EDISON, N.J., Aug. 25, 2015 /PRNewswire/ — The Musculoskeletal Transplant Foundation (MTF) announced today the Patent Trial and Appeal Board (“PTAB”) has ruled in favor of MTF’s challenge to the primary EpiFix®patent in the related lawsuit brought by MiMedx Group, Inc. (MiMedx) against MTF, Liventa Bioscience, Inc., and Medline Industries, Inc. As previously announced, on February 2, 2015 MTF filed Inter Partes Review (IPR) Petitions on two MiMedx patents: US Patent Nos. 8,372,437 (the ‘437 patent) and 8,323,701 (the ‘701 patent). On August 18, 2015 the PTAB ruled in favor of MTF by granting an IPR proceeding for the ‘437 patent, stating that there is “a reasonable likelihood that [MTF] would prevail in showing claims 1 and 2 of the ‘437 patent are unpatentable” (IPR 2015-0064; Paper No. 13).
MTF also announced that its request for IPR proceeding on the ‘701 patent was not granted by the PTAB. The PTAB preliminary finding does not, however, preclude MTF from challenging the validity of the ‘701 patent in the related patent infringement lawsuit, and MTF intends to vigorously contest both of those issues in the district court and/or any other available forums.
Mark Spilker, Ph.D., MTF’s Executive Vice President of Research & Development, Quality Assurance and Regulatory Affairs, said, “We are encouraged that the PTAB agrees that MTF has provided sufficient basis to challenge the validity of the primary MiMedx EpiFix patent and has accepted our request for review on the validity of the patent claims. We are also encouraged by the fact that a significant majority of these PTAB proceedings result in complete removal of all claims in the challenged patents.”
Bruce Stroever, MTF’s President and CEO added, “MTF strongly believes we do not infringe any of the patents in question and we will continue to vigorously defend our position. We are anxious to move forward with IPR and Court proceedings following this favorable PTAB decision.”
Under the America Invents Act (AIA), IPR is a mechanism to challenge validity of claims in issued US Patents at the US Patent and Trademark Office (USPTO). The first step in this process is the filing of formal petitions with the USPTO to request a review of the patents at issue. An IPR may be instituted upon “a showing that there is a reasonable likelihood that the requestor would prevail with respect to at least 1 of the claims challenged” [35 USC section 311]. Once a trial is ordered by the USPTO, a final ruling can be expected approximately 18 months from the filing of the IPR petition.
According to USPTO statistics, 46% of IPR requests since inception of the PTAB have been granted a trial. For IPR cases where the trial was granted and completed, all instituted claims were deemed unpatentable in 66% of cases, and some claims were deemed unpatentable in an additional 18% of cases. (AIA trial statistics data is available at www.uspto.gov)
The Musculoskeletal Transplant Foundation, a non-profit organization based in Edison, NJ, is a national consortium comprised of leading organ procurement organizations, tissue recovery organizations and academic medical institutions. Since its inception in 1987 MTF has received tissue from more than 100,000 donors and distributed more than six million grafts for transplantation. For more information visit: www.mtf.org
CONTACT: Anne Burns, 609-375-2270, email@example.com