Recent Developments in the Patenting of Medical Technology at the European Patent Office

1. Recent Developments in the Patenting of Medical Technology at the European Patent Office Oxford Intellectual Property Research Centre 7 March 2011 Adrian Bradley

2. Industry Trends

3. Enlarged Board Decisions • Surgical methods (G2/08). • Dosage regimes (G1/07).

4. Surgical Methods (G 1/07) • Article 53 Exceptions to patentability European patents shall not be granted in respect of: … (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

5. The Claim • A method for MRI imaging the pulmonary and/or cardiac vasculature using dissolved –phase polarized 129Xe comprising the steps of… delivering polarized 129Xe to a predetermined region of the patient's body... • 129Xe had no therapeutic effect. • “Delivery” included injection into heart – mentioned in specification, but not claims.

6. “Surgery” • Is a claimed imaging method for a diagnostic purpose…which comprises…a step consisting in a physical intervention practised on the human or animal body…to be excluded…if such step does not per se aim at maintaining life or health? • Defined by nature or purpose of intervention? • Required involvement of a medical practitioner?

7. Divergent Board of Appeal Decisions • T182/90, T35/99 • Treatment not confined to curative purpose – cosmetic treatments, sterilisation, embryo implantation. • “In their nature” methods for treatment by surgery.

8. “Purpose” decisions • T 383/03 – Hair removal using optical radiation. • Non-insignificant intentional physical intervention. • Not potentially suitable for maintaining or restoring health. • Merely cosmetic results. • Patentable.

9. Enlarged Board • Examined travaux préparatoires. • Looked into rationale for exclusion. • Criticised approach taken in T 383/03. • 53(c) defines three separate exclusions.

10. Indicative Features of Surgical Methods • “A claimed...method, in which, when carried out...maintaining the life and health of the subject is important and which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise”

11. Advances in Technology • Certain non-therapeutic invasive techniques have routine character not excluded from patentability. • No reason in principle why medical techniques of similar nature excluded.

12. Further Questions • Claim cannot encompass such a surgical step. • It is in principle possible to disclaim methods having excluded surgical step. • Possibility of omitting surgical step depends on circumstances. • Imaging method not excluded merely because of use in surgery.

13. Putting it into Practice - T266/07 Method for producing a magnetic resonance angiogram of selected vasculature in a subject, wherein a contrast agent has previously been introduced into the selected vasculature so that the intensity of the NMR signal of the vasculature dominates the intensity of NMR signals in other materials within an entire field of view, comprising the steps: a) operating the MRI system to perform a pulse sequence which includes: i) producing an RF excitation pulse to excite spins in the entire field of view which includes the selected vasculature; ii) applying a phase encoding gradient along a first axis; iii) applying a radial gradient directed at an angle θ in a plane perpendicular to the first axis; and iv) acquiring an NMR signal during the application of the radial gradient to sample an angular projection of the data in k-space having NR data points radially spaced along a projection; b) repeating step a) with a set of different phase encoding gradient values for each of a plurality of different radial gradient angles θ until k-space is sampled, wherein the plurality of different radial gradient angles θ is less than NR π/4 in number so that a sparsely sampled three-dimensional k-space data set is acquired; c) Fourier reconstructing along the first axis a three-dimensional volume image of the entire field of view from the sparsely sampled k-space data set, whereby the spacial resolution of the resulting image is not affected by the sparse angular sampling and the artifacts associated with the sparse angular sampling are acceptable being no more than a few percent of the signal associated with the tissue surrounding the vasculature, d) providing reduction of image artifacts generated by the sparse sampling by subtracting from the image reconstructed in step c), a mask image of the selected vasculature that was acquired before the contrast agent was introduced into the selected vasculature; and e) displaying the reconstructed image produced in step d).

14. Application of Principles • Examining division found claimed method implicitly covered injection of contrast agent => contravened 53(c). • BoA – presence of contrasting agent obligatory for functioning of method; BUT • imaging method not functionally related to actual administration of contrast agent.

15. Relevant Paragraph “Methods which are merely directed to the operating of a device without themselves providing any functional interaction with the effects produced by the device on the body are teachings in which the performance of a physical activity or action that constitutes a method step for treatment of a human or animal body by surgery or therapy is not required in order for the teaching of the claimed invention to be complete. Hence, even if in such a case the use of the device itself requires the application of a surgical step to the body or is for therapeutic treatment the same does not apply to the claimed method for operating the device.”

16. Impact on Practice • Diagnostic/imaging methods not involving substantial physical interventions should be patentable (e.g. methods involving routine blood sampling). • Some cosmetic/non-therapeutic techniques may be excluded if they involve substantial intervention. • Consider use of terms such as “previously obtained,” “previously injected,” or “pre-adminstered agent” to circumvent the exclusion.

17. Dosage Regimes (G2/08) • Known medicament for treatment of known indication. • Only novel feature “use in the treatment by oral administration once per day prior to sleep”. • A 53 European patents shall not be granted in respect of.... (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body. • A 54(5) …shall not exclude the patentability of any substance or composition…for any specific use in a method...provided that such method is not comprised in the state of the art.

18. Position Under EPC 1973 • Only “First Medical Uses” mentioned in Article 54. • Methods of medical treatment deemed to lack industrial applicability. • Subsequent uses protected by form of claim approved in G5/83. • “Use of substance X for the manufacture of a medicament for the treatment of disease Y”

19. Divergent Case Law • First line of cases - • Mere dosage regime incapable of imparting novelty. • Feature exclusively pertaining to skill of practitioner; thwarts purpose of 53(c). • Second line - • “Specific use” covered all therapeutic uses prohibited by 53(c). • Legislator did not distinguish between new indication and new dosage regime. • As scope of claim under EPC 2000 & 1973 different, important point to address.

20. Enlarged Board's Reasoning • Article 54(5) does not define the nature of the “further therapeutic use”. • On the contrary, the provision provides that “any specific use” not comprised in the state of the art is eligible. • Legislative history – contemplated doing away with prohibition on methods of treatment provided there was a technical problem solved; no re-patenting of substances.

21. The Decision • “A seamless fit” • Either - • A method is prohibited by A 53(c), and so may be protected by via a claim to a composition for use in such a method; or • Method is not prohibited by A 53(c), and may be claimed as such. • Whole jurisprudence relating to novelty and inventive step applies.

22. Impact on Practice • Useful protection available in Europe for novel and inventive • routes of administration; • dosage formats/regimes; • patient populations. • Focus should be on unexpected results compared with known therapies. • “Swiss claim” no longer allowable.

23. Highlights of Other TBA Decisions • T 1002/09 • A liquid nutritional composition for use in promoting gut health in an elderly patient comprising a protein source, a source of digestible carbohydrates and a source of dietary fibre, characterised in that it has an energy density of 1.3-1.8 kcal/ml and dietary fibre in an amount of more than 2.5g/100ml. • Composition was novel per se.

24. T1002/09 • Issue – could feature “for use in promoting gut health in an elderly patient” be considered amethod for treatment of the human or animal body by therapy?

25. T1002/09 - Decision • In the board’s judgement, alleviation of pain and suffering by promoting gut health in applying measures which regulate gut flora and improve intestinal transit are therefore therapeutic measures (at least in the sense of prophylaxis) for preventing malfunctions or illness of the human body. • Limitation to elderly population group distanced claim from prior art, which taught that high amounts of fibre where undesirable in old people.

26. T 566/07 – Vital Dyes for Vitreo-Retinal Surgery “1. Use of at least one vital dye for the manufacture of a composition for staining a retinal membrane in an eye to visually distinguish the retinal membrane from the underlying retina in a method for performing retinal membrane removal.”