Claims &Gene Patents

1. Claims &Gene Patents • As already noted, claims delimit the scope of legal rights and extent of property rights to which the patentee is entitled. • A crucial foundation for the legitimate exercise of property rights by a patentee is the presumption that the patentee has specifically and clearly outlined HOW the invention is to be worked by persons skilled in the art.

2. Inutility and Claims • Given the inextricable link between the claim(s) in a specification and the test of utility, it follows that an invention lacking in utility or which the inventor is unable to explain and delimit AT THE TIME the application for a patent is made is fatally flawed. • If such an application is mistakenly granted by the Patent Office, weighty questions of law and policy are implicated.

3. Claims and Genetic Patents • Arguably, the most problematic patents issued in contemporary times pertain to pioneer genetic patents and other types of biotechnological inventions with as yet undetermined utility. • This phenomenon often gives rise to a situation in which overly broad, sometimes speculative claims are used to prop up or support questionable patent applications.

4. Genetic Patents and Claims • What is troubling about some patented gene sequences is that unlike other chemicals with known utility, the functions of certain genetic material are often unknown even when scientists know the function of a similar gene sequence.

5. Homology and Sound Prediction • A considerable number of genetic patents have been issued on the basis of homology rather than specific and ascertained utility or function. • While this approach may be justified in respect of certain classes of chemicals on the basis of the doctrine of sound prediction, an application of that doctrine to genetic sequences flies in the face of the science of genetics.

6. Homology & the Limits of Sound Prediction • As the National Institutes of Health (NIH) and the Association of American Medical Colleges (AAMC) have observed, patents on homologous sequences are flawed because a “difference in a single base pair in a gene sequence can have important functional implications.”

7. Homologous Genes • Granting patents on gene sequences with unknown functions simply on the basis of homology or “sound prediction” is speculative and presumptuous. • According to Bruce Alberts & Sir Aaron Klug, such patents are contrary to the essence of patent law.

8. Sir Aaron Klug • “Those who would patent DNA sequences without real knowledge of their utility are staking claims not only to what little they know at present, but also to everything that might later be discovered about the genes and proteins associated with the sequence. They are, in effect, laying claim to a function that is not yet known or a use that does not yet exist. This may be in current shareholders’ interests. But it does not serve society well.”

9. Homologous Genes • Both the CIPO and USPTO have issued thousands of patents on ESTs. The corresponding gene, protein product, and biological role of gene fragments are not fully characterized. • Generally, only putative functions are proposed on the basis of homology-based comparisons with conserved gene families.

10. Inutility and Claims • There is little question that where patents are issued on genetic materials without demonstrable utility the society is short-changed. • At the juridical level, the granting of speculative genetic patents distorts the evidential burden of proof which is crucial in patent law litigation.

11. Presumption of Validity • “After the patent is issued, it shall in the absence of any evidence to the contrary be valid and avail the patentee and the legal representatives of the patentee for the term mentioned in section 44 or 45, whichever is applicable.” s. 43 (2) Patent Act.

12. Evidential Burden? • In Canada, opinion is divided as to whether the presumption of validity is an evidential burden to be discharged by the dft in a patent validity trial or an incidental burden of introducing preliminary evidence. Dube, J. opined that the burden is on the dft. Pratte J., in Rubbermaid opined that it depends on the circumstances of the case.

13. Misleading Claims • S. 53 (1) of the Patent Act provides that a patent is “void if the specification and drawing contains more or less than is necessary for obtaining the end for which they purport to be made and the omission or addition is WILFULLY made for the purpose of misleading.”

14. Implications of Homologous Patents • It has been increasingly shown that overly broad claims in genetic patents or genetic patents without proven utility has had a chilling effect on medical research. • In the US, 30% of the laboratories surveyed ceased to provide or develop genetic tests for fear of infringing on overly broad claims on some patented gene sequences. • There is increasing evidence of an unwillingness to share scientific findings.

15. Implications of Patents on Homologues • Scientists are still at the very early stages of understanding the human gene. Overly broad claims in genetic material has a tendency of restricting access to such materials especially, to private sector researchers who are usually in the downstream sector where therapeutic products are more likely to emerge from biomedical research.

16. Implications of Patents on Homologues • Biomedical research necessarily requires access to a number of genetic materials. Where there are overlapping patent claims and licenses, access to such materials requires significant transaction cost. • The development of new therapeutic agents by private firms requires a process of receptor screening. Even in the case of plant therapeutic pharmacognosy, assaying is a crucial part of research.

17. Implications of Patents on Homologues • Similarly, the screening of large numbers of drug candidates in order to assess possible effects on cellular function requires obtaining an extensive group of licensing agreements to avoid patent infringement suits, and private firms cannot qualify under research exemptions in developing commercial products.

18. Implications of Patents on Homologues • In effect, biotechnology and pharmaceutical firms may be dissuaded from engaging in necessary downstream research. • Patent licensing of upstream genetic sequences may result in numerous overlapping rights in downstream commercial products.

19. Implications of Patents on Homologues • License agreements may contain conditions granting the licensee royalties in future commercial products developed. Upstream genetic patent holders may thus acquire rights to subject-matter outside of the original patent claims, and exert control over downstream research and product development.

20. Implications of Patents on Homologues • Patents over gene sequences of unidentified utility may prevent researchers from collaborating and contributing to proteomics research, the characterization of protein structure and function. • There is no doubt that the field of proteomics will eventually replace genomics as the major field of biomedical research and will provide a novel array of protein-based platform technologies and products.

21. Genetic Patents and Claims • In the light of the problems highlighted above, certain proposals fall for consideration. • The first is a restriction on patents on gene sequences or tags without proven utility and a careful calibration of the role of the doctrine of sound prediction in claims pertaining to genetic materials.

22. Genetic Patents and Claims • The use of computer analysis of genetic sequence data based upon homology, or sequence similarity, to previously discovered gene sequences and patent utility submissions based on such data is a flawed mechanism for assessing utility. • There is scientific consensus that sequence homology analysis is unreliable and should no longer form the basis of an alleged assignment of gene function.

23. The Trouble with Homologues • Even in circumstances where such analysis provides a reasonable general function, such putative assignment does not assess the actual biological role of the gene sequence and protein product. • Again, even if such homology-based utility analysis is employed, the genetic sequence should be considered obvious with respect to prior art.

24. Genetic Patents and Claims • Further, a patent applicant must provide in the claims and supporting written description a specific and substantial utility that would be considered credible by a person of ordinary skill in the art. • Insubstantial and non-specific uses should not suffice for the purposes of the utility requirement.

25. Genetic Patents and Claims • The exemption granted to private researchers deserves a critical rethink. Given that most downstream research and product development occur in private laboratories, the exemption granted to such researchers should be extended. DNA and RNA constitute the blueprint for protein production, enzyme and hormone regulation, and basic cellular processes. Exclusive monopolies on DNA fragments bears enormous consequences.