MARIETTA, Ga., Oct. 21, 2014 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spinal, Sports Medicine, Ophthalmic and Dental sectors of healthcare, issued an update on its outstanding patent litigations.
MiMedx has repeatedly stated that it will vigorously defend and enforce its patent portfolio against infringement by third parties. To that end, MiMedx filed two separate patent infringement lawsuits. These include an action pending in the Northern District of Georgia against Musculoskeletal Transplant Foundation, Liventa and Medline and another action pending in the Western District of Texas against Bone Bank, et al.
Georgia lawsuit brought by MiMedx against Musculoskeletal Transplant Foundation, Liventa and Medline
As previously announced, the first patent infringement suit was filed on April 21, 2014, in the United States District Court for the Northern District of Georgia against defendants Liventa Bioscience, Inc., Medline Industries, Inc. and Musculoskeletal Transplant Foundation. The original complaint filed in the action alleged infringement of four MiMedx patents. On April 29, 2014, MiMedx announced that it had amended the complaint to allege infringement of two additional, newly-issued patents. In addition to the allegations of infringement of MiMedx’s patents, the lawsuit alleges that Liventa and Medline knowingly made false and misleading representations about their respective products to providers, patients and in some cases, prospective investors.
Texas lawsuit filed against Bone Bank, et al.
On May 16, 2014, MiMedx filed a second patent infringement suit in the United States District Court for the Western District of Texas against Tissue Transplant Technology Ltd. d/b/a Bone Bank Allografts and Texas Human Biologics, Ltd. The suit alleges infringement of two MiMedx patents.
Current Status of Lawsuits
Both lawsuits are in the “discovery phase” and “claim construction phase.” During the discovery phase, the parties gather from each other and third parties information about the facts and issues in the case. While in the claim construction phase, the Court will engage in a determination of the meaning of the metes and bounds of certain claim terms in dispute between the parties.
As expected, the defendants are alleging that their respective products do not infringe MiMedx’s patents and/or that the Company’s patents are invalid. Because a patent is granted only after the United States Patent and Trademark Office (“USPTO”) has examined it, an issued patent is presumed to be valid (35 U.S.C. section 282). Therefore, a defendant seeking to invalidate a patent claim as a defense to a lawsuit must prove invalidity by “clear and convincing evidence.” This is a higher evidentiary standard than what a plaintiff, such as MiMedx, has to meet in order to prove infringement.
To avoid this higher standard, many defendants are attempting to challenge the validity of a plaintiff’s patent claims outside of court through a more recent process known as “inter partes review.”
An inter partes review is a request for a specialized group within the USPTO to review the validity of plaintiff’s patent claims.
- In order to petition the USPTO for an inter partes review, the challenger must allege that the challenged patent claims are invalid as anticipated or obvious under Sections 102 or 103 of the Patent Act (35 U.S.C. sections 102 and 103) based on prior art patents or printed publications.
- In some circumstances, the litigation may be “stayed” until the inter partes review is complete, which means that, in the interim, the defendant does not have to incur expenses to defend the lawsuit, which is another reason this process is often favored by many defendants it can be an effective delaying tactic.
- An inter partes review proceeding can take as long as 18 months from start to finish.
- Historically, a majority of requests for inter partes review have been granted, but the results of such reviews vary. A decision could uphold all of the patent claims, invalidate some claims but uphold other claims, or invalidate all of the challenged patent claims. In some cases, the patent holder can even amend its claims to avoid invalidity or more particularly capture infringement.
The Company fully expects that one or more parties in the pending litigations may request an inter partes review of one or more of the Company’s patent claims. Even if one or more of the Company’s patent claims were invalidated, it would not affect the Company’s ability to market its products.
Parker H. “Pete” Petit, MiMedx’s Chairman and CEO, commented, “In the course of this litigation, there will be many motions, filings, proceedings and skirmishes along the way. Although litigation can be a long and arduous process, and outcomes can be uncertain, we feel strongly about defending our intellectual property rights. MiMedx respects the intellectual property rights of other companies and individuals and expects others to do the same. In addition, we intend to continue to expand our patent portfolio and rapidly build our position and respect in the marketplace, which is where success ultimately is determined.”
About MiMedx
MiMedx® is an integrated developer, processor and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include AmnioFix® and EpiFix®, our tissue technologies processed from human amniotic membrane that is derived from donated placentas. Through our donor program, a mother delivering via full-term Caesarean section birth can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx® is the leading supplier of amniotic tissue, having supplied over 300,000 allografts to date for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the validity of the Company’s patent claims and the extent to which the defendants in the lawsuits are infringing the same, the prospect of one or more defendants requesting an inter partes review, the Company’s non-infringement of third party intellectual property, that the Company will continue to expand its patent portfolio and rapidly build its position and respect in the marketplace and, ultimately, succeed. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that one or more of the Company’s patent claims could be invalidated, that the defendants could be found not to have infringed the Company’s patents, that the defendants may not request an inter partes review, that the outcome of the litigation may not otherwise be favorable to the Company, that the Company may infringe a third party’s intellectual property rights, that the Company does not continue to build its patent portfolio, rapidly expand its position and/or respect in the marketplace or, ultimately, succeed, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2013, and subsequent Forms 10-Q. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.
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SOURCE MiMedx Group, Inc.
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