P-IV filing: Dr reddy’s sued for filing of P-IV to Mozobil®

Genzyme Corporation, a fully-owned subsidiary of drug major Sanofi-Aventis filed a suit against Dr. Reddy's Laboratories for ANDA filing to Plerixafor (Mozobil®).

Genzyme is the holder of New Drug Application (“NDA”) No. 022311, which relates to Plerixafor solution 20 mg/mL for subcutaneous injection. On December 15, 2008, the FDA approved the marketing of the drug product described in NDA No. 022311 for use in combination with granulocyte-colony stimulating factor (“G-CSF”) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.

Letter dated July 19, 2013, DRL notified Genzyme that DRL had submitted ANDA No. 205182 to the FDA (21 U.S.C. § 355(j)) seeking approval to engage in the commercial manufacture, importation, use, and sale of 20 mg/mL Plerixafor injection (“Plerixafor ANDA Injection Product”) as a generic version of Genzyme’s Mobozil® drug product.

 

the Notice Letter, DRL notified Genzyme that its ANDA contained a “paragraph IV” certification that in DRL’s opinion the ‘152 patent, and ‘590 patent, and the ‘102 patent are invalid or will not be infringed by the commercial manufacture, use, sale, offer to sell, or importation of DRL’s Plerixafor ANDA Injection Product.

Genzyme also filed suit against Teva and Sandoz for the P-IV filing to Plerixafor.

Hatch-Waxman Litigation: Invalidating “Public use” need not be the intended use of the invention, as long as the invention is fully disclosed without restriction

We generally do not see the claims of the patents invalidated under prior public use as it is critically difficult to establish and support the evidence. But in an interesting decision on September 12, 2013, (Pronova Biopharma Norge v. Teva Pharmaceuticals USA, No. 2012-1498), Federal Circuit unanimously held the asserted claims of Pronova's U.S. Patent No. 5,656,667 invalid as anticipated by prior public use, reversing a District of Delaware trial decision in the process. The grounds for reversing the District Court's finding that the defendant had not established invalidity under the public use statutory bar under 35 U.S.C. § 102(b) was based on the Court's determination that Pronova's predecessor in interest had permitted unrestricted use of formulations falling with the scope of the claims and disregarded Pronova's argument that public use was negated because there was insufficient evidence that the use was for the inventions' intended.

The case concerned U.S. Patents Nos. 5,502,077 and 5,656,667 involved in ANDA litigation between Pronova and, in separate ANDAs, Teva and Par Pharmaceuticals, who propounded Paragraph IV letters contending that these patents were invalid and non-infringed by their generic formulations of the branded drug Lovaza®.

The main facts surrounding defendants' arguments for an invalidating public use involved transfer of samples of formulations falling within the scope of the asserted claims by Pronova' predecessor in interest in the patents, all of which occurred prior to the critical date of the '677 patent. These transfers included samples sent to Dr. Victor Skrinska, with disclosure of the contents of the formulations, with no restrictions, confidentiality requirements, or obligations to report the results of any experiments performed using the formulations. Dr. Skrinska analyzed the contents of the formulations but did not perform any testing on the clinical use or benefits of the formulations.

Federal circuit held that the disclosure by transfer of samples of the formulation constituted an invalidating public use. Factors supporting this determination were that the transfer contained no evidence of confidentiality restrictions and the fact that Pronova conceded there was no experimental use involved in this transfer. The panel concluded that the transfer was "with no secrecy obligation or limitation for [Dr. Skrinska's] unfettered use" and that the shipment of the formulations "made public all aspects of the claimed inventions, since it included a certificate of analysis revealing the composition of the supplied products." It was also undisputed that Dr. Skrinska was "one highly skilled in the art, with the full ability to know, understand, and fully disclose the invention to others.

Federal circuit also said that they are not persuaded by Pronova’s argument that “use” of a pharmaceutical formulation cannot occur until it is used to treat the condition it is intended to counteract (to reduce triglyceride level in this case), or at least physically ingested.

Below are the important take away points from the decision regarding “Public Use”:

(1)   Unrestricted Use of the invention falls under Public use;

(2)   Confidentiality Agreement should be in place so as to avoid unrestricted use;

(3)   Strictly Experimental Use may overcome invalidating attack under Public use.

(4)   Public Use not necessarily should be the intended use, as described in patent

Dasatinib (Sprycel) Compulsory License Application Rejected by Indian Patent Office

In recent development in compulsory license domain, as reported by Economic Times, The Indian Patent Office (IPO) has rejected Mumbai-based BDR Pharmaceutical's application for Compulsory Licence (CL) on cancer drug Dasatinib, according to an affidavit filed by Bristol Myers Squibb (BMS), the patent holder for the drug.

As we already aware that BDR had filed CL application in March 2013 with IPO under section 84 of Indian patent Act.  Dasatinib was one of the three drugs considered for compulsory licensing by the government under the section 92 route. Dasatinib, which Bristol-Myers Squibb sells as Sprycel, is used in the treatment of chronic myeloid leukaemia. In India, a month's dose of this drug costs about Rs 1 lakh while BDR Pharmaceutical said its version will cost Rs 8,100/month.

But on May 04, 2013, BDR received notice from IPO that prima facie case has not been made for the making of an order under section 84 of Patents Act. BDR then requested hearing in accordance with rule 97 (1) of the Patent Rule 2003 and hearing scheduled on May 23, 2013. Then petition under Rule 137 on same day was filed to condone the delay in complying with procedural irregularities to make compulsory license application to meet the requirement of prima facie case and further proceed with the application. BDR subsequently submitted written submissions on June 24, 2013 pursuant to the oral gearing held on May 23, 2013. On July 10, 2013, BDR filed correspondence in relation to Voluntary License, sought form BMS and requested patent office to take it on record.

In its affidavit filed in the Delhi High Court last month, the US-based drug maker has accused BDR Pharmaceutical of suppressing information regarding the status of its application and patent.

"It is respectfully submitted that, as per the knowledge of the plaintiffs, the Controller of Patents has not found a prima facie case as regards the defendant's application under Section 84 of the Patents Act, 1970 and the same stands rejected," Bristol Myers has said in its affidavit.

"It is further submitted that the defendants are guilty of suppression as they have not informed this hon'ble court about the aforementioned order of Controller of Patents, nor have they supplied a copy of the application to the court," the affidavit added.

Transformation of Indian Patent Office......In Autobots way

Indian patent office has come long way in terms of technological advances and still has to trade much distance when compared to its counterparts. But it’s never too late to do the right things. Below is the summary of recent developments in terms of functioning of IPO website.

1.      Launch of IPAIRS 2.0 version of website with faster browsing and many more search capabilities (24 Apr. 2012)

2.      Online availability of list of Patent Applications related to Traditional Knowledge  (25, July, 2012)

3.      Launch of online public view of GI documents (14 February, 2013)

4.      Availability of a dynamic utility to view "The Month of Request for Examination for which First Examination Report is being issued" for each examination group of all jurisdiction of Patent Office (17 June, 2013)

5.      Publication of information received from Patentees regarding working of Patented inventions-Form 27 (24 June, 2013)

6.      Reply to the Examination Reports by using the 'Comprehensive e-filing services for Patents', which will result in internal automation and speedy disposal of Applications  (07 July, 2013)

7.      The utility displaying the pending and grant status of Patent applications (19 August, 2013) 

8.      In yet another effort to increase transparency CGPDTM launches a further dynamic utility to view issued First Examination Reports at a glance  (26 August, 2013) 

On could see the vast changes and think the speed with which IPO has transformed itself. But the efforts put by most of IP professional are main driving force behind this. These changes started mainly from the era of one man ie. Mr. Kurian. He literally took the challenge and decided to make over the IPO.

Recently DIPP proposes an increase of fee up to 100% in several categories, with a lower fee for those preferring to take the e-filing route. This suggests many more changes to come in future as patent office decided to go online for literally all the activities. Already patent office grapples with severe manpower crunch, office space and lots of troubles. It would be good change if IPO spends some part of surplus revenue in reforms to increase transparency and shareholders confidence. Hope for the best….