Showing all posts written by Christopher Lewis

Christopher Lewis
Christopher Lewis

Medtronic Completes Acquisition of Cardiac Mapping Company Affera

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.

Pfizer Australia Announces Deal to Acquire ResApp Health

Pfizer Australia Announces Deal to Acquire ResApp Health

ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc.  Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of approximately AUD $100 million.  ResApp directors announced a unanimous recommendation to sell, and their intent to vote their own shares accordingly.  A shareholder vote is scheduled for June.

ResApp Health develops point of care diagnostics for telehealth that integrate with existing platforms.  Their algorithms can diagnose disease from sounds.  For example, one platform reportedly diagnoses respiratory problems based on the sound of a patient’s cough or breathing, and no physical contact is required.

The companies will also enter a Research & Development License Agreement to collaborate on products in the field of COVID-19.

In a statement, Pfizer Australia’s Lidia Fonseca stated that “this proposed acquisition and research collaboration add to our growing digital capabilities and bolster our efforts to pave a new era for digital health.”  ResApp CEO Tony Keating expressed excitement, stating “the material premium and certainty of an all cash consideration is an attractive outcome for our shareholders.”

This acquisition would be the second for Pfizer this year.  Earlier, it acquired ReViral, the developer of therapeutics for respiratory viruses, for $525 million.

Bioventus’ Shareholders Approve Acquisition of Misonix

Bioventus recently announced that its shareholders approved its agreement to acquire Misonix.  Bioventus agrees to pay Misonix shareholders either 1.6839 shares of Bioventus class A common stock or $28.00 for each share of Misonix common stock held.  The amount paid to Misonix shareholders results in an approximate valuation of $518 million for Misonix, based on share prices from around the time the acquisition agreement was reached.  With the completion of this acquisition, Misonix will become a wholly-owned subsidiary of Bioventus.

Misonix develops minimally invasive therapeutic ultrasonic medical devices and regenerative tissue products for a variety of orthopedic applications.  For example, Misonix is the developer of the BoneScalpel, an ultrasonic bone cutting tool. Additionally, Misonix is the developer of the Nexus, an ultrasonic surgical aspirator for precision hard and soft tissue removal.

In a press release, Bioventus’ CEO Ken Reali stated:

We are pleased by the outcome of today’s vote and thank our stockholders for supporting the acquisition.  The combination with Misonix creates significant value and provides a deeper global portfolio of pain treatments, restorative therapies and surgical solutions for patients.  We are excited to welcome the Misonix team to Bioventus.

Bioventus plans to accelerate the adoption of Misonix’s BoneScalpel and Nexus products through the footprint of Bioventus in the spine surgical solutions area.  Bioventus also plans to augment its current lower extremity product offerings with Misonix’s products.

This acquisition is one of three acquisitions by Bioventus this year.  Earlier this year, Bioventus acquired Bioness, the developer of neuromodulation and rehabilitation medical devices. Bioventus also has an agreement in place to acquire CertiHeal, the developer of the Agili-C implant.

Supreme Court Upholds, but Limits, Patent Infringement Defense of “Assignor Estoppel”

The U.S. Supreme Court recently decided a case resolving a patent dispute between two medical device companies, Hologic, Inc. and Minerva Surgical.  The opinion was closely watched because it raised the question of whether an inventor who has assigned a patent is legally prevented from later attacking the validity of that same patent — a doctrine historically referred to as “assignor estoppel.”

The Supreme Court’s opinion on June 29, 2021, upheld but limited this doctrine, defining its boundaries and emphasizing it is based on legal principles of equity and fair dealing.

In the case, Csaba Truckai was a listed inventor on a patent application, the rights to which were subsequently acquired by Hologic, Inc. Mr. Truckai then founded Minerva Surgical, Inc. and developed an endometrial ablation system.  Hologic sued Minerva for patent infringement of one of the assigned patents related to endometrial ablation.

In response to the claims of patent infringement, Minerva attacked the patent as allegedly invalid. In response, Hologic argued that, under assignor estoppel, Minerva should be prevented from attacking the patent’s validity because Minerva’s founder, Mr. Truckai, was an inventor on the same patent.

In deciding the case, the Court recognized the fairness principle of assignor estoppel — that an inventor shouldn’t be able to initially tout an invention to the patent office, only to later disclaim its worth after assigning it. However, the Court decided that the lower court had applied assignor estoppel too expansively to muzzle inventors.  Thus, the Court held that the doctrine applies only when an inventor makes statements (explicitly or implicitly) in assigning a patent, and later contradicts those statements in litigating against the owner of the patent. The Court reasoned that an assignment does carry an implied assurance of a patent’s validity, but where the assignor has not made explicit or implicit representations that contradict an invalidity defense, there is no ground for assignor estoppel.

To illustrate the boundaries of assignor estoppel, the Court provided three non-exhaustive examples of when assignor estoppel does not apply:

  • First, when assignment occurs before an inventor can make a warranty of validity (e.g., “when an employee assigns to his employer patent rights in any future inventions he may develop during his employment”);
  • Second, when a later legal development renders the warranty of validity irrelevant (such as a change in the law); and
  • Third, when a change in patent claims occurs for an assigned application (e.g., “the new claims are materially broadened” during patent prosecution after the assignment takes place).

Nevertheless, each assignor’s and each company’s situation is unique, and the application of assignor estoppel depends on the particular situation. Medical device companies and others concerned about patents should seek the guidance of professional legal counsel when making any determination regarding whether assignor estoppel applies.

Balancing Intellectual Property (IP) Interests with National Interest in Response to the Coronavirus

Traditionally, it has been fairly uncommon to see new legislation in intellectual property (IP) law, compared to other areas of law.  Instead, courts have generally been the avenue through which changes in IP law have been brought about and, for some, the Leahy-Smith America Invents Act of 2012 is the most recent IP legislation of particular relevance.  This can provide a certain confidence to companies exploring or entering the IP field.  However, developments associated with the coronavirus pandemic have, for some, highlighted issues with balancing the rights of a patent owner with a protection of the national interest.

As an example of the issues highlighted by the coronavirus pandemic, on January 21, 2020, the Wuhan Institute of Virology filed a Chinese patent application directed to the use of remdesivir in the treatment of coronavirus.  Previously, in 2016, Gilead had also filed a Chinese patent application directed to a similar use of remdesivir in the treatment of coronavirus.  The issue for the Chinese Patent Office was in balancing the traditional intellectual property rights of Gilead with the national interests at stake due to the coronavirus pandemic as proposed by the Wuhan Institute of Virology.  While the Chinese Patent Office ultimately granted the patent to Gilead, it highlighted the potential for conflicts in IP law due to the coronavirus pandemic and further illustrated the need for a proper balancing of the rights of the patent owner with the protection of the national interest.

In an effort to balance the dual interests, numerous legislation has been proposed to modify the patent system in response to the coronavirus pandemic.  Specifically in the US, Senator Ben Sasse recently introduced a bill dubbed the “Facilitating Innovation to Fight Coronavirus Act” designed to limit IP liability for healthcare professionals who are fighting coronavirus.

Under the Facilitating Innovation to Fight Coronavirus Act, healthcare providers would be protected from liability for:

  • Using or modifying a medical device for an unapproved use or indication;
  • Practicing without a license or outside of an area of specialty if instructed to do so by an individual with such a license or within such an area of specialty; or
  • Conducting the testing of, or the provision of treatment to, a patient outside of the premises of the standard health care facilities.

The Facilitating Innovation to Fight Coronavirus Act would further limit the rights of a patent owner to protect the patent from unauthorized use as the effective date of eligible patents (e.g., pharmaceutical patents, medical device patents, or other patents related to the coronavirus) would be delayed until the cessation of the National Emergency corresponding to the coronavirus.  The aforementioned portions of the Bill seek to protect the national interest by providing numerous protections to healthcare providers.  However, the bill also seeks to balance the interests of the patent owners by providing for the extension of the term of each eligible patent for 10 years.

In defense of the Facilitating Innovation to Fight Coronavirus Act, Senator Sasse is quoted as saying “These heroes need a common-sense liability shield so that they don’t have to worry about lawsuits while they’re scrambling to save lives.