Weekly Patent Update – Jan 2022 (2 of 3)

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“The United States Patent and Trademark Office (USPTO) published a notice in the Federal Register announcing an extension of its COVID-19 Prioritized Examination Pilot Program. Requests that are compliant with the program’s requirements and are filed on or before March 31, 2022, will be accepted.

The full text of the notice is available on the Patent Related Notices webpage. Please see the USPTO’s COVID-19 Prioritized Examination Pilot Program webpage for more information about the program.”

“On December 27, 2021, a draft project of amendments to the Constitution of the Republic of Belarus was distributed for the nationwide discussions.

The full text of the amendments project can be found here.

Position of Belarusian citizens concerning the amendments project, along with their probable suggestions and remarks can be addressed to the National Center of Legal Information of the Republic of Belarus.

Please click hereto get the application form.

The received materials will be thoroughly summarized, systematized and processed by the National Center of Legal Information.”

The following sections set out below have been amended or added by the UKIPO.

“60.23

Exempted from constituting infringement are certain acts done privately for non-commercial purposes (sub-section (5)(a)); for experimental purposes (sub-section (5)(b)); in preparing or dealing with a prescribed medicine (sub-section (5)(c)); in connection with a temporary or accidental incursion into or crossing of UK territory or air space by a ship, aircraft, hovercraft or vehicle as defined in s.60(7) (sub-sections (5)(d), (e) and (f)); by farmers in connection with certain harvested products, animals or animal reproductive material (sub-sections (5)(g) and (h)), or conducting studies, tests and trials on certain medicinal products (sub-section 5(i)). Sub-sections (5)(g) and (h) were added by the Patents Regulations 2000 (SI 2000/2037), along with ss.60(6A), 60(6B) and 60(6C). These subsections have effect in the Isle of Man by virtue of the Patents Act 1977 (Isle of Man) Order 2003 (SI 2003/1249). Article 31 of the CPC (renumbered as Article 27 [1989]) corresponds to s.60(5)(a) to (f). Sub-section (5)(i) was added by the Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (SI 2005/2759), and came into force on 30 October 2005. Sub-sections 6D to 6G were added by the Legislative Reform (Patents) Order 2014 (SI 2014/1997) and came into force on 1st October 2014. The exception set out in sub-sections 6D to 6G does not apply to acts committed before 1st October 2014.”

“60.24.1

Sub-section 6D sets out that for the purposes of subsection (5)(b), anything done in or for the purposes of a medicinal product assessment which would otherwise constitute an infringement of a patent for an invention is to be regarded as done for experimental purposes relating to the subject-matter of the invention. Use of a patented product is permitted when carrying out work to provide information to the regulatory authorities who decide whether a drug should be given a marketing authorisation. It is also possible to use a patented product in work done to supply information for health technology assessments. Only products which fall within the definition of medicinal product provided by the Directive on the Community code relating to medicinal products for human use (2001/83/EC) or the Directive on the Community code relating to veterinary medicinal products (2001/82/EC) are covered by this exception (see also 60.33) although, as mentioned below, the product does not have to be being used for approval in the UK or the EU.”

“60.24.2

Sub-section 6E defines what is meant by “medicinal product assessment”. The definition covers activities carried out to provide information required by regulatory authorities e.g. clinical trials; or activities carried out to enable a government or public body to assess if a medicine should be used in the provision of healthcare e.g. health technology assessments. Examples of regulatory authorities include the Medicines and Healthcare Products Regulatory Authority (MHRA) and the European Medicines Agency (EMA). An example of a body which assesses if a new drug should be used in the provision of healthcare is the National Institute for Health and Care Excellence (NICE). Provided the purpose of the work is for assessment of a medicinal product, as defined in sub-section 6E, it will fall within the exemption even where the work is performed for drug approval abroad. The “medicinal product assessment” exception does not extend to commercial activities but does cover assessments of combinations where the patented drug is part of the combination.”

“60.28

Sub-section (5)(i) relates to clinical trials on patented medicinal products, and implements the so-called “Bolar” exemption. The exemption was derived from the limitation set out in Article 13(6) of Directive 2001/82/EC on veterinary medicinal products and in Article 10(6) of Directive 2001/83/EC on medicinal products for human use (see also 60.32-33). It exempts from patent infringement acts relating to any studies, tests and trials carried out to show that a generic medicine is bioequivalent to an approved, patented product, where these acts are required to obtain marketing authorisation for the generic medicine under an abbreviated authorisation procedure (where the generic can rely on the data for the patented product to demonstrate its safety and efficacy, provided that bioequivalence is demonstrated).”

“60.33

Although Directives 2001/82/EC and 2001/83/EC were not retained as domestic law at the end of the transition period by the European Union (Withdrawal) Act 2018, any pre-existing references to EU legislation remain functional. Under paragraph 2A of Schedule 8 to that Act, such “non-ambulatory” references – references that are not to the legislation as amended from time to time – are interpreted with respect to the EU legislation in the form it was in at the time the reference was made. Definitions or other references informed by the non-ambulatory reference are therefore construed on that basis.”

“The United States Patent and Trademark Office (USPTO) today announced a new Deferred Subject Matter Eligibility Response (DSMER) Pilot Program for nonprovisional patent applications that will launch on February 1, 2022. This pilot program was initiated in response to a letter from Senators Thom Tillis and Tom Cotton and is designed to evaluate how deferred applicant responses to subject matter eligibility (SME) rejections could affect examination efficiency and patent quality as compared to traditional compact prosecution practice.

Participation in this program is by invitation only. Applicants may receive invitations to participate if their applications meet certain criteria, including a requirement that the first Office action on the merits makes both SME and non-SME rejections.

More information about this pilot program is available in the Federal Register Notice announcing the program and on the DSMER Pilot Program page of the USPTO website.”