Proposal on the origin of genetic resources

CIPA has submitted to the UK IPO a response to WIPO’s proposal for a requirement to disclose the country of origin of genetic resources and the details of the indigenous people or local community that provided associated traditional knowledge.

The basis of the patent system

It should be remembered that the basis of the patent system is to encourage innovation by requiring publication of inventions so that others can use and build on the disclosure, and in return the patentee is given a statutory monopoly on the use of their invention for a limited and defined period of time. Anything that discourages innovation should be resisted.

The basis of the CBD and the Nagoya Protocol

The Convention on Biological Diversity (CBD) and the subsequent Nagoya Protocol were designed to encourage sustainable use of genetic resources from the perspective of protecting the traditional knowledge of indigenous peoples.

There has been an amount of mission creep from that position such that it has expanded to any genetic resource irrespective of whether it was associated with traditional knowledge or not. Now it is extending further with attempts to expand the definition of genetic resources to include digital sequence information.

CIPA’s view is that such expansion should be strongly resisted and in particular that proposals that make it more difficult for researchers to do their work and which are impractical to follow or apply should be rejected. CIPA has commented in the past about the problems raised by the EU’s requirements for using genetic material obtained from countries applying Nagoya.

The difficulties raised by disclosure of origin and possible penalties for failure

The recitals to the draft refer to:

“The promotion of the efficacy, transparency and quality of the patent system in relation to genetic resources (GRs) and traditional knowledge associated with genetic resources (Associated TK); Emphasizing the importance of patent offices having access to appropriate information on GRs and Associated TK to prevent patents from being granted erroneously for inventions that are not novel or inventive with regard to GRs and Associated TK; and Recognizing the potential role of the patent system in contributing to the protection of GRs and Associated TK”.

This recital reaffirms the intention that the CBD and Nagoya apply where there is a combination both of GRs and TK, and not GRs alone.

However, the proposal is limited solely to patents and patented inventions. It does nothing to identify the source of materials where no patent is involved. For example, if confidentiality is used to protect an idea; or where a new product is developed without any patenting.

In addition, knowing where the basic genetic material originated will do nothing “to prevent patents from being granted erroneously for inventions that are not novel or inventive with regard to GRs and Associated TK”. That can only be done by showing that the invention as claimed in the patent was part of the prior art or obvious in the light of the prior art. The prior art is, of course, worldwide prior art. Knowing where the material originated does little or nothing to identify the relevant prior art or to identify whether or not the patented invention claimed is indeed novel and inventive.

Further, the requirement to disclose country of origin will increase the burden upon patent offices. It will also delay the grant of patents and lead to greater expense in getting a patent.

Accurate verification of the country of origin is not always straightforward. In particular, if the genetic resource is obtained from a third party (e.g. a vendor or collaborator) to identify that third party will do nothing to identify the ultimate origin of the material.

CIPA is also concerned that an obligation to include a designation of origin will, in short order, create a future liability of some sort under the CBD or under the Access and Benefit Sharing Arrangements under Nagoya. Such a liability is completely unquantified and will reduce the incentive to invest in biotechnology. Further, there is the concern the additional burdens will be introduced in future agreements to the greater detriment of researchers and therefore of the common good.

CIPA notes with particular concern the possible penalties under article 6. In particular and notwithstanding article 6.3, which provides that:

“Subject to article 6.4, no Contracting Party shall revoke or render unenforceable a patent solely on the basis of an applicant’s failure to disclose the information specified in article 3 of this instrument”.

There is provision in article 6.2 that “Each Contracting Party shall provide an applicant an opportunity to rectify a failure to include the minimum information detailed in article 3 before implementing sanctions or directing remedies”, which clearly implies that penalties will be exacted for failure, presumably even if such failure is inadvertent or compliance was not possible or was impractical.

Of greater concern is the provision of article 6.4,

“Each Contracting Party may provide for post-grant sanctions or remedies where there has been fraudulent intent in regard to the disclosure requirement in article 3 of this instrument, in accordance with its national law.”

The presence of such a provision will inevitably mean that in very many cases, perhaps every case, the objection will be raised that there has been “fraudulent intent in regard to the disclosure requirement”. While strictly under English law “He who alleges must prove” there must be a real risk that a low level of proof will be required. The mere fact of error, inadvertent or otherwise, may be enough. For a patentee to prove that there has not been fraudulent intent will be difficult, if not impossible. In any event, it will expand the scope of any litigation hugely. Patent litigation is already complicated and far reaching enough, and accordingly expensive. All efforts should be made to limit such expense, not to encourage it. In countries where the standard of legal proceedings are less stringent, it may be yet more difficult to overcome the allegation of “fraudulent intent”.

These obligations and requirements in article 6 do not fit with the note 2 to article 3 indicating the need for light-touch regulation.

Additionally, the provisions of article 3 itself are open to manifold interpretations. They will inevitably lead to divergent approaches by different patent offices further complicating the applications for patents. In particular, who is “the applicant”? The inventor, as in the US? The company named on the application? The group of companies of which the applicant is a member? To find relevant information, perhaps deeply buried in the knowledge of the company, or worse of the group, of which the applicant is unaware will impose an impossible burden on the applicant, while failure to do so may lead to penalties in some unascertained future.

In support of a number of our concerns set out above, we refer in particular to: the US paper, The Economic Impact of Patent Delays and Uncertainty: US Concerns About Proposals for New Patent Disclosure Requirements; and the report from CropLife and FPMA.

The object of the patent system is the promotion of invention. Anything which conflicts with that objective should be resisted strenuously. To do otherwise will discourage invention. We are particularly concerned that the current proposals are directed at the biotechnology industry, an area of endeavour of which the UK is proud and which it is keen to promote as a future source of commercial success. Many of the inventors and developers in the biotechnology industry are small companies, universities or university spin-outs. They all have very limited funds and have great difficulty in raising sufficient funds to fully develop their ideas.

The effect of these proposals will be:

  • to delay the grant of patents;
  • to oblige applicants to spend further monies in getting their patents granted;
  • to increase the uncertainties as to the validity of the patents when granted;
  • to create a potential and unquantifiable future liability; and
  • to increase the expense of defending patents.

All this will make the getting of funds more difficult by discouraging investment into the industry, so reducing the opportunities for inventions to be developed and turned into commercial products, to the detriment of UK plc.

We believe that the proposal should be strongly resisted.

Prepared by CIPA Life Sciences Committee

Date Published: 02 March 2020

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