FDA Publishes Draft Ethical Consideration Guidance to Protect Children Participants in Clinical Trials of Medical Products
On September 23, 2022, the Food and Drug Administration (FDA) published a draft guidance aimed to protect children who participate in clinical trials, titled Ethical Considerations for Clinical Investigations of Medical Products Involving Children. The draft guidance describes the FDA’s current position regarding ethical considerations for clinical investigations of drugs, biological products, and medical devices involving children. The guidance explains the fundamental concepts for the ethical framework that institutional review boards (IRBs), sponsors, and the industry should consider when reviewing or conducting clinical trials involving children.
Of note, the guidance outlines additional considerations and recommendations IRBs should assess when enrolling children in clinical investigations of medical products. The guidance explains that, in principal, the risk of the clinical investigations must be balanced by the prospect of direct and potential benefits and must at least be as favorable as any available accepted alternative treatment. Accordingly, the guidance suggests medical product developers need to use a dose or treatment level expected to be effective for the child which should also have a positive impact on the child’s life.
The FDA’s Office of Pediatric Therapeutics noted that “the best way to provide children with safe and effective treatment options is by including them in clinical research.” The Office of Pediatric Therapeutics further noted that children are afforded additional safeguards when participating in a clinical investigation since they are a vulnerable class who cannot provide informed consent for themselves. The FDA’s guideline comes at an important time. By way of example, although 48.2% to 72.6% of parents are willing to vaccinate their children against the COVID-19 virus, a lower rate of parents allow their children to participate in clinical trials.
The FDA’s draft guidance is available here, and is available for comments until December 27, 2022.
Medtronic recently announced that its acquisition of Affera, Inc. has been completed. The acquisition was previously announced to be for $925 million with a $250 million contingency, as reported by MedCity News. Medtronic had previously been a strategic investor in Affera and, prior to the acquisition, owned a 3% interest in Affera as stated in a prior press release dated January 10, 2022.
Affera develops an integrated platform to deliver therapy to cardiac arrhythmia patients. The platform is referred to as Affera Prism-1™ cardiac mapping and navigation platform, per the announcement. Additionally, Affera also develops catheters, such as the pulmonary vein isolation pulsed field ablation catheter, as previously announced on July 27, 2021.
In the latest announcement, Rebecca Seidel, president of Medtronic’s Cardiac Ablation Solutions business, stated:
We’re incredibly proud to have led the industry with the introduction of the proven safe and effective cryoablation technology; and now these new additions to our portfolio help support a leap forward in our commitment.
Founder and chief executive officer of Affera, Doron Harlev, also expressed excitement to be joining Medtronic by stating that “the acquisition enhances and accelerates our ability to treat millions of patients around the world suffering from cardiac arrhythmia with our innovative technology.”
This acquisition would be the second acquisition completed by Medtronic this year. Earlier this year, Medtronic completed the acquisition of Intersect ENT, the developer of sinus implant technology, for $1.1 billion, as reported by MassDevice.
The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes information on diagnostic testing, Laboratory Developed Tests (LDTs), and information for test developers. With more than 22,000 confirmed Monkeypox cases in the U.S., the new Monkeypox Medical Devices web comes as FDA takes significant actions to increase Monkeypox testing capacity nationwide following the Secretary of Health and Human Services’ August 9th announcement of public health emergency.
The FDA’s guidance issued for test developers under Policy for Monkeypox Tests to Address the Public Health Emergency describes, among other things, review priorities of Emergency Use Authorization (EUA) requests for monkeypox diagnostic tests. And, on the same day as the FDA guidance was issued, the FDA also issued the first EUA to a commercially available monkeypox test in the United States to Quest Diagnostics for its Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR device. “With this FDA emergency authorization, Quest is positioned to complement the response of public health laboratories and help fight the spread of the virus,” said Jay G. Wohlgemuth, M.D., Senior Vice President, R&D, Medical and Chief Medical Officer, Quest Diagnostic.
Quest Diagnostics is not the only company that has been working on monkeypox diagnostic test kits. Earlier in June, Becton Dickinson announced partnership with CerTest Biotec to collaborate on molecular diagnostic test for monkeypox. Several other healthcare and pharmaceuticals companies have also been linked with this effort. This comes at a time when many of these companies are preparing for a drop in revenue from COVID-19 testing as the threat of COVID-19 reduces.
Rather than simply reading radiological scans, Ibex Medical Analytics is employing its artificial intelligence (AI)-powered cancer detection solutions to assist pathologists in the lab. Ibex’s Galen Platform is a clinical-grade, multi-tissue platform that helps pathologists detect a variety of cancers and grade their malignancies. Ibex states that the platform can also “detect more than a hundred other clinically relevant diagnostic features in multiple tissue types.” Ibex leverages data extracted from millions of pathology slides along with AI and machine learning to perform its platform’s diagnostic functions.
Ibex reports that its breast cancer diagnostic tool, Galen Breast, delivered clinical grade accuracy in diagnosing multiple breast cancer types in a recent multi-site clinical study conducted at Institut Curie in France and Maccabi Healthcare Services in Israel. The study compared the performance of pathologists using Ibex AI against pathologists using traditional microscopes to diagnose multiple types of breast cancer. The study results showed the Galen Breast tool could detect various forms of breast cancer at a level of accuracy on par with trained pathologists. According to an Ibex press release, Galen Breast technology has shown the ability to detect both invasive and in-situ cancers in breast biopsies, distinguish between multiple sub-types of cancer (e.g., lobular versus ductal carcinoma), grade cancer severity in situ, and identify rare tumors. The Galen Platform additionally offers AI solutions for the detection of prostate and gastric cancers, which Ibex states also deliver clinical grade accuracy.
More recently, the company announced the launch of its latest Galen Platform version, Galen 3.0. Ibex reports that Galen 3.0 provides expanded detection capabilities and a broader set of features to support pathologists in diagnosing breast, prostate, and gastric cancers.
Federal Circuit Upholds Lower Court Decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.
By Rory Lootsma
(August 18, 2022) The Federal Circuit has affirmed that Eagle Pharmaceuticals, Inc. did not infringe Par Pharmaceutical, Inc. patents, easing Eagle’s path to market a generic competitor to Par’s Vasostrict®
product. Par had alleged that Eagle’s abbreviated new drug application (ANDA) infringed U.S. Patent Nos. 9,744,209 and 9,750,785, both titled “Vasopressin formulations for use in treatment of hypotension.” An example molecular structure is shown here:
Some of Par’s arguments had alleged that because the pH of Eagle’s products would be so close to Par’s claimed ranges for pH, inevitable drift in pH would occur over time, causing infringement. In affirming, Chief Judge Moore explained that the District Court had not committed clear error in finding otherwise. The infringement inquiry “begins and ends” with Eagle’s ANDA specification, so predicting future drift cannot show infringement.
Thus, the Federal Circuit upheld the District Court’s decision against Par Pharmaceutical and affirmed the finding of no infringement. The Federal Circuit’s decision is available here.
Teleflex announced on August 22, 2022 that it has reached an agreement to acquire Standard Bariatrics. Teleflex agreed to acquire Standard Bariatrics for a cash payment of $170 million at closing and could pay up to an additional $130M if Standard Bariatrics reaches certain commercial milestones.
Standard Bariatrics is a Cincinnati-based company that makes the Titan SGS® surgical stapler for bariatric surgery, among other products.
Teleflex claims to have a well-developed existing bariatric surgeon call point and a portfolio of surgical devices, including products for interventional cardiology, urology and vascular access. As part of the announcement, Liam Kelly, Chairman, President and Chief Executive Officer of Teleflex, stated the following regarding the acquisition:
The acquisition of Standard Bariatrics adds an exciting and differentiated product serving the large and growing sleeve gastrectomy market, which we estimate to be approximately 120,000 procedures annually in the U.S.
The announcement states that the deal is expected to close in the fourth quarter of 2022, subject to regulatory approval. Teleflex plans to finance the acquisition at closing through borrowings under its revolving credit facility based on the announcement.
Boston Scientific announced on August 15, 2022, that it acquired Obsidio, Inc. for an undisclosed fee. Obsidio has technology called the Gel Embolic Material (GEM™), which is used in minimally invasive blood vessel embolization. According to its press release, Boston Scientific intends to expand its interventional oncology and embolization portfolios.
An embolization treatment procedure uses a material to obstruct or reduce blood flow through a blood vessel. The treatment may be used to stop hemorrhaging, to stabilize blood vessel malformations, or to reduce blood flow to tumors, which are often highly vascularized.
Founded in 2019, Obsidio initially sought to commercialize technology relating to NIH-funded research on hemorrhage control and aneurysm treatment. Obsidio subsequently obtained FDA approval for GEM™ on July 1, 2022, claiming equivalence to Biosphere Medical’s EmboCube™ Embolization Gelatin. According to Obsidio, GEM™ is a semi-solid made up of bioresorbable gelatin, layered silicate, and tantalum powder. The material is delivered to a target vessel via catheter. As a semi-solid, the material is supposed to conform to the shape of the target vessel. Additionally, GEM™ is supposed to be shipped in a ready-to-use form, which, according to Boston Scientific, may save some preparation time relative to other embolization materials.
Boston Scientific is a multinational biomedical engineering company. In 2021, Boston Scientific spent over $4 billion across five acquisitions. Obsidio is the second of Boston Scientific’s acquisitions in 2022, the other being a $230 million deal for Synergy Innovation’s majority stake in M.I.Tech, a developer of a conformable, self-expanding metal stent called HANAROSTENT®.
On July 29, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice by Director Kathy Vidal that may be relevant to those seeking or holding patents on medical devices that require Food and Drug Administration (FDA) approval. The Notice relates to certain duties owed to the USPTO with regard to statements and documents submitted to the FDA and other government agencies. The duties include a duty to disclose certain information and a duty of reasonable inquiry.
The Notice states “[t]he duty of candor and good faith in dealing with the USPTO includes the duty to disclose to the USPTO information material to the patentability of a claimed invention.” Further, “[e]ach party submitting a paper to the USPTO has an additional duty to perform an inquiry that is reasonable under the circumstances, including reviewing documents to identify information that is material to the patentability of a claimed invention.” The Notice states it “is intended to clarify the duties, including as to materials or statements material to patentability or statements made to the USPTO that are inconsistent with statements submitted to the FDA and other governmental agencies.”
The Notice was issued against the backdrop of an Executive Order by President Biden regarding competition in the economy, specifically in the pharmaceutical industry. Additionally, U.S. Senators sent a letter to the USPTO requesting “that the Office ‘take steps to reduce patent applicants’ making inappropriate conflicting statements in submissions to the [USPTO] and other federal agencies.'” Regarding the letter, the Notice further states:
The letter provided a specific example in which “inconsistent statements submitted to the Food and Drug Administration (FDA) to secure approval of a product—asserting that the product is the same as a prior product that is already on the market— can then be directly contradicted by statements made to the [USPTO] to secure a patent on the product.” The Letter noted that such inconsistent statements “should be cause for rejecting the application and, when made knowingly and with bad intent, potentially other sanctions.”
Against this background, the Notice states it “is part of the USPTO’s efforts to put into effect the Administration’s goals and address the Senators’ concerns.”
The Notice thus discusses which parties have a duty to disclose information to the USPTO in various patent examinations and proceedings, and what material information must be disclosed. For example, the duty to disclose “applies to positions taken by applicants or parties involving the claimed subject matter. For instance, in PTAB proceedings, parties should not take a position about the patentability of challenged claims that is inconsistent with positions taken in submissions to other Government agencies regarding the same subject matter.” An example PTAB proceeding is cited which resulted in “suspending a practitioner for four years for failure to correct the written record after learning of inaccuracies in a declaration the practitioner had filed.” The Notice discusses similar duties in the context of patent examination and prosecution.
In addition to the duty to disclose, the Notice discusses the duty of reasonable inquiry and when these two duties arise in dealings with other government agencies besides the USPTO. For example, the Notice cites a Federal Circuit decision “affirming a district court’s determination of inequitable conduct because the patent owner’s Chief Science Officer failed to provide to the USPTO submissions he made to the FDA about the prior art that were inconsistent with positions taken before the USPTO during the prosecution of a pending patent application.” In another case, the Federal Circuit “inferred intent to deceive and found inequitable conduct occurred when an official involved in both the FDA and the USPTO submissions chose to disclose material prior art to the FDA but not to the USPTO.”
The Notice provides further detail on these and other relevant issues, and the full text may be found here.
The 3M Company announced on July 26th that it will spin off its health care business into a separate, publicly-traded company. The health care business will focus on wound care, oral care, healthcare IT, and biopharma filtration. The current health care business lines include bandages, skin adhesives, oral aligners, air purifiers, optical lenses, and the Bair Hugger™ surgical warming system that is currently the subject of nearly 6,000 lawsuits.
3M’s health care business generated $8.6 billion in 2021, which amounted to about one-quarter of the company’s total revenue. 3M confirmed that the non-healthcare main company will retain liability for all non-healthcare-related litigation, including the Combat Arms Earplugs litigation and PFAS litigation.
3M expects the move to increase the companies’ agility and focus to better position both companies for long term success and ability to tailor capital allocation strategies. In discussing the proposed move, 3M chairman and chief executive officer Mike Roman stated:
Disciplined portfolio management is a hallmark of our growth strategy. Our management team and board continually evaluate the strategic options that will best drive long term sustainable growth and value. The decision to spin off our Health Care business will result in two well-capitalized, world-class companies, well positioned to pursue their respective priorities.
This move comes off a string of similar moves from multi-national conglomerates, including General Electric Co.’s separation of its power, aviation, and healthcare businesses; Johnson & Johnson’s spin-off of its consumer health company; and United Technology’s spin-off and subsequent merger with Raytheon. The trend towards spinning off various businesses within these conglomerates comes as consensus grows among investors that businesses perform best when streamlined, according to Reuters.
AliveCor, Inc., a company focused on cardiac data and remote medicine, successfully convinced an International Trade Commission (ITC) judge that Apple, Inc. infringed multiple AliveCor patents related to electrocardiogram (ECG) technology. AliveCor asserted that the Apple Watch (Series 6 and 7) infringes multiple AliveCor ECG patents and seeks to ban the watches from importation into the U.S.
In a June 27, 2022 Notice of Initial Determination, an ITC Administrative Law Judge (“ALJ”) agreed with AliveCor, determining Apple had violated Section 337 of the Tariff Act of 1930 (19 U.S.C. § 1337), related to “Unfair practices in import trade.” The ALJ found the ECG functionality of the Apple Watch Series 6 and Series 7 (pictured below) infringed multiple, valid claims of two AliveCor patents: U.S. Patent Nos. 10,638,941 (titled “Discordance Monitoring”) and 10,595,731 (titled “Methods and Systems for Arrhythmia Tracking and Scoring”).
AliveCor is the complainant in ITC Investigation No. 337-TA-1266 (the “1266 Investigation”), captioned Certain Wearable Electronic Devices with ECG Functionality and Components Thereof. A public version of the ALJ’s complete Initial Determination should be released soon. By October 26, 2022, the full ITC is expected to issue a final decision in the 1266 Investigation. If the Commission affirms the ALJ’s findings, the Apple Watch Series 6 and Series 7 could be banned from importation into the United States.