[Ip-health] Divide and Rule: Companies File 'Divisional' Applications to Avoid Oppositions Against HIV Drug Patents

[Tahir Amin]

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In our previous posts,
here<http://www.i-mak.org/i-mak-blog-updates/2009/5/23/update-india-abbott-files-a-divisional-application-for-its-h.html>and
here<http://www.i-mak.org/i-mak-blog-updates/2009/5/26/divisional-or-continuation-application-abbott-re-files-the-s.html>,
we alerted you to Abbott re-filing the same application for its heat stable
ritonavir, ritonavir/lopinavir formulation under the guise of a divisional
application. Given the loose wording in section 16 of the Indian Patents
Act, we began to wonder whether other companies were using the right to file
a further divisional application as a continuation application in order to
avoid pre-grant oppositions filed against their parent applications. Our
concerns appear to be well founded.

Take for example the patent application for the HIV drug atazanavir, which
patient groups had opposed. In August 2007,
reports<http://www.medicalnewstoday.com/articles/80857.php>circulated
that Novartis had abandoned its application for the drug
atazanavir after the patent office had released a letter to that effect. A
copy of the patent office letter confirming the abandoning of the parent
application 805/MAS/1997 can be viewed
here<http://www.scribd.com/doc/818175/India-atazanavir-abandoned-letter>.
We ran a post<http://www.i-mak.org/i-mak-blog-updates/2007/9/13/whats-happening-an-update-on-hiv-drug-patents.html>at
the time wondering whether this was true, or if Novartis had another
application in the system.

It turns out that Novartis does still have a pending application for
atazanavir in India. More worrying is that Novartis adopted the same
strategy that Abbott is attempting with its patent application. On 17
February 2007, Novartis filed a 'divisional' application to its parent
application 805/MAS/1997. The new application number is 310/CHE/2007 ('310)
and was published on 28 November 2008. The publication notice for '310 can
be viewed here<http://124.124.220.66/patentpublishedsearch/%28S%28qckg5555u0vqyd45e4tl0x55%29%29/publishApplicationNumber.aspx?application_number=310/CHE/2007>.
We have reviewed the new application and it makes the same claims as the
parent application, plus a few more.

Gilead Sciences has also resorted to the same strategy with respect to its
applications for tenofovir disoproxil (originally filed as 2076/DEL/1997)
and tenofovir disoproxil fumarate (originally filed as 896/DEL/2002). These
applications were also opposed by patient groups - see
here<http://www.i-mak.org/tenofovir/>for more details. The original
application 2076/DEL/1997 was divided out to
602/DEL/2007 on 20 March 2007 and makes the same claims. Similarly
896/DEL/2002 was re-filed as a divisional on 29 May 2007, with the new
number 1135/DEL/2007. Both publication notices can be viewed here
<http://124.124.220.66/patentpublishedsearch/%28S%28gansbyiexxgtmwzjtjinzh55%29%29/publishApplicationNumber.aspx?application_number=602/DEL/2007>and
here<http://124.124.220.66/patentpublishedsearch/%28S%28pvxczkuhmmu10k242lf3px45%29%29/publishApplicationNumber.aspx?application_number=1135/DEL/2007>
.

There are two issues of grave concern arising from these developments.

The first is whether oppositions that patient groups filed against the
parent applications in the above cases will still be applicable against
these so called 'divisional' applications. Considering that all the
'divisional' applications make the same claims that were opposed by patient
groups, one would think that in the interests of justice the patent office
would still apply the oppositions during examination. Otherwise, the purpose
of the pre-grant opposition system becomes defunct.

The other worrying factor is the Indian patent office, whether intentionally
or not, is allowing applicants to re-file the same or essentially the same
patent application under the guise of a divisional. One could accept
divisional applications that claim subject matter that was disclosed in the
original patent specification, but not previously claimed. However, this is
not what is happening. What is happening is applicants are filing what are
akin to continuation applications as permitted in the U.S. (For those of you
not familiar with how continuation applications work in the U.S., see Mark
Lemley and Kimberley Moore's paper 'Ending Abuse of Patent Continuations'
available here<http://i-mak.squarespace.com/storage/Lemley%20Moore%20-%20Ending%20Abuse%20of%20Patent%20Continuations.pdf>
).

If such practices are allowed to flourish, the patent system in India is
going to become the subject of abuse by applicants. Provisions like section
3(d) and the pre-grant opposition procedure will serve little purpose as
applicants will be able to continuously file 'divisional' applications every
time they run up against an opposition or rejection by an examiner.

The administrative and financial cost of all this to the patent office,
interested opponents and especially those who are in need of affordable
medicines will be significant.

The Indian Patent Office needs to realise quickly what is going on and curb
the abusive practice of these continuation type applications.
( For access to links in the above post see:
http://www.i-mak.org/i-mak-blog-updates/2009/5/30/divide-and-rule-companies-file-divisional-applications-to-av.html
)

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Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
www.i-mak.org