CDX Diagnostics, and Histologics LLC has settled.
As of March 18, 2015, Histologics has an exclusive worldwide license under U.S. Patent No. 6,258,044 and the rights to manufacture and sell Spirabrush CX® for use in the Gynecological Body Area.
Since the rights to Spirabrush were just recently transferred to Histologics on March 18th, (following the resolution of Shared Medical Resources (SMR) legal action and SMR exiting the business), the transition through regulatory and manufacturing channels will take some time to navigate.
Spirabrush is a time honored exocervical biopsy brush that was developed in the 1990's and marketed until 2005 by the same inventor and team that now manage Histologics. Spirabrush users should be aware that Histologics currently markets the FDA-compliant and patented Kylon® fabric-based brush technology for exocervical tissue biopsy sampling. It also has the added FDA registered benefit of trapping and retaining the tissue removed, resulting in a research proven consistent, abundant, reliable, and diagnostic sample.
As Histologics evaluates the future of the Spirabrush, we encourage all colposcopists to use the SoftBiopsy®.
The SoftBiopsy® device provides a minimally invasive approach with greater value (reprints of fabric based colposcopy research evidence is available upon request). The list price of SoftBiopsy® is lower than Spirabrush; $4.25 per disposable device with additional price/volume discounts available. Pathology labs that have processed both Spirabrush and Soft-Biopsy® samples report to Histologics that the fabric-based specimens are of higher diagnostic yield.
Many labs nation-wide have received fabric based biopsy specimens, and some buy in volume and provide superior pricing to their colposcopist clients. Thus, the colposcopist could reach out to their lab, and if fabric-based biopsy is not yet available, encourage the lab to contact Histologics to purchase in volume and pass along savings based on their purchase advantages over smaller or group clinical practices.
Furthermore, many Spirabrush users have requested a minimally invasive brush for endocervical curettage (ECC). The fabric-based Soft-ECC® is similarly priced, comes in two sizes (regular and small), and is the only minimally invasive simultaneous biopsy device combined with a tissue trap system available for this use. The 2014 ASCCP Meeting Award winning research on fabric ECC showed a simple single insertion/ rotation/withdrawal method with simultaneous tissue trapping, increases the diagnostic specimen yield that returns to the laboratory, nearly eliminating insufficient samples, while remaining a very gentle approach to ECC that patients appreciate.
Finally, Histologics LLC did not acquire the Shared Medical Resources (SMR) company, it only obtained the rights to the gynecologic applications for Spirabrush CX®. Any purchases made prior to March 18, 2015 from SMR that have not been fulfilled should be directed to SMR.
We welcome questions and value your business during this transition period.
Neal M. Lonky, MD, MPH
Inventor and Founder; Histologics LLC
Histologics wants to take this opportunity to illuminate the public regarding the verbal, written and web site allegations by Shared Medical Resources LLC (“Shared Medical”) over the past several months regarding our products, Soft-ECC® and Soft Biopsy®, and the future innovations from the patent pending material, Kylon®.
You have probably read that Shared Medical filed a patent infringement lawsuit against Histologics and other defendants in Federal Court in Orange County, CA on April 19, 2012. Histologics wants its customers and the public to realize that Shared Medical filed this lawsuit when it lacked standing and the legal right to maintain this lawsuit. In the ensuing five-month period after bringing this defective lawsuit, Shared Medical continued to make accusations against Histologics, its staff, and partners, while concurrently warning our customers, research scientists, and friends. However, while Shared Medical engaged in this extra-judicial conduct, it did so without proper standing to maintain this lawsuit in court.
The case was dismissed on October 1, 2012 by the Federal Court because the Court granted Histologics’ motion to dismiss and confirmed that Shared Medical did not have standing to maintain the lawsuit. The Court confirmed that the lawsuit could not be maintained because “if one or more co-owners [of the ‘044 patent] will not voluntarily join in a patent infringement suit then the owner bringing the suit will lack prudential standing. If the owner lacks prudential standing, the court will lack jurisdiction and the action must be dismissed.” (Order, pg. 3). Therefore, at this time, any allegations of patent infringement would be in conflict with the Court's decision and would be made without proper standing to sue.
Histologics will do all it can to avert these episodes in the future, by fighting vigorously against what we feel are baseless claims to enforce an invalid and unenforceable patent. We do not infringe the ‘044 patent, and we also believe the ‘044 patent is invalid because Spirabrush was on-sale years before the ‘044 patent was filed. Under U.S. law, a patent is invalid and is statutorily barred if the subject matter of the patent, as in this case, was on-sale or in use before the filing of the ‘044 patent application.
We sincerely appreciate our customers, welcome new clients, and appreciate your patience and loyalty during these last five months. We believe our products are indeed the innovations our partners are seeking to enhance women's health. Histologics remains dedicated to the improvement of health through the innovation of tissue-based technologies that enhance the lives of patients, worldwide. We welcome any questions.
Thank you all for your patience and support.
On March 1, 2013, Shared Medical Resources, LLC (SMR) issued a press release stating that issues pertaining to dismissal of its lawsuit against Histologics had been resolved, clearing the way for SMR to resume its patent infringement action against Histologics and other parties promoting or using Histologics' Soft-ECC® and SoftBiopsy® Device.
Notwithstanding SMR's misleading press release, there is no change to the status of this case. The Court dismissed SMR’s lawsuit on October 1, 2012 for SMR's lack of prudential standing to sue. (Case No. SACV 12-0612, Dkt. No. 45). Histologics has not mischaracterized the Court's Order or its impact. The case remains dismissed and SMR has not attempted to re-file or lift the stay or join the proper parties to obtain standing to sue.
Histologics respects intellectual property rights and is confident that should SMR attempt to resume its anti-competitive lawsuit, Histologics will succeed in proving that the Soft-ECC® and SoftBiopsy® devices do not infringe the '044 patent ((U.S. Patent No. 6,258,044).
We sincerely appreciate our customers, welcome new clients, and appreciate your patience and loyalty. We believe our products are indeed the innovations our partners are seeking to enhance women's health. Histologics remains dedicated to the improvement of health through the innovation of tissue-based technologies that enhance the lives of patients, worldwide. We welcome any questions.