Drug Firms and Patent "Working": Extent of Compliance with Form 27


As promised in a previous post, we now bring you the full report of our RTI investigation into Form 27 (patent working) compliance issue. This report details out our rather tortuous tryst with the patent office in terms of getting this information…it took us more than 6 months to get this information!

One of the key reasons we spent so much time on this is to showcase the difficulty of getting this information, and to therefore plead with the Controller General that he must publish all Form 27 information on the patent office website on a regular basis. He is authorised to do so under Section 146 and has already committed to doing so in his interview with CH Unni of the Mint.

Our report spells out the various Form 27 non disclosures (or incomplete disclosures) and lists out the revenues earned by these drugs in India…with Rs 42 crores by Pegasus (for the year 2009-2010) being the highest.

I also attach copies of Form 27’s as received by us from the patent office in relation to the 7 drugs that we studied.

In this post, I extract our findings on the extent of non compliance with Form 27 by these drug patentees:

Non Filing

1. All the pharmaceutical firms that we studied appear to be in breach of section 146 norms. They have either not filed Form 27s for some years (particularly the years 2007-2008 and 2008-2009) or have filed incomplete information. All these forms are attached as Annexure D.

2. Notably, Bayer (drug: Nexavar) did not file any Form 27 for the years 2008-2009, despite being granted a patent in March 2008 .

3. Sugen Inc (drug: Sutent) did not file any Form 27’s for the years 2007-2008 and 2008-2009, although it was granted a patent in October 2007.

4. Despite being granted a patent for Dasatinib in January 2007, Bristol Myers Squibb (BMS) did not file any Form 27 for this drug for the years 2007-2008.

5. Further, a company such as Roche, which otherwise filed very comprehensive Form 27 information for the year 2009-2010 does not appear to have filed any form for 2007-2008 and 2008-2009 for Pegasus. Unlike most of the patents that were granted only in 2007 and 2008, Pegasus was granted way back in 2006, rendering an obligation on Roche to begin submitting this information in 2007 itself. It bears noting that the Chennai Patent Office expressly mentioned that it received the Form 27 for Pegasus for only one year i.e. 2009-2010.

Further, despite being granted a patent for Tarceva in Feb 2007, Roche does not appear to have filed any Form 27’s for this drug for the year 2007-2008. It must be noted that the patent over Tarceva has been registered by Pfizer and OSI. However, as the exclusive licensee for this drug, Roche has been filing the requisite Form 27’s.

6. Schering has been particularly lax on this count, since it did not bother to file any Form 27 for its drug Viranferonpeg even as late as 2009-2010! We note this in particular, since the Controller General Kurian had clearly indicated that he was serious about Form 27’s in the year 2009-2010 and had even put up an official notice to this effect on the website, calling upon companies to file this information.

Caveat: We had asked the Patent Office for all Form 27’s filed for each of the drugs filed ever since the patent was first granted. Since most of the drug patents were granted during the years 2007-2008 (barring Pegasus which was granted in 2006), this effectively meant that we were asking for Form 27 filings for 3 years (2007-2008; 2008-2009; 2009-2010). The patent office gave us only what they had on record with them, stating that these were the only forms that has been filed and on record with them.

It bears noting that given the record keeping reputation of the patent and trademark office (which has misplaced or lost files in the past), there might be a possibility that a firm might have submitted a form, but the patent office may have misplaced or lost it. If this is the case, we hope the firm in question will immediately take it up with the patent office, and also send us a notification to this extent, so that we can update our report.

Incomplete Filing

7. As noted earlier, most firms have not made filings at all for certain years. Most egregiously, firms such as Schering Corp. (drug: Viraferonpeg) and Sugen (drug: Sutent) have filed forms for only one year (Schering filed for 2008-2009 only and Sugen for 2009-2010 only).

8. Even in respect of Form 27’s that were actually filed, we found that the information was incomplete. Illustratively, Schering merely mentions that it is importing Viraferonpeg, an anticancer drug from Ireland in its filing for 2008-2009. It does not provide any further details in the columns asking for information relating to the quantum and value of imports. Rather, it merely states: “Information not readily available. Information will be provided if asked for.” This is very curious, as it is clear that Form 27 is a mandatory requirement and the statute has already asked for this information. There is no further “asking” required under the Act.

One wonders why information pertinent to imports by a certain firm is not available in the records of that very firm! One can only conclude that Form 27 requirements have been taken lightly.

9. Sugen Inc (drug: Sutent) has not filed the information in the required Form 27 format. Rather, it has come up with its own format, merely stating in two lines “Indian Patent No. 209251 claims a pharmaceutical product imported into India from Italy, more than 7000 units of which were sold in India in 2009.“ Notably, it does not state the quantum and value of imports. It merely states the quantum of sales. It also does not state if it has licensed the patent. From all accounts, this patent has been licensed to Pfizer, but this information is not stated in the Form 27 filing.

10. BMS (drug: Entecavir) has to be lauded for a rather honest statement. It rightly notes that it did not work the patent in 2008-2009, despite being granted the patent in January 2008. However, when asked for the reasons as to why it did not do so, it states “nothing in particular”. In so far as it’s working for 2009-2010 is concerned, it does not state whether it was manufacturing or importing the product. One has to infer that it was merely importing the product. Further, it does not list out either the “quantum” of imports or where it has been importing the drug from.

11. We also found that firms have been careless with their filings. Illustratively, Bayer filed two forms for the same drug (Nexavar) with different information (Form 27 for the year 2009-2010). However, here again, we leave the possibility open that the patent office might have received both forms, and the firm might have instructed the patent office to use only the updated form in its record.

Violation of “working disclosure” norms

12. From the facts on record with us and as supplied to us by the patent office, it is clear that none of the pharmaceutical firms that we studied have provided full and complete Form 27 information. In some cases, Form 27 has not been filed at all. And in others, the information provided is woefully inadequate.

13. It bears noting at this stage that even if the patent is not worked, a Form 27 must be filed and the tick box stating “not worked’ must be ticked. Only BMS and Bayer have stated “not worked’ in two filings.

14. Assuming that the patent office information given to us is correct, we can only conclude that none of these firms take the Form 27 and section 146 working requirement seriously. That Form 27 disclosure is serious business is evident from the fact that Section 122 of the Patents Act, 1970 permits the Controller to take those who file incomplete information to task and fine them Rs. 10 lakhs.

SpicyIP urges the Controller to do so in order that an example might be set and that the threat of sanction would induce other companies to comply. We are given to believe that this non-compliance is not specific to pharmaceutical drugs alone but is rampant even amongst patentees belonging to other technology sectors. We will be investigating these other sectors in the near future.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is 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 Professor Basheer joinedAnand 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. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

3 comments.

  1. AvatarP.S.R.C.Murthy

    Dear Shamnad

    Excellent Work.

    You and your team members spending lot of your valuable time in providing and educating IP related information.

    I am great fan of your website.

    Used to follow your website every day.

    Regards
    P.S.R.C.Murthy
    Senior Scientist – Intellectual Property Management
    Suven Life Sciences Ltd.

    Reply
  2. AvatarS

    The thing which surprised me the most is why there is a backlog of consecutive years? Why the granted patent was not inspected for F-27 compliance every year after the grant and especially when it is meant for such important lifesavers?
    I think the IPO should strictly follow this and certain others like undertaking u/s 8 and all.

    Reply

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