Small step, super scope patents for molecules

1. Small step, super scope � patents for molecules David Brennan Pacific Rim Innovation Conference IPRIA Melbourne January 2010

2. Late 19th / Early 20th CenturyEuropean chemical patenting UK patent law, originating from the 1623 Statute of Monopolies, regarded chemicals as suitable subject matter for product patent protection as a matter of course The precepts of UK patent law forged in an era of mechanical invention Germany had no uniform patent law until 1877 At that time the synthetic dye industry was emerging as a major industry in which Germany had strong comparative advantage

3. Late 19th / Early 20th CenturyEuropean chemical patenting German dyestuff industries favoured the inclusion of processes for making chemical products but the exclusion of chemical products from the patent system because �the grant of a patent for the product itself would prevent better processes discovered subsequently from being brought into effect� (Chemical Association) Section 1 of the 1877 Patent Law excluded �substances prepared by chemical processes in so far as the inventions do not relate to a definite process for the preparation thereof�

4. In Congo Red (German Supreme Court 1889) use of a standard process yielded a valuable new dye Court holds that while the process alone lacked any inventive step, as specifically applied it created a �new technical effect� [the particular properties of Congo Red] which conferred inventive merit upon the process The new technical effect theory has been credited as heralding the �routinization of innovation� insofar as trial and error within corporate research teams rather than the individual�s flash of genius became the hallmark of the patent system Late 19th / Early 20th CenturyEuropean chemical patenting

5. In the midst of WWI the UK Parker Cttee observed Much German chemical product patenting in the UK and that such patents were �injurious�, �obstructive� and �aid the establishment of monopoly� because �they prevent research and invention on analogous lines� In 1919 the UK patent law inserted section 38A �In the case of inventions relating to substances prepared or produced by chemical processes ... the specification shall not include claims for the substance itself except when prepared or produced by the methods or processes of manufacture particularly described and ascertained� Late 19th / Early 20th CenturyEuropean chemical patenting

6. US chemical product patent history Since its first patent laws (1790) the US has conferred patentability on chemical products per se No serious judicial questioning of this except by a dissenting Frank J in Schering (1946) A claim for a mere product, regardless of the process for producing it, is, I think, virtually a claim to what has sometimes been described as a �principle� or �idea�, held not to be patentable. If [the statutory provision] �composition of matter� were interpreted to validate such claims, then that statutory provision might well be unconstitutional, since it would authorize the creation of monopolies which �would discourage arts and manufactures�.

7. Modern Law UK repealed section 38A in 1949 Germany abolished the prohibition upon claiming chemical products per se in 1967 TRIPS article 27 obliges WTO members to confer patentable status on any inventions, whether products or processes, in all fields of technology without discrimination as to the field of technology Mandating the availability of pharmaceutical product patents has been tied to the TRIPS and public health debate

8. The difficult issue of inventive step and chemical product scope Known process applied in a particular way to make a new chemical with particular properties Where is the inventive step? Identification of the need for such a chemical? The particular way the process was applied to make the chemical? The actual properties of the new chemical? What is the scope of rights in a chemical product claim? All ways of making & all uses: TRIPS article 28

9. The global Lundbeck litigation Citalopram is a racemate chemical (comprising a joined pair of mirrored isomers) with anti-depressant properties Lundbeck split the isomers and thereby made escitalopram (comprising the + or S isomer) with improved anti-depressant qualities

10. Lundbeck claims escitalopram per se What is the inventive step involved? Identification of the need? There was a clear industry desire to split the racemate to test the individual isomers Preparation process? Lundbeck disclosed in the patent a process for splitting the isomers involving an established techniques applied in a particular way Improved pharmaceutical properties of the chemical? (None disclosed in the patent.) It was likely that only one of the two isomers might be active � although escitalopram turned out to be surprisingly effective Patent challenged globally by competitors who (inter alia) argued that escitalopram was obvious

12. Closing observations In all countries other than Australia, it was largely an assessment of the method of its making which determined whether the claim to escitalopram involved an inventive step Lundbeck disclosed a customized existing method to achieve isolation and arguably (like Congo Red) this is a case where it is really the �new technical effect� � the properties of escitalopram � which influenced the assessment about inventiveness US: properties reinforced obviousness conclusion UK, DE, NL: properties not relied upon in assessing obviousness Australia: the �surprising� nature of the properties controlled the obviousness conclusion