Intellectual property

Patentability and inventorship

What are the most noteworthy rules and considerations relating to the patentability and inventorship of digital health-related inventions?

A key patentability consideration of digital health inventions is subject matter eligibility under 35 USC section 101. The Supreme Court has held that ‘abstract ideas’ are not patentable, but ‘inventive concepts’ are. Subject matter eligibility under section 101 remains in flux with the US Patent and Trademark Office (USPTO) and federal courts seemingly contradicting one another or themselves at times.

Digital health inventions may fall within the definition of ‘abstract idea.’ Natural phenomena and mathematical equations (algorithms) are considered abstract ideas, not patent-eligible. Implementing abstract ideas on a computer does not make them patent eligible. For example, one federal court has held using a computer to store information about medical providers and schedule appointments with patients was deemed to be an unpatentable abstract idea.

Application of abstract ideas may be patentable if an ‘inventive concept’ is included. Patent applications should focus on technological improvements or practical usage of an otherwise abstract idea. The Court of Appeals for the Federal Circuit held that a patent related to wearable trackers may have included an inventive concept based on the ‘plausibly inventive way of arranging devices and using protocols rather than the general idea of capturing, transferring, and publishing data’.

Inventors should craft patent applications and claims narrowly and incorporate hardware to avoid merely claiming an abstract idea.

The USPTO has made clear in denying a petition to list AI as an inventor that only a natural person can be an inventor. Applicants should ensure sufficient human involvement in the development process to list a human as an inventor. The USPTO recently issued a report on AI. Applicants using AI should familiarise themselves with USPTO positions.

Navigating section 101 and inventorship can be difficult. Anyone thinking of applying for a patent should consult an IP attorney.

Patent prosecution

What is the patent application and registration procedure for digital health technologies in your jurisdiction?

Patents are obtained by filing an application with the USPTO. The digital health technology patent process is the same as for any patent application. Two types of patents may protect digital health assets: utility and design patents. Generally, utility patents protect how an invention is used or works, while design patents protect an article’s appearance.

For utility patent protection, an invention must be useful, novel and non-obvious (35 USC sections 101, 102 and 103). A patent application must include a written description enabling persons skilled in the art to make and use the invention, and show the inventor possessed the invention.

Design patents cover ‘new, original and ornamental design for an article of manufacture’ (35 USC section 171). They do not protect functional aspects. Design patents merely require drawings meeting USPTO requirements. They are useful in protecting, for example, the ornamental design of a wearable device.

Other IP rights

Are any other IP rights relevant in the context of digital health offerings? How are these rights secured?

Copyrights, trademarks and trade secrets are important in protecting digital health offerings.

Copyrights are federal rights that protect original works of authorship fixed in a tangible medium (17 USC section 102). Registration is handled at the US Copyright Office and is necessary to sue under copyright law. Unlike patents, copyrights do not need to be registered for copyright protection. Protection attaches once the work of authorship is ‘fixed in a tangible medium,’ for example, written to paper or entered into a computer.

Trademarks identify the source of goods and services in commerce. A trademark can be registered at the USPTO or the state, or arise based on use of in commerce. Obtaining a federal or state trademark registration requires filing of an application. Common law rights attach once the mark is used in commerce. All trademark rights are premised on use in commerce with goods and services. If properly maintained, trademark protection can last in perpetuity.

Trade secret protection comes from reasonable efforts to maintain the secrecy of valuable information. Trade secret information must be:

  • information having value by not being generally known;

  • valuable to others who cannot legitimately obtain the information; and

  • be subject to reasonable efforts to keep it secret.

 

Trade secrets are not registered and may last in perpetuity.

Licensing

What practical considerations are relevant when licensing IP rights in digital health technologies?

Key considerations to IP licensing rights include confidentiality, modifications or improvements, and termination.

Confidentiality of IP may be essential in a licence, particularly for trade secrets. A licence should have confidentiality requirements, such as limiting disclosure to third parties or employees on a need-to-know basis.

Digital health is an innovative area. Licences need to account for modifications or improvement of the licensed IP. Will improvements be owned by one party or jointly owned?

Termination – for example, for breach or bankruptcy – is a major consideration. A licensor will need to ensure a third party is not granted a right to the licence through bankruptcy proceedings. Such a transfer of licence rights may eviscerate any trade secrets.

Enforcement

What procedures govern the enforcement of IP rights in digital health technologies? Have there been any notable enforcement actions involving digital health technologies in your jurisdiction?

IP rights for digital health technologies are enforced in the same manner as other property rights, in civil litigation in state and federal court.

A recent decision by a Wisconsin federal court shows the breadth of coverage and remedies for trade secret protection. Where a defendant improperly accessed the plaintiff’s trade secret information regarding healthcare software, the court granted compensatory (US$140 million) and punitive monetary damages (not to exceed US$140 million), and also granted injunctive relief, including future monitoring of the defendant.

A recent decision by the Federal Circuit held that although a patent claim was directed to an abstract idea, the specific configuration of hardware and software provides a ‘plausibly inventive’ step to overcome a motion to dismiss. This does not mean that claim is in fact patentable, only that the district court could not make such a determination as a matter of law, allowing the case to progress further.

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20 November 2020.