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Healthy Food – Healthy Patent Claims? Jenny Cromsigt & Hajo Kraak Food Valley Expo, 25 October 2012. Brief Patent Knowledge (1). Claims that define rights Description that enables working of the rights defined Examples that provide evidence of workability within the claims
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Healthy Food – Healthy Patent Claims? Jenny Cromsigt & Hajo Kraak Food Valley Expo, 25 October 2012
Brief Patent Knowledge (1) • Claims that define rights • Description that enables working of the rights defined • Examples that provide evidence of workability within the claims • Comparative Examples (to show working of claimed features and/or effects vis-à-vis prior art)
Brief Patent Knowledge (2) • Rights as defined must differ from prior art (= novelty) • Rights as defined must involve an inventive step over prior art • Invention must be useful (US) • Invention must be industrially applicable (EP) • Invention must have technical character (EP)
“Unpredictable arts” • Contribution vs justified rights • Sufficiency of disclosure vs claim scope
Smart patent claims in Pharma • Single compound, yet the right compound (approved as a drug) • Approved form of the compound • Approved administration route • Use in specific (and approved) patient population The better aligned with regulatory label, the smarter
Is such alignment possible in food? • EFSA health claim accorded if • food or ingredient is defined • health effect is defined • evidence is sufficient • E.g., suppose health claim accorded to beta-carotene as being “good for night-vision” • Patent claim: beta-carotene for use in night-vision improvement Smart patent claims in food: defined foods and ingredients for defined effects
Functional Food: Medical use • Europe: No patents on methods for treatment of humans or animals • Does not apply to products for use in such methods • Novelty issue: • Although product is known but when related to specific use and use is not known then there is novelty
Only for medical methods Substance / composition X for use • in therapy • as a medicament for Y • in a method of therapy for Y • in a method for treatment for Y
But… food ≠ pharma • Does a patent on a “medical use” protect the interests of a food or ingredients manufacturer? • “treatment” can also be prevention (this may come with food) • if the health claim does not imply a medical act, then a non-medical use claim should be possible (“use of beta carotene for improving night vision via food intake”)
Take home: • Be alert whether the evidence used in seeking an EFSA claim can also be used in seeking a parallel patent claim. • Be conscious whether the patent claims be in the “medical” or “non-medical” use format. • Be aware whether the patent claims are in alignment with the (eventual) food label