101 Patient Organizations Ask Congress to Curb IPR Abuse

McDonnell Boehnen Hulbert & Berghoff LLP

Last month, in a letter to the Senate and House Committees on the Judiciary, 101 patient organizations expressed "concern[] that, as currently written, H.R. 9 [the Innovation Act] falls short of preserving important patent protections for the biopharmaceutical innovation our communities rely on to achieve a better quality of life."  While commending the House Judiciary Committee for its work to combat "the problem of patent trolls," the group noted that it "remain[ed] concerned that the bill does not address some forms of abuse in our patent system that, left unaddressed, could undermine the investments that sustain medical research into lifesaving treatments and cures."

And the form of abuse in the patent system that is drawing the attention of the organizations?  That would be inter partes review (IPR) proceedings.  The letter contends that "IPR opened the door to abuses that threaten the unique and specialized mechanisms under the Drug Price Competition and Patent Term Restoration Act (commonly referred to as the Hatch-Waxman Act) and the Biologics Price Competition and Innovation Act (BPCIA)."  According to the group "Congress established these carefully-crafted patent dispute resolution frameworks to balance the interests of innovators, generic and biosimilar manufacturers, and, most importantly, the individuals waiting for a treatment or cure."

The letter explains that "[d]eveloping new medical treatments can cost billions of dollars and take more than a decade of research and development," and that "[b]oth small and large research and development companies rely heavily on the certainty of their patents to justify the significant long-term, risky investments needed to obtain approval from the U.S. Food and Drug Administration, often many years after a patent is granted."  According to the organizations, "[c]urrent abuses in the IPR proceedings could ultimately undermine the ability to raise capital and recoup development costs needed to fund future research."  Suggesting that Congress never intended IPR proceedings to undermine the patent dispute resolution frameworks in Hatch-Waxman and BPCIA, the group concludes its letter by "urg[ing] Congress to include language in H.R. 9 that would preserve the highly-detailed and sophisticated systems designed by Hatch-Waxman and BPCIA to avoid weakening the patents that sustain medical research."  The letter does not provide any details about the specific language the organizations seek.

The organizations that were signatories to the letter were as follows:  Addario Lung Cancer Foundation; AIDS Delaware, Inc.; Alabama Lifespan Respite Resource Network; Allergy & Asthma Network; Alliance for Patient Access; Alzheimer's Association; American Autoimmune Related Diseases Association; Asthma & Allergy Foundation of America, New England Chapter; Asthma and Allergy Foundation of America; Benign Essential Blepharospasm Research Foundation; Bladder Cancer Advocacy Network; Brain Injury Association of Nebraska; Bridge the Gap - SYNGAP Education and Research Foundation; California Hepatitis C Task Force; California Senior Advocates League; Caregiver Action Network; Chris4Life Colon Cancer Foundation; Community Health Charities of Nebraska; Cure SMA; Delaware HIV Consortium; Dystonia Medical Research Foundation; Elder Care Advocacy of Florida; Epilepsy California; Epilepsy Foundation; Epilepsy Foundation New England; Epilepsy Foundation of Connecticut; Epilepsy Foundation of Florida; Epilepsy Foundation of Greater Chicago; Epilepsy Foundation of Kentuckiana; Epilepsy Foundation of Michigan; Epilepsy Foundation of Mississippi; Epilepsy Foundation of Nevada; Epilepsy Foundation Heart of Wisconsin; EveryLife Foundation for Rare Diseases; Florida State Hispanic Chamber of Commerce; Global Colon Cancer Association; Global Genes; Hannah's Hope Fund; HEALS (Hepatitis Education Awareness & Liver Support) of the South; HealthHIV; Healthy Women; Hepatitis Foundation International; ICAN, International Cancer Advocacy Network; Immune Deficiency Foundation; International Essential Tremor Foundation; International Foundation for Autoimmune Arthritis; Kentucky and S. Indiana Stroke Association; Kidney Cancer Association; Lupus and Allied Diseases Association, Inc.; Lupus Foundation of America; Lupus Foundation of Florida; Lupus Foundation of Northern California; Lupus Foundation of Southern California; Massachusetts Association For Mental Health, Inc.; Men’s Health Network; Mental Health America of Indiana; Michigan Lupus Foundation; Minnesota State Grange; MLD Foundation; NAMI Alabama; NAMI Greater Des Moines; NAMI Indiana; Nashville CARES; National Alliance on Mental Illness; National Association of Hepatitis Task Forces; National Association of Social Workers, NC Chapter; National Council for Behavioral Health; National Grange; National Hispanic Council on Aging; National Minority Quality Forum; National MS Society; National Prostate Cancer Awareness Foundation; National Psoriasis Foundation; Neurofibromatosis, Inc. Mid-Atlantic; New England Community for Cancer Survivorship; New Jersey Association of Mental Health and Addiction Agencies, Inc.; Ovarian Cancer National Alliance; Parent Project Muscular Dystrophy; Parkinson's Action Network; Prevent Cancer Foundation; Rare and Undiagnosed Network (RUN); RetireSafe; Rio Grande Valley Diabetes Association; Rocky Mountain Stroke Center; Rush to Live; Rx Partnership; Salud USA; Solidarity Project Access Network; St. Baldrick's Foundation; ST/Dystonia, Inc.; Texas Nurse Practitioners; The AIDS Institute; The ALS Association; The Playing For Life Foundation; Tuberous Sclerosis Alliance; United Spinal Association; US Pain Foundation, Inc.; Veterans Health Council; Vietnam Veterans of America; Wellness and Education Community Action Health Network; and ZERO - The End of Prostate Cancer.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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