Another Step of Indian Patent office

Yesterday, IPO has published a list of FER issued in 2013. This list can be checked by Month from Jan, 2013 to till today.  All this shows that patent office is working very hard to clean up the backlog of application in queue. I appreciate the patent office efforts.

The link for the FER status can be accessed from here.

 

New Notification by Indian Patent Office – Status of pending patent application

Indian Patent office, recently (Aug 19, 2013), published dynamic status of patent applications, which are categorised under 23 categories (Classification based on respective filed of invention). Categories are:

Agrochemicals, Biotechnology, Chemical, Civil, Communication, Electrical, Electronics, Food, General Engineering, Mechanical Engineering, Pharmaceuticals, Textile, Computer Science, Physics, Bio-Chemistry, Polymer Technology, Micro Biology, Metallurgy, Bio-Medical Engineering, Agriculture Engineering, Traditional Knowledge Biotechnology, Traditional Knowledge Chemical, Traditional Knowledge Mechanical

The patent applications are listed under 5 headings:

ü  In process

ü  Granted

ü  Refused u/s 15

ü  Abandoned u/s 21 (1)

ü  Withdrawn after 15 months

The above can be accessed here. However one needs to go through whole list after selecting the category and type of status, to look for the desired patent application. This is not in searchable format. One more important thing is that this is data after Jul 01, 2012.

New Drug for HIV patients:- Tivicay

FDA recently (Aug 12, 2013) approved Tivicay (dolutegravir), a new antiretroviral agent for HIV-1 infection. Tivicay is approved to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children ages 12 years and older weighing at least 40 kilograms (kg) who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors. Dolutegravir is available as 50 mg tablets. Dolutegravir is taken orally without regard to meals.

For complete information, click here

 

 

Strict Procedural Requirement at Indian Patent Office

Recently, Controller has given decision for the two divisional applications which are related to Herceptin, Drug for Breast Cancer developed by Genentech.  Herceptin (Trastuzumab) is a monoclonal antibody that interferes with the HER2/neu receptor. Trastuzumab costs about US$70,000 for a full course of treatment and brought in $327 million in revenue for Genentech in the fourth quarter of 2007. A news (inEconomic times) regarding the compulsory license has also been there but still DIPP is under consideration for this drug.  Below is shown patent situation for the Herceptin in India:  

 

(i).   IN 205534 (Main patent for Herceptin) – As per the e-register (Indian Patent office) of this patent has been ceased on 3 May, 2013. From the e-Register, it appears that Genentech has paid last maintaince fee in Mar, 2012 and this time perhaps they have missed the deadline.

 

(ii). 1638/KOLNP/2005 (divisional application) - This application is still under opposition by Glenmark Pharmaceutical Limited.

 

(iii).      3272/KOLNP/2008 & 3273/KOLNP/2008 (divisional application): Both applications are held abandoned by IPAB recently on Jul 17, 2013. The reason for the abandonment of the two applications is summarised below:

 

ü  Missed out a day in Filing request for examination: Last date for Request for examination for these application was Feb 11, 2009 as per sec 24 B (iv) of Indian Patent Act, but Genentech has filed the examination request one day late i.e. Feb 12, 2009.

 

ü  Not divisional as per Patent act: Applications was filed as divisional of 1638/KOLNP/2005 which is also divisional of Main patent. It was held that there is no scope in patent act for filing further divisional application of a divisional application. In spite of this, if a divisional is further divided, later application will be considered as divisional of first parent application. In this case, original parent application was granted in Apr, 2007 and divisional applications (3272 & 3273) were filed in Aug, 2008 i.e. after the grant of Main Patent.

 

ü  Not a proper divisional on the basis of plurality of the invention.

 

Genentech is also provided with an opportunity to be heard for the above matter, but they did not appear for the hearing. So this is another mistake on part of Genentech.

 

Above situation indicate that patent office is having strict compliance requirements, which needs to be fulfilled. Even a delay of one day or a single mistake can cost a lot for the Patent applicant. Also, there is now only one application of Herceptin (1638) which if granted can block the generic players to enter in the market. Also need to check the step taken by the Genentech to save its Main Patent whether they will request for restoration?

 

 

 

Allergen Yesterday Lost Patent For Combigan Eye Drops

Combigan, product of Allergen, was patented under the Indian patent no.  IN 219504. This patent  is related to “combination of brimonidine and timolol” for topical opthalmic use. Ajantha Pharma limited has filed petition for the revocation of this patent at IPAB and succeed yesterday in revoking the patent.

 

IPAB revoked the patent on the basis of Obviousness and Non compliance of Sec. 8. However, opponent filed the application with several grounds viz. Patent was obtained on a false suggestion or representation, that it is not an invention that it is obvious, that it does not sufficiently disclose and that Section 8 of the Patents Act, 1970 was violated. The brief analysis of judgement is as follows:

Section 8:  First of all, Hon'ble Smt. Justice Prabha Sridevan provided the importance & scope of section 8 of Indian Patent Act and this read as follows:

“The Inventors and the Challengers must remember that

- S 8 must be complied with.

- It must be pleaded and proved that the lapse was with regarding applications in respect of the same or substantially the same invention( vide ORA 17/2012/PT/KOl order no 162/2013)

- The documents to prove this must be filed at the earliest if they are filed belatedly, costs may be imposed.

- The law does not say that the failure to furnish the S.8 details must be deliberate and willful or that the failure must be in regard to material particulars.

- It has been introduced to facilitate examinations and therefore the patentee must be candid and fair.

- The Controller cannot deal with this ground casually. They must adhere to the law nor can they dilute it. .

- The Patentee has a statutory duty under S.8, he cannot say that the particulars are available on the website. Nor can the Examiner condone the non-disclosure by saying the details are on the website.( vide Sugen vs Cipla IPAB)

- It is not a penal provision and the object of the law is clear disclosure and there can be no dilution.

- Rule 12(3) is part of the statute and indicates why this provision has been introduced and reflects the sentiments of the Ayyangar Committee report.

- The article “a” in the law cannot be understood to mean only one. Once the S.8(1) detailed particulars are given, the Controller may ask for the details relating to ‘a’ country. This means any. The Controller May ask for the Rule 12(3) details regarding any application.

- It is repeated that S.8 must be complied with.”

IPAB held that the respondent withheld information that ought to have been furnish under Section 8. In this case, EPO has rejected the patent and after appeal USA has also rejected the patent. Respondent has only served the controller with Canadian granted patent, which is in favour of him. This was clear case of hiding out the material facts.  

Sec 3(d)- This ground was rejected  and also provides elaborate the term “combination” used in explanation part of sec 3(d) by stating that

“The combination mentioned in the Explanation can be only mean a combination of two or more of the derivatives mentioned in the Explanation or combination of one or more of the derivatives with the known substance which may result in a significant difference with regard to the efficacy. A combination of two active drugs like Brimonidine and Timolol cannot be considered derivatives of each other”.

Obviousness: Here Justice referred to the decision of European (rejected), USA (on appeal) and Canada (affirmed) counterpart.  Justice, also referred the judgment of Justice Pumfrey in (2004 EWHC 477 (Ch) Cipla Limited Vs. Glaxo Group Limited and also provide a clear explanation with respect to each reference. The invention was held obvious. The obviousness of the invention by the judgment is read as follows:

“Ms. P. Sita already knows from D1 and D2 that the serial combination has an additive effect and therefore the closest prior art was this combination”.  

“It held that when viewed under a proper standard the evidence establishes a motivation to combine since it was common at that time to provide Brimonidine and Timolol sequentially and DeSantis taught fixed combination”.

Section 3(e): As described earlier, patent is liable to be revoked on the basis of sec 8 and obviousness so IPAB has not taken sec 3 (e) in to consideration as they were not provided with any comparison test to show that improvement in the concerned invention is only additive or more

Final Judgment:  Petition is allowed and IN 219504 is revoked.

The above judgement gives a clear warning to applicants regarding the importance of Sec. 8 and also provides an explanation for the term “combination” referred in “Explanation” part of “Sec 3(d)”. The whole judgement can be accessed here.

Appreciation to Indian Patent office

Guidelines for examination of computer related invention were published on Indian Patent Office site in Jun, 2013 inviting for the comments.  The feedback for the guidelines has been provided by 32 organisations/individuals. Today patent office has published the draft guidelines along with the feedback/suggestion by different organisations/individuals. I appreciate the patent office for providing public an opportunity to help in making the final guidelines.  Also appreciate the organisations/individuals, who participated in providing feedback/suggestion.

Guidelines for examination of computer related invention &  Feedback  can be accessed from Patent office site.

ANNOUNCEMENT BY IPAB

 IPAB announced the launch of a vibrant, user-friendly new website with the url http://www.ipabindia.in/. This has been launched by the Hon’ble Chairman Smt. Justice Prabha Sridevan. The new-look website is packed with a lot of features including search string operations. In order to make the transition of the website smooth, IPAB will continue to host the existing website till the new website is fully loaded with the entire data available on the existing website. The new website will go a long way in fulfilling the expectations of the users with regard to finding the relevant information easily.