[Ip-health] Briefing Document on Grounds for Opposing Patent Applications on Sofosbuvir in India

Tahir Amin tahir at i-mak.org
Thu Mar 20 15:55:32 PDT 2014


*THE GROUNDS FOR OPPOSING PATENT APPLICATIONS ON SOFOSBUVIR*

*Briefing document, March 2014*



Hepatitis C is a significant public health issue for low‐ and middle‐income
countries, which are home to 60% of the 185 million people infected
worldwide. The disease is curable, but high drug prices make treatment
inaccessible, leaving people at risk for liver cancer or liver failure.



Sofosbuvir is the first of several direct-acting antivirals against
hepatitis C to be approved by the US FDA and Europe, and holds significant
promise to improve, shorten and simplify treatment of the disease. Access
to affordable sources of the drug is therefore critical.



Gilead Sciences/Pharmasset has applied for multiple patents (including
divisional patents) in India on sofosbuvir, a drug to treat hepatitis
C.  India’s
patent law allows third parties, including civil society organisations, to
file ‘pre-grant’ oppositions, to challenge the patent application before
the patent is granted. Two pre-grant oppositions by civil society groups
have now been filed in India on key patents that would provide exclusivity
over sofosbuvir.  Their intention is firstly to prevent unmerited patent
applications from being granted, and secondly to open up the market for
generic producers and increase competition, which will result in lower
prices and increased access.  This short briefing note explains the grounds
for these two patent oppositions.



*19 March 2014: opposition to the patent application on the base compound*



The opposition, filed at the Indian Patent Office by the Initiative for
Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive
People (DNP+) targets Gilead’s patent application 6087/DELNP/2005 (WO
2005/003147).  The opposition is based on three primary grounds: novelty,
inventive step and efficacy.



   - *Novelty:* *The drug is not new.* The base compound has been disclosed
   in various earlier patents, which already reveal the free base compound
   that is used in sofosbuvir (1).
   - *Inventive step: The patent application is for old science, and
   patents should not be granted** to products which are based on
   well-known techniques that are obvious to try.* In addition to the
   earlier patents that reveal the free base compound used in sofosbuvir,
   additional patents and literature would have made obtaining these compounds
   obvious to a person skilled in the art (2).
   - *Efficacy: India’s Patents Act stipulates that new forms of known
   substances have to demonstrate that they enhance the therapeutic efficacy
   of the product in order to deserve a patent.*  This clause, known as
   Section 3 (d), was designed to clamp down on evergreening, a standard
   industry practice whereby companies apply for patents on minor changes to
   existing drugs and compounds in order to extend their monopolies and keep
   prices high. In April 2013, Section 3 (d) was upheld by the Supreme Court
   of India following a landmark six-year legal battle involving Novartis.
   Gilead’s patent application covers a new form of 2’-modified nucleoside
   analogs, which already exist in the field and are classified as
   derivatives. Gilead Sciences has not provided evidence in its application
   that shows that these derivative compounds have enhanced efficacy over
   known forms.



For the reasons outlined above, the patent application should be rejected
as it does not meet the standards required for a patent to be granted under
India’s law.  In addition, the patent opposition raises several
technicalities:



   - There are different applicants listed for the international patent
      application as compared to the Indian patent application. Gilead has thus
      far not been able to provide lawfully required documentation around chain
      of title that affects the priority of the application and when
the claimed
      invention was made. This technicality is critical for
determining what was
      already known in the field.
      - The patent document describing the invention is not sufficient, and
      therefore does not fully comply with patent law requirements.
      - India’s law requires applicants to inform the patent office of
      other examinations and legal proceedings around this application. Gilead
      Sciences has failed to meet this requirement.



*24 November 2013: opposition to the patent application on the pro-drug*

The opposition, filed at the Indian Patent Office by I-MAK targets Gilead’s
patent application 3658/KOLNP/2009 (WO2008/121634). This opposition is
based on three primary grounds:



   - *Novelty: The drug is not new.* The pro-drug form in
   Gilead/Pharmasset’s 2007 application was already disclosed in an earlier
   2005 application by the University of Cardiff for the treatment of
   cancer.
   - *Inventive step: The patent application is for old science, and
   patents should not be granted** to products which are based on
   well-known techniques that are obvious to try.* Several exhibits
   included with the opposition demonstrated how the “ProTide” pro-drug method
   had been used repeatedly in the past for drugs.
   - *Efficacy:* *India’s Patents Act stipulates that new forms of known
   substances have to demonstrate that they enhance the therapeutic efficacy
   of the product in order to deserve a patent.* The pro-drug step
   represents a new form of a known substance, and Gilead/Pharmasset’s patent
   application provides no data demonstrating enhancement in therapeutic
   efficacy over the free base compound.



*What happens next?*



The Indian Patent Office will review the oppositions. We believe the Indian
Patent Office should reject the applications based on the evidence.  Networks
of people living with hepatitis C, community‐based organisations, legal aid
groups and treatment providers are campaigning to demand that
Gilead/Pharmasset price sofosbuvir affordably at US$500 based on the actual
cost of production. (3)



*Notes:*

*(1)   **In particular, patents including WO2002/057425 and WO2004/002999*

*(2)  **For example, earlier documents discuss 2’-modified nucleoside
analogs, their prodrugs and pharmaceutical compositions. Sofosbuvir is
based on 2’-modified nucleoside analogs with substitutions that have
already been revealed or would have been minor changes to someone skilled
in the art. Furthermore, as far back as 1996, literature shows that using
2’-modified nucleoside analogs, including uridine nucleoside derivatives as
antiviral compounds would be useful. Gilead/Pharmasset use a uridine
derivative nucleoside for the free base compound application for
sofosbuvir. *

*(3)   **Minimum Costs to Produce Hepatitis C Direct-Acting Antivirals.
Andrew Hill et al. November 2013 poster presented at the American
Association for the Study of Liver Disease. Available from:
http://freepdfhosting.com/d4a7e2bba6.pdf
<http://freepdfhosting.com/d4a7e2bba6.pdf>*

The complete patent opposition documents are available at:
http://www.i-mak.org/sofosbuvir/

-- 
Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+1 646 884 7418/+44 771 853 9472
*Press: *The Guardian http://tinyurl.com/mooycg5 |The New York Times:
http://tinyurl.com/kowtmzn



 <http://tinyurl.com/kowtmzn>



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