Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary heart valves. Medtronic touts the Melody TPV as providing these patients with a minimally invasive treatment option as an alternative to additional open-heart surgery.
The Melody TPV was previously approved under the FDA’s Humanitarian Device Exemption (HDE), a program for technologies that may treat fewer than 4,000 patients a year, subject to additional regulations, without meeting all of the traditional pre-market approval rules.
Commenting on the approval, Dr. Jeremy Asnes of the Yale School of Medicine said:
As the 1st commercially available transcatheter heart valve, the Melody TPV brought a breakthrough non-surgical option to treat failing pulmonary valve conduits. Thousands of congenital patients globally have benefited from this therapy in the past decade. With this expanded indication, we can further reduce the need for obtrusive open-heart surgery and allow even more patients to benefit from this minimally invasive treatment option.
Grand View Research predicts that the global transcatheter valve market is expected to reach a worth of $8.62 billion by 2024. According to the Centers for Disease Control and Prevention, congenital heart defects are the most common birth defect in America and the top killer of infants with birth defects. An estimated 40,000 babies are born with congenital heart defects in the United States every year.
BioSig Technologies recently announced a ten-year strategic agreement with Mayo Clinic and Mayo Clinic Ventures. According to the press release, the agreement aims to advance clinical features of BioSig’s PURE EP System, which BioSig describes as a novel platform designed to obtain and display important clinical data during procedures that test the electrical activity of the heart, through close collaboration with leading Mayo electrophysiologists. BioSig intends the collaboration to result in the development of future technologies.
Speaking of the agreement, Greg Cash, President and CEO of BioSig Technologies commented:
“Adding innovation and intellectual property to the equation should raise this collaboration to a whole new level, likely resulting in better diagnosis and treatment of complex arrhythmias in many patients.”
BioSig Technologies describes itself as a Minneapolis-based medical device company developing a platform for cardiac electrophysiology. According to Yahoo! Finance, BioSig is publically traded over-the-counter and has a current market cap of about $36 million.
Mayo Clinic describes itself as a nonprofit organization committed to clinical practice, education, and research.
In 1992, the United States Court of Appeals for the Federal Circuit held that manufacturers of patented medical devices can use the patent laws to enforce single-use restrictions on medical devices. Mallinckrodt, Inc. v. Medipart, Inc., 976 F.2d 700 (Fed. Cir. 1992). The basic rationale of the decision was that a patent owner, when selling a patented product, may choose to part with all or only some of its patent rights associated with that product. If the patent owner chooses not to sell to the purchaser the right to re-use the patented product after its initial use, then that right remains with the patent owner. Accordingly, if the purchaser, or even a downstream purchaser, re-uses the patented product, it is exercising a right that was not granted by the patent owner, and the patent owner may, in some circumstances, sue for infringement.
In the 25 years since the Federal Circuit decided Mallinckrodt, medical device manufacturers have relied on the patent laws to enforce single-use restrictions. However, medical device manufacturers may be unable to rely on Mallinckrodt for much longer. The Supreme Court recently agreed to consider a case, Lexmark International, Inc. v. Impression Products, Inc., which may have implications on the availability of using the patent laws to enforce single-use restrictions.
In Lexmark International, Inc. v. Impression Products, Inc., 816 F.3d 721 (Fed. Cir. 2016) (en banc), Lexmark alleged that Impression Products infringed Lexmark’s patent by selling refilled printer cartridges, which were originally sold by Lexmark to a purchaser and subject to a single-use/no-resale restriction. A panel of 12 judges, representing the full United States Court of Appeals for the Federal Circuit, determined that a third-party who did not take part in the original conditional sale of the patented item may be held liable for infringing the patent covering the item for failing to abide by the single-use restrictions contained in the original sales agreement.
On December 2, 2016, the Supreme Court agreed to hear the appeal from the Federal Circuit. Before hearing arguments from the parties involved, the Supreme Court allows non-litigants to submit amicus curiae (friends of the Court) briefs. These briefs provide additional information to the Court to help it better understand the potential implications of the Court’s decision. Reflecting the magnitude of the Supreme Court’s forthcoming decision, at least thirty-four amicus curiae briefs were filed. Fourteen briefs were filed in full or partial support of the petitioner, Impression Products, Inc., by amicus curiae such as: Huawei Technologies Co., Ltd.; Costco Wholesale Corporation, et al.; Intel Corp., Dell Inc., and Vizio Inc.; Association of Medical Device Reprocessors; and HTC Corporation and HTC America, Inc. Sixteen briefs were filed in full or partial support of the respondent, Lexmark International, Inc. by amicus curiae such as: Intellectual Property Owners Association; Medtronic PLC, and Zimmer Biomet Holdings, Inc.; Qualcomm Incorporated; Pharmaceutical Research and Manufacturers of America; Dolby Laboratories, Inc.; and Nokia Technologies Oy, and Nokia USA Inc. Copies of all amicus curiae briefs may be found here.
Due to the possibility that the Supreme Court’s decision may affect the ability of medical device manufacturers to sell patented devices subject to single-use restrictions, Knobbe Martens filed an amicus curiae brief on behalf of the Medical Device Manufacturers Association, advocating affirmance of the Federal Circuit’s Lexmark decision and retention of the legal principle announced in Mallinckrodt. The Medical Device Manufacturers Association, in its brief, explained that single-use restrictions are consistent with existing patent laws, which permit patent owners to restrict the patent rights conveyed with the sale of a patented product, as long as the restriction does not impermissibly broaden the scope of the patent owner’s rights in violation of the antitrust laws or principles of patent misuse. The Medical Device Manufacturers Association further explained that single-use restrictions on medical devices are designed to maximize public safety by preventing imperfectly refurbished medical devices from entering the market.
Oral argument for Lexmark International, Inc. v. Impression Products, Inc. occurred on March 21, 2017. A transcript of the proceedings may be found here.
The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA pursuant to the 21st Century Cures Act, signed into law on December 13, 2016.
Premarket notification (510(k)) is one of several alternative procedures that medical device manufacturers must undergo before being able to market their medical devices intended for human use. The 510(k) notification is required for medical devices that do not need to receive premarket approval (PMA) from the FDA and are not exempt from the 510(k) requirement. The FDA explains that medical devices are classified into three classes (Classes I, II, and III) based on based on the level of control necessary to assure the safety and effectiveness of the device. Most Class I and II devices and a few Class III are subject to the 510(k) requirement. Although a 510(k) applicant does not need to provide scientific evidence of safety and effectiveness for the intended use of its device, the applicant must demonstrate that the device is at least as safe and effective (“substantially equivalent”) to a legally marketed device (“predicate device”).
The FDA may exempt devices from 510(k) requirement. A list of factors that the FDA use to determine whether the device is exempt from 510(k) requirements includes: (1) whether the device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) whether characteristics of the device necessary for its safe and effective performance are well established; (3) whether changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means before causing harm or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not likely to result in the device’s classification.
Section 3054 of the 21st Century Cures Act amended sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The amended sections 510(l) and 510(m) of the FD&C Act require the FDA to publish any Class I and Class II devices that the FDA determines no longer require premarket notifications under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. The FDA is required to publish initial lists for Class II devices and Class I devices within 90 days and 120 days, respectively, after the enactment of the 21st Century Cures Act and then to update the lists at least once every 5 years.
A list of 510(k)-exempt Class I devices is expected to be published in about 30 days.
Previously, Medtronic received Ministry of Health, Labor and Welfare approval for the device in Japan during September 2016, launching the product shortly after. Medtronic now seeks to duplicate its successful launch in the United States.
As shown on the right, the Reveal LINQ ICM is designed to be implanted just under the skin of a patient’s chest during a minimally invasive procedure. Once implanted, the monitor can help doctors properly diagnose and treat patients having an increased risk of cardiac arrhythmias and patients who experience symptoms, such as dizziness, palpitation, fainting or syncope, and chest pain that may be related to cardiac arrhythmia.
According to Medtronic’s press release, the device “offers exclusive algorithms that result in a 95 percent reduction in false bradycardia (slow heartbeat) episodes,” a 47 percent reduction in false pause (brief absence of cardiac activity) episodes,” and “a 49 percent reduction in false detections” of atrial fibrillation (AF) when compared with its predecessor.
To achieve these reductions, Medtronic’s next generation device “features a self-learning atrial fibrillation . . . algorithm, which learns and adapts to a patient’s heart rhythm over time.” According to Dr. James Allred of Greensboro, N.C.’s Cone Health Medical Group Heartcare, “The enhancements with the Reveal LINQ ICM with TruRhythm Detection make it smarter by streamlining device data review so physicians can make decisions more accurately and quickly for patients.”
To that end, Nina Goodheart, Vice President and General Manager of the Patient Monitoring & Diagnostics business at Medtronic, stated,
We collaborated with hundreds of clinicians and analyzed more than 50,000 ECGs allowing us to pinpoint how we could redesign our algorithms to improve detection specificity, without compromising sensitivity.
According to the press release, such collaborations have produced one of the world’s smallest cardiac monitors—the device is approximately one-third the size of a AAA battery. Because the device is so small, is MR-conditional, and can wirelessly connect to Medtronic’s network, Medtronic’s website states that the device allows a doctor to continuously monitor a patient for up to 3 years without removing the device.
As a result, Medtronic has continued its global launch of the product. According to Randy Lieberman, M.D., director of electrophysiology at Detroit Medical Center, the technology is going to help “reach more patients at risk for cardiac arrhythmias and help healthcare systems more efficiently manage difficult patient populations.”
BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for hospital use. The device will be available in the European Economic Area, Iceland, Liechtenstein and Norway.
According to BodyCap, the e-Celsius® device is a disposable electronic capsule coated in a biocompatible medical grade plastic and allows for the continuous and non-invasive monitoring of a patient’s core temperature. The pill wirelessly transmits temperature measurements to a monitor viewable by a health care professional and exits the body in about 1 to 3 days. Sébastien Moussay, co-founder of BodyCap stated:
“The e-Celsius device is a true alternative method to the current use of rectal or eosophageal probes, which are invasive, uncomfortable, generate stress and limit the patient’s mobility.”
“Our device is less intrusive and requires less from the medical staff, while at the same time increasing the well-being of both patients and healthcare personnel by lightening the workload. With the internal memory embedded in each capsule, e-Celsius ensures the monitoring of the patient’s temperature kinetics in real time or deferred time, whatever the measurement conditions.”
BodyCap’s website indicates that the broad medical applications of the e-Celsius® capsule ranges from general diagnostic to monitoring of patients during surgery or chemotherapy. Related e-Celsius® capsules have already been used outside the hospital setting, particularly in the monitoring of athletes. The device has previously been used during athletic events including the New York Marathon and the 2016 Summer Olympics.
Persistent Market Research estimates the market for global ingestible e-pills will reach almost $1.5 billion by the end of 2024. The e-Celsius® capsules reportedly will be sold for a unit price of $42 to $63, depending on volume, according to a MedGadget article.
Other ingestible sensors on the market include products by Proteus Digital Health.
According to public databases, BodyCap is the listed Applicant of U.S. Pat. No. 9,559,290.
Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza
Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib), AstraZeneca’s PARP inhibitor. The results are based on a collaborative effort between Myriad Genetics and AstraZeneca for identification and treatment of patients with metastatic breast cancer and underlying BRCA 1/2 mutations.
In 2014, the FDA approved the use of BRACAnalysis CDx to identify patient with advanced ovarian cancer that would benefit from treatment with olaparib. Jonathan Lancaster, the chief medical officer of Myriad Genetics stated that, “we believe the results of the OlympiAD trial support use of BRACAnalysis CDx test to help inform treatment decisions in the metastatic breast cancer setting and will expand the patient population who can benefit from BRCA testing.”
The recent announcement is the first report of data from a Phase 3 Clinical Trial (the OlympiAD trial) that compares treatment options in Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutations. The treatments compared the responses to Lynparza and so-called physician’s choice chemotherapy, where the investigators will choose Capecitabine, Vinorelbine, or Eribulin. Mydriad’s BRACAnalysis CDx test was used to identify patients with germline BRCA 1/2 mutations and these patients showed a statistically-significant improvement of progression-free survival when treated with olaparib compared to treatment with a chemotherapy of the physician’s choice. Information about the clinical trial can be obtained here: https://clinicaltrials.gov/ct2/show/NCT02000622.
According to Myriad, BRACAnalysis CDx is an in vitro diagnostic device that detects and classifies variations of BRCA1 and BRCA2 in both protein coding and intron/exon junctions regions of the genes. The device analyzes genomic DNA obtained from whole blood. Small genetic variations including single nucleotide polymorphisms (SNPs) are identified using PCR with Sanger sequencing. Larger genetic variations, including large deletions and duplications, are detected using multiplex PCR.
Republican lawmakers recently proposed a replacement of Obamacare known as the American Health Care Act (AHCA). One provision of the proposed legislation would permanently repeal Obamacare’s 2.3% medical device excise tax. Beginning in 2013, manufacturers and importers of certain medical devices were required to pay a 2.3% tax on sales of these devices. Although the medical device tax was suspended for 2016 and 2017, it was set for reinstatement in 2018.
Introduction of the AHCA is not the first time that lawmakers and industry lobbyists have attempted to permanently repeal the medical device tax. For example, in January 2017, a group of more than 220 Representatives introduced a bill in the House of Representatives that sought to repeal the tax. In introducing that bill, Rep. Erik Paulsen (R-MN) released a statement citing improvements in the industry after temporarily suspending the tax:
We are already seeing new American jobs and increased investment in research and development as a result of the temporary suspension of this tax. With over 200 cosponsors at the start of this new session, and with overwhelming bipartisan support, permanent repeal should be a top priority for Congress.
Beyond repealing the medical device tax, the Washington Post reports that the AHCA seeks to repeal a wide array of taxes that were expected to cost insurance, medical device, and other healthcare companies billions of dollars over the next decade. Indeed, according to the Joint Committee on Taxation the 2.3% medical device tax, alone, was expected to cost these companies $20 billion over the next ten years.
Repealing the tax will provide medical technology innovators with the long-term certainty necessary to support future job growth and sustainable, cutting-edge R&D that will ultimately lead to the next generations of breakthroughs in patient care and treatment. We urge the House and Senate to act expeditiously to pass this important legislation.
Voxello recently announced FDA 510(k) clearance of its noddle™ device, following submission of its application in October 2016. According to the press release, the noddle gives patients who are unable to speak a way to communicate through voluntary gestures. Voxello touts the noddle as allowing patient access to nurse call systems, environmental controls, communication apps, and speech generating devices with a touch or a click of the tongue.
Coralville, Iowa-based Voxello was founded in 2013 through the Iowa Medical Innovations Group (IMIG) at the University of Iowa. IMIG is an interdisciplinary program that includes students from the Colleges of Medicine, Business, Law, and Engineering. The noddle student team consisted of Vince Hahn, Zihan Zhu, Blake Martinson, and Ben Berkowitz, with Richard Hurtig serving as professor mentor.
At Voxello, our mission is to provide an effective and universal means to overcome communication barriers faced by hospitalized and long-term care patients. Today 3.9 million hospitalized patients each year are unable to communicate through traditional means, which results in an estimated three billion dollars in preventable adverse events. The FDA clearance of the noddle brings us one step closer to offering a solution for this urgent, unmet need.
The following video is provided on Voxello’s website:
Matthew A. Howard, Chair and DEO, Dept. of Neurology, University of Iowa Healthcare System, commented on his experience with the device:
The technology incorporated in the Voxello noddle has been extremely helpful in enabling us to provide the best possible care for neurosurgery patients with severe neurological injuries.
As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2 billion in 2016, and is projected to continue to grow. The medical device industry is outsourcing not only the manufacturing of medical devices, but also associated services, such as regulatory consulting and contract manufacturing, to medical device service providers. Medical device manufacturers and outsourced medical device service providers should be conscious of the regulatory and legal ramifications of the delocalization associated with the outsourcing that is increasingly common in today’s global market.
While outsourcing has traditionally been linked to manufacturing, outsourcing of services has become a major growth engine in the medical device industry. Outsourced services include regulatory consulting, product design and development, testing and sterilization, implementation, upgrades, maintenance, and manufacturing contracts. Regulatory consulting, which in 2015 already commanded over 50% of the outsourcing market for services, is particularly expected to grow. Regulatory consulting includes services directed to compliance with national agencies that approve and continually monitor the safety of medical devices, including the F.D.A. in the United States and the E.F.S.A. in Europe. In addition, contract manufacturing is reported to be the fasted growing service in the medical device industry and is projected to grow at a compound annual growth rate of over 11.5% through 2025.
There are several benefits associated with medical device outsourcing. According to an MDDI article, outsourcing can help original equipment manufacturers (OEMs) accelerate time to market for a new product, and speed up return on investment. Furthermore, the article states outsourcing can provide specialized knowledge, expertise, and facilities without the significant resources required to acquire such expertise in house. Moreover, outsourcing can leverage the pre-existing large supply chain of the contractor.
However, outsourcing also carries potential risks. The issues associated with outsourcing so many aspects of services uniquely associated with the medical device industry may not be as well known or well understood as the issues presented by outsourcing manufacturing. According to another MDDI article, these issues may include an increased risk of civil lawsuits from consumers of medical devices. This is especially true as medical devices become increasingly digital, and cybersecurity vulnerabilities are found. The medical device industry may also face increased regulatory scrutiny from national agencies as more regulatory compliance is outsourced to consulting services. Consequently, the medical device industry and medical device legal community will increasingly face new challenges from a world in which more and more industry services are outsourced.
The European Council has released the final versions of its Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR). According to JDSupra, the Council of the European Union will vote on March 7, 2017 whether to adopt the MDR and the IVDR. That vote will be quickly followed on March 20, 2017 by a vote by the European Parliament. If adopted, the MDR and IVDR texts could be published by May 2017 and enter into force in May or June 2017. The MDR would be applicable by 2020 and the IVDR by 2022.
The final texts retain much of the same information of the current Directives released in May 2016. According to Regulatory Affairs Professionals Society (RAPS), an EU official stated that:
The content of the two regulations on medical devices and in vitro diagnostic medical devices is still the same as in the agreement reached between the Council of the EU and the European Parliament in May 2016 which has been approved by the Council on 20 September 2016… The difference between these ‘old’ documents and the ‘new’ documents is that the new documents have undergone a legal-linguistic review to make sure that the texts are coherent and equivalent in all 24 official EU languages. So in other words: the wording might have changed, but apart from corrections of some obvious mistakes and addition of necessary clarifications the new EU rules remain unchanged.
The regulations generally strengthen pre-market requirements and post-market surveillance, including establishment of a unique identification system. For example, some experts note that under the current IVD Directive, a manufacturer is able to self-certify about 80% of all IVDs on the EU market. However, when the IVDR becomes applicable five years after its publication, this ratio will flip so that approximately 80% of all IVDs on the EU market will require approval from a notified body.
JDSupra also reports that the two Regulations include transitional provisions that allow CE mark certificates issued in accordance with the current Directives to remain valid until the end of the period indicated on the certificates. According to the Emergo Group consulting company, CE mark certificates issued prior to final implementation of the new regulations in late 2019 or early 2020 will have a maximum validity of five years. CE mark certifications issued before implementation of the new regulations will expire automatically four years after the new regulations come into force.
As the Regulations will impact nearly every device manufacturer that sells products in the EU, device manufacturers are well-advised to consider their existing products and procedures in view of the Regulations to avoid future problems when marketing their devices.
Ethicon Inc. announced on February 17 that it reached an agreement to acquire Torax Medical, Inc. According to its website, Torax Medical is a privately held medical device company developing a minimally invasive surgical treatment for GERD acid reflux known as the LINX system. The website indicates that the LINX system supports the body’s barrier between the stomach and esophagus with a band of interlinked titanium beads. The beads are said to have a magnetic core, and the magnetic attraction between the beads helps close the division between the stomach and esophagus after swallowing.
Ethicon stated in its announcement that the transaction would “enable Ethicon to offer patients a safe and effective alternative to the anatomy-altering laparoscopic Nissen fundoplication surgical procedure.”
The financial terms of the deal have not been disclosed. A previous press release noted that Torax Medical completed a $25 million Series E financing round in August 2016, led by Johnson & Johnson Innovation – JJDC and existing investors including Sanderling Ventures, Thomas McNerney & Partners, Accuitive Medical Ventures, Kaiser Permanente Ventures, Piper Jaffray Companies, and Mayo Clinic Ventures.
Ethicon is a subsidiary of Johnson & Johnson, and has headquarters in Somerville, NJ, and Cincinnati, OH.
Sportbrain Holdings LLC (“Sportbrain”) is a company that was previously engaged in the business of selling fitness trackers. Sportbrain recently sued eight smartwatch manufacturers for alleged infringement of its U.S. Patent No. 7,454,002 (“the ’002 patent”), which describes a method of capturing and analyzing personal data of a user and providing feedback to the user based on the analysis. FIGS. 1B and 3 of the ’002 patent are reproduced below. These defendants included Jawbone, Frédérique Constant, Apple, Michael Kors, HP, BLOCKS Wearables, Razer, and New Balance. The complaint in each case identified a smartwatch or fitness tracker (having an accelerometer, motion sensor, pedometer, calorie counter, and/or gyroscope) and its companion app as the accused product.
A day after Sportbrain filed its most recent lawsuit, the Patent Trial and Appeal Board (PTAB) granted a petition for inter partes review (IPR) of the ’002 patent. The IPR petition had been filed on July 22, 2016 by Unified Patents. According to its website, Unified Patents is a member-based organization seeking to deter non-practicing entity activity in specific technology areas. Unified Patents argued in its petition that the claims of the ’002 patent were obvious over four different combinations of prior art references.
In instituting the IPR proceeding, the PTAB concluded that the petitioner’s evidence established a reasonable likelihood that the combinations of prior art references would render all of the claims of the ’002 patent obvious.
The ’002 patent is now the subject of over 40 active cases brought by Sportbrain.
On February 14, 2017, U.S. District Judge Michael Mosman of the United States District Court, District of Oregon granted a Joint Stipulated Motion for Dismissal with Prejudice submitted by Plaintiffs Smith & Nephew, Inc. and John O. Hayhurst, M.D. (inventor) and Defendant Arthrex, Inc. subject to the terms of a Settlement and License Agreement. Information about the settlement terms is not publicly available.
This agreement ends a 12-year long dispute between Smith & Nephew and Arthrex over Smith & Nephew’s U.S. Patent No. 5,601,557, which is directed to a method and apparatus for anchoring cartilage within a joint.
In 2004, Smith & Nephew sued Arthrex and alleged that certain products of Arthrex’s SutureTak® and PushLock® suture anchor families infringed the ‘557 patent (case number 3-04-cv-00029). According to the United States Court of Appeals for the Federal Circuit’s opinion of March 18, 2015, the parties had gone through three jury trials and two previous appeals. The third jury trial in 2011 produced a verdict of willful infringement and damages awards. Arthrex moved for Judgment as a Matter of Law (JMOL) of noninfringement, which was granted by the district court without an opinion. The Federal Circuit reversed and remanded the JMOL and reinstated the verdict in its S&N II opinion in 2013.
We previously reported the district court’s entering of judgment in favor of Smith & Nephew on remand, awarding a total of $88 million in damages and granting a permanent injunction against Arthrex. The judgment was affirmed by the Federal Circuit in its March 18, 2015 opinion. In June 2015, Smith & Nephew reported receiving a $99 million patent infringement payment from Arthrex.
In 2008, Smith & Nephew also sued Arthrex and alleged that different products from the same SutureTak® and PushLock® families infringed the ‘557 patent (case number 3:08-cv-00714). Judge Mosman granted in-part Smith & Nephew’s motion for summary judgment of infringement and denied Arthrex’s motions for summary judgment as of non-infringement. He also granted Smith & Nephew’s motion for summary judgment as to reasonable royalty damages.
According to the court’s public record, a jury trial was set for February 13, 2017 for the remaining issues in the lawsuit filed in 2008. On February 10, 2017, Judge Mosman vacated the jury trial, followed by the parties’ Joint Stipulated Motion for Dismissal with Prejudice.
Smith & Nephew and Arthrex filed a similar Joint Stipulated Motion for Dismissal with Prejudice in the 3-04-cv-00029 case, and in another lawsuit in the Eastern District of Texas relating to Arthrex’s patents (case number 2:15-CV-1047). The motion was granted by the Eastern District of Texas court, but denied as moot in the 3-04-cv-00029 case, which was closed when the September 2013 judgment was entered.
Forward Pharma A/S (“Forward”) recently announced that a necessary super majority of its shareholders have approved a settlement of various patent disputes with two wholly-owned subsidiaries of Biogen Inc. (“Biogen”) in which Forward will receive USD $1.25 billion cash from Biogen. 77% of the voting shareholders voted in favor of accepting the settlement agreement.
Founded in 2005, Forward, a Danish biopharmaceutical company, develops pharmaceutical treatments for patients with neurological conditions such as multiple sclerosis. The company reports that it is currently conducting Phase 1 clinical trials for its formulation of dimethyl fumarate (DMF).
Boston, Massachusetts-based Biogen, founded in 1978, is also a biopharmaceutical company specializing in treatments for multiple sclerosis and other neurological conditions and rare genetic disorders. Biogen developed and now markets an oral multiple sclerosis medication (a DMF therapy) under the trade name TECFIDERA™ for which FDA approval was obtained in early 2013.
Forward and Biogen have been engaged in patent disputes before tribunals in the US and Europe since at least 2014. As exemplified by its suit for patent infringement brought in Germany, Forward alleges that Biogen infringes certain of Forward’s patents relating to oral DMF therapies for the treatment of multiple sclerosis. Forward has also brought an interference proceeding (seeking priority over Biogen’s patent to DMF therapy) in the U.S. Patent and Trademark Office (“USPTO”), and multiple opposition proceedings in the European Patent Office (“EPO”). Under the terms of the settlement agreement, one of the EPO oppositions and the patent infringement suit will be terminated, but the USPTO interference proceeding and the other EPO opposition will be allowed to continue to a final determination of patentability (appeals included).
In addition to the up-front cash payment it agreed to pay Forward, Biogen will pay royalties (10–20%) on U.S. and non-U.S. sales of its orally administered DMF products, but only if Forward successfully obtains patent rights covering those treatment methods as a result of the USPTO and EPO proceedings referenced above.
Since 2012, Inter Partes Review (“IPR”) has emerged as one of the most significant new procedures in patent law. An IPR is a proceeding in the Patent Office, and allows a party to challenge an issued patent on certain prior art grounds. If successful, the challenging party can invalidate some or all of the patent claims. IPRs can be an alternative to challenging a patent in court, although oftentimes IPRs are filed while a patent lawsuit is also ongoing.
Here at Knobbe Medical, we continue to track and identify Medical Device IPRs that have been filed.
Below is a summary of the 315 Medical Device IPRs Knobbe Medical has identified between December 22, 2012 – November 30, 2016:
Cases Filed – 315
- Decision Regarding Institution Made – 222
- Pending Institution Decision – 63
- Instituted and Subsequently Settled/Patent Owner Terminated – 51
- Instituted and Pending Final Decision – 45
- Not Instituted – 73
- Final Decision Reached – 53
- Settlement/Patent Owner Termination Prior to Institution Decision – 30
- Average Time for Decision of Institution to be Reached = 181 days
- Average Time for Final Decision to be Reached = 529 days
As the number of IPR filings in the medical device industry continues to increase, this procedure is proving to be a powerful tool for companies and patent owners to challenge issued patents.
Please note that determining what is considered a “Medical Device IPR” was subjective and the data above is only intended to provide a general overview of medical device IPRs filed in the last couple of years, is based on public databases, and may not be accurate or complete.
Even if you are already familiar with IPRs, the following videos illustrate how actual IPR practitioners might approach some common issues.
Introduction to IPRs
Learn or refresh yourself on the basics of IPRs. Topics include:
- An overview of the patenting process and ways in which patent disputes can arise
- A description of how the Patent Trial and Appeal Board (PTAB) is structured and how IPRs function
- High-level strategic considerations for both patent holders and petitioners to help position themselves for success throughout the IPR process
Strategic Insights for IPRs
Hear insights into the process of successfully managing IPRs. Topics include:
- A clear description of the timeline associated with an IPR proceeding
- A walk-through of an IPR proceeding, including a trial
- What skills a successful IPR practitioner must possess to ensure the best representation at the PTAB
With the upcoming Republican-dominated Presidency and Congress in 2017, the Affordable Care Act, or at least parts of it, look to be on the chopping block. One of the changes that may be forthcoming is a repeal of the 2.3% medical device excise tax. While currently being suspended through 2017, under the present law the medical device tax would be reinstated in 2018.
Some producers of medical devices hope that the tax is never reinstated. Mark Throdahl, president and CEO of OrthoPediatrics Corp., a northern Indiana based orthopedic company, has said that the suspension of the tax allowed the company to hire new workers and hopes for a full repeal after the Republican transition. According to Throdahl, the tax led to a hiring freeze, and suspension of the tax allowed for them to resume “an aggressive pace of hiring and investment.” Complaints from companies like OrthoPediatrics, as well as medical device associations like AvaMed, were what led to the initial temporary suspension of the tax.
The medical device tax has been a significant drag on medical innovation, and resulted in the loss or deferred creation of jobs, reduced research, spending and slowed capital expansion.
According to some lawmakers, lobbyists, and industry executives, Trump and U.S. lawmakers will likely repeal the tax which could help some of the larger medical device manufacturers such as Medtronic, Boston Scientific, St. Jude Medical, and Johnson & Johnson. Senate Republican Leader Mitch McConnell has stated that repealing the Affordable Care Act will be one of the first order of business starting in January. Senator John Barrasso (R-Wyoming) has also stated that the medical device tax would likely be repealed.
There are still a number of decisions on how to approach the repeal of the medical device tax, whether in one single bill to repeal the Affordable Care Act or a number of smaller bills removing different parts of the Act. We should be receiving more clarity once President-elect Donald Trump officially takes office.
Repeal of the tax may remove approximately $2.5 billion of annual federal funding.
Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a clinical study finding that the Myriad diagnostic device accurately identifies patients for olaparib treatment.
Commenting on the results of the clinical study, Johnathan Lancaster, M.D. Ph.D., Gynecologic Oncologist and Chief Medical Officer of Myriad Genetic Laboratories, stated that:
These outstanding findings represent another meaningful advancement for ovarian cancer patients. Importantly, the results demonstrated that BRCA status as determined by BRACAnalysis CDx can identify patients likely to benefit from PARP inhibition therapy.
According to the press release, the BRACAnalysis CDx® test is an FDA approved diagnostic device that detects and classifies mutations in the BRCA1 and BRCA2 genes, using genomic DNA obtained from whole blood samples from a patient. Mutations in BRCA1 and BRCA2 are known to be associated with Hereditary Breast and Ovarian Cancer (HBOC) Syndrome. These mutations can be detected and quantified using the BRACAnalysis CDx® detection platform. In its Press Release, Myriad announced that BRACAnalysis CDx® may be used to aid in the identifying ovarian cancer patients who would be eligible for treatment with olaparib.
According to its website, Olaparib (Lynparza) is an FDA-approved targeted therapy for cancer, developed by AstraZeneca. Olaparib is a poly ADP ribose polymerase (PARP) inhibitor. Olaparib prevents PARP DNA repair, resulting in a buildup of damaged DNA, and resulting in cell death. Olaparib acts against hereditary BRCA1 or BRCA2 mutations.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Office of AstraZeneca stated that:
We are pleased with the robust improvement in progression-free survival demonstrated by Lynparza in the SOLO-2 trial. We will work with regulatory authorities to make Lynparza tablets available as quickly as possible to patients with ovarian cancer. We remain committed to investigating the full potential of Lynparza, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine.
According to its website, Myriad Genetics is a molecular diagnostic company that develops diagnostic assays for the detection of genetic diseases. Specifically, these assays are said to determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, measure disease activity, and guide treatment decisions. Myriad states that it discovered and sequenced the breast cancer gene, BRCA1 in 1994, and has developed numerous diagnostic products related to the diagnosis of hereditary cancers.
Isto Holdings, the parent company of Isto Technologies, has acquired Massachusetts based Arteriocyte Medical Systems Inc. and the two companies will be combined under the name Isto Biologics under the current CEO of Isto Technologies, George Dunbar.
According to its website, Isto Technologies is a medical device company involved with bone and cartilage repair and regeneration. Public records indicate that there are several pending patent applications listing Isto as the applicant. According to its website, Arteriocyte focuses on improving surgical outcomes and there are several patents and applications listing Isto as the applicant covering a number of technologies, such as centrifuge systems and autologous fibrin sealants, to name a few.
Accordingly, Isto Biologics’s expanded product portfolio will now include Arteriocyte’s MAGELLLAN autologous platelet separator with Isto’s bone-growth and cell therapy products including InQu bone graft extender and substitute, Influx natural bone-grant material, and CellPoint concentrated bone marrow aspirate system.
We’re excited to bring together two great organizations under the Isto umbrella and build upon their leading biologics platforms.
At this time, the terms of the acquisition deal have not been disclosed. While the combined company will be headquartered in St. Louis under CEO George Dunbar, Isto’s base of operations, they will maintain operations in Massachusetts.
The third annual Security of Things® Forum (SECOT) in Cambridge, Massachusetts fostered discussion on a variety of cyber-security related topics ranging from a standards-based approach to security connected devices to connected healthcare platforms. Even the Department of Homeland Security weighed in on its own efforts to influence the next generation of connected networked devices by developing strategic principles for developers to consider when addressing the Internet of Things.
Keynote speaker Dr. Kevin Fu of the University of Michigan spoke specifically about both the benefits and security problems in networked medical devices. Dr. Fu noted that pacemakers, for example, require direct contact from a sterile needle to adjust or maintain them, which creates an infection risk; and thus a wirelessly controlled pacemaker therefore can offer both the benefits of easier access and control, but also the security risk of being accessible—and therefore hackable—via a network. Moreover, a password protected pacemaker cannot simply lock out the user or attending physician because they fumbled the password at a critical moment.
While cyber-security for medical devices is a complex problem, especially in view of the aging infrastructure of most healthcare systems, Dr. Fu concludes that overall “patients prescribed an implant are far safer with those devices than without” despite even “major security problems.” In fact, he believes that most security flaws can be addressed by practicing basic security hygiene, addressing the “low lying fruit” and designing critical systems to “fail gracefully” by localizing breaches.
A second session of the SECOT Forum occurred on October 27, 2016 in Washington, DC. Speakers included: Suzanne Schwartz, FDA Director of Emergency Preparedness/Operations and Medical Countermeasures; Beau Woods, Deputy Director of the Cyber Statecraft Initiative in the Brent Scowcroft Center on International Security; and keynote speaker Ralph Langer, Managing Principal of Langer Communications.