I-Mak Blog

What's happening: An update on HIV drugs in India

Pfizer granted patent for important HIV therapy in India

Maraviroc has been granted a patent in India under Patent No. 204132. Originally filed for under Application no. 885/BOM/1999 titled 'CCR5 Modulators', it was published as granted in the Official Journal of the Patent Office of 8 June 2007.

Interestingly, the corresponding application at the European Patent Office (EPO), published as EP 1140085, is still under examination because of objections raised by the Office. The outstanding objections against EP1140085 are that the application does not sufficiently describe the invention, does not solve the problem claimed and lacks inventive step in the light of prior art.

It would be useful to compare the examination report of the Bombay Patent Office, which granted the patent in India, with the EPO's, but alas s144 of the Indian Patents Act does not allow the reports of examiners to be made public, a policy that must change sooner than later. Neverthless, as is permitted in India, 'any person interested' can oppose Granted Patent No. 204132 within one year of the date of publication of grant i.e 7 June 2008.

Approved by the FDA in August 2007, Maraviroc, also known by the brand name Selzentry ( or Celsentri outside of the U.S) is being positioned as an important salvage therapy for patients that are not responding to other HIV drugs.


Time to re-write or clarify the pre-grant opposition rules?

To add to the post below:

The Chennai Patent Office issued the Valganciclovir patent without providing a hearing to the Opponent, despite the fact that the Opponent requested one. This suggests to us that there is a strong case for re-writing or clarifying the pre-grant opposition rules and procedure (Rule 55).

This is not the first time that the rules for pre-grant opposition have been applied inconsistently between the four patent offices. In the matter concerning the opposition against Gilead’s application No. 896/DEL/2002 and 963/DEL/2002, the Delhi Patent Office refused to provide the opponents with Gilead’s response to the opposition. It was only after the matter was taken to the High Court in Delhi that the Delhi Patent Office agreed to provide Gilead’s response. In another matter concerning the patent for Nevirapine Hemihydrate, the same office (Delhi) provided the applicant's response. In the Gleevec patent opposition, the Chennai patent office applied the post-grant opposition rules whereby the opponent received Novartis’s response to the opposition from the Chennai Patent Office and the procedure/hearing was conducted inter partes.  The Mumbai patent office has been known  to adopt the practice of not passing on the applicant’s response to an opponent in a pre-grant opposition and deciding matters on the papers in front of it.

The problem appears to lie in the wording of Rule 55 and the lack of guidelines for examiners. Based on the wording of Rules 55(3) and 55(5), which state that ‘on consideration of the representation of opposition or response of the applicant, the Controller can either refuse to grant a patent for the application or request amendment’, it would seem that bar a hearing requested by either party, technically the representation of opposition or the application could be  dismissed at either of these points of the procedure by the Controller based on the merits of the opposition/response of the appplicant. It would appear this can happen without any further exchanges between the opponent, applicant and the patent office.

But where a hearing has been requested by either party – then it is difficult to see why the party should not be heard, even if the Controller is leaning towards granting the patent. Otherwise what is the point of providing the right to a hearing in s25(1)? Also, if a hearing is requested, then surely the opponent should be entitled to see the response of the applicant – else what is the opponent going to address at the hearing, his/her own opposition?

It is also worth noting Rule 129, which says that before using any discretionary powers  under the Act or Rules which is likely to adversely affect an applicant or a party to the proceeding, the Controller shall give the applicant/party a right to a hearing. The question here though is whether an opponent to a pre-grant opposition is a 'party' to proceedings?

It appears the rules for pre-grant opposition were drafted in a way to make them different from the rules for post-grant oppositions – and possibly to resemble an ex parte/observation procedure (but with a hearing - which is a strange format in itself). But the different patent offices are applying a mixture of the pre and post grant opposition rules, which is resulting in a dysfunctional pre-grant opposition system.

It would make sense to re-write Rule 55 so that it mirrors the post grant opposition rules and avoid this inconsistency and undue discrimination – but more importantly to ensure a stronger patent system for weeding out bad patents prior to grant. Alternatively, if it was not the intention to have the pre-grant opposition procedure be the same as the post-grant opposition, then the rules need to be re-written to clarify this. Otherwise, opponents (and applicants) may gain in one opposition, but be prejudiced in others.


Pre-95 drugs are not patentable in India – or are they?

The latest battle to interpret the law may impact whether several drug product patent applications in India are patentable. 

Ask the question whether pre-95 drug inventions are patentable in India under the 2005 Patents Act – and the answer you are likely to get is ‘no they are not’. The reason? India became a member of TRIPS on 1 January 1995 and so any invention for a drug, and its related patent, before that date does not have to be granted protection in India.

However, in a recent report by Livemint.com , it appears that the Chennai Patent Office disagrees with that reasoning  by granting patent Application No. 959/MAS/1995, for the drug Valganciclovir, (otherwise known as the L-monovaline ester pro-drug of the compound Ganciclovir), which is used for treating cytomegalovirus retinitis in patients with AIDS.

The patent was granted despite a pre-grant opposition by HIV/AIDS patient groups arguing that the drug is a pre-95 invention, because although the application was filed in India on 27 July 1995, it claims a convention priority from an earlier U.S Application No. 281 893 filed on 28 July 1994. So has the Chennai Patent Office got it wrong by granting a patent application claiming priority from a 1994 application?  

The key Article in TRIPS that is relevant to this question is Article 70.8. The WTO Appellate Body in the India – Mailbox Case , in particular paragraphs 56 and 57, help shed some light on how Article 70.8 should be interpreted. The Appellate Body states:

We believe the Panel was correct in finding that the "means" that the Member concerned is obliged to provide under Article 70.8(a) must allow for "the entitlement to file mailbox applications and the allocation of filing and priority dates to them".  Furthermore, the Panel was correct in finding that the "means" established under Article 70.8(a) must also provide "a sound legal basis to preserve novelty and priority as of those dates.”

One interpretation from the above passages of the Appellate Body's Report is this: the WTO interprets Article 70.8 as a mechanism for preserving the novelty of patent applications filed after 1 January 1995, including the entitlement for applicant’s to claim priority from earlier convention filings. This seems to be confirmed by the Appellate Body endorsing the Dispute Panel's view that 'Without legally sound filing and priority dates, the mechanism to be established on the basis of Article 70.8 will be rendered inoperational. [Panel Report, para 7.28]'. So on this interpretation, it might  incorrect to state that pre-95 drugs are not patentable in India. It could be that an application filed on 1 January 1995, may be able to claim priority from an earlier application filed on 1 January 1994.

However, the wording in Article 70.8 is not the clearest and could be open to alternative interpretations.  The obvious point is because TRIPS came into force on 1 January 1995, Members like India did not have any obligations to TRIPS before that date.

It is also worth noting that the concept of priority originates from Article 4 of the Paris Convention, which was installed into Article 2.1 of TRIPS. Article 65 clearly states that other than Articles 3, 4 and 5 of TRIPS, developing countries can delay the application of the provisions of TRIPS until 1 January 2000 (and an additional five years before granting protection to pharmaceutical product patents). So by this interpretation, does India have to recognise the right to priority claims under the Paris Convention before 1 January 2000? (In fact, India only became a member of the Paris Convention on 7 December 1998).  However, the problem with this interpretation is that Article 70.8 clearly states that it applies ‘notwithstanding the provisions of Part VI’ i.e Article 65. This very phrase means that Article 70.8 applies irrespective of the transistional provisions.

Also, the now defunct s24B of the Patents(Amendment ) Act 1999 only provided exclusive marketing rights (EMRs) for patent applications under s5(2) relating to inventions made in India or in a country other than India for the same invention claiming an identical article or substance in a convention country on or after 1 January 1995. But is it possible to apply the EMR standard to priority claims for applications?

The interpretation of priority dates for inventions dating before 1 January 1995 is likely be another drawn out battle which could affect whether a number of pharmaceutical patent applications are granted in India.


What's Happening: An Update on HIV Drug Patents

Abbott Abandons its U.S Patent Application for "Heat-Stable" Lopinavir/Ritonavir

An inspection of the U.S Patent and Trademark Office (USPTO) file wrapper for Abbott's application on "Heat-Stable" Lopinavir/Ritonavir, which forms the priority application for the Indian and European patent applications that we opposed/filed observations against last month, shows that Abbott has abandoned its application. Abbott failed to respond to the USPTO's examination report to restrict or make an election given that the application claims more than one invention. Unfortunately, as the U.S allows applicants to re-file applications, under what is known as a continuation application, it is highly likely that Abbott will re-file. For those of you who want to access the file wrapper it is
application no. 10/650,178 (published as US 2005/0048112 A1).

The Mystery of the Atazanavir Patent in India

Press reports and a letter we have seen from the patent office suggest that the Indian patent application 805/MAS/1997 for Atazanavir, the base compound for the well-known HIV drug Atazanavir Sulfate (known as Reyataz when marketed by BMS), has been abandoned by the patent holder Novartis AG. At the same time reports also suggest that Novartis may have another application on Atazanavir.

What is interesting about the 805/MAS/1997 application is that it was not published under the new patent regime after the 2005 Patents Act, but was published in 1997. In fact, (thanks to Professor Bhaven Sampat, who retrieved the publications), records show that along with Atazanavir, several other pharmaceutical product patents were published prior to 21 January 2005, when the publications began under the new patent regime in India. This raises a number of questions about what is going on at the Indian Patent Office and whether there are a number of earlier publications that may have been missed by parties seeking to file oppositions.

As for Atazanavir, I-MAK has searched the nearly 200 Novartis patents published before 2005 to see if the application was filed in duplicate or whether a similar application existed with a different title. We haven't found anything to suggest there is a duplicate patent for Atazanavir in India, but given the double entry of some patent applications we're still looking.

Gilead has no patent protection for Tenofovir in South Africa, Namibia or ARIPO

After all the voluntary licenses handed out by Gilead for Tenofovir DF, we thought it would be interesting to see where Gilead actually has patent protection. Surprisingly, we found that Gilead does not have patents for Tenofovir Disoproxil or Tenofovir DF in key countries such as South Africa and Namibia, or even ARIPO (although information from the patent office in Namibia and ARIPO is not without disclaimers due to the manual searching of patents). It is interesting to note that Aspen, South Africa's largest generic producer, struck a voluntary licensing deal with Gilead -- knowing Gilead had no protection there. The lack of protection in these countries is probably one of the reasons why Gilead is refusing to drop its application in India - so that it can prevent companies like Cipla, who did not take a license - from exporting from India should an application be granted.
Page 1 ... 6 7 8 9 10