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License by Gilead and Tibotec, patent pool aurobindo; Ranbaxy Antimalarial launch;  Varenacline salt form patent was revoked in India (Link); P.H.Kurian to leave IPO  (News) ; new price control policy (draft, NLEM) (news); Exparte Injunction: (Link); SpicyIP’s post: summary of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 ….

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.

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]

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].

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]

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]

Presumption of patent validity in granting interim injunction

[Order] [SpicyIP]

A granted patent can not be presumed to be valid. The presumption of patent validity is very less when defendant shows substantial doubts on violation of procedures in patent grant and credible challenge on patentibility and also when patent is granted recently.

In a recent verdict given by Delhi high court, Judge denied request to grant interim injunction filed by Patentee. In this case, Patent No: 240893 (1683/MUMNP/2008); Assignee: Tenxc Wireless Inc, Title: ASYMMETRICAL BEAMS FOR SPECTRUM. EFFICIENCY.

In this case, defendant established credible challenge to patent on various aspect such as 1) Patentability of invention was not examined under section 3(d) and 3(f)?; 2) Whether claimed invention is novel and inventive or not based on certain prior art?; and 3) Patent is not granted by USPTO and EPO on the grounds of lack of novelty and inventive step.

Court made certain observation on the record of the patent office 1) Patent office did not examine the patent application under Section 12 and 13 of the act (Sections 12 and 13 of the Act are mandatory); 2) Patent Office did not examine whether the invention falls under any of the categories of non-patentable inventions under Sections 3 and 4 of the Act; 3) No valid publication under Section 11A as there was an error in the first publication; 4) A Canadian patent equivalent was not disclosed as required under section 8; 5) The patent was granted by a non-speaking order (????); 6) Patent Office has granted the patent to the plaintiffs in undue haste without following the due process of law; 7) patent is a recent one; 8) The findings of the ISR and IPRP are not binding on the Indian Patent Office.

The important challenge seems to be hastened grant of patent by violating of procedural steps of conducting search and examination on patent grant.

Bayer Vs Controller of patents

[SpicyIP] [Order]

Yesterday, a interesting news is posted in SpicyIP blog.  Bayer challenges ambiguity in statutory language of “prima facie case” of section 87(1). Controller has published Natco’s compulsory license as per section 87(1) as prima facie case made out (published on Aug 12th 2011). Patentee/Person interested can oppose within two months (can be extended U/S 87(2)) from the publication date [Rule 98(1)]. Note: We recall that in imatinib case Novartis has challenged the ambiguity in term “efficacy” of section 3(d).

PS: DIPP recently initiated discussion paper on compulsory license (CL) for deciding whether or not any guidelines required for granting CL and finally concluded that no additional guidelines are required.

Update: Bombay high court disposed of this writ petition by considering that patent infringement proceeding is pending before Delhi High court against the same respondent and asked the petitioner to file the petition before Delhi High court. Time to file opposition for CL is extended till 18-11-2011. (Order)

Update (on 22nd Nov): Bayer has petitioned before Delhi high court on 16th Nov 2011. Delhi high court ordered that the impugned order is mere prima facie view that a case under Section 84(1) of the Patents Act has been established and petitioner is still entitled to contest the said proceedings before the Controller of Patents in the opposition. This petition is dismissed/withdrwan [Order] [Blog post]. 

Claim format Indian patent applications

In a recently uploaded decision in ipindia which is related to Humira dosing regimen patent, patent applicant successfully traverse 3(e) and 3(i) grounds of opposition. Patent application no 6618/DELNP/2006 and titled: “MULTIPLE-VARIABLE DOSE REGIMEN FOR TREATING TNF -RELATED DISORDERS“, Patent applicant is Abbott and opponent is Glenmark.

Inventive step of this application is related to multiple variable dosing method for treating TNFa disorders (pls refer PCT claims) and their Indian national phase application claims are amended to contain claim preamble of “pharmaceutical composition” with dosing restriction.

This 6618 application is opposed on various grounds including 3(e) and 3(i). As per controllers opinion, opposing under 3(i) is not applicable, since claims are related to pharmaceutical composition. Opposition under 3(e) is traversed by submitted expert evidence (Dr. Hoffman affidavit who is one of the inventor) and synergism between TNFa inhibitor and methotrexate.

Indian patent office grants such use/dosing regimen invention in a claim format of “pharmaceutical composition”. Another example is recently published patent grant of 249114 (1693/DEL/1998) assigned to smithkline beecham. This application is filed with claim preamble of “method of treating” and subsequent granted claims preamble is “Pharmaceutical composition for use in the treatment of“.

Important message here is invention related to use/dosing regimen/combination can be patented by pharmaceutical composition claim format such as pharmaceutical composition comprising X for the treatment of disorder Y with dosing/combination/ratio/some inventive step limitation.

Ranbaxy-MMV-Antimalarial

Today Economic times reported that Ranbaxy received conditional approval for combination of its NCE molecule (Arterolane) and piperaquine phosphate.

Drug Controller General of India ( DCGI) Surinder Singh said the marketing licence was subject to the condition that the Chinese plant from where Ranbaxy imported key ingredients for the drug was inspected and approved. Though the final phase of its clinical trial used the same ingredients from China and has been cleared for both safety and efficacy, the government wants to play it safe. “Since it (the drug) will be widely used we want to check for our satisfaction,” Singh said.

[Businesswire]

Arterolane maleate is patent protected in India. Arterolane is licensed from Medicines for Malaria venture (MMV) and Ranbaxy will have worldwide rights for the registration and commercialisation of the product. Arterolane falls in the chemical class of Synthetic Peroxide Anti-Malarial Drug.

Arterolane seems to be protected by 245779 (1514/DEL/2004)  titled “Spiro and Dispiro 1, 2, 4-Trioxolane Antimalarials” granted recently on 02/02/2011. The ’779 patent is presently assigned to Allergan.

PS: WIPO recently launched a database called WIPO Re:Search aims to provide access to intellectual property for developing products to treat Neglected tropical diseases (NTD).