Some pharmaceutical products are based on, or consist of, biological materials. These include compounds extracted from plants and algae as well as human proteins33 obtained by extraction or through genetic engineering techniques (e.g.. interferon, erythropoietin, growth hormone). Plants, in particular, are an indispensable source of medicines34.
33 For instance, a patent claim relating to a protein isolated from nature reads as follows: “Homogeneous erythropoietin characterized by a molecular weight of about 34,000 dalton on SDS PAGE, movement as a single peak on reverse phase high performance liquid chromatography and a specific activity of at least 160,000 IU per absorbance unit at 280 nanometers” (US patent No. 4,677,195). This claim was deemed invalid by a U.S court as overly broad and indefinite. See Silbey, 1994, p. 17.
34 See, e.g., Lambert, Srivastava and Vietmeyer, 1997, p. 1.
Whether biological materials are patentable depends in significant part on whether they are characterized as “inventions” (and therefore patentable) or “discoveries” (not patentable). Different patent law traditions treat this question differently.
If the philosophy underpinning patent law is that broad protection can foster inventive activity, then biological materials exceptions may seem unnecessary, or even counterproductive. Moreover, some developing countries may worry that excluding substances found in nature from patentability could conceivably hinder investment in some local activities, including activities that might otherwise lead to patents on products derived from traditional knowledge or specific local skills or know-how. The extent of any such disincentive, however, would depend on local industrial capabilities and on the existence of laws providing alternative forms of protection, including utility model laws or proposed laws to protect non-secret know-how35.
35 See, e.g., Reichman, 1997.
Countries with scarce local research capabilities and countries prioritizing medicine affordability and access may prefer a different approach, choosing to seek limitations on the patentability of substances existing in nature. Countries which deem patentability of such substances as contrary to basic cultural and ethical values36 may similarly seek to limit biological materials’ patentability. The ability to do so will be limited, however, by the provisions of the TRIPs Agreement which requires the patentability of microorganisms and of non-biological and microbiological processes for the production of plants and animals (Article 27.3.b).
36 See, e.g., the proposal for review of article 27.3. b of the TRIPs Agreement submitted by Kenya on behalf of the African countries (WT/GC/W/302, of August 6, 1999).
National laws vary considerably in characterizing biological materials as inventions or discoveries. In some jurisdictions (e.g., the United States) an isolated or purified form of a natural product, including genes,37 is patentable38. The European Directive on Biotechnological Inventions (No. 96/9/EC of March 11, 1996)39 adopts a similar approach. The Directive, essentially declaratory of long standing law throughout much of Europe, establishes that “biological material” and substances isolated from nature (such as new antibiotics) will be considered patentable40.
37 For instance, claim 2 of a U.S patent obtained by Amgen reads: “A purified and isolated DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin”.
38 See, e.g., Bent et al, 1991, p, 123; Grubb, 1999, p. 213. The extent of patentability of biological materials in the USA has not been addressed yet, however, by the Supreme Court.
39 “Biological material which is isolated from its natural environment or processed by means of a technical process may be the subject of an invention even if it already occurred in nature” (article 3.2).
40 See, e.g., Grubb, 1999, p. 213. See also Sena (1999, p. 736-738) who suggests the use of compulsory licenses to remedy the possible negative effects on subsequent research that may result from the extension of patentability to simply isolated materials.
PATENTING OF GENES
In many jurisdictions, gene patenting has become common practice. Claims often include natural DNA sequences without limitations.a) The only condition on these patents is that genetic materials must be claimed in a non-naturally-occurring form, that is, as an isolated or purified molecule. In the United States, for example, the doctrine of Re Deuel (1995) has paved the way for the patenting of DNA even when encoding known proteins on the grounds that - due to the degeneracy of the genetic code - their structure could not have been predicted.b) However, the principle set out in re Duel does not apply in Europe. Gene sequences which code for a known protein are generally now regarded as prima facie obvious, although such was not the case in the earliest days of molecular biology.
a)Patenting may relate to genomic DNA, a natural substance, or cDNA, that is, a DNA copy of mRNA that does not exist as such in nature. The US Court of Appeals for the Federal Circuit has affirmed the validity of claims to full length DNA or genomic DNA molecules in the pharmaceutical field. See, e.g., Ducor, 1998.
b)See, e.g., Baldock, 1999, p. 21.
Some developing countries, in contrast, have explicitly excluded the patentability of existing biological materials, unless they are genetically altered.c) This stance may exclude certain biotechnology-based products from the patent domain, though patents may still be granted for the process used to obtain the biotechnology-based product.
c)Thus, the Mexican law (1991/1994) excludes the patentability of all genetic materials. The Argentine patent law (1995) and the Andean Group Decision 344 (1993), do not allow, in principle, the patentability of materials existing in nature. The Brazilian patent law (1996), stipulates that no patents shall be granted with respect to living beings or “biological materials found in nature”, even if isolated, including the “genome or germplasm” of any living being.
In Canada, the Federal Court of Appeal (in a case relating to a new hybrid soybean variety) rejected the claim that hybrid plants were a “manufacture or composition” (and hence patentable). The court held that since the hybrids were not “produced from raw materials” or “a combination of two or more substances united by chemical or mechanical means” d), they were not patentable. Since that decision, the Canadian Patent Office has denied patents for higher life forms like plants and animals. For instance, the patentability of the Harvard University “oncomouse” was rejected in 1995 and the denial upheld by a court in 1998 (still pending final decision).
d)PioneerHi-Bred Ltd. v. Canada (Commissioner of Patents), 1989, l S.C.R. 1623. See e.g., Vaver, 1997.
The TRIPs Agreement does not define what an “invention” is; it only specifies the requirements that an invention should meet in order to be patentable. This leaves Member countries considerable freedom to determine what should be deemed an invention, and to exclude from patentability any substance which exists in nature41. In particular, DNA molecules may be regarded as building blocks of nature, which should be free for use by the scientific community and for any productive application.
41 The Agreement obliges Member States to protect “microorganisms” but nothing in the Agreement can be interpreted as requiring the patentability of microorganims found in nature and not “invented”, for instance, by alteration through genetic engineering.