TRIPS Pre-Grant Flexibilities:
Patentable Subject Matter
Christoph Spennemann, Legal Expert
IP Unit/Division on Investment &
Enterprise
UNCTAD
UNCTAD/CD-TFT
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Overview
• What is patentable subject matter?
• Reasons for exclusions in the area of
pharmaceuticals
• Lack of « invention »
• Methods of medical treatment, 27.3(a) TRIPS
• Relevant issues
• Natural substances
• New uses of known products
• Product derivatives
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TRIPS Article 27.1 on patentable
subject matter
• Patents shall be available for
• Any inventions
• Whether products or processes (unlike
India 1970-2005)
• In all fields of technology (including
medicines)
• No discrimination as to place of invention,
field of technology, imports or local
production (local / foreign patentees)
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Patentable subject matter:
inventions (1)
• Products or processes may qualify as invention
• In addition, need to meet patentability criteria
(novelty, inventive step, industrial application)
• Anything not considered invention may be excluded
from patent protection without even examining
patentability criteria
• Countries lacking expertise in patent examination
might prefer broad exclusions on subject matter
grounds (rather than complex case-by-case
applications of patentability criteria)
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Patentable subject matter:
inventions (2)
• No international definition of invention
• The following have traditionally been
considered not to be inventions:
• Abstract ideas & scientific principles as
cornerstones of technological progress
• Substances found in nature (some
countries): discovery, no human/technical
intervention
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Invention: natural substances
• Importance in the pharmaceutical context:
drugs based on natural substances
• EPO grants patents on isolations/purifications
from nature, even where isolated substance
remains unchanged
• Argentina, Brazil: isolations are no invention
• Alternative: invention (+) if structural change
in isolated substance
• Process of isolation always patentable
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Patentable subject matter:
methods of medical treatment
• Article 27.3(a) TRIPS: may exclude from
patentability diagnostic, therapeutic and
surgical methods for the treatment of humans
or animals
• Scope of exclusion
• Administration or dosage of drugs (=doctor’s
everyday work)
• Uses of pharmaceutical products to fight various
diseases exclusion of new uses of known
products on subject matter grounds
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New uses of known products (1)
• First medical use
• Example: discover medical properties of
foods, beverages (green tea, etc)
• Second and subsequent medical uses
• Example: Retrovir (anti-cancer drug)
discovered to also treat HIV/AIDS
• Exclude from patentable subject matter
through Article 27.3(a) TRIPS?
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New uses of known products (2)
• DCs should identify priorities
• Local capacity to discover new uses?
• Exclusive rights?
• « Use & Pay » approach to promote new
applications of traditional medicine
• In any case, subject matter exclusion under
Article 27 concerns only uses of drugs, as
opposed to drugs themselves
• Process – Product
• Issue of novelty  patentability criteria
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Patentable subject matter: product
derivatives (1)
• Definition: slight structural changes of known
chemical substance (different from new use
issue: no identical product!)
• New Indian Patent Law excludes
pharmaceutical product derivatives on subject
matter grounds (= no inventions), unless
significant improvement in efficacy
• Policy rationale: avoid exclusive rights on
trivial modifications of existing drugs
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Patentable subject matter: product
derivatives (2)
• Example Novartis case
• Novartis applied for patent for anti-cancer drug
(Glivec)
• Patent Office rejected patent
• No patentable subject matter/invention: lack of
« significantly enhanced efficacy » when
compared to previously known molecule
• Public order at stake: Higher prices of patented
drugs prevent access by poor
• Confirmed in 2009 by IP Appellate Board
• Novartis appeal to India’s Supreme Court
pending
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Patentable Subject Matter:
Conclusions
• Natural substances, new uses of known drugs
and derivatives may be excluded from
patentability
• Invention – discovery
• Methods of medical treatment (TRIPS 27.3(a))
• Indian example: enhanced efficacy
• DCs must identify priorities
• Exclusive rights – whose benefits?
• « Use & pay » alternative, especially traditional
medicines
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Contact
Christoph Spennemann
Legal Expert
Intellectual Property Unit
Division on Investment and Enterprise (DIAE)
UNCTAD
E-mail: Christoph.Spennemann@unctad.org
Tel: ++41 (0) 22 917 59 99
Fax: ++41 (0) 22 917 01 97
http://www.unctad.org/tot-ip
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