SupremeCourt

  • Subscribe to our RSS feed.
  • Twitter
  • StumbleUpon
  • Reddit
  • Facebook
  • Digg

Monday, October 15, 2012

Guest Post: Bayer-Natco decision TRIPS Compliant?

Posted on 6:34 PM by Unknown

The Bayer-Natco decision broke ground as the first compulsory license earlier this year, and last month Bayer's appeal was dismissed by the IPAB. Dr Enrico Bonadio sent us a commentary he published in the current issue of the European Intellectual Property Review, questioning the TRIPs compliancy of the ruling. Dr Bonadio is a lecturer of IP and EU law at The City Law School University, London and was practicing as an IP attorney in top tier international firms for several years. His paper is available here. We asked him to put forth a brief guest post regarding the same: 

Compulsory Licensing of Patents: the Bayer-Natco Case 

On 9th March 2012 the Indian Controller of Patents granted the first compulsory licence in India. With this decision Indian generics producer Natco Pharma Ltd. has been granted the right to produce and sell in the Indian territory Bayer’s patented medicine “Sorafenib”, which is useful for treating advanced stage liver and kidney cancer. Natco will pay Bayer a quarterly royalty at 6% of the net sales of the drug. 

One of the most relevant issues dealt with in the decision regards the so-called “local working” requirement. Indeed the Controller held that the mere importation of goods incorporating the patented invention does not prevent the issuance of a compulsory licence (in the case at hand Bayer imported in India small quantities of its patented drug). Just the local production of the relevant goods by the patent owner or with its consent could prevent it. Yet, this did not occur in Natco/Bayer as Bayer did not produce any pills of Nexavar in India (even though it could have done so). As noted by the Controller, the patentee claimed to have manufacturing facilities in India for several products, including oncology-related drugs, so that there was no obstacle preventing Bayer from locally manufacturing the medicine or in any case from granting a voluntary licence on reasonable conditions to anyone including Natco. The Controller also rejected the argument put forward by Bayer according to which the low quantities required in India would not have justified setting up a manufacturing facility by Bayer in that country. 

In reaching its decision, the Controller also relied on a provision of the Indian Patent Act, ie Sec. 83(b). It states that patents are not granted merely to allow patent owners to enjoy monopolistic rights for the importation of the patented goods. 

Having said that, it seems that the above findings do not take in due consideration the TRIPS debate surrounding the working requirement and might be in violation of TRIPS itself. It is indeed believed that the above provisions of the Paris Convention as well as Article 31 TRIPS have to be read and interpreted together with Article 27(1) TRIPS, according to which “patents shall be available and patent rights enjoyable without discrimination as to […] whether the products are imported or locally produced”. In other words, this provision clarifies that where national legislations impose a local working requirement (as the Indian Patent Act does), patentees should have the possibility of satisfying such requirement by showing to have imported locally the patented product. There is no doubt therefore that the concept of working under TRIPS includes both the local production of the patented goods and their importation. Article 27(1) has therefore an impact on compulsory licences. This has been confirmed by the WTO Panel’s decision in Canada - Patent Protection of Pharmaceutical Products: it was held that the non-discrimination principle under Article 27(1) also applies to Article 31. 

Therefore, Article 27(1) TRIPS should be interpreted as not allowing any limitation of patent owner’s rights, including the issuance of a compulsory licence, merely because the patentee does not produce locally the relevant goods: what the Controller refused to accept in Natco/Bayer. It is also believed that Paragraph 5(b) of the Doha Declaration on TRIPS Agreement and Public Health (according to which countries have the freedom to determine the grounds upon which such licences are granted) could not be invoked to justify the need of a local production requirement (the Doha Declaration was adopted on 14 November 2001 by the WTO Ministerial Conference and strongly reaffirmed the rights of WTO Member States to use the flexibilities envisaged by TRIPS with a view to guaranteeing better access to essential medicines). Indeed, said Paragraph 5(b) should be read in the broader context of TRIPS and in particular in light of Article 27(1) which mandates states not to discriminate as to whether the patented products are imported or locally produced. 

It should be further noted that the local production requirement is also rejected under EU law. In Case C-235/89 the Court of Justice of the European Union (at that time it was called European Court of Justice) released a decision with reference to the old Italian provisions on compulsory licences, according to which said licences were granted in case the patentee did not manufacture locally the products incorporating the invention. The Court held that this provision basically had the effect of encouraging patent owners to locally produce the patented products rather than to import them from other Member States. They therefore amounted to, stressed the Court, measures having an equivalent effect to quantitative restrictions on imports under (what is now) Article 34 of the Treaty for the Functioning of the European Union.
Email ThisBlogThis!Share to XShare to FacebookShare to Pinterest
Posted in Compulsory Licensing, natco vs bayer, TRIPS | No comments
Newer Post Older Post Home

0 comments:

Post a Comment

Subscribe to: Post Comments (Atom)

Popular Posts

  • IPAB on Payyannur Ring
    [*S lightly long post] Background: The Intellectual Property Appellate Board (“ IPAB ”), in its recent order in SubhashJewellery v. Payyan...
  • Guest Post: Intermediary liability in defamation cases - Parle, Mouthshut & Visakha cases to clarify the law
    Chaitanya Ramachandran, who has blogged for us previously over here and here , has sent us this excellent guest post analyzing the extent of...
  • IP Research Assistant position at IIT, Madras
    Feroz Ali Khader, MHRD IP Chair at the Indian Institute of Technology (IIT) Madras, is looking for research assistants to work on various is...
  • Dorling Kindersley v. Sanguine Technical Publishers
    A recent Delhi High Court order passed on 21 January, 2013  with respect to copyright licensing has come to our notice. An analysis of the j...
  • Call for Papers: IIT Bombay and MHRD jointly announce the 2nd International Conference on Management of Intellectual Property and Strategy
    The readers may be interested to know that the Shailesh J. Mehta School of Management of IIT Bombay is geared up to host, in collaboration w...
  • SpicyIP Tidbit: ALCS August Distribution
    In the UK, the Authors' Licensing and Collecting Society is an organization run and owned by writers that collects money due to its mem...
  • Delhi HC rejects the "Hot News" Doctrine: A Summary
    The applicability of the Hot News doctrine was rejected recently in a landmark ruling delivered by Justice Bhat of the Delhi HC. This post i...
  • Satyajit Ray's sketches and copyright controversies
    A copyright row appears to have started between the Satyajit Ray Society and the Delhi Art Gallery, that is organising a countrywide exhibit...
  • Thalappakatti biryani trademark row
    The southern district of Dindigal in Tamil Nadu occupies a special place in the hearts of biryani lovers. In the late 1950s, one Nagasamy N...
  • Karnataka High Court temporarily restrains German company from exploiting trade secrets of Homag India
    Image from here In an interesting judgment dated 10th October, 2012 the Karnataka High Court, sitting at Bangalore, has passed an interim in...

Categories

  • 126 (1)
  • 3(d) (4)
  • 3(f) (1)
  • 3(i) (1)
  • 3(k) (2)
  • Academic Writing (1)
  • access (10)
  • access to food (1)
  • access to health (3)
  • AIA (1)
  • AIDS/HIV (3)
  • Antitrust (2)
  • Bajaj v LML (1)
  • Basmati Row (2)
  • Biological Diversity (5)
  • Biologics (2)
  • biopiracy (4)
  • biotech (7)
  • Bollywood (25)
  • Broadcasters Rights (5)
  • Budget (1)
  • business method patent (2)
  • Call for papers (2)
  • Cipla (2)
  • Comparative Advertising (4)
  • Competition law (8)
  • Compulsory Licensing (27)
  • condonation of delay (1)
  • Conference (4)
  • Constitution (12)
  • Contracts (1)
  • Controller's decisions (8)
  • Copyright (112)
  • Copyright Amendment Bill 2010 (23)
  • copyright board (4)
  • Copyright Exceptions (6)
  • copyright office (1)
  • Copyright Rules (2013) (5)
  • Copyright Societies (9)
  • Counterfeiting (1)
  • creativity (1)
  • Cross Retaliation (1)
  • csir (4)
  • d (1)
  • D.U. Photocopy Case (16)
  • Darjeeling Tea (3)
  • Data Exclusivity (2)
  • Database (1)
  • DCGI (2)
  • decompilation (2)
  • defamation (9)
  • Designs (3)
  • Designs Act (3)
  • Differential Pricing (2)
  • Dilution (1)
  • Disabilities (3)
  • Disability (2)
  • DMCA (2)
  • Doha Declaration (1)
  • Domain Names (2)
  • Draft Policy of the Indian Government (2)
  • DRM (1)
  • Drug Regulation (7)
  • education (12)
  • Enercon (1)
  • Enforcement (1)
  • EU (2)
  • ex parte (2)
  • exhaustion (3)
  • Exhaustion of Rights (2)
  • Fair Dealing (8)
  • Fair Use (11)
  • Federal Circuit (1)
  • Fees (3)
  • FICCI (7)
  • FRAND (2)
  • free trade agreement (3)
  • FTA (3)
  • G.I. Registry (4)
  • gene sequences (3)
  • Generic medicine (4)
  • Geographical Indication (14)
  • Gilead (1)
  • Glenmark (5)
  • Gopika (34)
  • Guest post (11)
  • guidelines (1)
  • GWU-CII (1)
  • Herceptin (1)
  • hot news (3)
  • ICANN (1)
  • incremental innovation (1)
  • independence (1)
  • india (5)
  • Indian Government (1)
  • Indian patent litigation (27)
  • Indian Pharma (35)
  • Injunction (10)
  • Innovation (7)
  • INTA (1)
  • Intermediaries (10)
  • internet (11)
  • Internet Access Providers (IAPs) (5)
  • Internet Censorship (7)
  • IP scholarship (3)
  • IP aware (4)
  • IP Course (3)
  • IP Education (1)
  • IP Policy (11)
  • IP update (4)
  • ip writing competition (1)
  • IPAB (34)
  • ipchair (1)
  • IPO (1)
  • IPRS (5)
  • IT Act (1)
  • Journal (2)
  • judicial independence (3)
  • Jurisdiction (1)
  • Kruttika (4)
  • Legal Education (3)
  • Legal Research Tools (1)
  • Legal Scholarship (2)
  • library (2)
  • Licensing (7)
  • Madhulika (20)
  • mathematical methods (1)
  • Media law (3)
  • medical method (1)
  • Merck (4)
  • mhrd ip chair (1)
  • Microsoft (3)
  • Middle Path (1)
  • Moral Rights (2)
  • Movies (18)
  • musical work (2)
  • nanotechnology (1)
  • Natco (3)
  • natco defamation suit (5)
  • natco vs bayer (4)
  • need for transparency (1)
  • Novartis (8)
  • Novartis patent case in India (11)
  • NPEs (2)
  • nujs (1)
  • NUJS Conference (2)
  • Obituary (1)
  • obviousness (7)
  • Off-Topic (2)
  • online course (4)
  • Open Access (6)
  • Open Source (2)
  • Opposition (3)
  • Parallel Imports (4)
  • Parliament (1)
  • passing off (5)
  • Patent (52)
  • Patent act (10)
  • patent agent (5)
  • patent agent exam (9)
  • patent agent exam qualifications (3)
  • patent infringement (5)
  • Patent Licensing (2)
  • Patent litigation (2)
  • Patent Office (19)
  • patent pool (3)
  • Patent Prosecution (7)
  • Patent rules (2)
  • Patent Strategies (8)
  • Patents (9)
  • pegasus (1)
  • Personality Rights (1)
  • Pfizer (1)
  • Pharma (18)
  • Piracy (5)
  • plagiarism (3)
  • Plant Variety Protection (2)
  • post grant (1)
  • Prashant (2)
  • Preventive Detention (1)
  • Price Control (6)
  • prior publication (1)
  • Privacy (3)
  • Prizes (1)
  • public health (3)
  • Public Interest (4)
  • Publicity Rights (4)
  • Publishing (3)
  • radio (2)
  • Rajiv (18)
  • Rectification Petition (2)
  • Rejection (1)
  • research (3)
  • reverse engineering (2)
  • revocation (4)
  • rip (1)
  • Roche (2)
  • Roche vs Cipla (1)
  • Royalty (2)
  • RTI (2)
  • Scholarship (4)
  • section 16 (1)
  • Section 3(d) (7)
  • section 8 (6)
  • shamnad (11)
  • Shan Kohli (4)
  • Shouvik Kumar Guha (30)
  • Smartphones/Tablets (2)
  • Social Innovation (1)
  • Software (10)
  • software enforcement (3)
  • software patent (3)
  • Special 301 Report (1)
  • Spicy Tidbits (6)
  • spicyip (1)
  • SpicyIP Accolades (1)
  • SpicyIP Announcements (9)
  • SpicyIP Case (1)
  • SpicyIP Cases (3)
  • spicyip commiseration (1)
  • SpicyIP Events (11)
  • SpicyIP Fellowship (5)
  • SpicyIP Guest Series (22)
  • SpicyIP Interview (2)
  • SpicyIP Jobs (4)
  • SpicyIP Jobs/General (2)
  • SpicyIP Review (1)
  • SpicyIP Tidbits (11)
  • SpicyIP Weekly Review (27)
  • Statutory Licensing (1)
  • STI Policy 2013 (4)
  • Sugen (3)
  • Supreme Court of India (5)
  • Swaraj (19)
  • Tarnishment (1)
  • Technology (6)
  • Technology Transfer (5)
  • TKDL (5)
  • TPP (1)
  • trade (4)
  • Trade Secret Protection (1)
  • Trademark (59)
  • Trademark dilution (1)
  • Trademark Registry (9)
  • Traditional Knowledge (7)
  • Transparency (5)
  • treaty (1)
  • trial (1)
  • tribunals (2)
  • TRIPS (11)
  • UK (3)
  • unfair competition (5)
  • UNFCCC (1)
  • Universities Research and Innovation Bill (2)
  • US (1)
  • US Patent Reform (1)
  • US Supreme Court (3)
  • viva (3)
  • WIPO (5)
  • Working a Patent (2)
  • Workshop (4)
  • writ (1)
  • WTO (1)

Blog Archive

  • ►  2013 (364)
    • ►  September (13)
    • ►  August (41)
    • ►  July (36)
    • ►  June (36)
    • ►  May (32)
    • ►  April (51)
    • ►  March (66)
    • ►  February (40)
    • ►  January (49)
  • ▼  2012 (131)
    • ►  December (29)
    • ►  November (42)
    • ▼  October (50)
      • 5 Reasons Why Course Packs are Legal in India
      • Academia struggles to pay up as Journal prices soar!
      • First sale doctrine under threat in US
      • Guest Post: Ownership and Assignment of Indian Pat...
      • Supreme Court grants BharatMatrimony stay against ...
      • IP in the multiverse: Law of Superheroes
      • Govt. of India follows up on SpicyIP reporting – r...
      • Karnataka High Court temporarily restrains German ...
      • Copyright Aggression vs Educational Access: The "G...
      • Rebutting arguments against multiple copyright soc...
      • Mapping out the future of Indian copyright societies
      • Add a disclaimer says Supreme Court: Bata has happ...
      • Spicy IP Weekly Review (October Week 3)
      • Delhi University Restrained for Alleged Admission ...
      • Appeal to Publishers to Withdraw Suit Filed agains...
      • September 2012: Controller's decisions at the IPO
      • The ‘Register of Owners’ for future copyright soci...
      • Bata sho(o)ed out of Court - No defamation says De...
      • Sugen’s desperate attempt to save its Sunitinib pa...
      • Internet Fraud: Bogus Open Access Journals
      • Guest Post: Bayer-Natco decision TRIPS Compliant?
      • Guest Post: ‘Xerox’ is not Generic.......Yet?!
      • Spicy IP Weekly Review (October Week 2)
      • Roche vs Cipla: A Patent Disappointment?
      • Ever participated in a clinical trial? Perhaps.
      • An anonymous comment in response to the DU Campaig...
      • A test case for India’s new safe harbour provision...
      • Karnataka High Court quashes Controller General’s ...
      • The perils of selective journalism
      • Defensive Patent Licensing: A way out of the Paten...
      • Delhi High Court seeks to break the Myth of 'Break...
      • DU Photocopy Case: Who's Afraid of Copyright?
      • Guest Post: Exide v. Exide: Too much Exidement?
      • Guest Post: The New India Guidelines on Similar Bi...
      • Intellectual Property Rights: Infringement and Rem...
      • More controversy during appointments to IPAB: Delh...
      • SpicyIP Weekly Review (October Week 1)
      • SC on the new drug policy
      • India signs Nagoya protocol ahead of Hyderabad CBD...
      • WIPO defers PPI observer status
      • The need for iron-clad enforcement of Section 8 di...
      • NBA set to prosecute Monsanto’s Indian subsidiary:...
      • Breaking News: Delhi High Court recognizes interna...
      • Breaking news: Cipla succeeds in revoking Pfizer /...
      • TKDL poised to draw first blood before Indian pate...
      • ICANN set to change the topography of the internet
      • Call for Papers: Christ University, Law Journal
      • A Glass and a Half full of Purple Joy: Cadbury win...
      • EBC granted injunction against Lexis Nexis for inf...
      • Novelty of Design: Tarun Sethi v. Vikas Budhiraja
    • ►  September (10)
Powered by Blogger.