Abstract
In this chapter we review recent developments in patent law in the US and Europe in relation to the patenting of ‘isolated’ human body materials, noting the tension in patent law between its general aspiration of promoting the (bio) economy while at the same time ring-fencing products of nature from effective monopolisation by patentees. Central to this is the proposition that patents should be granted for ‘inventions’ but not for ‘discoveries’, two symbolic terms that lack clear definitions. We find that hard law has been used in Europe to define a boundary between these categories that is industry-favourable – mere isolation transforms a discovery into an invention. By contrast, in the US, the Supreme Court has rejected this view, a view that was dominant for a century in US practice, considering that something beyond mere novelty over the natural material in its natural environment is required – some act of invention must have occurred.
A discovery may be brilliant and useful, and not patentable.No matter through what long, solitary vigils, or by what importunate efforts, the secret may have been wrung from the bosom of Nature, or to what useful purpose it may be applied. Something more is necessary.(Morton v. New York Eye Infirmary 1862, emphasis added).
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Notes
- 1.
On a more general note regarding the communication criterion, we should point out that, in Europe, particular “structures for deliberation” are in place “which stimulate the communication between the executive, the judiciary and the addressees of the law” (van Klink <CitationRef CitationID="CR39" >2016</Citation Ref>), viz. the oral hearings before the Opposition Divisions, Technical Boards of Appeal and Enlarged Board of Appeal of the EPO, all of which are open to the public.
- 2.
The same is true for the EPC’s exclusions from patentability of methods of medical treatment and of plant and animal ‘varieties’. These issues fall outside the scope of this chapter.
- 3.
However, we must add a note of caution since, at least under European patent law, process claims also provide protection for the products directly obtained by the claimed process.
- 4.
Novelty, viewed from a patent law perspective, is somewhat counterintuitive for those outside the field and is construed very strictly. For a patent claim to lack novelty, the prior art (i.e. all that was known or available publically before the patent application was filed), must not contain something that falls within the scope of the claim and was reproducible on the basis of publically available teachings. Put differently, to deny patentability for lack of novelty, the prior art must do more than point towards the invention, it must take you by the hand and drag you to it.
- 5.
In Europe, following the adoption of the European Biotech Directive, the acceptability of this patent claim format has been written into the Regulations of the European Patent Convention, as will be discussed below.
- 6.
Recently, the Full Court of the Federal Court of Australia in September 2014, has poured scorn upon the US Supreme Court’s decision in AMP v Myriad (D’Arcy v Myriad Genetics Inc. <CitationRef CitationID="CR7" >2014</Citation Ref>).
- 7.
He also significantly funded the Japanese gift of cherry trees to Washington DC, trees which are a feature of Spring in Washington. We are most grateful to Dr Jon Harkness for his help in elucidating the patent history of Takamine, Parke-Davis & Co, and adrenalin (see Harkness <CitationRef CitationID="CR21" >2011</Citation Ref>).
- 8.
The USPTO has since changed its guidelines to USPTO Examiners to make this clear (USPTO <CitationRef CitationID="CR38" >2014b</Citation Ref>).
- 9.
This has been developed further by the US Supreme Court in its more recent decision Alice v. CLS (<CitationRef CitationID="CR2" >2014</Citation Ref>), a decision relating to the patentability of computer-implemented inventions.
- 10.
In spite of the exclusion from patentability of plant and animal varieties by art. 53(b) EPC, this decision, handed down in December 1999, accepted the patentability of plants and animals as long as they were claimed at a higher than lowest taxonomic level – thus rodents are potentially patentable, while Mus mus domesticus is not (see Sterckx and Cockbain <CitationRef CitationID="CR31" >2012</Citation Ref>, chapter 7).
- 11.
In this chapter we do not have the space to explain the reasons why the new Rules tempered the morality clause (Art. 53(a) EPC) (see Sterckx and Cockbain <CitationRef CitationID="CR31" >2012</Citation Ref>, chapter 8).
- 12.
Therefore, we would argue that only subject matter which is both novel and inventive over a discovery should be patent-eligible. Detailed arguments for this position are provided in Sterckx and Cockbain (<CitationRef CitationID="CR31" >2012</Citation Ref>).
- 13.
Discovery – (a) The act of finding anything hidden; (b) The act of revealing something secret.
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Sterckx, S., Cockbain, J. (2016). The Natural, the Informational, the Claimable? Human Body Material in US and European Patent Law. In: van Klink, B., van Beers, B., Poort, L. (eds) Symbolic Legislation Theory and Developments in Biolaw. Legisprudence Library, vol 4. Springer, Cham. https://doi.org/10.1007/978-3-319-33365-6_13
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