Showing all posts written by Allyson Brown
The Patent Trial and Appeal Board (the “Board”) recently issued Final Written Decisions in two inter partes reviews filed by Stryker Corporation regarding two related Orthophoenix, LLC patents – U.S. Patent Nos. 7,153,307 (the ’307 patent) and 6,241,734 (the ’734 patent). The ’307 and ’734 patents are both entitled “Systems and Methods for Placing Materials Into Bone.” The Abstracts, which are also identical, state: “Systems and methods for delivering material into bone deploy a cannula through soft tissue to establish a subcutaneous path into bone. A material is introduced into bone through the cannula. The systems and methods advance a tamping instrument through the cannula to urge material residing in the cannula into bone.” Figures 31 and 32 from the patents are reproduced below.
In the Final Written Decision of IPR2014-01434 regarding the ’307 patent, the Board determined that Stryker had shown by a preponderance of the evidence that Claims 1-3, 7, and 10-17 are unpatentable as anticipated by U.S. 3,893,445 to Hofsess and that Claims 1-18 are unpatentable as obvious over U.S. Pat. No. 5,108,404 to Reiley et al. and U.S. Pat. No. 4,576,152 to Muller et al. In the Final Written Decision of IPR2014-01433 regarding the ’734 patent, the Board determined that Stryker had shown by a preponderance of the evidence that Claims 15, 16, 19, and 20 are anticipated by an article in Seminars in Musculoskeletal Radiology and that Claims 1-21 are unpatentable as obvious over the same article.
Orthophoenix asserted the ’307 and ’734 patents, among others, against Stryker in its complaint for patent infringement that was filed October 1, 2013 in the District of Delaware. According to the USPTO Assignment Database, the ’734 patent, to which the ’307 patent claims priority, was assigned from the inventors to Kyphon Inc. The complaint states that Medtronic, Inc. purchased Kyphon in 2007 for $4.2 billion. The complaint further states that Orthophoenix acquired the Kyphon technology, including approximately 500 patents and applications, from Medtronic in 2013. Stryker filed an amended answer and counterclaims against Orthophoenix, IP Navigation Group, LLC, and Medtronic, Inc. on July 30, 2014. On April 28, 2015, the court granted Stryker’s motion to stay with respect to four patents, including the ’307 and ’734 patents, pending inter partes review.
Orthophoenix is a subsidiary of Marathon Patent Group, which, according to its website, “is a patent and patent rights acquisition and licensing company.” According to its website, Stryker is a medical technology company that offers “products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine.”
Lombard Medical, Inc. recently announced that it has acquired Altura Medical. Lombard is an Irvine, California-based medical device company that makes devices for endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), including the AorfixTM Endovascular Stent Graft. Altura Medical is a privately-held, venture-backed company, which is based in Silicon Valley. Altura has developed an ultra-low profile endovascular stent graft technology for the treatment of AAA, which received a CE Mark this year.
Depending on milestones, the acquisition could be worth $50 million. According to the terms of the transaction, Lombard will pay $23 million now in the form of: the issuance of $15 million of Lombard common stock at $4 per share; the assumption of $5.5 million in bank debt; and $2.5 million in liabilities and transaction-related costs. Additional payments of up to $27.5 million may be paid over the next five years based on achievement of commercial and regulatory milestones.
Lombard plans to launch Altura’s endograft system in Europe in January 2016, to be followed by a larger international launch later in the year. Simon Hubbert, Lombard’s CEO, stated:
The combination of Altura’s technology with our flagship AorfixTM platform creates a truly patient driven platform that we believe will allow us to capture share from our competitors. The Altura device offers a simple, safe and efficient treatment option for standard AAA anatomy, while Aorfix offers the only on-label solution for patients with Aortic neck angulation up to 90 degrees.
Sorin S.p.A. and Cyberonics, Inc. recently announced that the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for their pending merger has ended. In February, the two companies announced an agreement to merge in an all-stock transaction to result in a combined equity value of $2.7 billion. The transaction was unanimously approved by both companies’ boards of directors, and the merger agreement was signed in March. The deal has now cleared its next hurdle with US antitrust approval. The transaction is still subject to approval by the shareholders of both companies, regulatory clearances, and other closing conditions, and is expected to be completed by the third quarter of this year.
According to its website, Sorin develops, manufactures, and markets medical technologies in the areas of cardiac surgery and cardiac rhythm management. According to its website, Cyberonics has expertise in neuromodulation and developed the Vague Nerve Stimulation Therapy system for the treatment of refractory epilepsy and treatment-resistant depression. The combined company is expected to launch heart failure, sleep apnea, and percutaneous mitral valve replacement/repair products.
Under the terms of the proposed merger, the companies will combine under a new company that will be domiciled in the UK and will operate as three business units – Cardiac Surgery, with operating headquarters in Mirandola, Italy, Cardiac Rhythm Management, with operating headquarters in Clamart, France, and Neuromodulation, with operating headquarters in Houston, Texas.
San Diego-based Aethlon Medical, Inc. recently announced that the United States Food and Drug Administration (FDA) has approved the use of its Aethlon Hemopurifier® bio-filtration device in a clinical protocol for Ebola treatment. The approval allows for an investigational study at up to 10 U.S. locations with up to 20 U.S. subjects.
According to PRNewswire, Aethlon’s Ebola protocol was submitted to the FDA as a supplement to a previously approved Investigation Device Exemption (IDE) under which Aethlon is conducting a clinical feasibility study of Humopurifier® therapy in Hepatitis C patients who are also receiving chronic dialysis therapy. Aethlon previously reported that the Hemopurifier® was used to treat a critically-ill Ebola patient at Frankfurt University Hospital in Germany. According to Aethlon’s website, the device has also been used to reduce viral load in HIV patients, and in vitro studies have shown it captures exosomes underlying various types of cancer. Fierce Medical Devices reports that a collaboration between Aethlon and the Sarcoma Oncology Center (SOC), which is based in Santa Monica, California, is studying the ex vivo effectiveness of the Hemopurifier® to remove exosomes from the blood of advanced-stage cancer patients.
The government of Queensland, Australia recently announced a partnership between San Diego-based Organovo and UniQuest, the commercialization arm of the University of Queensland. According to Organovo’s website, the company “design[s] and create[s] functional human tissues using [its] proprietary three-dimensional bioprinting technology.” According to Invetech’s website, Invetech and Organovo partnered to create the first commercial bioprinting platform in 2009. Organovo has also developed 3D printed liver assays for testing drug toxicity.
Ian Walker, Queensland’s Minister for Science and Innovation, announced that the collaboration will allow Organovo to print kidney tissue using cells developed by Australian scientists. Professor Melissa Little of the Institute for Molecular Bioscience led the research effort, which was supported by a grant of AUD$1 million received from Queensland’s government.
According to 3Dprint.com, the printed kidney tissue will initially be used in the pharmaceutical industry to test drug toxicity. According to UQ News, the technology may also allow researchers to create better models of kidney disease. But, Organovo and Professor Little hope to eventually develop bioprinted human kidneys for transplantation.
In the United States, chronic kidney disease affects 26 million adults, and over 100,000 people currently await kidney transplants. While there exists considerable demand for human kidneys, the supply of such organs is limited. As a result, artificial kidneys may present a potentially significant market. In the meantime, kidney tissue produced by Organovo may help pharmaceutical companies effectively conduct toxicity screening prior to conducting clinical trials.
On April 11, 2014, according to a press release, the U.S. District Court for the District of Delaware issued a preliminary injunction barring Medtronic, Inc. from selling its CoreValve TAVI product to most new customers in the U.S. This ruling is the latest installment in a patent dispute between Medtronic and Edwards Lifesciences Corp. involving transcatheter heart valve technology. According to Bloomberg, this developing market is expected to reach $3 billion a year. In 2011, Edwards received FDA approval for its Sapien transcatheter aortic valve, which was the first approved transcatheter aortic valve in the U.S. until the CoreValve system was approved in January 2014.
In 2010, a jury found that the CoreValve device infringed Edwards’ U.S. Pat. No. 5,411,552 to Andersen et al. (the “Andersen patent”) and awarded Edwards $73 million in damages. The verdict was upheld on on appeal, and last October the U.S. Supreme Court declined to review that decision. In December 2011, Edwards filed an application for patent term extension on the Andersen patent. Edwards’ petition noted that the patent was due to expire on May 2, 2012, and requested an extension of 1,757 days based on the FDA regulatory review period of the Sapien valve, such that the new requested extended expiration date would be February 22, 2017. The USPTO has not yet made a final determination of the length of the patent term extension, but has granted multiple interim patent term extensions, the latest of which extends the Andersen patent’s term until May 2, 2015.
A NASDAQ article states that although the court believed that “CoreValve ‘is a safer device’ and produces ‘better outcomes with a lower risk of death,’” patients’ needs must be balanced against the public interest in enforcing patent rights. The article states, however, that Medtronic will still be allowed to sell the CoreValve for patients who are not candidates for Edwards devices. The injunction is scheduled to go into effect seven business days from the April 11th ruling. Medtronic has already filed a Notice of Appeal.
On February 24, 2014, Orthopaedic Hospital filed a lawsuit against DePuy Orthopaedics, Inc. in the United States District Court for the Central District of California. The complaint alleges that DePuy’s AOX Antioxidant Polyethylene for its Sigma and LCS Rotating Platform Knee Systems infringes U.S. Patent No. 8,658,710 (“the ‘710 Patent”).
The ‘710 Patent is entitled “Oxidation-Resistant and Wear-Resistant Polyethylenes for Human Joint Replacements and Methods for Making Them” and was issued on February 25, 2014. According to the Abstract, the patent describes “methods for making oxidation-resistant and wear-resistant polyethylenes and medical implants made therefrom. Preferably, the implants are components of prosthetic joints, e.g., a bearing component of an artificial hip or knee joint.”
According to its website, Orthopaedic Hospital is a nonprofit corporation that treats children with musculoskeletal disorders and conducts orthopaedic research. Its primary location is in downtown Los Angeles. According to its website, DePuy Orthopaedics , a Johnson & Johnson company, offers orthopaedic devices and supplies, including hip, knee, extremity, trauma, cement, and operating room products.
Valeant Pharmaceuticals International, Inc. announced this week that it has entered an agreement to acquire PreCision Dermatology, Inc. According to Valeant’s announcement, Valeant will pay $475 million in cash initially, plus $25 million upon achievement of a sales-based milestone. Valeant expects the transaction to close in the first half of 2014.
According to its website, Valeant is a Canadian-headquartered specialty pharmaceutical company that primarily focuses in dermatology, eye health, neurology and branded generics. According to its website, PreCision is a dermatology company that operates in two key segments – Onset Dermatologics for prescription therapies, and PrecisionMD® for physician dispensed products.
Last month Valeant announced the completion of its acquisition of Solta Medical for approximately $250 million. Zacks Investment Research has reported that Valeant also acquired Bausch + Lomb Holdings Inc. for $8.7 billion in August 2013, Obagi Medical Products for $440 million in April 2013, and Medicis Pharmaceutical Corporation for $2.6 billion in December 2012.
On January 6, 2014, I.C. Medical, Inc. filed a lawsuit against ConMed Corporation in the United States District Court for the District of Arizona. The complaint alleges that ConMed’s GoldVac® electrosurgical pencils infringe U.S. Patent Nos. 7,935,109 (“the ‘109 Patent”) and 8,414,576 (“the ‘576 Patent).
The ‘109 Patent is entitled “Multifunctional Telescopic Monopolar/Bipolar Surgical Device and Method Thereof” and was issued on May 3, 2011. The Abstract states that “a multifunctional telescopic monopolar/bipolar electrosurgery pencil is disclosed for use with an electrosurgery unit (ESU). . . . The monopolar/bipolar electrosurgery pencil is capable of functioning as both a monopolar and bipolar device and can be used for open and closed laparoscopic and endoscopic procedures.” Figure 3c of the ‘109 Patent is reproduced below:
The ‘576 Patent is entitled “Swivel Device for Electrosurgery Pencil and Surgical Smoke Evacuation” and was issued on April 9, 2013. The Abstract explains that “a swivel device for connection to an ESU pencil, an exhaust port of an ESU pencil with an integrated smoke evacuation system, or an exhaust port of an ESU pencil smoke evacuation shroud attachment includes a fixed member attached to a rotating member. The rotating member allows an electrical cord and/or vacuum tube to twist and coil freely during operation of an ESU pencil with or without the smoke evacuation system.” Figure 3 of the ‘576 Patent is reproduced below:
I.C. Medical’s’s website states that I.C. Medical is a privately owned company based in Phoenix, Arizona that focuses on surgical smoke collection. According to ConMed’s website, ConMed offers products in areas such as patient monitoring, endomechanical instrumentation, advanced energy, gastroenterology and pulmonology, advanced visualization, and orthopaedics.
On November 27, 2013, Atom Medical International filed a petition with the U.S. Patent Trial and Appeal Board requesting inter partes review of U.S. Patent No. 7,335,157, owned by Draeger Medical Systems. The Petition seeks review of Claims 1-3, 6-9, 11-14, 18, and 23-25 of the ‘157 patent.
The ‘157 patent is entitled “Humidifier Module” and explains that the “disclosure relates to a humidifier module for use with a thermal patient support such as an infant incubator to supply humidified air to a patient resident in the support apparatus.” Figure 1 of the ‘157 patent is shown below:
Atom Medical’s request for inter partes review of the ‘157 patent is the latest chapter in a running dispute between the parties. On September 17, 2012, Draeger filed a patent infringement suit in the Middle District of Florida alleging that Atom Medical’s neonatal incubator products, including the Dual Incu i, infringe several Draeger patents including the ‘157 patent. Draeger also filed a complaint with the U.S. International Trade Commission requesting an investigation of certain infant incubators manufactured by Atom and alleging infringement of Draeger patents including the ‘157 patent.
There seems to be a mobile app for just about everything now. Among the multitude of apps available are an increasing number of medical apps. In response to this growing trend, the FDA has issued a final guidance document for developers of mobile medical apps. The guidance explains that the FDA plans to limit its scrutiny to apps that transform a mobile device into a regulated medical device or are intended to be used as an accessory to a regulated medical device because these types of apps could be harmful if they don’t function properly.
The final document follows a draft issued in July 2011 that received more than 130 comments. In response to comments seeking more clarity, the FDA included in the final version more examples of what the agency does and does not intend to regulate. According to the guidance document, examples of apps that will be the subject of oversight include apps that calculate the amount of radiation to be given to a cancer patient and apps that control inflation and deflation of a blood pressure cuff. The guidance indicates that these types of apps essentially perform the functions of traditional medical devices, and notes that the FDA will regulate them as it does traditional devices.
According to the guidance document, the agency plans to leave low-risk apps alone, even those that might fall under the definition of a medical device. For example, apps that allow doctors or patients to log blood pressure readings or diet related apps that recommend the number of calories a person should consume may not be scrutinized. The guidance document also clarifies that providers of medical apps, for example, the iTunes app store, will not be treated as medical device manufacturers.
On August 14, SafeStitch Medical, Inc. announced it has entered into an agreement to merge with TransEnterix, Inc. According to the press release, SafeStitch is a publicly traded medical device company based in Miami, and its mission is to develop disposable medical devices to advance minimally invasive surgery for hernia repair and treatment of obesity and other gastroesophageal disorders. The press release notes that SafeStitch has received FDA approval to market the AMIDTM Hernia Fixation Device for inguinal and ventral hernia repairs.
The press release states that TransEnterix is “pioneering the use of flexible instruments and robotics to improve how minimally invasive surgery is performed.” According to its website, TransEnterix has obtained FDA and CE Mark approval for the SPIDER® Surgical System, which uses flexible articulating instruments to create triangulation via single site access. TransEnterix is based in Research Triangle Park, North Carolina.
The press release notes that according to the terms of the merger agreement, SafeStitch Medical will be the surviving entity, its shareholders will own approximately 35% of the combined company while TransEnterix holders will own approximately 65%, and the company will be headquartered in Research Triangle. According to Yahoo! Finance, the current market capitalization of SafeStitch is approximately $49.36 million.
On July 3, 2013, Smiths Medical ASD, Inc. sued Rocket Medical plc in the United States District Court for the District of Massachusetts. Smiths Medical’s complaint alleges that Rocket Medical’s embryo replacement catheters infringe U.S. Patent No. 8,092,390 entitled “Medico-Surgical Devices.”
The Abstract of the ‘390 Patent describes a catheter in which “[g]as bubbles of a diameter in the range of 5µ to 10µ are incorporated into the thickness of the wall of the shaft by adding gas during extrusion. The bubbles are selected to increase the visibility of the catheter under ultrasound imaging whilst still enabling material flowing along the catheter to be seen.” Figure 2 from the ‘390 Patent is shown below:
Smiths Medical is a division of Smiths Group plc, which is headquartered in London. According to their website, Smiths Medical supplies a variety of medical devices for hospital and home use. Rocket Medical is also headquartered in the UK, and according to their website manufactures a range of single use medical devices. The complaint and patent at issue are available here.
On June 10, 2013, AngleFix Tech, LLC sued Wright Medical Technology, Inc. in the Western District of Tennessee. AngleFix’s complaint alleges that Wright Medical’s plate and screw systems for bone fixation infringe U.S. Patent No. 6,955,677 entitled “Multi-Angular Fastening Apparatus and Method for Surgical Bone Screw/Plate Systems.” The accused systems include the Claw, Claw II, Charlotte Claw, Ortholoc, Ortholoc 3Di, and Ortholoc 3Di2.
The complaint states that the ‘677 Patent was the result of the inventor’s “desire to capture bone fragments during orthopedic surgery that would otherwise evade locking screws set at a single fixed angle.” The Abstract of the ‘677 Patent describes an apparatus including a fastener and a fastener receiving member that “enables the fastener to be affixed to the fastener receiving member at a variable insertion angle selected by the user.” Figure 3 from the ‘677 Patent is shown below:
AngleFix is based in North Carolina and holds an exclusive license to the ‘677 Patent from the University of North Carolina. AngleFix sued NuVasive, Inc. on the same patent in the Southern District of California earlier this year.
scPharmaceuticals LLC announced today a strategic partnership and product development agreement with Sensile Medical Holding AG under which the companies will collaborate on a new treatment option for patients with heart failure. According to the press release, scPharmaceuticals has developed a reformulation of the diuretic furosemide, which is currently administered in tablet form or intravenously. The press release states that Sensile and scPharmaceuticals plan to develop and manufacture a drug-device combination using Sensile’s SenseCore technology in a wearable minipump to deliver scPharmaceutical’s furosemide product subcutaneously.
Dr. Bertram Pitt, one of the co-founders of scPharmaceuticals, stated:
This innovative product is expected to provide rapid and more effective diuretic therapy that can be used at home under physician guidance when the patient experiences symptoms of decompensation. We expect that this innovative approach will in many cases avert the need for emergency or in-hospital care, and for those patients who still require hospitalization, their hospital stay will be shortened and their outcomes improved.
ABL Medical, LLC has announced the official launch of its SilvrSTAT® Antibacterial Wound Dressing Gel in the U.S.
According to the press release, SilvrSTAT® is based on the company’s patented nano-molecular silver technology and has United States Food and Drug Administration clearance as a 510(k) medical device. ABL Medical states that SilvrSTAT “results in a 32ppm antibacterial wound dressing gel which provides quick and continuous antibacterial activity allowing for efficient wound management” and “has no known or expected adverse events due to the low 32ppm silver concentration.” ABL Medical promotes SilvrSTAT® as inhibiting the growth of a wide range of bacteria, viruses, yeast, and molds in laboratory tests.
The press release is available through Canada Newswire here.
DMH International announced today that its subsidiary, Touch Medical Solutions, Inc. (TMSI), has received approval from the United States Food and Drug Administration for TMSI’s “TouchPACS” medical imaging software suite. According to the press release:
TouchPACS is a cutting edge software suite for the PACS medical imaging market (Picture Archiving and Communications Systems). The market was valued at approximately $2.8 billion in 2010 and it is expected to grow to over $5.4 billion by 2017 . . . .
The press release states that DMH International, through TMSI, specializes in PACS, electronic hospital records, electronic medical records, personal health records, medical transcription, and paperless medical office solutions. The press release is available here.