Alexandria, VA, United States
Alexandria, VA, United States

Time filter

Source Type

IRVINE, Calif.--(BUSINESS WIRE)--Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and fecal dysfunction, announced today that the United States Patent and Trademark Office has granted Axonics four new U.S. patents relating to its implantable sacral neuromodulation technology. “The diverse and rapid expansion of the Axonics U.S. patent portfolio further demonstrates the level of innovation applied by our Company in addressing the unmet needs of clinicians and patients relating to implantable Sacral Neuromodulation. With these four new U.S. patents, we now have 73 granted and 78 pending patent applications in our portfolio in various jurisdictions around the world,” said Raymond W. Cohen, Axonics Chief Executive Officer. The Axonics patent portfolio represents technology internally developed by Axonics and under license from the Alfred Mann Foundation. The Axonics r-SNM System® received European CE Mark approval in June 2016 and Health Canada approval in December 2016 for the treatment of overactive bladder (including urinary urge incontinence and urinary urgency-frequency), urinary retention, and fecal incontinence. The Company has completed enrollment of its RELAX-OAB multi-center post-market clinical study for patients with overactive bladder in select centers in the Netherlands, Belgium, France and the UK. Axonics anticipates initiating a U.S. FDA pivotal clinical study for overactive bladder patients in select centers in the U.S., Canada and Europe in the second half of 2017. The Axonics neuromodulation platform includes, among other innovations, a miniaturized rechargeable implantable neuromodulation stimulator that is approximately one-fourth the size of the smallest currently marketed rechargeable neuromodulation devices and can be directed toward numerous clinical applications. The Axonics stimulator is qualified to last at least 15 years in the body and needs to be recharged once every week or two for approximately one hour via a charging system designed to optimize ease of use and patient comfort. In addition, the Axonics platform features a key-fob sized, patient-friendly remote control and an intuitive clinician programmer that will guide and support physician implanters throughout the clinical procedure, from lead placement to programming. Axonics’ initial clinical application for its technology is Sacral Neuromodulation (SNM) for the treatment of urinary and fecal dysfunction which affects over 100 million adults in the U.S. and Europe. SNM is a reimbursed FDA-approved therapy that has proven to be an effective and durable treatment widely used in Europe and the U.S. for the past two decades with more than 200,000 patients having benefited from the therapy to date. Axonics, based in Irvine, CA, is a privately-held company developing novel implantable neuromodulation technology directed toward a number of clinical indications. Investors include Edmond de Rothschild Investment Partners, Advent Life Sciences, NeoMed Management, Legend Capital, Cormorant Asset Management and The Alfred E. Mann Foundation. For more information, visit the Company’s website at www.axonicsmodulation.com.


CARLSBAD, Calif., Jan. 13, 2017 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (TSXV:ASG) announced today the allowance of its United States Patent Application No.: 14/732,240 entitled “POLYAXIAL INTERSPINOUS FUSION IMPLANT AND BONE GROWTH STIMULATION SYSTEM.”   In addition to Aurora’s implant family of ZIP® ISPs, including its ZIP Ultra®, ZIP 51™, ZIP LP™ and Dyna-ZIP™, this patent application covers the company’s first polyaxial implant design. “The polyaxial ZIP® Interspinous patent allowance is another milestone in Aurora Spine’s history. Our latest patent will be issued for our newest interspinous device design that permits for full polyaxial maneuverability of the implant components in difficult situations during minimally invasive fusion cases. The newly allowed patent features our already patented ONE-STEP™ locking mechanism that eliminates the use of a set screw in Aurora’s Screwless Procedure™ surgeries,” said Laszlo Garamszegi, Chief Technology Officer of Aurora Spine. “Aurora is changing spine surgery, and we are thrilled that our newest patent has been allowed by the United States Patent and Trademark Office (USPTO). This patent further validates the modern advancements of our Screwless technology,” said Trent Northcutt, President and CEO of Aurora Spine, “and it maintains our commitment to introduce advanced, minimally invasive spine surgery technologies.” This is Aurora’s second allowed U.S. patent.  Aurora Spine has several other U.S. and international patent applications pending directed to the ZIP system and its future technologies. Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies.  Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies.  Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex. This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Information" in Aurora Spine's final prospectus (collectively, "forward-looking information"). Forward-looking information in this news release includes information concerning the proposed use and success of the company’s products in surgical procedures. Aurora Spine cautions investors of Aurora Spine's securities about important factors that could cause Aurora Spine's actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.


News Article | March 2, 2017
Site: www.prweb.com

Greenfield Advisors is excited to announce that its two principals have been issued their first patent by the United States Patent and Trademark Office (USPTO). The patent, U.S. Patent 9,582,819, is entitled “Automated-valuation-model training-data optimization systems and methods.” The inventors are former Greenfield Advisors employee Andy Krause [currently a Lecturer at the University of Melbourne (Australia)], Clifford A. Lipscomb, and John A. Kilpatrick, both Co-Managing Directors of the firm. The technology covered by the patent is related to the firm’s long history of using sophisticated quantitative tools in its work. In valuing real estate, predictive models have been used for decades. These predictive models, however, have not been used to go back and optimize the training data sets used in the initial passes of the predictive model. What the patent does is describe a process for optimizing the training data sets used by a predictive model for automatically performing real estate valuations. As stated in the Background of the patent, “there is a need for an improved method of selecting training data to provide more accurate value predictions.” “Greenfield Advisors, in our 40-year history, has developed significant expertise in predictive modeling. We have applied that expertise to situations where we have been tasked with valuing properties affected by environmental contamination as well as properties underlying residential mortgage backed securities (RMBS),” said Dr. Lipscomb. “What we learned from our predictive modeling efforts is that the underlying data shape our predictive models – some jurisdictions have better data than others. Predictive models must be flexible in using the best available data in each jurisdiction. That reality was one of the reasons we decided to pursue a patent.” “The rapid popularization of real estate valuation models has led naturally to a demand for increased accuracy, precision, and reliability,” said Dr. Kilpatrick. “We have worked hard to make sure the results from our predictive models, in particular the Greenfield AVM, are state-of-the-art so our clients can be confident they are receiving the best data analyses available.” About Greenfield Advisors Founded in 1976, Greenfield Advisors is a boutique economic and financial analysis firm that provides government and private sector clients with customized consultations and advisory services. Best known for its analysis of complex economic, financial, and real estate situations in high-profile litigation matters, Greenfield Advisors also develops feasibility studies, business plans, and appraisals for its clients. Greenfield Advisors’ subsidiary, Bartow Street Capital LLC, serves as its investment banking and capital raising arm, and its subsidiary, Accre LLC, acts as an investment principal. Learn more about Greenfield Advisors by calling 206-623-2935 or visiting http://www.greenfieldadvisors.com.


News Article | February 4, 2017
Site: www.techtimes.com

Samsung may be gearing up for the launch of a new device in the U.S. as the company has filed for a trademark at United States Patent and Trademark Office (USPTO) for the brand name "Galaxy J7 Sky Pro." The request has already been accepted by the USPTO and an examining attorney will be assigned within three months of filing. The has been no further information about the device other than the official filling which can be seen on USPTO's website. It is unclear how this device is going to be different from the Samsung Galaxy J7 or why the moniker "Sky Pro" has been used in the brand name. Tech enthusiasts are not even sure if the name belongs to a smartphone, but given that the name says Galaxy J7 it may be safe to assume that "Sky Pro" is a variant of the smartphone. There have been speculations of Samsung launching the Galaxy J7 (2017) in U.S. via carriers like Verizon, U.S. Cellular and AT&T. Now rumors are rife that Samsung may plan to launch Galaxy J7 (2017) under the name Galaxy J7 Sky Pro. The Galaxy J7 (2017) has already surfaced on Geekbench, which is a benchmarking website, and even prior to that some renders of the device have been leaked online. The smartphone has been granted the Federal Communications Commission (FCC) certification as well. A few days ago, the Galaxy J7 (2017) was also spotted on GFXBench. While nothing has been officially confirmed by Samsung, some specifications and features of the Galaxy J7 (2017) leaked out after the handset appeared on Geekbench and more recently GFXBench. Previous and recent leaks suggest that the device may sport a 5.5-inch display with a resolution of 1280 x 720 pixels. While both the benchmarking sites reveal that the Galaxy J7 (2017) may come with 2 GB of RAM, there are contradictory reports regarding its processor. The Geekbench listing notes that the rumored smartphone will house a Snapdragon 625 processor, whereas the recent GFXBench listing shares that the handset will come with an Exynos 7870 CPU. Previous leaks also suggest that the battery fueling the handset will be a 3000 mAh one. It seems that the Galaxy J7 (2017), which is the successor of the Galaxy J7 (2016), may be launched as the Galaxy J7 Sky Pro in the U.S. in the near future. Only once Samsung launches the Galaxy J7 Sky Pro the mystery will be solved. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.


BRIDGEWATER, N.J., Feb. 14, 2017 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent Number 9,566,234 for ARIKAYCE, the Company’s liposomal amikacin for inhalation. The claims of the patent relate in part to systems and methods for treating pulmonary infections, including nontuberculous mycobacteria (NTM) infections. The systems each include a pharmaceutical formulation containing an aqueous dispersion of liposomal complexed aminoglycoside, which can be amikacin sulfate, with a nebulizer. The patent, the seventh U.S. patent to issue to Insmed for ARIKAYCE in NTM, is expected to provide patent coverage for ARIKAYCE in NTM into January 2034, thereby extending previously existing patent coverage by five years and five months. Insmed is currently evaluating ARIKAYCE in a global Phase 3 trial in patients with NTM lung disease. “This new patent significantly extends our long-term intellectual property protection for ARIKAYCE in the U.S., and provides us with further protection at a time when we will have potentially reached a mature point in our commercial efforts for ARIKAYCE in NTM," said Will Lewis, president and chief executive officer of Insmed. “We will continue to pursue additional patents in the U.S. and other major markets worldwide to further strengthen our patent estate and enhance the value potential of ARIKAYCE.” Insmed Incorporated is a global biopharmaceutical company focused on the unmet needs of patients with rare diseases. The company is advancing a global phase 3 clinical study of ARIKAYCE (liposomal amikacin for inhalation) in nontuberculous mycobacteria (NTM) lung disease, a rare and often chronic infection that is capable of causing irreversible lung damage and can be fatal. There are currently no products indicated for the treatment of NTM lung disease in the United States or European Union (EU). Insmed's earlier-stage clinical pipeline includes INS1007, a novel oral reversible inhibitor of DPP1 with therapeutic potential in non-CF bronchiectasis, and INS1009, an inhaled nanoparticle formulation of a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders. For more information, visit www.insmed.com. "Insmed" and "ARIKAYCE" are the company's trademarks. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners. This press release contains forward looking statements. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) identify forward-looking statements. Forward-looking statements are based upon the company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such factors include, among others, the factors discussed in Item 1A "Risk Factors" in the company's Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent quarterly reports on Form 10-Q, and the following: the ability to complete development of, receive, and maintain regulatory approval for, and successfully commercialize ARIKAYCE, INS1007, and INS1009; the number of patients enrolled and the timing of patient enrollment in the company's global phase 3 clinical study of ARIKAYCE; the ability to successfully develop INS1007 (formerly known as AZD7986) for the treatment of non-CF bronchiectasis; estimates of expenses and future revenues and profitability; status, timing, and the results of preclinical studies and clinical trials and preclinical and clinical data described herein; the sufficiency of preclinical and clinical data in obtaining regulatory approval for the company's product candidates; the timing of responses to information and data requests from the US Food and Drug Administration, the European Medicines Agency, and other regulatory authorities; expectation as to the timing of regulatory review and approval; estimates regarding capital requirements, including milestone payments and royalty obligations due to AstraZeneca, and the needs for additional financing, the ability to repay our existing indebtedness, estimates of the size of the potential markets for product candidates; selection and licensing of product candidates; the ability to attract third parties with acceptable development, regulatory and commercialization expertise; the benefits to be derived from corporate license agreements and other third party efforts, including those relating to the development and commercialization of product candidates; the degree of protection afforded to the company by its intellectual property portfolio; the safety and efficacy of product candidates; sources of revenues and anticipated revenues, including contributions from license agreements and other third party efforts for the development and commercialization of products; the ability to create an effective direct sales and marketing infrastructure for products the company elects to market and sell directly; the rate and degree of market acceptance of product candidates; the impact of any litigation the company is a party to, including, without limitation, the class action lawsuit filed against the company; the timing, scope and rate of reimbursement for product candidates; the success of other competing therapies that may become available; and the availability of adequate supply and manufacturing capacity and quality for product candidates. The company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Insmed disclaims any obligation, except as specifically required by law and the rules of the Securities and Exchange Commission, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.


News Article | February 16, 2017
Site: www.marketwired.com

SAN JOSE, CA--(Marketwired - February 16, 2017) - Align Technology, Inc. ( : ALGN) today announced that it has prevailed in proceedings initiated by ClearCorrect Operating LLC before the United States Patent and Trademark Office ("USPTO") that challenged the validity of three of Align's U.S. patents. Last week, the USPTO issued reexamination certificates confirming the patentability of all challenged claims of Align's U.S. Patent Nos. 6,217,325, 6,722,880, and 8,070,487. Align was not required to amend or alter any of the challenged patent claims -- they were all confirmed based on the existing claim language. The confirmed patents include two of the patents (the '325 and '880 patents) that Align is asserting in its patent infringement lawsuit against ClearCorrect pending in the Southern District of Texas. These same two patents previously emerged from a prior reexamination proceeding a decade ago and were also found valid in the recent ITC proceedings against ClearCorrect. Thus, the current reexamination decision marks the third time Align successfully defended these patents. ClearCorrect responded to its latest defeat this week by filing two more reexamination requests regarding the same '325 patent that was just confirmed by the USPTO last week. "These reexaminations have now ended with Align prevailing on every claim of every challenged patent. ClearCorrect's previous attempts to challenge the validity of Align patents -- at trial before the International Trade Commission -- also resulted in the rejection of all of ClearCorrect's invalidity contentions and a finding of validity of all of the asserted patents. Align's confidence in the validity of its patent portfolio continues to be borne out by the positive rulings of neutral decision makers like the USPTO and the ITC," said Roger E. George, Align Technology vice president and general counsel. About Align Technology, Inc. Align Technology is the leader in modern Clear Aligner orthodontics that designs, manufactures and markets the Invisalign® system, which provides dental professionals with a range of treatment options for adults and teenagers. Align also offers the iTero 3D digital scanning system and services for orthodontic and restorative dentistry. Align was founded in March 1997 and received FDA clearance to market the Invisalign system in 1998. Visit www.aligntech.com for more information. For additional information about the Invisalign system or to find an Invisalign provider in your area, please visit www.invisalign.com. For additional information about the iTero 3D digital scanning system, please visit www.itero.com.


IRVINE, Kalifornien (USA)--(BUSINESS WIRE)--Axonics Modulation Technologies, Inc., der Entwickler des ersten wiederaufladbaren Sacral Neuromodulationssystems (r-SNM™) zur Behandlung von urinaler und fekaler Dysfunktion, hat heute bekannt gegeben, dass das United States Patent and Trademark Office (amerikanisches Patent- und Markenamt) Axonics vier neue US-amerikanische Patente in Bezug auf seine implantierbare sakrale Neuromodulationstechnologie gewährt hat. „Die vielfältige und schnelle Expansion des US-Patent-Portfolios von Axonics ist ein weiterer Beweis für das hohe Niveau an Innovation, das unser Unternehmen zur Deckung unerfüllter Bedürfnisse der Patienten in Bezug auf implantierbare sakrale Neuromodulation anwendet. Mit diesen vier neuen US-Patenten besitzen wir nun 73 gewährte und 78 angemeldete Patentanmeldungen in unserem Portfolio in verschiedenen Rechtsordnungen rund um die Welt“, erklärte Raymond W. Cohen, Chief Executive Officer von Axonics. Axonics plant in der zweiten Jahreshälfte 2017 eine kritische klinische Studie für hyperaktive Blasenpatienten in bestimmten Zentren in den USA, Kanada und Europa zu starten. Die Neuromodulationsplattform von Axonics umfasst unter anderen Innovationen einen aufladbaren, implantierbaren Mini-Neuromodulationsstimulator, der etwa ein Viertel so groß ist wie die derzeitig auf dem Markt erhältlichen aufladbaren Neuromodulationsgeräte und der für zahlreiche klinische Anwendungen geeignet ist. Der Axonics Stimulator hat eine Haltbarkeit von mindestens 15 Jahren im Körper und muss einmal jede Woche oder jede zweite Woche etwa eine Stunde mit einem Ladegerät aufgeladen werden, das einfach und bequem für den Patienten zu verwenden ist. Die Axonics-Plattform bietet ferner eine patientenfreundliche Mini-Fernsteuerung und eine intuitive klinische Programmierfunktion, die die Implanteure durch das klinische Verfahren führt, vom Leitungsersatz bis zum Programmieren. Die erste klinische Anwendung der Axonics-Technologie ist Sacral Neuromodulation (SNM) für die Behandlung von urinaler und fekaler Dysfunktion, an der über 100 Millionen Erwachsene in den USA und Europa leiden. SNM ist eine erstattbare und von der FDA zugelassene Therapie, die sich als eine wirksame und haltbare Behandlung bewährt hat und in Europa und den USA in den letzten zwei Jahrzehnten über 200.000 Patienten geholfen hat.


IRVINE, California--(BUSINESS WIRE)--Axonics Modulation Technologies, Inc., la società che ha sviluppato il primo sistema di neuromodulazione sacrale ricaricabile (rechargeable Sacral Neuromodulation, r-SNM™) per il trattamento della disfunzione urinaria-fecale, ha annunciato oggi che l'Ufficio Marchi e Brevetti degli Stati Uniti (United States Patent and Trademark Office) le ha rilasciato quattro nuovi brevetti statunitensi per la sua tecnologia di neuromodulazione sacrale impiantabile.


Company's TotalSocial™ data solution receives patent pending alongside release of version 1.6 of its proprietary measurement system MONTREAL, QC--(Marketwired - February 10, 2017) - Engagement Labs Inc. (TSX VENTURE: EL) announced today that its TotalSocial technology is now patent pending as a result of a provisional application that was filed with the United States Patent and Trademark Office (USPTO). In addition, the Company has also announced the release of TotalSocial version 1.6, focusing on new automated reporting tools and functionalities that provide additional utility for clients. TotalSocial is the only comprehensive social data solution that delivers insights about both online and offline consumer conversations -- the most persuasive form of marketing and a proven driver of sales. Bringing together social media listening data with face-to-face conversation metrics into a single performance dashboard, TotalSocial is designed to enhance marketing ROI and increase sales. TotalSocial analytics allows marketers to track and evaluate marketing effectiveness for their brand, to benchmark against key competitors, and to learn from the most socially successful brands. TotalSocial is built on the four essential drivers of a brand's social marketing performance: volume, sentiment, brand sharing, and influence. Consumer conversations and advocacy -- online or face-to-face -- can make or break sales momentum. By using TotalSocial, marketers are equipped with the insights they need to harness the full power of social influence. The provision patent application for a Method for Measuring Social Influence of a brand for improving the Brand's Performance was filed with the United States Patent and Trademark Office and was assigned U.S. Application No. 62/437,342. This application provides Engagement Labs with protection for up to 12 months, while also allowing the Company to roll out the solution via marketing and sales. Further, Engagement Labs has continued to make improvements to the TotalSocial user interface since its first release in September. With this new release, version 1.6 users are now able save dozens of favorite reports that are automatically updated with new data releases; export data visualizations and the underlying data with the touch of a button; and dynamically modify graphics by pointing and clicking. The upgrades allow users to more efficiently and effectively uncover and share insights about their brands' social performance, both online and offline. The Company also announced its intent to satisfy its obligation to pay independent director fees for the period of September 27, 2016 to December 31, 2016 by issuing shares, pending approval from the TSX Venture Exchange. The Corporation will issue 382,809 Common Shares with a deemed value of $0.11 per share (for an aggregate value of $42,109) to the independent directors of the Corporation for services provided. Such aggregate value is the net amount owed to the independent directors after making all statutorily required source deductions. The Board has also approved the issuance of 3,769,328 restricted share units to four officers of the Corporation. One third of the restricted share units vest on each of the first, second and third anniversaries of the date of grant. Engagement Labs (TSX VENTURE: EL) is the world's first TotalSocial™ company, offering intelligent data, analytics and insights for marketers. We are leaders in tracking, measuring and benchmarking the impact of conversations happening around a brand and industry -- both online and offline. Consumer conversations are a proven driver of critical business outcomes, including sales. The patent pending TotalSocial data solution provides brands with unique insights and powerful analytics to understand online and offline social impact and drive business results. TotalSocial demonstrates to marketers how their online and offline conversation compare and contrast and helps identify areas of competitive opportunity or significant emerging threats. TotalSocial is an "always-on" proprietary scoring system, based on the most important drivers of brand performance: Volume, Sentiment, Brand Sharing and Influence. TotalSocial was built on the pillars of Engagement Labs' patented social media measurement tool and the world's only offline word of mouth tracking system for brands and tracks 500 brands within the U.S. across 17 major industry categories, and 350 brands in the UK. "Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release."


News Article | February 28, 2017
Site: www.businesswire.com

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) (“Eagle” or “the Company”) today announced that the United States Patent and Trademark Office (USPTO) has issued an 11th patent related to Bendeka. Patent number 9,579,384 will expire March 2033. The USPTO has allowed a total of 14 patents in the Bendeka family of patents expiring from 2026 to 2033, of which three will issue over the next few months. The newly issued patent will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange-Book) bringing Eagle’s total Orange Book listed patents for Bendeka to ten. Bendeka has also received Orphan Drug Designation from the FDA. Eagle continues to pursue obtaining a grant of Orphan Drug Exclusivity which would provide Bendeka exclusivity through December 2022. “We continue to build the intellectual property portfolio protecting Bendeka’s longevity. Bendeka is an important product for us and we see tremendous value in it well beyond 2020,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals. Several companies have unsuccessfully challenged one of the Orange Book listed patents (U.S. Patent No. 8,791,270) in both federal court and in the USPTO’s Patent Trial and Appeal Board (PTAB). Both the U.S. District Court for the District of Delaware and the PTAB have confirmed validity of the ‘270 patent which expires in 2026. The other patents have previously not been challenged. The following table lists issued patents for liquid Eagle’s bendamustine hydrochloride formulations: Under a February 2015 exclusive license agreement for Bendeka, Teva Pharmaceutical Industries, Ltd. is responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle’s strategy is to utilize the FDA's 505(b)(2) regulatory pathway. Additional information is available on the company’s website at www.eagleus.com. This press release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended and other securities laws. Forward-looking statements are statements that are not historical facts. Words such as “will,” “may,” “believe,” “intends,” “anticipate(s),” “plan,” “enables,” “potentially,” “entitles,” and similar expressions are intended to identify forward-looking statements. These statements include statements regarding future events including, but not limited to: the approval by the USPTO of Eagle’s patent applications covering Bendeka; Eagle’s ability to defend against third party attempts to design around or invalidate its patents covering Bendeka; the timing and the outcome of any legal proceedings involving Bendeka; the ability of Eagle to achieve Orphan Drug Exclusivity for Bendeka; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; the ability of Eagle to deliver sustained shareholder value over time; and other factors that are discussed in Eagle’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the U.S. Securities and Exchange Commission. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagle’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks include, but are not limited to whether Eagle’s management and/or board of directors will be effective in managing Eagle’s business and future growth, as well as the other risks described in Eagle’s filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Loading United States Patent and Trademark collaborators
Loading United States Patent and Trademark collaborators