Pharmaceutical inventions and patenting methods in India

We all are well aware of the fact that intense lobbying is happening on both to protect improvement inventions by innovator pharmaceutical companies and strategies to tackle these attempts by generic pharmaceutical companies.

Pharmaceutical innovations are always treated special in India and most of developments in patenting are happening because of pharmaceutical opposition/litigation. There are many  precedential patent case laws are related to pharmaceutical patents such as novartis case on 3(d), prodrug of ganciclovir on efficacy, appealing pre-grant opposition decisions, date of grant etc. Although, no patent linking with regulatory drug approvals, Indian patent office publishes product patent granted in India.

According to Indian Patents Act 1970, certain inventions are not patentable like polymorphs, mere development of composition for known drugs, methods of treating human/animals etc which are covered under sub-sections of section 3. In spite of section 3(d), 3(e) and 3(i) in Patents Act 1970 which prevents patenting of incremental invention thereby prevents ever-greening, many companies successfully tackle these statutory provisions and patent them by drafting them into pharmaceutical composition claims and like.

Indian patent office increasingly alert on such practices and tries overcome them, not only on non-patentable inventions, but also other statutory requirements such as unity of inventions and sufficiency of disclosure. In continuation to that, IPO conducted a session on inclusion of international non-proprietary name (INN) of chemical substance into patent specification at the time of filing or later stages, further to this IPO issued a notice and draft guidelines on examination of pharmaceutical innovations and invite comments/suggestions before March 21, 2014.

Update: IPO extended the date to April 04, 2014.

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Online filing of Indian patent application and practical difficulties

Recently, Indian patent office announced new fee structure and proposed some amendments [Patents (Amendment) Rules 2014] for filing/prosecuting Indian patent applications and now it is notified that those amendments are published in Gazette Of India, hence it is effective from the date of publication that is Feb 28, 2014.

According to this new amended rules, If an applicant files patent application in physical mode, they have to pay 10% percent additional fee. Indirectly, IPO wants to bring e-filing mode to large number of applicant by offering fee concession.

The comprehensive e-filing module launched in Dec 2012 added additional advantages over older version, however larger part of prosecution can not be taken up through e-filing module.

Even an applicant wishes to file and prosecute his/her application through e-filing module, that can not be done completely online, because of following reasons

  1. All the forms submitted through e-filing module are digitally signed and again applicant needs to send originally signed documents to IPO branch.
  2. Most of the time, patent applicant encounter technical problem during their submission such as error while signing application, database down time etc
  3. When an applicant files Form-3 updates or Form-18 for an unpublished applications, module does not capture those application
  4. No proper technical support from IPO
  5. Module does not include all the options available in the “First Schedule”, such as procuring certified copies of the documents from IPO and/or non-categorized petitions etc
  6. All the follow up activities should be communicated to application by email.

IPO must issue the detailed guidelines for using e-filing module and provide support for technical issues faced by applicant, further module downtime should be notified prior and follow them in right manner.

Some other amendments include, 1) inclusion of new category of applicant “small entity”; 2) Form 7A for filing Pre-grant opposition; 3) Form 28 (Declaration by Small Entity)

We will have to wait and see how e-filing module is going to be maintained due to increase in online filings and IPO should eliminate the step of submiting Physical copies after filing online (there should be improvement on digitally signing documents and their reliability).

Update: March 09, 2014

IPO announced some additions to e-filing module, following are the inclusions/changes:

Facility for Online filing of following entries of Schedule 1 of Patents (Amendment) Rules 2014 has been added to Comprehensive e-filing services for Patents (07 March, 2014)
- Form 16 (Entry no. 25 of Fee Schedule),
- Request for Certified Copies (Entry no. 41 of Fee Schedule),
- Certifying office copies, printed each (Entry no. 42 of Fee Schedule),
- Request for Information u/s 153 (Entry no. 44 of Fee Schedule),
- Preparation of certified copy of priority document and for transmission of the same to IB of WIPO (Entry no. 49 of Fee Schedule).

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Comprehensive e-Filing module Demo

Comprehensive e-filing module demonstration was conducted on Aug 13, 2012 at Chennai patent office.

E-filing module is developed to enable patent applicant to send all prosecution related communications to IPO online.

E-filing module is completely web based, no software installation is required.

This new e-filing module will be announced to public formally by September first week.

Requirement:

We need to create a new account to use this e-filing module.

Digital signatures (Class III) from (n)code, TCS, safescrypt, E-Mudhra)

SBI/Axis bank account can be used for fee payment online.

Windows XP with SP3 and internet explorer 6 or above.

Advantages:

Filing patent application (ordinary/National phase/Divisional/patent of addition) is completely online.

An applicant could file online all the forms/requirements which are mentioned in schedule I of Patent Act 1970.

Form 3/Form 27 can be filed for old cases (which are filed offline) too.

Patent renewal fee can be paid online.

Minimized transaction errors OR we can retrieve failed transactions due to network failure.

All the fees are calculated automatically.

Petitions under rule 137/138 can also be filed online.

Dual login option (Digital certificate OR username/password based – which is again linked to digital certificate).

Disadvantages:

Maximum size of file should be 5 MB (To confirm again, other person told 15 MB).

Only “pdf” format is acceptable (digitally signed).

For drawings, “jpeg” format.

Documents like power of attorney/Form 1, should be sent to patent office in original.

Communications from IPO will not be online, like FER or any other communication.

For further information please contact: chennai-patent@nic.in

UPDATE (Dec 17, 2012): IPO officially inaugurated comprehensive online filing services (http://bit.ly/VLezlv).

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Third party observation in PCT

I have come across this blog post in IP Kat. I surprised to see this news and want to share with my friends.

WIPO has now introduced a web option to submit prior art documents to published PCT applications at Patentscope. To submit a prior art document (before 28 months from priority date) to any PCT applications, we need to register an account at ePCT.

This really welcoming move from WIPO and it enables every users to submit closest prior art published applications. PCT applicant may reply to such submitted documents, if he wish, but those documents will be publically available.

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Consolidation 2011

Disclaimer: This blog/post is an amateur effort

Consolidated 2011 IP news

INDIA First

Patent Rules amendments: Indian Patent Office (IPO) published two draft patent rules amendments in 2011. The first one was on (Jan 2011) (Link) and second one was on (March 2011) (Link).

New patent manual: IPO published the final patent manual (html) (pdf)

Justice Prabha Sridevan was appointed as IPAB Chairman (News): Many new decisions were updated at IPAB site this year (link).

Compulsory license india: Domestic companies set to invoke CL in India (news). Natco’s CL on sorafenib was published in journal by controller and Bayer opposed this CL application by Natco.

Discussion paper’s on utility model (response received) and Patent office functionality (response received)

Patent infringement cases (pharma): Natco – sorafenib, Micro lab – Amoxicillin, Roche filed ten new patent infringement suits for Erlotinib (News) and Madras High Court dismissed two patent infringement suits filed on Matrix and Intas for Erlotinib product was dismissed as lack of jurisdiction.

Novartis case’s final hearing and Justice Bandari’s recusal (News)

Other news: Acquisition & JV of 1) Sun-Merck, 2) Bayer-Zydus, Karo Bio Zydus, Karo Bio alkem; Voluntary License by Gilead and Tibotec, patent pool aurobindoRanbaxy Antimalarial launch;  Varenacline salt form patent was revoked in India (Link); P.H.Kurian to leave IPO  (News) ; new price control policy (draft, NLEM) (news); Exparte Injunction: (Link); SpicyIP’s post: summary of controller’s decision.

In India few orders from controllers clarified that suo moto filing of divisional application under section 16 (link).

Other countries:

1) USA: The major change in Title 35 of the United States Code: America invents Act (Link).

2) Europe: Excerpts from the (Link) : Unitary patent system: On June 2011, european union agreed on a general approach to two draft EU regulations on the unitary patent for Europe.  25 EU member states have now embarked on enhanced co-operation with a view to creating unitary patent protection for their territories. Italy and Spain, which do currently not participate in enhanced cooperation. Unified Patent Court (UPC): The UPC will comprise a Court of First Instance, a Court of Appeal and a Registry. The Court of First Instance will be composed of a central division, as well as local and regional divisions in the contracting states. The European Commission hopes that the first unitary patents will be granted in 2013.

Web-Databases: In 2011, Espacenet and patentscope took new face with many additional features over older version. New databases may be useful for us (HIV Drugs Patent status Database), Common Citation Document Application (CCD).

I wish you all very very happy new year 2012.

PS: Whatever happens … life has to go on ….

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AN UPDATE: India – Natco – Compulsory license

This is an update of Natco’s compulsory license application for Sorafenib and continuation of the earlier post. Controller of patent posted this CL opposition hearing on Jan 06, 2012. (DNA article). Bayer/patentee has sought for adjournment of this hearing (copy of letter found from IPO site).

Background: We are aware that Natco pharma has applied compulsory license (CL) for Bayer’s drug Sorafenib (Nexavar) for marketing in India on various grounds available under section 84. Controller has published Natco’s CL application in official journal dated Aug 12th 2011 as per 87(1) and any person interested could file notice of opposition. Meanwhile, Bayer was challenging this controller decision of prima facie case made out under 87(1) in Delhi High court. Delhi high court dismissed this petition challenge and said that Bayer’s entire proceedings before the Controller is still open and they can raise all the issues before the Controller. Now, this is about opposition filed by Bayer on Natco’s CL, and the hearing is scheduled on Jan 06 2012.

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Mexico: Medicine Patent journal updated

Mexico INPI has updated new medicine patent journal last week.

[December 2011]

After April 2011 update, MX INPI has updated some addendum to the journal like [July 2011] [July 2011] [July 2011] [August 2011] [Aug 2011] [Aug 2011] [Oct 2011] [Oct 2011] [Oct 2011] [Nov 2011]

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Madras High Court – Erlotinib patent infringement suits

[Business Line] [India Infoline] [Order]

We are aware that Roche has filed patent infringement suit against some companies (Intas, Matrix) in Madras High Court which is related to Erlotinib and the patent No. 196774. Both of the suits and connected petitions, are dismissed by Madras HC as lack of jurisdiction.

The case filed against Intas pharma is dismissed by  the Madras HC due to the lack of jurisdiction. This case judgement/order is not yet updated on High Court site (Order). This is based only on Business Line article. Roche had filed a case against Intas to stop the sale of erlotinib, on the basis of a single sale from a retail chemist in Chennai. Madras HC dismissed this contention and said that sporadic sale does not constitute commercial sale. The retail agent is not authorized agent by Intas. Moreover, Intas product is originally manufactured by NATCO. A separate patent infringement suit is filed in Delhi high court against NATCO.

In another suit against Matrix Lab, Madras High Court dismissed the suit filed  by Roche. In this order, court said that mere filing of revocation petition in IPAB will not amount to patent infringement [Order].

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Common Citation Document Application (CCD)

[http://www.trilateral.net/ccd]

Common Citation Document (CCD) Application is web based patent information tool developed by trilateral offices (USPTO, EPO & JPO) to provide single point access to citation data for their examined patent applications. It consolidates the prior cited by all three participating offices. References/Prior art cited by all three office to be visualized in  single page.

CCD application uses EPO’s global patent family database system and is hosted by EPO. The “citation only view” provides aggregation of patent application No. with their filing date, below that patent/non patent prior art cited by offices (USPTO, EPO, JPO & WIPO ISA)  is given. and the other option “Time line view” shows in interactive way.  The double inspector window shows two documents parallel.

Related reading:

[Link] [Link1] [Link2] [Link3] [CCD presentation with screen shots]

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Lipitor generic predictions

As Nov 30 approaches and Pfizer prepares to lose exclusivity on Lipitor, analysts are offering a variety of theories
[Settelement bwt Ranbaxy and Pfizer]
===============================================================
….Two of Ranbaxy’s India plants have been banned by the USFDA. While Ranbaxy is confident of a positive resolution with the USFDA, there’s no clarity yet if this resolution will include approval for generic Lipitor, analysts echo this worry.
An HSBC report said, “The key downside risk to our call is the forfeiture of Lipitor exclusivity and potential heavy fine payment to FDA
But looking at the larger picture, analysts feel Ranbaxy will gain from the lifting of the ban, since this will open doors for the launch of over 30 branded generic drugs from these plants.
As far as Lipitor is concerned, Ranbaxy will have a fight on its hands. It will face tough competition from authorised generic Watson and Pfizer, which is aggressively trying to save prescriptions by tying-up with many pharmacy benefit managers…..
[Money control]
===============================================================
On the other hand, pfizer going to make lipitor available at generic drug price to ensure that patients taking Lipitor continue to receive the brand name drug for the next six months (till May 2012), even as lower-cost generic versions of Lipitor become available from December 1.
Pfizer partnered with several US pharmacies with health plans that pays around the same price for the branded product as for a generic version.
Pfizer strategy include discounts, direct to consumer sale, co-pay cards, rebates, conversion to OTC etc

[Link] [Link 1] [Link 2] [Link 3]

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