I thank noble Lords for their amendments regarding intellectual property laws. I will first take the probing amendment in the name of the noble Baroness, Lady Bennett of Manor Castle, which would prevent an organism from qualifying for precision-bred status if it was subject to a patent, either on the product itself or on the process used to
produce it. This provides an opportunity for us to explore how a precision-bred organism can be patentable, and what it means for such an organism to be capable of having
“resulted from traditional processes or natural transformation”.
As I am sure she is aware from previous debates in Committee, it is the final genetic composition of an organism that we are considering when assessing whether a plant or animal meets the criteria for being “precision bred” as set out in the Bill. This is in line with the scientific advice we have received: that it is the final genetic and phenotypic characteristics of an organism that are important and not the technology or process used to produce it.
This approach differs fundamentally from the current principles used to determine whether patents are available for plants and animals whose DNA has been altered using modern biotechnology. Unlike the definition employed in the Bill to determine whether an organism is precision-bred—which, as I have said, focuses on the end result—patent principles focus on the technology or processes used to produce these plants and animals.
The definition of a “precision bred organism” should continue to be based on scientific evidence and advice. In continuation of this logic, it would be disproportionate and unscientific to prevent a qualifying precision-bred organism from having precision-bred status on the basis of the granting or not of a patent. To prevent precision-bred organisms from obtaining patent protections would go against the core principles on which the Bill is based: that regulation should be proportionate, robust and driven by the evidence.
An invention must meet a number of legal requirements if a patent is to be granted. The granting of a patent is determined not only by the nature of the invention but by other legal requirements, including whether the invention is new or non-obvious. This is not the same as asking whether an invention that did not exist previously could, in principle, have been produced through a different method. As such, the presence or absence of patent protection cannot be used to determine if a particular DNA sequence could have resulted from traditional processes or natural transformation.
Patents represent an important mechanism for innovators to gain return on their investments. As a result, preventing organisms from being classed as “precision bred” if those organisms or the processes used to create them are subject to patent protection, would likely deter uptake of the technologies that the Bill wishes to facilitate. Ultimately, the UK would lose the significant benefits that implementation of the Bill could bring.
Amendment 74 would require the Defra Secretary of State to review and publish guidance on the implications of the genetic technology Bill for intellectual property law. As I am sure that noble Lords are aware, in the UK the Intellectual Property Office is responsible for patents. I assure noble Lords that we have worked closely with the Intellectual Property Office in this area. UK patent law does not specifically exclude patents from being granted on precision-bred plants and animals. Indeed, a patent may be granted if all the requirements for a particular invention are met—novelty, utility, and non-obviousness.
The Bill does not make any changes to laws associated with obtaining a patent; nor does it alter the process by which an applicant would apply for patent protections. Breeders wishing to patent their precision-bred plant or animal should therefore undertake this process in the same manner as for all other inventions and under the guidance of the Intellectual Property Office.
Most interest in this area has revolved around the use of patents that protect precision-bred organisms. However, it is important to note that other protections for intellectual property are available. For example, a plant breeder may want to obtain protection using plant variety rights. In animals, breeders generally gain protections through contracts with buyers, which stipulate terms to ensure their trait of value is protected. Engagements with industry stakeholders have highlighted that fair access and value gains for farmers must balance with restrictions on the use of protected material in order to enable a return on investment. In plant breeding, licensing platforms which facilitate access to patented material have been borne out of the need to create this equilibrium. We envisage that a similar situation would arise should breeders decide to protect their precision-bred organisms. Ultimately, patent law strikes a balance between incentivising innovation and allowing access for farmers and breeders, precisely the point that the noble Baroness, Lady Wilcox, was making.
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