Drug Regulation Patent

The Drug Patent Linkage Fiasco Continues


Pursuant to our last post pointing to a highly egregious Delhi High Court order that came close to mandating patent linkage in contravention of existing law, a number of news reports have emerged on this theme. For those interested, please see Mint Report by Unni and Radhika; ET report by Khomba Singh, and most recently, see Peter Ollier’s report in MIP.

Interestingly, there is a short analysis in DNA by someone going by the name of “Pillman”–does anyone know who this is?

Khomba Singh of the ET did another report highlighting the fact that the Bristol Myers case was not the first case involving “patent linkage”. Rather an earlier case that had been filed by Bayer against the DCGI and Cipla was ever more troubling. Particularly since this was in the nature of a writ petition directed specifically against the DCGI (Drug Controller General of India).

Note that that Hetero case was a private law suit between BMS and Hetero and the DCGI was not even a party to this. Further the court order did not directly mandate “linkage”–rather it was couched in terms of an “expectation” that the DCGI would ensure that no patent rights were violated. As we stated in an earlier post:

“…since the DCGI is not a party to the law suit between BMS and Hetero, one might argue that he is not “technically” bound by the Delhi High Court order. However, going by a Mint news item, where the DCGI demonstrated a keenness in policing patents, one might expect the Delhi High court order to have some persuasive impact on him.”

CH Unni and Radhieka Pandeya of the Mint also report on this second Bayer vs DCGI and Cipla case, noting that:

“Meanwhile, another controversial ex parte order of December by the Delhi high court, unlike in the Hetero case, had directly asked DCGI to reject a generic drug application filed a few months ago by Cipla. Cipla has sought the revocation of that decision, as reported in the Economic Times on Monday.

Cipla had sought approval for a generic version of German multinational Bayer AG’s cancer drug Nexavar. Bayer holds a 2007 patent for this drug in India. The court order was on a writ petition filed by Bayer claiming patent violation. DCGI, as the first accused in the writ petition where Cipla is also a party, will be replying to the court in due course, and the case will come up for hearing on 19 January.”

And lastly, for those who have more of a “ear” for podcasts, I’ve discussed the above two cases at length with Jeremy Philips and Duncan Bucknell last week.

Shamnad Basheer

Prof. (Dr.) Shamnad Basheer founded SpicyIP in 2005. He's also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof. Amartya Sen. Professional History: After graduating from the NLS, Bangalore Prof. Basheer joined Anand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Later, he was the Honorary Research Chair of IP Law at Nirma University and also a visiting professor of law at the National Law School (NLS), Bangalore. Prof. Basheer has published widely and his articles have won awards, including those instituted by ATRIP, the Stanford Technology Law Review and CREATe. He was consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also served on several government committees.

9 comments.

  1. Patent

    The Indian Patent Office has also become grossly understaffed now with the promotion of 47 Examiners as Assistant Controllers. This means that very few Examiners are left to deal with examination of applications for Patents. The recent promotion was done in great haste without any justification. This has resulted in a higher number of Controllers vis a vis Examiners. Therefore Examiners are being pressurised to examine and grant cases unrelated to their subjects and also to increase the number of granted patents,or threatened with transfers. This would further dilute the quality standards of the Indian Patent Office which is already one of the lowest.

    Reply
  2. Anonymous

    thats true… in delhi patent office the ratio between controller and examiners is not even 1:1 in some cases. 1 examiner is reporting to more than 1 assitant controller in some cases… this is a way to check the quality of examiner.. Our Indian football team should learn such types of man-to-man marking from Indian Patent Office..

    Reply
  3. Susan

    Dear Shamnad,

    As I have mentioned to you offline, I do not share your view that patent linkage is a “disaster” for India. Far from it. With linkage combined with early working, the government can provide greater certainty for patent holders and for generic producers in terms of orderly market entry at the conclusion of the patent term, reduce litigation and attendant costs for both parties, and benefit consumers as well with speedy entry of generics at the appropriate time. Win/win/win.

    After all, the Government of India as a whole signed the TRIPS Agreement and DCGI’s actions are key to provide effective patent protection throughout the lifetime of the patent. Also, linkage policies are much fairly accepted among WTO Members, including Australia, China, Mexico, among others.

    In light of renewed interest in this issue I am reposting a 2006 Overview on Patent Linkage to my website at http://www.finstonconsulting.com.

    Warm regards,

    Susan

    Reply
  4. Shamnad Basheer

    Dear Susan,

    Thanks for sharing your views.

    Firstly, I am not entirely sure how this is a win win win, as you put it. How on earth will the DCGI decide a Roche vs Cipla kind of dispute, which as you know involves complicated issues of claim scope and infringement (Cipla claims that they dont fall within the scope of claims).

    Or is your stand that the moment Roche alleges infringement, the DCGI should automatically bar Cipla’s approval. In which case, how exactly is this a win for either Cipla or the patients that might have got cheap drugs?

    And why should the DCGI, an authority with no patent expertise spend its much needed time and resources to help patentees with their rights. Let the patentee expend resources and time and do this himself/herself. In fact, if you study the BMS order carefully, you’ll notice that the judge restrains Hetero from introducing their product in the market. Isnt this order sufficient for the patentee? Why on earth should the DCGI also be called upon to prevent the grant of a regulatory approval? The processes are distinct and need to be kept separate.

    Lastly, how exactly is “linkage” a TRIPS mandate? TRIPS does not require a non IP authority such as the DCGI to enforce or monitor a private patent right.

    As you may be aware, the EU has very cleverly avoided creating any linkage. Other countries that are adopting this disastrous practice appear to be doing so under bilateral trade pressure. Thankfully, India is an economically strong position to hold out on this and take a stand that reflects its own national interest.

    Reply
  5. Susan

    Shamnad,

    Just a quick note on the EU situation where they did not need linkage because they did not have early working. The two provisions generally go hand in hand. So I don’t take that as a particularly persuasive point, or something that Europe has “cleverly avoided.”

    Also, watch out for saying this is not India’s national interest as the same thing was said about product patents by many who are now eating their words!

    See you soon,

    Susan

    Reply
  6. Shamnad Basheer

    Dear Susan,

    The EU introduced the Bolar provision in 2004–so I think it is fair to say that if they haven’t yet introduced “linkage” despite the efflux of 5 years, there must be some strong sensible reason underlying their failure to do so.

    Also, your argument that India’s product patent regime is unequivocally a good thing for India is a view that is not shared by all. Many continue to feel that India is worse off by this change. I personally am agnostic about this and want to wait to see how things pan out in the next couple of years before commenting on the wisdom or folly of such a change in the regime.

    But in any case, your point about the Indian product patent regime change is neither here nor there. Its almost like arguing that folks who thought the US had a good case for the Iraq war at the start are eating their words now! And therefore we must not listen to those who argue against drug linkage now, because they could be wrong later on!

    Let us try and argue on the merits or otherwise of the current policy issue: whether or not it would make sense for India to introduce linkage, given the Bolar exception; the complexity of patent disputes and the sheer lack of institutional competence on the part of the drug regulator (DCGI) to decide such issues.

    Reply
  7. Anonymous

    This is not a point of debate at all! The very reason of obtaining patents for inventions is defeated if all and sundry are allowed to blatantly copy the invented drug molecules with the sole intention of making money. The copiers blatantly display their utter disrespect to the efforts involved in making discoveries and the amout of time money spet on them by the innovators.Mere copying a molecule and punching tablets does not take any efforts, money and intellect. A thousand Indian drug manufacturing units can copy any patented discovery and the DCGI can license all saying patents are not in their jurisdiction. The most important point has however much larger and far reaching implications i.e. Whats then the difference in the scinario before and after jan 1 2005? and with prevailing conditions, will any Indian Pharma Industry ever try and invent its own new Drugs?

    Reply
  8. Anonymous

    This is not a point of debate at all! The very reason of obtaining patents for inventions is defeated if all and sundry are allowed to blatantly copy the invented drug molecules with the sole intention of making money. The copiers blatantly display their utter disrespect to the efforts involved in making discoveries and the amout of time money spet on them by the innovators.Mere copying a molecule and punching tablets does not take any efforts, money and intellect. A thousand Indian drug manufacturing units can copy any patented discovery and the DCGI can license all saying patents are not in their jurisdiction. The most important point has however much larger and far reaching implications i.e. Whats then the difference in the scinario before and after jan 1 2005? and with prevailing conditions, will any Indian Pharma Industry ever try and invent its own new Drugs?

    Reply

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