Indian Pharma Patent Cases

1) Imatinib

Imatinib product patent is not exist in India and Novartis had filed beta crystalline form patent application (1602/MAS/1998) in 1998. This application is published after 2005 and which was opposed by many Indian companies & NGOs. This application was rejected in pregrant opposition and in appeal IPAB also rejected. While this application was rejected under section 3(d), Novartis challenged the section 3(d) in HC and this HC judgement is precedential for the term efficacy in section 3(d). Novartis had appealed in Supreme court. On 6th Sep, this case is transferred to another bench (where Mr Justice Dalveer Bhandari is not a member). This case is listed for hearing on  28/02/2011.

2) Erlotinib

Erlotinib product patent (537/DEL/1996) was challenged at pre grant level by Natco, it was not successful. Opposition filed by Natco was rejected and patent was granted as 196774 with specific claims of Erlotinib Hcl and its process of preparing. Cipla announced and launched Erlotinib even when patent was granted in India.  Roche/OSI sued Cipla and requested injunction for marketing generic version. Delhi High court rejected Roche’s injunction request. Polymorphic patent applications filed (IN/PCT/2002/507/DEL & IN/PCT/2002/497/DEL) by Roche were also opposed by Cipla. Polymorphic claims were rejected and only process claims were granted. This product patent infringement suit is pending with delhi high court. As a new development, Divisional application of Erlotinib product patent published last year march as 2018/CHE/2006 (Application is expressly withdrawn). This application is opposed by Glenmark and Matrix at pre grant level. Many patent revocation applications are pending at IPAB on ‘774 patent.

Pending cases on Erlotinib are  1) F HOFFMANN-LA ROCHE Vs REDDY’S LAB (case no: CS(OS) No. 81/2010); 2) F HOFFMANN-LA ROCHE  Vs GLENMARK PHARMA (Case No: CS(OS)402/2010);3) F.HOFFMANN-LA-ROCHE Vs NATCO PHARMA(Case No: CS(OS)2465/2009);4) F. HOFFMANN-LA ROCHE Vs CIPLA (Case No: CS(OS)89/2008); 5) F. HOFFMANN-LA-ROCHE Vs MATRIX LAB (Case No:5166; 993; 801 – Dismissed); 6) F. HOFFMANN-LA-ROCHE Vs AUREATE HEALTHCARE PVT. LTD (Case No: CS(OS) 2460/2011); 7) F. HOFFMANN-LA-ROCHE Vs ONCARE LIFE SCIENCES (Case No: CS(OS) 2459/2011); 8) F. HOFFMANN-LA-ROCHE Vs INNOVA LIFE SCIENCES (Case No: CS(OS) 1936/2011); 9) F. HOFFMANN-LA-ROCHE Vs ACCURA CARE PHARMACEUTICALS (Case No: CS(OS) 1935/2011); 10) F. HOFFMANN-LA-ROCHE Vs INTAS (Dismissed)

3) Sorafenib

Sorafenib product patent is granted in India 215758 (IN/PCT/2001/799/MUM) and divisional is 1633/MUMNP/2007. This patent is opposed by Cipla at post grant level. Cipla launched generic sorafenib and patent infringement case is filed by Bayer at Delhi High court pending outcome. Bayer tried to prevent generic launch by arguing for Patent-product approval linkage, that was rejected by Delhi high court and by SC in appeal. Pending Cases are Bayer Vs Cipla CS(OS) 523/2010 Next Hearing date is 30/01/2012. Natco has been sued by Bayer on 06/05/2011 (CS(OS) 1090/2011). Bayer’s writ petition challenging controller decision on Natco’s CL is disposed of by Bombay high court and asked Bayer to file in Delhi high court (Order). Bayer Vs Emcure Pharmaceuticals CS(OS) 2641/2011 (Sorafenib???).

5) Valganciclovir

Valganciclovir product patent (959/MAS/1995) was opposed at pre grant level by NGOs and opposition rejected and patent granted as 207232. In this case, NGO were considered as person interested to participate in post grant opposition (order by Madras High Court). This patent was opposed at post grant level by Cipla, Matrix, Ranbaxy & NGOs. Product claim was revoked in post granted opposition and patent maintained with process claim.

6) Entecavir

Entecavir is protected by pharmaceutical formulation related patent 213457 (IN/PCT/2002/891/MUM). BMS filed patent infringement and permanent injunction at delhi high court against Ranbaxy. Injunction was not granted. Pending case details are BRISTOL-MYERS SQUIBB Vs RAMESH ADIGE CS(OS) 534/2010.

7) Dasatinib:

Dasatinib is protected by 203937 (IN/PCT/2001/1138/MUM) and assigned to Bristol Myer Siqubb. BMS sued Natco (CS(OS) 2279/2009) and Hetero Drugs (CS(OS) 2680/2008).

8) Amoxicillin Formulation patent

Astellas sued Micro labs for patent infringement of 234753 (1398/MAS/1997) on May 2011 [(C.S. (O.S.) No. 1166 of 2011)] in delhi high court. [SpicyIP 1] [SpicyIP 2]

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8 Responses to Indian Pharma Patent Cases

  1. Pankaj Kumar says:

    Hi
    I found the information and the updates over Indian pharma patent here very useful for analysing the trend in India. The time spent in litigation seems to be frustrating and the above said many patent litigation is yet to conclude.

  2. sharada says:

    Hi,
    I found this post really informative. I was really amazed by your research. I was wondering as to how did you find out the pending cases on these drug molecules. It would be really great if you can share the source from where you get to know the Patent litigations pending on any particular product.

    Waiting for your reply.

    Thank you.

    • Guna says:

      You can find this information from news papers/blogs and from the Indian court sites. This is just a compilation of publically available information.

  3. Nidhi says:

    I found it really informative and helped me to keep a track of the patent cases in my seminar…

  4. RATNA RAO GANDLA says:

    Excellent information to all pharma companies and patients as well. Drug prices shold be reasonable to indian patients.

  5. Mahen says:

    Hi Guna,

    Nice to c u and ur posts, good work

    Mahendra
    (frnd from glenmark)

  6. Atul Bhopale says:

    Very informative and interesting

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