PHARMACEUTICAL PATENT CASE LAW

Many of you have asked us for a resource of case law on pharmaceutical patents, especially from developing countries.

This page has been set up to:

  • accommodate this need
  • provide transparency to help identify how patents are being decided upon in different jurisdictions
  • understand how countries are implementing different standards of patentability for pharmaceuticals

Have any case law on pharmaceutical patents that may be useful to add? Please contact us here. We will try to get non-English cases translated.

 

INDIAN PATENT DECISIONS

 

 

Aventis Pharmaceuticals Inc, Application No. 1021/CHENP/2006, Chennai Patent Office (2009)

Application for a calcium dietary supplement in a chewable dosage form.

Novartis AG, Application No. 728/CHENP/2006, Chennai Patent Office (2009)

Application for epothilone B in a loading dosage form.

Scherer Technologies Inc, Application No. 1993/DELNP/2004, Delhi Patent Office (2009)

Application for a liquid fill composition for a soft capsule dosage form comprising vinorelbine (used as an anti-mitotic chemotherapy drug).

Shanghai Huayi Bio Lab, Application No. 1878/DELNP/2003, Delhi Patent Office (2009)

Application for a recombinant insulinotropic peptide.

Board of Regents of the University of Texas, Application No. 1435/DELNP/2006, Delhi Patent Office (2009)

Decision of the patent office in relation to an application for a 'method of enhancing the blastocyst size, the inner cell mass or the trophectoderm size of a mouse or human blastocyst'.

Astra Aktiebolag (Application No. 1255/DEL/1995) v Torrent Pharmaceuticals Ltd, Delhi Patent Office (2009)

Pre-grant opposition against Astra's application for a process and product relating to the enantiomer of omeprazole. The decision also deals with whether an application under s5(2) can also include process claims.

Otsuka Pharmaceutical Factory, Application No. 633/DEL/1998, Delhi Patent Office (2009)

The decision deals with whether an application which does not specify that it is mailbox application can be divided out to overcome such an objection.

Boehringer Ingelheim Pharma, Application No. 628/DELNP/2003, Delhi Patent Office (2009)

An application for an inhalable formulation of solution containing tiotropium salt.

Hoffman La Roche AG (Application No. 474/MAS/1996) v Wockhardt Ltd, Chennai Patent Office (2009)

Pre-grant oppostion against an application for an aqueous interferon solution.

Tibotec Pharmaceuticals Ltd (Application No. 329/DEL/2004) v Cipla Ltd, Delhi Patent Office (2009)

Pre-grant opposition against a method for the synthesis of of an intermediate of darunavir (Prezista).

Wockhardt Ltd (Application No. 106/MUM/2003) v Torrent Pharmaceuticals Ltd, Mumbai Patent Office (2009)

Pre-grant opposition against a pharmaceutical composition for the oral administration of glimepiride (markerted as Amaryl for diabetes) and thiazolidinedione.

AstraZeneca AB, Application No. 2488/DELNP/2004, Delhi Patent Office (2009)

Application for a crystalline form of the compound ZD 1839, otherwise known as gefitinib (marketed as Iressa) to treat non-small cell lung cancer.

Algorx Pharmaceuticals Inc, Application No. 2648/DELNP/2005, Delhi Patent Office (2009)

Application for an 'injectable, implantable or infiltratable capsaicinoid composition' for reducing pasin associated with various forms of arthritis.

AstraZeneca, Application No. 2825/DELNP/2004, Delhi Patent Office (2009)

Application for 'thioxanthine derivatives as myeloperoxidase inhibitors'.

Abraxis BioScience LLC (Application No. 2899/DELNP/2005) v Natco Pharma Ltd, Delhi Patent Office (2009)

Pre-grant opposition against an application for a pharmceutical composition comprising an ant-cancer agent, including taxane, camptothecin, epothilone and a pharmaceutical acceptable carrier. The decision discusses whether during the pre-grant opposition process, the opponent is entitled to submit further arguments against an applicant's amended specification.

Pierre Fabre Medicament, Application No. 3436/DELNP/2005, Delhi Patent Office (2009)

Application for a mixture of enantiomers of milnacipran (marketed as Ixel or Savella) and their pharmaceutically acceptable salts.

Advanced Inhalation Research Inc, Application No. 3513/DELNP/2005, Delhi Patent Office (2009)

Application for a pharmaceutical composition comprising trospium.

Novartis AG, Application No. 3544/CHENP/2005, Chennai Patent Office (2009)

Application for a pharmaceutical preparation comprising a dose of epothilone in an effective amount to treat cancer. The decision deal with the issue of s3(i) and dosage regimens as methods of treatment.

Schering AG (Application No. 3764/DELNP/2005) v Sun Pharmaceuticals, Delhi Patent Office (2009)

Pre-grant opposition against a composition formulated for an intramuscular injection, comprising testosterone undecanoate, castor oil and benzyl benzoate in specific weight weight ratios.

Millenium Pharmaceuticals Inc (Application No. 5633/DELNP/2006) v Natco Pharma Ltd, Delhi Patent Office (2009)

Pre-grant opposition against an application for the synthesis of a boronic ester.

GlycoScience Laboratories Inc, Application No. 1752/CHE/2006, Chennai Patent office (2009)

An application for a medicament to treat inflammation due to multiple sclerosis or neural dysfunction. The decision deals with the question of a new use of a known compound.

OSI Pharmaceuticals Inc (Application No. IN/PCT/2002/00497/DEL) v Cipla Ltd, Delhi Patent Office (2009)

Pre-grant opposition by Cipla against OSI's application for a process for the production of the polymorph B of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride, otherwise known as erlotinib hydrochloride (marketed as Tarceva).

Venus Remedies Ltd (Application No. 2510/DEL/2004) v FDC Ltd, Delhi Patent Office (2009)

Pre-grant opposition against an antibiotic treatment combining cefepime and amikacin.

Tibotec Pharmaceuticals (Application No. 1647/DELNP/2000) v Cipla Ltd, Delhi Patent Office (2009)

Pre-grant opposition against Tibotec's application for a combination of protease inhibitors e.g. ritonavir ) and cytochome P450 inhibitors. The decision also deals with when an application is considered to have been granted under the Act for the purpose of a pre-grant opposition to be admitted.

Les Laboratories Servier, Application No. 1003/DEL/2006, Delhi Patent Office (2009) 

Application for a pharmaceutical compositon commprising agomelatine, its hydrates and crystalline forms and pharmaceutically acceptable acid addition salts for use in the treatment of bipolar disorders. The application also claimed the synergystic combination of agomelatine and a thymoregulatory agent.

Bayer AG, Application No. 1427/DEL/1999, Delhi Patent Office (2009)

Application by Bayer for quineolinecarboxylic acids and their derivatives. The decision deals with whether an application which does not specify that it is mailbox application can be divided out to overcome such an objection.

Sanofi Synthelabo, Application No. 237/DEL/2001, Delhi Patent Office (2009) 

Application by Sanofi for a pharmaceutical product patent. The decision deals with whether an application which does not specify that it is mailbox application can be divided out to overcome such an objection.

Gilead Sciences Inc (Application No. 3383/DELNP/2005) v Cipla Ltd, Delhi Patent Office (2009)

Pre-grant opposition against Gilead's application for a HIV treatment combining tenofovir disoproxil fumarate (Viread) and emtricitabine (Emtriva).

Medvet Science Pty Application No. 4262/DELNP/2005, Delhi Patent Office (2009)

Application by Medvet for a method of diagnosis and treatment used to detect an apoptotic cell in a subject. The decision deals with the issue of methods of treatment under s3(i).

Dainippon Sumitomo Pharma Co. Ltd Application No. 3485/CHENP/2005, Chennai Patent Office (2009)

Application for a therapeutic agent (lurasidone) and its acid additiona salt used to treat senile dementia. The decision deals wth the issue of disclosure and sufficiency.

Indena S.P.A Application No. 3498/DELNP/2005, Delhi Patent Office (2009)

Application for the use of lupin conglutin for the treatment of type-II diabetes.

Schering AG (Application No. 3764/DELNP/2005) v Sun Pharmaceuticals Industries Ltd, Delhi Patent Office (2009)

Pre-grant opposition by Sun Pharmaceuticals against Schering's application for 'methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels.'

Merck & Co, Inc Application No. 2542/DELNP/2005, Delhi Patent Office (2009)

Decision of the patent office in relation to Merck's application for a 'novel substituted amide useful as modulators of Cannabinoid-1 (CB1) receptor. The decision deals with whether the examiner was correct to abandon the application because the applicant failed to place it in order within 12 months as required under s21(1) of the Act.

Novartis AG (Application No. IN/PCT/2001/00016/CHE) v Sun Pharmaceuticals Ltd, Chennai Patent Office (2009)

Pre-grant opposition against Novartis' application for a pharmaceutial combination comprising valsartan or a pharmaceutically acceptable salt, amlodipine and a pharamceutically acceptable carrier (marketed as Exforge for treatment of high blood pressure).

Pfizer Product Inc (Application No. 2571/DEL/1998) v Torrent Pharma Ltd, Delhi Patent Office (2009)

Pre-grant opposition by Torrent against Pfizer's application for the combination amlodipine (a calcium channel blocker) and astorvastatin (a HMG-CoA reductase inhibitor), or their pharmaceutical salts. This combination is marketed as Caduet.

Gilead Sciences Inc (Application No. 896/DEL/2002) v Intermed Labs Pvt Ltd, Delhi Patent Office (2009)

Pre-grant opposition against Gilead's application for the fumarate salt of tenofovir disoproxil, otherwise known as tenofovir disoproxil fumarate (Viread). Viread is used for the treatment of HIV.

Gilead Sciences Inc (Application No. 896/DEL/2002) v Cipla Ltd, Delhi Patent Office (2009)

Pre-grant opposition by Cipla against Gilead's application for the fumarate salt of tenofovir disoproxil, otherwise known as tenofovir disoproxil fumarate (Viread). Viread is used for the treatment of HIV.

Gilead Sciences Inc (Application No. 2076/DEL/1997) v Cipla Ltd, Delhi Patent Office (2009)

Pre-grant opposition by Cipla against Gilead's application for an ester derivative of tenofovir disoproxil.

Tibotec Pharmaceuticals Ltd (Application No. 3598/DELNP/2004) v Cipla Ltd, Delhi Patent Office

Pre-grant opposition by Cipla against Tibotec's application for pseudopolymorphic forms of the compound darunavir. Darunavir (Prezista) is used in the treatment of HIV.

Bayer Corporation & Others v Union of India & Others, High Court of Delhi (2009)

Decision on the writ petiton of Bayer requesting its granted patent for sorafenib be linked to the marketing approval process for Cipla's generic version.

Novartis AG v Union of India & Others, Intellectual Property Appellate Board (2009)

The Intellectual Property Appellate Board's decision with respect to Novartis's appeal against the patent office's refusal of its patent application for the beta-crystalline form of imatinib mesylate (Glivec/Gleevec).

Gilead Sciences Inc (Application No. 712/DEL/2002) v Ranbaxy Laboratories, Delhi Patent Office (2009)

Pre-grant opposition by Ranbaxy against Gilead's application for a crystalline form of adefovir dipivoxil and compositions. Adefovir dipivoxil (brand name Hepsera) is used to treat Hepatitis B.

F.Hoffmann La Roche v Cipla Ltd, High Court of Delhi (2009)

Appeal by Roche and OSI Pharmaceuticals against the decision of the single judge of the Delhi High Court to decline an interim injunction restraining Cipla from infringing the patent on erlotinib. Erlotinib, marketed as Tarceva, is used to treat non-small cell lung cancer.

Smithkline Beecham, Application No. 00295/DELNP/2003, Delhi Patent Office (2009)

Decision of the patent office on Smithkline Beecham's application for the ethane sulphonate salt of the compound thiazolidione. The subject of the patent application is used to prevent or treat diabetes.

Novartis AG (Application No. 799/CHE/2004) v Sun Pharmaceuticals & Another, Chennai Patent Office (2009)

Pre-grant opposition by Sun Pharmaceuticals and others against Novartis's application for the alpha-crystalline form of imatinib mesylate (Glivec).

AstraZeneca AB, Application No. 2145/DELNP/2004, Delhi Patent Office (2009)

Decision of the patent office on AstraZeneca's application for a pharmaceutical composition comprising formoterol and budesonide in an inhaler form. The compoosition formoterol and budesonide (marketed by AstraZeneca as Symbicort) is used to treat asthma and chronic obstructive pulmonary disease.

F. Hoffmann-La Roche AG (Patent No. 198952/App No. 1032/MAS/1997) v Wockhardt Ltd and Sanklap Rehabilitation Trust, Chennai Patent Office (2009)

Post-grant opposition by Wockhardt and Sankalp against Roche's granted patent for a pegylated interferon (marketed as Pegasys), used to treat Hepatitis C.

Gilead Sciences Inc (Application No. 396/DEL/1996) v Cipla Ltd, Delhi Patent Office (2009)

Pre-grant opposition by Cipla against Gilead's patent application for oseltamivir (marketed as Tamiflu), used to treat flu viruses.

Gilead Sciences Inc (Application No. 963/DEL/2002) v Cipla Ltd, Delhi Patent Office (2009)

Pre-grant opposition by Cipla against Gilead's application for a method of making a lithium salt of the anti-retroviral drug tenofovir.

F.Hoffmann La Roche AG (Application No. 959/MAS/1995) v Indian Network of People Living with HIV & Anr, Chennai Patent Office (2009)

Decision of the Chennai Patent Office in the pre-grant opposition filed by HIV patients against Roche's application for valganciclovir (marketed as Valcyte), used to treat CMV retinitis.

Yeda Research & Development Co (Application No. 93/DEL/2003) v Natco Pharma Ltd, Delhi Patent Office (2009)

Pre-grant opposition by Natco against Yeda's application for glatiramer acetate (marketed as Copaxone or Copolymer 1), used to treat multiple sclerosis.

Toyama Chemical Co. Ltd  (Application No. 1891/CAL/1998) v G.M.Pharma Ltd, Kolkata Patent Office (2008)

The decision deals with whether an applicant's statement of reply to a pre-grant opposition can be taken on record after the three month period to respond as stipulated in Rule 55(4), and whether Rule 138 permits an extension of time in such a case.

Boehringer Ingelheim Pharmaceuticals (Application No. 2485/DEL/1998) v Indian Network for People Living with HIV/AIDS (INP+) and Positive Womens Network (PWN), Delhi Patent Office (2008)

Pre-grant opposition by INP+ and PWN against Boehringer's application for nevirapine hemihydrate, marketed as Viramune.

OSI Pharmaceuticals Inc (Application No. IN/PCT/2002/507/DEL) v Cipla Ltd, Delhi Patent Office (2008)

Pre-grant representation by Cipla against OSI's application for a polymorph B of erlotinib hydrochloride (Tarceva), a compound used to treat non-small cell lung cancer.

Indian Network of People Living with HIV/AIDS & Anr v Union of India & Anr, High Court of Madras (2008)

Petition filed by the Indian Network of People Living with HIV/AIDS against the Indian Patent Office's decision to grant Roche's Application No. 959/MAS/1995 for valganciclovir without providing a hearing for the opponent.

AstraZeneca AB (Application No. 1120/DEL/1995) v Torrent Pharmaceuticals Ltd, Delhi Patent Office (2008)

Pre-grant opposition by Torrent against AstraZeneca's application for a multiple unit tableted dosage form of omeprazole, its enantiomers or alkaline salt. Omeprazole (brand name Prilosec/Losec) is used to treat dyspepsia.

Boehringer Ingelheim Pharma (Application No. 2632/DELNP/2005) v Cipla Ltd, Delhi Patent Office (2008)

Pre-grant opposition by Cipla against Boehringer's application for an inhaler comprising a tiotropium salt of salmeterol xinafoate (marketed as Serevent), used to treat asthma and chronic obstructive pulmonary disease.

Pfizer Health AB (Application No. IN/PCT/2001/00788/CHE) v Ranbaxy Laboratories, Chennai Patent Office (2008)

Pre-grant opposition Ranbaxy against Pfizer's application for a controlled release bead of tolterodine, a metabolite of tolterodine or its pharmaceutically acceptable salts. Tolterodine (marketed as Detrol or Detrutisol) is a antimuscarinic drug used to treat urinary incontinence.

Sugen Inc and Pharmacia Upjohn (Patent No. 209251/Application No. IN/PCT/2002/00785/DEL) v Natco Pharma Ltd, Delhi Patent Office (2008)

Application by Natco Pharma for a compulsory licence for exporting the patented product sunitinib to Nepal. This decision also deals with an interlocutory petition by Natco that the law and rules do not require the patentee to be a party to the hearing. Sunitinib (marketed as Sutent by Pfizer) is used to treat advanced kidney cancer and cancer of the digestive system.

F.Hoffmann La Roche & Anr v Cipla Ltd, High Court of Delhi (2008)

Application by Roche and Pfizer for an interim injunction restraining infringement of its patent on erlotinib (Tarceva) and a counterclaim by Cipla.

Corixa Corporation, U.S.A, Application No. 1145/DEL/2001, Delhi Patent Office (2008)

Decision of the patent office in relation to whether the applicant's divisional application complied with the requirements of the Act.

Astra AB (Application No. 1354/DEL/1998) v Torrent Pharmaceuticals Ltd, Delhi Patent Office (2007)

Pre-grant opposition by Torrent against Astra's application for a pharmaceutical formulation of omeprazole, comprising an enteric coating.

Astra AB (Application No. 1344/DEL/1998) v Torrent Pharmaceuticals Ltd, Delhi Patent Office (2007)

Pre-grant opposition by Torrent against Astra's application for a magnesium salt of S-omeprazole trihydrate.  

Eli Lilly & Co (Application No. IN/PCT/2000/00119) v USV Ltd (2007)

Pre-grant opposition by USV against Eli Lilly's application for a non-freeze dried stabilised pharmaceutical composition of teriparatide. Teriparatide (sold as Forteo) is used to treat some forms of osteoporosis.

Warner-Lambert Company (Application No. 1577/DEL/1996) v Torrent Pharmaceuticals Ltd, Delhi Patent Office (2007)

Pre-grant opposition by Torrent Pharmaceuticals against Warner-Lambert's application for the crystalline form III of atorvastatin and hydrates. Atorvastatin (marketed as Lipitor) is a compound used to lower blood cholesterol.

Novartis AG (Application No. 237/MAS/1998) v Ranbaxy Laboratories Ltd, Chennai Patent Office (2007)

Pre-grant opposition by Ranbaxy against Novartis's application for a film coated tablet comprising oxacarbazepine. Oxacarbazepine (sold as Trileptin) is used to treat primary generalised tonic-clonic and partial seizures.

Eli Lilly & Co (Application No. 85/DEL/1995) v Ranbaxy Laboratories Ltd, Delhi Patent Office (2007)

Eli Lilly & Co (Application No. 85/DEL/1995) v Ajanta Pharma Ltd, Delhi Patent Office (2007)

Pre-grant oppositions by Ranbaxy and Ajanta Pharma Ltd against Eli Lilly's application for tetracyclic derivatives as potent and selective inhibitors of cyclic guanosine 3' 5' monophosphate and their method of treatment for cardiovascular disorders.

Novartis AG (Application No. IN/PCT/2001/00864/CHE) v Torrent Pharmaceuticals Ltd, Chennai Patent Office (2007)

Pre-grant opposition by Torrent Pharmaceuticals against Novartis's application for a pharmaceutical composition for the treatment of invasive lung comprising a therapeutically effective amount of valsartan. Valsartan is used to treat high blood pressure, congestive heart failure and post-myocardial infarction.

Pfizer Healh AB (Application No. IN/PCT/2000/00084/CHE) v Ranbaxy Laboratories, Chennai Patent Office (2007)

Pre-grant opposition by Ranbaxy against Pfizer's application for a capsule or tablet capable of providing controlled release of tolterodine or a pharmaceutically acceptable salt to achieve constant serum level of the active moiety. Tolterodine (marketed as Detrol or Detrutisol) is a antimuscarinic drug used to treat urinary incontinence.

F.Hoffmann La Roche AG (Application No. 190/MAS/1998) v Ranbaxy Laboratories, Chennai Patent Office (2007)

Pre-grant opposition by Ranbaxy against Roche's application for a pharmaceutical composition, comprising a plurality of particles having an average diameter from 0.25mm to 2mm, each particle comprising tetrahydrolipstatin and various excipients. Also known as orlistat (marketed as Xenical by Roche), tetrahydrolipstatin is a drug used to treat obesity.

Pfizer Products Inc (Application No. 537/DEL/1996) v Natco Pharma Ltd, Delhi Patent Office (2007)

Pre-grant opposition by Natco against Pfizer's application for quinazoline derivatives and compositions.

Novartis AG (Application No. 1440/MAS/1998) v Ranbaxy Laboratories, Chennai Patent Office (2007)

Pre-grant opposition by Ranbaxy against Novartis's application for a crystalline ascomycin derivative or its tautomeric or solvated form.

AstraZeneca (Application No. 841/DEL/1996) v G M Pharma Ltd, Delhi Patent Office (2007)

AstraZeneca (Application No. 841/DEL/1996) v Natco Pharma Ltd, Delhi Patent Office (2007)

Pre-grant oppositions by GM Pharma and Natco against AstraZeneca's application for a quinazoline derivative, also known as gefitinib (or the brand name Iressa). Gefitinib is used to treat lung and breast cancers.

Applied Research Systems ARS Holding N.V., Application No. 404/MUMNP/2005, Mumbai Patent Office (2007)

Application for the use of FSH and/or a bilogically-active analogue thereof in the production of a medicament for the treatment of fertility in women. The decision deals with the issue of filing a divisional with the same claims as the parent application.

Novartis AG v Union of India & Anr, High Court of Madras (2007)

Petition by Novartis arguing that section 3(d) of the Patent Act is not TRIPS compliant and is unconstitutional.

Schering Corporation (Application No. IN/PCT/2000/0434/CHE) v Cadila Healthcare Ltd, Chennai Patent Office (2006)

Petition by Cadila requesting the Controller and set aside the grant of Schering's application for formulations of peg-inteferon alpha conjugates.

Wockhardt Ltd (Application No. 308/MUM/2002) v Cipla Ltd, Mumbai Patent Office (2006)

Pre-grant opposition by Cipla against against Wockhardt's application for topical cream formulation containing benzoquinolizines and optical active benzoquinolizines (nadifloxacin).

Novartis AG (Application No. 1602/MAS/1998) v Cipla Ltd, Chennai Patent Office (2006)

Novartis AG (Application No. 1602/MAS/1998) v Cancer Patients A J Association, Chennai Patent Office (2006)

Pre-grant opposition by Cipla and Cancer Patients group against Novartis's application for beta crystalline form of imatinib mesylate (marketed as Glivec) to treat chronic myeloid leukemia.

Wockhardt Ltd v Hetero Drugs Ltd & Another, High Court of Madras (2006)

Application for an interim injunction by Wockhardt to restrain Hetero and others from infringing its exclusive marketing rights on nadifloxacin (Nadiderm) cream.

Novartis AG v Mehar Pharma & Another, High Court of Bombay (2004)

Novartis AG v Adarsh Pharma & Another, High Court of Madras (2004)

Application by Mehar Pharma and others requesting the removal of the ex parte order of injunction restraining the infringement of Novartis's exclusive marketing rights for imatinib mesylate (Glivec).

Tai-Wook Yoon, Republic of Korea, Application No. 1377/DEL/1999, Delhi Patent Office (2003)

Application for a 'method for in vitro culturing and proliferating isolated langerhans islets endocrime cells so as to be suitable for transplantation.' The decision deals with whether natural material adapted by man amounts to a method of manufacture and whether the invention claimed is a method of treatment under s3(i).