Reach Through RT Claims   Are research tools, and associated patents and licences, a good thing for industrial research

Reach Through RT Claims Are research tools, and associated patents and licences, a good thing for industrial research PowerPoint PPT Presentation

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Reach Through RT Claims Are research tools, and associated patents and licences, a good thing for industrial research

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1. 1 Reach Through (RT) Claims – Are research tools, and associated patents and licences, a good thing for industrial research? J C Gaal PhD RPA EPA Head of Biotech Patents, Syngenta Limited M T Flattery BS JD Global Head IP & Licensing, Syngenta Group

2. 2 Disclaimer The views expressed here do not necessarily reflect those of our present or former (or possible future) employers. Views, however, are dictated by the needs of the client!

3. 3 Patents “solely” to keep the competitor out Patents are commercial weapons – used to deter a competitor from entering the same market/territory. The principal entities precluded by the patent are unlikely to be the Patentee’s customers. No need (desire) for Patentee to licence to survive

4. 4 Research Tool Patents Patents are the principal means by which to generate revenue by licence. The principal entities precluded by the patent are likely to be the Patentee’s customers Need to licence to survive.

5. 5 RT Claims Potentially offensive RT claims may be present in:- Licences - invoices, etc for receipt of goods Patents

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8. 8 Licences with RT provisions The Patentee may seek to enforce RT claims through licence agreements. i.e. licences to use screening techniques/material which contain high royalty rates based on commercialisation of a product obtained by use of the technique. If the licence is imposed by contract per se the validity of the patent claim is irrelevant because the cause of action will be for breach of contract and will operate outside the terms of the patent.

9. 9 RT Claims Sadly, just as in purely “academic” research, most industrial research does not lead to any “commercial” product or process. The majority of contracts which contain RT provisions, based on sales of products, the development of which involved early use of the research tool, are unlikely to generate revenue for the Patentee/Licensor.

10. 10 RT Claims We need to be wary of licences containing RT provisions in small print on the back of an invoice or acceptance of order form for the supply of a screening agent which is signed innocently in routine manner by a purchasing officer.

11. 11 RT Claims Possible unfair competition law issues – depending on the form and substance of the “licence” and the length and scope of the intended “reach”. We expect the sympathy of the court if the “licence” terms are oppressive or operate to stifle research.

12. 12 When are patents for research tools infringed? (S60 UKPA) Infringement requires some Making Using Disposing of Offering to dispose of Importation Keeping Of the claimed invention within the jurisdiction of the court, or Some supply (or offer to supply) of essential means for carrying out the claimed invention, except that – when the supply is of a staple commercial product the supply must have been intended to induce the purchaser to work the claimed invention And provided that the act does not fall within permitted exceptions.

13. 13 Permitted exceptions to patent infringement in UK S60(5)a. private acts, (experimental or otherwise) performed for non-commercial purposes S60(5)b. private or public acts performed for experimental purposes relating to the subject matter of the invention S60(6) a supplier to someone who per se is exempted under S60(5) is not himself exempted.

14. 14 Research Tool patents with RT Claims during each stage research RT claims of the form: “Compounds having a function, obtainable/obtained by use of the assay …….” are unlikely to be infringed during early stage research: Success is a possible “infringing” act Failure is not.

15. 15 Research Phase During the research phase –Industry can, usually, relatively easily:- Move research to a patent-free territory Probably avail itself of statutory exemptions to patent infringement for truly experimental and/or private and non (immediately) commercial acts possibly including clinical and field trials, depending on the territory

16. 16 Production But what about production?

17. 17 Production Functionally equivalent, non patented, non licensed alternatives may be available/could be made Licences may be obtained – where the terms are “objectively” equitable – or the upfront costs and RT royalties are less than the likely costs of litigation – taking “stacking” into account and the need to return a reasonable profit margin.

18. 18 Production 3. Patent/licence impediments may have to be removed by litigation/opposition. 4. “Big Industry” is not averse to law suits and has the financial clout to carry them through to a successful conclusion.

19. 19 Validity Granted patents have a presumption of validity: Noble sentiment Is that presumption now greater for some technology areas than others? Biotech patents have a poor record in terms of being held to be valid (and infringed).

20. 20 Patentable Invention A patent is granted in respect of an invention – i.e. a Novel; Non-obvious; Industrially applicable; Non-excluded; Technical solution to a problem.

21. 21 Patent Description The invention must be described in the patent in a manner sufficiently clear and complete to enable the skilled man to make/use it; and Materials for use in a process must be adequately described in the patent or obtainable without undue burden; and Some evidence in the patent (file) that the patentee was truly in possession of the invention at the effective filing date of the patent.

22. 22 Claims RT claims – almost by definition – attempt to cover things not specifically disclosed in the patent – otherwise they would not “reach”. Each case needs to be considered on its own merits – but …..

23. 23 Claims RT claims normally fail (somewhere in the process) on at least one of the following: Lack of written description of the RT products, or materials for use in a process – i.e. no evidence that the patentee was in possession of the invention; Lack of enablement – over the effective scope of the claim; Lack of novelty; Lack of inventive step; Lack of utility.

24. 24 University of Rochester vs G.D. Searle, Pfizer & Pharmacia Assay and method of treatment claims which RT to Cox 2 inhibitors not known to the patentee Claim 1 A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment.

25. 25 University of Rochester vs G.D. Searle, Pfizer & Pharmacia No written description/sufficient disclosure of the inhibitors for use in the claimed methods – the essential technical limitations of the claims Fell at the first “objective” hurdle (“A description of what a material does rather than what it is usually does not suffice”) But might have been revoked for lack of enablement assuming written description had not been contemplated?

26. 26 Bayer AG & Bayer Corporation vs Housey Pharmaceuticals Inc. US patent for drug screening assay Claim 1 of USP4,980,281 A method of determining whether a substance is an inhibitor or activator of a protein whose production by a cell evokes a responsive change in a phenotypic characteristic other than the level of said protein in said cell per se, which comprises: a. Providing a first cell line which produces said protein and exhibits said phenotypic response to the protein; b. Providing second cell line which produces the protein at a lower level than the first cell line, or does not produces the protein at all, and which exhibits said phenotypic response to the protein to a lesser degree or not at all; c. Incubating the substance with the first and second cell lines; and d. Comparing the phenotypic response of the first cell line to the substance with the phenotypic response of the second cell line to the substance.

27. 27 Bayer AG & Bayer Corporation vs Housey Pharmaceuticals Inc. Bayer allegedly used the assay in Europe to develop drugs sold in the US. 35USC 271(g) Whoever without authority imports into the United States or offers to sell, sells, or uses within the Untied States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent …… A product which is made by a patented process will, for purposes of this title, not be considered to be so made after- 1. It is materially changed by subsequent processes; or 2. It becomes a trivial and nonessential component of another product.

28. 28 CAFL held that 271(g) only applies to manufactured products, or methods used directly in making a final product – not information which is the “product” of the Housey claim.

29. 29 Chiron Corporation vs Genentech Inc Chiron patent (USP6,054,561) granted with claim to MAb that “specifically” binds a human breast cancer Ag. Claim 1 A monoclonal antibody that binds to a human breast cancer antigen that is also bound by monoclonal antibody 454C11 which is produced by the hybridoma deposited with the American Type Culture Collection having Accession No. HB8484.

30. 30 Chiron Corporation vs Genentech Inc None of the priority applications satisfied the written description requires for the Ag CAFC decided that the ‘561 patent was not entitled to priority Interfering prior art deprived the claimed invention of novelty The patent was thus held invalid.

31. 31 Amendments “Wordsmithing” the claim, whilst useful to overcome novelty and inventive step objections, may not overcome written description and/or enablement deficiencies. A fundamentally deficient disclosure is very difficult to repair after the application has been filed – without changing the basic nature of the claimed invention.

32. 32 Patent System The object of the patent system is to reward and encourage innovation. An attempt to inhibit scientific progress by using research tools and/or patents or licences with RT claims, in a monopolistic manner, will likely bias the court in favour of the alleged infringer.

33. 33 Patent System In an area of uncertain law – as exists in relation to research tool patents – the courts have little difficulty in finding a way of reaching a decision in conformity with what they see as the over-riding public interest – which is likely to favour scientific progress, whether industrial or not, rather than stifle it.

34. 34 Conclusion Whatever the value of Research Tool patents and “covetous” RT claims to the Patentee – in terms of affecting industrial R&D, generally they are a nuisance rather than serious impediment.

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