Spiky Questions Around Patenting of Spike Proteins

In an interview David E. Martin, the Chairman of the world’s largest underwriter of intangible assets gave his sceptical take on patents concerning SARS-CoV. These were further elaborated in a subsequent interview.

Amongst others the following US patents were discussed:

US7279327 – Methods for Producing Recombinant Coronavirus, has a PCT filing date of 19th April 2002 and priority date of 20th April 2001. This was granted to the University of North Carolina – Chapel Hill on 10th September 2007 and on 14th December 2018 was assigned to the US National Institutes of Health (NIH). It expired on 10th September 2019 on account on non-payment of the 11.5 year maintenance fee. Prior to the assignment the US Government had rights to use of the invention in accordance with 35 USC 203 as the invention was produced with funding from the NIH.

US7220852 – Coronavirus Isolated from Humans has a filing date of 12th April 2004, and a priority date of 25th April 2003. This was granted to the Centre for Disease Control and Prevention, which is part of the US Department of Health and Human Sciences, on 22nd May 2007. It expired on 22nd May 2019 on account on non-payment of the 11.5 year maintenance fee. The US Government had rights to use of the invention as the Centre for Disease Control and Prevention is a US Government Agency.

US7151163 – Antiviral Agents for the Treatment, Control and Prevention of Infections by Coronaviruses, has a filing date of 28th April 2004 and a priority date of 28th April 2003. This was granted to Sequoia Pharmaceuticals Inc on 19th December 2006. It expired on 19th December 2018 on account on non-payment of the 11.5 year maintenance fee.

US7776521 – Coronavirus Isolated from Humans, is a divisional of US007220852 and so has a filing date of 12th April 2004. This was granted to the Centre for Disease Control and Prevention, which is part of the US Department of Health and Human Sciences, on 17th August 2010. It expired on 17th August 2018 on account on non-payment of the 7.5 year maintenance fee. The US Government had rights to use of the invention as the Centre for Disease Control and Prevention is a US Government Agency.

It was argued that negative inferences should be drawn from US7279327 having a filing date that preceded the SARS outbreak, which originated around November 2002. In particular, David E. Martin claims that it evidences that the SARS-CoV outbreak shortly thereafter was manufactured by humans. While US7279327 involves a method of producing replication defective coronaviruses, the implication is that if replication defective coronaviruses can be made, then so can non- replication defective coronaviruses.

In the detailed description section of the US7279327 specification (page 7, lines 17-27) coronavirus is delineated and it is noted that the invention may be carried out with human respiratory coronaviruses:

"Coronavirus" as used herein refers to a genus in the family Coronaviridae, which family is in turn classified within the order Nidovirales. The coronaviruses are large, enveloped, positive-stranded RNA viruses. They have the largest genomes of all RNA viruses and replicate by a unique mechanism which results in a high frequency of recombination. The coronaviruses include antigenic groups I, II, and III. While the present invention is described primarily with respect to porcine transmissible gastroenteritis virus (TGEV), the invention may be carried out with any coronavirus, such as human respiratory coronavirus, … .

The utility of the invention is noted on page 8, lines 12-16 and further elucidated on page 8, lines 29-32, where it is stated that subjects can be administered or treated with vaccines made with the viral particles:

Subjects which may be administered or treated by the viral particles or VLPs of the present invention may be any subject, generally vertebrates, for which the viral particles or VLPs are infectious, including but not limited to birds and mammals such as pigs, mice, cows, and humans).
…
The present invention describes the assembly of recombinant transmissible virus and replicons that express heterologous genes which can be used to make vaccines against homologous and heterologous pathogens

It was further asserted that SARS-CoV2 is a sub-clade of SARS-CoV and that all the elements that distinguish SARS-CoV2 from SARS-CoV can be found in 73 pre-2019 patents.

It was also argued that US7220852 should not have been granted as its only claim is to an isolated coronavirus and so, on the assumption that it is naturally occurring, should be invalid on s. 101 grounds of claiming a natural thing. That seems right, but at the time of its granting in 2007 it was not a clear point of law. It was not until the US Supreme Court’s June 2013 Myriad decision that this was made clear. The Myriad decision resulted in all isolated products of nature being excluded from patent eligibility including, gene sequences, proteins and microorganisms, but not artificially-created gene sequences such as cDNA. While US7776521, being a divisional of US007220852, also involves coronavirus isolated from humans, the claims are not open to the same invalidity point as they are drawn to methods of detecting and kits for detecting SARS-CoV.

Negative inferences were made from US7151163 having a priority date just three-days after that of US7220852, where each was applied for by different parties. Further US7151163 issued and published before US7220852 was allowed or published as the Centre for Disease Control and Prevention had paid to keep US7220852 secret. However, the basis for such negative inferences seems weak as the availability of a treatment does not require a detailed understanding of the cause of the infection. Both applications were filed after the spread of SARS-CoV. If a party develops a new and non-obvious composition that is shown before the filing date to have efficacy or to have plausible reasons for efficacy in the treatment of an infection, then that is sufficient for patenting that composition (and method of use if available). Specific knowledge of the infective agent is not required.

While not mentioned in the interviews, consideration of the patentability of coronavirus material and methods should also take into account the requirement for being capable of industrial application and whether a country has any relevant exclusions to patentable subject matter on public policy grounds.

Article 27 of the TRIPS Agreement specifies the patentable subject matter requirements and was required to be implemented in the law of developed WTO member countries by 1st January 1995. The relevant provisions of Article 27 are:

Article 27 - Patentable Subject Matter
1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.
2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

Notably, under Article 27(1), being capable of industrial application is a necessary criterion and a footnote to that provision notes that capable of industrial application is synonymous with useful. Also notably, Article 27(2) allows, but does not require, member states to exclude inventions from patentability if preventing their commercial exploitation is necessary to protect ordre public or morality and gives protecting human life or health as an example of a qualifying reason for such exclusion.

However, in giving legislative effect to Article 27 of the TRIPs Agreement countries have given their own nuances to those provisions. For the ‘capable of industrial application’ requirement the USA and the UK just use that terminology or its synonym, whereas New Zealand and Australia require the invention to have a specific, credible, and substantial utility.

Notably there is no equivalent of the optional ordre public or morality provision in the USA Patents Law (35 USC). However, the USA Atomic Energy Act of 1954 provides that no patent shall be granted for any invention which is useful solely in the utilization of nuclear material or atomic energy in atomic weapons. In contrast, the vast majority of countries have given legislative effect to Article 27(2). Section 1(3) of the UK Patents Act 1977 provides ‘[a] patent shall not be granted for an invention the commercial exploitation of which would be contrary to public policy or morality’. Section 18(2) of the Australian Patents Act 1990 has a narrow patentability exclusion for human beings, and the biological processes for their generation. New Zealand has more wide ranging exclusions. Under section 15(1) of the NZ Patents Act 2013 an invention is unpatentable if the commercial exploitation of the invention is contrary to public order or morality. Section 15(1) also contains a list of specific examples of inventions for which their commercial exploitation is contrary to public order or morality, which includes the following:

• an invention that is a process for modifying the germ line genetic identity of human beings:

Section 16 of the NZ Patents Act 2013 also specifies other exclusions to patentability, including:

(1) Human beings, and biological processes for their generation, are not patentable inventions.
(2) An invention of a method of treatment of human beings by surgery or therapy is not a patentable invention.
(3) An invention of a method of diagnosis practised on human beings is not a patentable invention.

The interplay between Articles 27(1) and 27(2) of the TRIPs Agreement is worth considering in the context of highly infectious viruses. As noted above, US7279327 was applied for before the SARS-CoV outbreak and claimed utility by way of the generated coronaviruses being used in producing vaccines. If, counterfactually speaking, the application was drawn to a method of producing recombinant coronaviruses that were not replication defective, there would appear to be nothing in the US Patents Law (at least) that would allow a public policy objection to the application even if it could claim utility in producing vaccines. In contrast section 1(3) of the UK Patents Act 1977 and section 15(1) of the NZ Patents Act 2013 could be used to deny patentability on the public policy grounds of undue risk to human health. Similar results would appear to apply if we take the counterfactual scenario in which US7220852 involved a manufactured non-naturally occurring isolated coronavirus.

A more optimistic take on mRNA technology is given in the podcast Biopharmaceutical Innovation: “Unleashing the Body’s Immune System, from mRNA Vaccines to Cancer Cures.

Author: Quinn Miller

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