is opposed to the measure:

The California campaign is the best chance for biotech labeling in the United States after the failure of similar bills in 19 states and the rejection of a petition to the Food and Drug Administration last month.

But the California voter initiative is likely to meet fierce resistance from agricultural and business interests, who predict it will prove costly both for growers and consumers. Opponents warn the measure constitutes a “right to sue” initiative that will undercut sales of numerous food items that have been consumed safely for years.

Monsanto opposes labeling modified ingredients because the move risks “misleading consumers into thinking products are not safe when in fact they are,” said Sara Miller, a Monsanto spokeswoman.

The initiative is a “back door” way to hurt the $13.3 billion biotech crop industry, according to Richard Lobb, managing director for the Council for Biotechnology Information. The Washington-based council represents Monsanto and five other biotech-seed developers. “They basically are trying to scare consumers through labeling,” Lobb said in a telephone interview. “The obvious objective is to push biotechnology out of the market altogether.”

Biotech labeling has never been endorsed by the FDA. The agency says crops engineered to tolerate herbicides or produce insecticide pose no greater health risks than conventional foods.

The California Farm Bureau opposes the ballot initiative, along with the California Chamber of Commerce, the California Seed Association, the California Grain and Feed Association, and California Women for Agriculture.

Jamie Johansson, vice president of the California Farm Bureau and an olive farmer from Oroville, Calif., said the initiative puts an enormous burden on growers and packagers, and it prevents any processed food from being labeled as “natural.”

An apple, for example, wouldn’t require a label, but it would if it were ground into apple sauce. The same for almonds: They are fine picked raw, but ground into almond butter, even without any other ingredients, they would not pass the test under provisions of the proposed label law.

Food labels should be reserved for “critically important food safety and nutritional information,” said Brian Kennedy, a spokesman for the Grocery Manufacturers Association, which opposes the California initiative.

The California proposal would mandate a label for foods in which more than 0.5 percent of the product is a genetically modified ingredient. The proposal exempts meat, dairy foods and beer.

The label “would be the equivalent of a skull and crossbones” that would drive away customers and force food producers to stop using engineered ingredients, Joseph Mercola, the labeling initiative’s leading funder with $800,000 in donations, said. Mercola is an osteopath who promotes natural remedies at his clinic in Hoffman Estates, Illinois.

Martina Newell-McGloughlin, director of the University of California Systemwide Biotechnology Research and Education Program, called the labeling proposal “completely blown out of context.”

“To me, the issue with this as a scientist is you are focusing on the labeling of process rather than the labeling of product,” she said. “The issue for safety should be on the product itself if you are going to look at risk-assessment and whether something should be of concern to the consumer.”

“You don’t have a label on sausage telling you how they are made and you probably wouldn’t want one. For biotech products, the issues are an individual’s right to know. If you were going to ask to supply all information made on a processed crop, you’d have a whole encyclopedia attached to everything on your grocery shelf.”

Chris Shaw, a New York-based analyst, said labels identifying genetically modified organisms, or GMOs, won’t change most consumers’ buying decisions. “People who are buying Oreos aren’t going to care if there is GMO soybean oil in there,” Shaw said. “It’s going to be a marginal group of people that will care.”

That’s the consensus of consumers who participated in the IFIC survey.  Seventy-six percent of respondents could not think of any additional information (other than what is already required) that they wish to see on food labels.  Of the 24 percent who wanted more information, only 3 percent (or about five people and less than 1 percent of all surveyed) wanted more information about biotechnology. In addition, 87 percent of Americans say they have not taken any action out of concern about biotechnology.

IFIC President and CEO David Schmidt said the strength of the methodology used in the IFIC survey sets it apart from other surveys looking at food technology issues.

“In the public landscape, we often see polling that tries to provoke or frighten people into giving a certain desired response,” Schmidt said.  “We don’t believe in leading consumers to any conclusion.  We believe our open-ended methodology used at the beginning of our survey provides a more accurate view of concerns on Americans’ minds, and the survey is the most objective and long-term publicly available data set on U.S. consumer attitudes toward food and agricultural biotechnology.”

The survey, formerly the “IFIC Survey of Consumer Attitudinal Trends toward Food Biotechnology,” is part of a series that has been conducted since 1997.

We’re very pleased to announce the Buzz of BIO Winner for the 2012 contest of the BIO International Convention. You voted for your favorites, and it was a tight, interesting race! As such, we’re pleased to introduce you to our winner for the Pipelines of Promise category.

Deuteria Pharmaceuticals, Inc,. who focuses on improving the product profile of approved drugs through ‘chiral switching’, won the Pipelines of Promise category. From Dr. Sheila DeWitt, the company’s president, “As an emerging company with a pioneering approach to therapeutics, Deuteria Pharmaceuticals is pleased to be recognized as a Pipeline of Promise company by the premier conference in the biotechnology industry. This recognition from BIO 2012 provides and strengthens the visibility of Deuteria Pharmaceuticals.” View their website here.

You’ll definitely be seeing these folks around the International Convention. Be sure to look for them in the One-on-One Partnering System, plus, they’ll be giving a presentation in the BIO Business Forum.

Thanks to everyone who participated!

This June, thousands will gather in the biotech hub of Boston!

One of the things the team has been hard at work on, is the online community of myBIO, as those who have attended the Convention in the past will recognize. It’s a very handy, interactive tool that allows you to track companies, communicate with other attendees, and get a bird’s-eye view of all the different events going on. As a registrant, you even have your own profile that can include your photo, your company’s website, and your own social media accounts, like LinkedIn and Twitter feeds.

For those who are completely new to the event, we thought we could dig in to some of the differences between myBIO, and what BIO One-on-One Partnering™ is. Here’s a brief run-down of some topics, the details of which will be discussed further into the post.

Now let’s go into this in more depth.

Number 1:  What’s the difference between a personal event planner, and a meeting scheduler anyway? Essentially, you should use myBIO to plan your day around the events at the BIO Convention, such as the breakout sessions, keynotes, happy hours and so on. Think of it as Google Calendar, with a little Buzz thrown in. myBIO is not the platform that’s used to schedule private meetings with other companies and attendees. After all, the One-on-One Partnering System is all about that: Partnering. So One-on-One Partnering is what you use to send meeting requests to companies you otherwise wouldn’t have access to, and where you can let others know about your products or exciting additions to your pipeline.

Number 2:  How do I know if I have access to myBIO or BIO One-on-One Partnering? Will I know the difference? Yes, you will! If you’re coming to the BIO International Convention, you’re automatically given a myBIO account. It’s just a part of the registration process. In fact, profile details are taken directly from the information you provide during registration, so you don’t need to sign up for it.

One-on-One Partnering on the other hand, because it provides exclusive access to companies, is a separate designation when Registering. If you’re interested in the Business Forum, you must choose either the “Full Convention Access & Partnering” or the “Convention Access & Partnering” Registration Packages. Or if you’re an exhibitor, you would have received information regarding Partnering when registering your booth personnel. Another way to know: if you have it, we’ll send you login info for it, plus details, and step-by-step instructions on how to use Partnering effectively and successfully.

Number 3:  Okay, let’s say I’m signed up for both. Then how do I get to myBIO? And how do I get to One-on-One Partnering? myBIO is always accessible through the main Convention website, at convention.bio.org/mybio

To access BIO One-on-One Partnering, just visit the link in the email that contains your login credentials or go to: oneononepartnering.bio.org/BusinessForum2012. Plus, there are multiple ways to log in from the Convention website that will take you to this page, too.

Everything about Partnering is contained within the One-on-One site. So if you want to send a meeting request, if you want to see your calendar of meetings, when and where — the One-on-One Partnering System is your one-stop shop. You can also add notes to your delegate meeting calendar.

Number 4:  Tell me more about the differences between these two profiles. Think of it this way: the One-on-One Partnering System provides a detailed overview of all the participating companies and who and what they are, while myBIO is more of a look at the individuals within those companies and the events their participating in.

Those who are Partnering at the event will also receive emails from us, reminding you to publish your profile before our deadlines. It’s an easy process, but actually clicking the Publish and Save buttons on the site is important.

This allows your company to be fully visible and searchable in the Partnering System, which also tends to get companies more meetings. And if you’re ever unsure about which profile needs updating, you can always just follow the link we provide you in these emails.

Questions? Comments? Let us know!

By Richard M. Dolinar, M.D., Chairman, Alliance for Safe Biologic Medicines

In today’s budget-constrained world, the goal for health care is not only to save lives but also to save money. On Friday, May 11, the Food and Drug Administration (FDA) will hold a one-day public hearing on important medicines, known as biosimilars, that are under FDA consideration to come to the United States (U.S.) and offer the opportunity to help achieve the second prong of the health care goal: to save money. However, similar to any new medicine approval, patient safety must be paramount.

Biosimilars are attempted copies of innovative biotech medicines that have been available in the U.S. for a number of years. As members of the biotech community know, biologics have revolutionized the treatment of many serious and life threatening diseases in the short history of this industry. Biosimilars offer the hope of bringing life saving biologic drugs from the bench to the bedside in a cost effective manner and serve as another tool in the toolbox of healthcare providers. Unlike traditional pharmaceutical drugs that are made from chemicals and have structures that are well characterized, most biologics are made from living cells, with highly complex structures that are not easily understood, characterized or replicated. As a result, biosimilar medicines differ from generic drugs in that they are “similar to” but not exact copies of the innovator drug they attempt to replicate.

In 2010, the Patient Protection and Affordable Care Act (PPACA) granted the FDA the authority to approve biosimilars. Later that year the agency began consulting with patient groups, physicians and industry to exchange information that would eventually lead to the approval of biosimilars in the U.S. A few months ago the FDA took the first concrete step to create a pathway and issued draft guidance. The public hearing on Friday will allow stakeholders to provide testimony in response to the draft guidance and I am honored to be able to speak on behalf of the Alliance for Safe Biologic Medicines (ASBM).

In addition to my day job seeing patients as a practicing endocrinologist, I serve as the Chairman of ASBM, an organization that is working to raise awareness of biologics and biosimilars, as well as the important steps that should be taken to ensure safe use of these important medicines.   Our organization is composed of diverse healthcare groups—from patients to physicians, medical innovators, and others who have come together to ensure that patient safety is at the forefront of the biosimilars policy discussion.  We were pleased but not surprised to see the FDA lay out a science-based approach in the draft guidance largely building on the foundation laid by the European Medicines Agency (EMA).

The EMA began to establish the first formal regulatory pathway for biosimilars in 2003 and has gathered much data over the past 8 years that can, at a minimum help inform the development of policy in the U.S.  Policy makers should take advantage of this opportunity to learn from their experiences, both positive and negative.

We must also acknowledge that are differences between the EMA and FDA approach most notably in the area of “interchangeability” where the FDA has the authority to designate a biosimilar as interchangeable with its reference product and the EMA does not. This difference is not insignificant for patients in the U.S. because in theory it could lead to biosimilars being automatically substituted for the originator product by the pharmacist without consulting the prescribing physician. In the draft guidance the FDA signaled that it is not ready to prescribe a path to interchangeability at this time, and instead indicated that additional guidance will be necessary to better understand the challenges involved.

Differences aside, there is much to learn from the EMA experience and we believe that it provides a solid blueprint for the FDA to follow. At a minimum, ASBM members believe that the FDA must require biosimilar manufacturers to conduct clinical studies and produce analytical data sufficient to reassure patients and doctors that their products are safe. We also believe that unique nonproprietary names must be assigned to all biologic therapies so that physicians and patients know what caused an adverse event if one occurs.  Finally, as a practicing physician it is imperative that doctors and patients should be able to carefully choose the best course of treatment rather than have legislators and regulators decide for them.

For nearly 18 months, ASBM has been working to educate the public and policymakers about the great promise that biosimilars offer to patients in the U.S. Our message has been relatively simple, making lower cost medicines available to patients should be a priority but their availability must come with the absolute assurance that they are first and foremost safe. Our organization and its members have written Op-Eds, conducted webinars and hosted policy forums to exchange information about the issues and challenges associated with biosimilars. I am proud of the work we have done but ultimately realize as the late great Karen Carpenter sang so many years ago “we’ve only just begun.”

You can find more information at safebiologics.org, find us on Facebook or follow us on Twitter @SAFEbiologics.

In the words of BIO’s Andrew Emmett, Managing Director, Science & Regulatory Affairs, ‘2012 is shaping up to be a momentous year for FDA reform.’ From the reauthorization of the Prescription Drug User Fee Act (PDUFA V) to modernizing and expediting the approval of new drugs and biologics, implementing the new biosimilars pathways and addressing the growing global drug shortage crisis, all eyes are on the current regulatory environment and its role in supporting innovation.

The 2012 BIO International Convention will return to Boston, MA and the Boston Convention and Exhibition Center, June 18-21, 2012 and will feature a breakout session track on regulatory issues.

Attendees can expect the Achieving Regulatory Approval and Compliance educational track to feature leading Food & Drug Administration (FDA) leaders who will share their prospective priorities, senior European medical agency executives discussing international and harmonization issues as well as major biotechnology and pharmaceutical companies exploring best practices and addressing questions.

With drug development a long and costly process, speakers will also address how companies can continue to innovate and attract investor capital.

Highlights include:

FDA Town Hall

Tuesday, June 19, 2:00 p.m. – 3:30 p.m.

Speakers: Karen Midthun, MD, Director, Center for Biologics Evaluation and Research, Food and Drug Administration (FDA) and Janet Woodcock, Center for Drug Evaluation and Research, Food and Drug Administration (FDA)

PDUFA V: Impact on Innovation, Patients, and Modern Medicines – Super Session

Wednesday, June 20, 3:30 p.m. – 5:15 p.m.

Moderator: Steve Usdin, Washington Editor, BioCentury, Co-host, BioCentury This Week

Speakers: Marc Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council, Peter Greenleaf, President, MedImmune, and Margaret Hamburg, M.D., Commissioner of Food and Drug Administration (FDA)

Analysis and Impact of PDUFA V: What Regulatory Affairs Professionals Need to Know

Tuesday, June 19, 8:30 a.m. – 9:45 a.m.

Moderator:  Janet Jenkins-Showalter, Senior Regulatory Group Director, Genzyme, A Member of the Roche Group

Speakers:  Andrew Emmett, Managing Director, Science and Regulatory Affairs, Biotechnology Industry Organization, Kay Holcombe, Senior Policy Advisor, Genzyme, a Sanofi Company, and Patrick Frey, Director, Office of Planning and Analysis, Center for Drug Evaluation and Research (CDER), Food and Drug Administration

Interchangeable Biosimilars: Distinguishing between Aspiration and Achievement

Thursday, June 21, 8:30 a.m. – 9:45 a.m.

Moderator:  Ramsey Baghdadi, Senior Editor, The RPM Report

Speakers: Erika Lietzan, Special Counsel, Covington & Burling LLP, Joseph Miletich, Senior Vice President, Research and Development, Amgen, Gregory Schimizzi, Co-Founder, Carolina Arthritis, Coalition of State Rheumatology Organizations and Jan Wyatt, Patient Advocate, Arthritis Foundation

Biological Product Pediatric Development in the US: Implementation of PREA and BPCIA

Monday, June 18, 3:45 p.m. – 5:00 p.m.

Moderator: Chin Koerner, Executive Director, Novartis Pharmaceuticals

Speakers: Barbara Buch, MD, Supervisory Medical Officer, Center for Biologics and Evaluation Research, Food and Drug Administration (FDA), Sharon Olmstead, Vice President, Novartis Pharmaceuticals and Karen Weiss, Vice President, Janssen Research and Development

To learn more about the Achieving Regulatory Approval and Compliance educational track and get the most up-to-date program and speaker information, visit http://convention.bio.org/program/.

Patent-Eligible Subject Matter after Mayo v. Prometheus: Exploring the Path Forward is a public round-table event hosted by the Biotechnology Industry Organization and the George Washington University Law School. Guest speakers at the round-table will discuss implementation of the Prometheus decision in patent prosecution practice, in examination guidance in the United States Patent Office, and in patent litigation.  Speakers will also discuss the implications of the decision on personalized medicine and possible ways forward.  Speakers include:

• The Hon. Paul R. Michel
• Richard P. Bress, Latham & Watkins
• Donald R. Dunner, Finnegan
• Raymond T. Chen, USPTO (invited)
• Q. Todd Dickinson, AIPLA (invited)
• Prof. Christopher Holman, UMKC
• Philip S. Johnson, Johnson & Johnson
• Seth P. Waxman, WilmerHale
• Hal Wegner and Andrew S. Baluch, Foley & Lardner
• Paul D. Yasger and Anat Hakim, Abbott Laboratories

Join us on May 16th from 2-5 PM at the Faculty Conference Center, Burns 5th Floor, George Washington University Law School, 716 20th Street NW, Washington, DC 20052.  A reception will follow the program.  For more information and to RSVP please email iplaw@law.gwu.edu with “BIO” in the subject line.

By Stuart Tart, Director of Development, Osteogenesis Imperfecta Foundation

Ten years ago, Greg and wife Leigh brought their new daughter, Mallie, home from the hospital.

Mallie

When she was 9 days old, Mallie was fussy, leading Greg and Leigh to discover that their baby girl had fractured her right tibia and fibula.  The new parents immediately took their daughter to the doctor, who advised them to take Mallie straight to the emergency room. They discovered that Mallie was born with osteogenesis imperfecta, a genetic bone disorder characterized by fragile bones that break easily.

“We were just absolutely frightened,” Leigh remembered.  “I am a nurse, and I don’t remember hearing any of this from nursing school.”

Osteogenesis imperfecta (OI) is a rare heterogeneous disease of connective tissue that affects 8/100,000, or about 30,000 persons in the United States. Although the cardinal manifestation of OI is bone fragility, this rare disease encompasses all body systems. A person is born with this disorder and affected throughout his or her lifetime.  Thus, an infant may be born with multiple fractures, or a child can break his arm and collarbone while putting on a T-shirt. Each fracture is as painful as the first!

Many children and adults with OI have multiple surgeries to try to correct bone deformities and straighten bones so they can live independently. Mallie had her first surgery when she was just 2 ½ years old! Rodding surgery is considered major surgery, and the Holmans knew that it would require their little girl to deal with an overnight stay at the hospital, a hip-spica cast for six weeks, and then months of physical therapy. This surgery was necessary to relieve the bowing in her legs and thus, to prevent osteogenesis imperfecta from stealing Mallie’s ability to walk. To make matters worse, the Holmans learned that Mallie would likely need to repeat the surgery every two to three years, depending on how fast she grows, to replace the rods with longer ones.

Mallie, who turned ten this year, is an excellent student, and she is active in a variety of activities, including swim team, golf, band and orchestra. Although she tries not to allow OI to slow her down so she can still just be a kid, Mallie recently fractured her forearm and reinjured her tibia in her lower leg. Her arm was so severely injured that she needed surgery to place two rods in her bones.  Even though this was her fifth surgery in eight years, it was still an extremely frightening and traumatic experience for her.  After a brief overnight stay in the hospital, Mallie was home and showing off her unbreakable spirit.

The Role of the OI Foundation

The Osteogenesis Imperfecta (OI) Foundation provides information and resources to parents, doctors, educators, and adults with OI; organizes the National Conference on OI for families to gain the medical, research, and coping information they need (to be held in July this year); and advocates for increased funding from the National Institutes of Health, foundations and corporations.

The Foundation also funds groundbreaking research, including the multi-site Longitudinal Study of OI, which is tracking the health of 500 children and adults with OI for 5 years. The goal of the study is to develop a more detailed picture of osteogenesis imperfecta across a lifespan and to improve the level of care.

Build Awareness and Improve Lives!

The OI Foundation is hosting its second annual National OI Awareness Week from May 5-12, 2012. Awareness Week is a week-long event designed to educate communities across the country about osteogenesis imperfecta. National OI Awareness Week is held in conjunction with Wishbone Day on May 6, an international community awareness effort.

Hundreds of volunteers have planned fundraising events, secured proclamations from their city and state officials proclaiming May 5-12 ‘OI Awareness Week’, and are distributing educational materials throughout their communities.

Excitement for this year’s Awareness Week is growing—just last month, the City of Rochester, NY proclaimed May 5-12, 2012 ‘Osteogenesis Imperfecta Awareness Week’!

Awareness efforts like National OI Awareness Week help educate the greater community, leading to additional funding towards research programs and vital information and resources for our caregivers, doctors, nurses, teachers, and the OI community.

For more information or to donate, please visit our website.

Together, we are creating a better future for children and adults living with OI!