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….

Updates on Herceptin saga in India

Here are some important updates on the Herceptin in India. As I previously reported in my blog about facts about divisional patent applications viz. 3272/KOLNP/2008 and 3273/KOLNP/2008 rejection and negative hype by media.

Now interestingly the basic patent IN205534 on which above divisional are based is lapsed because of non-payment of annuity fees as of 03.05.2013. However Section 53 of the Patents Act reads with Rule 80 allows the Patentee to pay the same within the extended period not more than six months, if the request for such extension of time is made in Form-4. But this request should be made before the expiry of last date of renewal ie 03.05.2013. Patentee still can restore the patent under Rule 60, but patentee has to be able to give the Patent Office a good enough reason to allow the restoration application. Already this patent is under post grant opposition filed by Glenmark. So it seems quite difficult path ahead for Genentech if they wish to restore the patent because Glenmark most likely to oppose the restoration.

And Roche (Genentech) said that it has no plans to seek a restoration of the patent. The decision to let the patent lapse was part of a new strategy it wants to follow in the local market for the high-value biological drug. “Regular reviews of our patent portfolio are a routine business practice. In this connection, Roche has come to the conclusion not to pursue Indian patent for trastuzumab”.

Herceptin contributes close to Rs 127 crore to Roche's annual turnover, according to industry estimates. Roche's decision of giving up its patent is a smart move, say IP experts as there is no Indian company manufacturing this drug due to the complex science involved. So, even after giving up the patent, Roche will be the only company that will be manufacturing this drug, and the company knows it. While the patent for Trastuzumab may no longer be in force, it is important to note that there are currently no approved biosimilars of Trastuzumab in India.

But latest news about Biocon launching the biosimilar of Herceptin could change the game. As announced by Ms. Shaw, Biosimilar version is in phase III studies and they intend to launch in India by end of March 2014. She has not disclosed the price but it would be much cheaper than the current price of Herceptin in India. Herceptin’s price, at around Rs 1 lakh a vial in 2011, was lowered to Rs 92,000 last year and then further Rs 72,000. Treatment cost with Herceptin may be reduced to about half with the launch of the drug’s cheaper version

Apart from Biocon, two other Indian firms, namely Dr. Reddy's Laboratories and Intas Pharmaceuticals are planning to launch their own version of Herceptin biosimilars.

Hue and cry about revocation of Herceptin patents in India Vs. Real facts and analysis of the case

Recent statement by Roche’s spokesperson regarding revocation of Herceptin Patent in India and its (mis)interpretation by world media led to the series of confusions. World media saw this news again through its pre-conceived notion about India’s weak intellectual regime and blindly followed it. Indian Government later opposed this statement and gave clarification about the whole issue.

I would rather put the facts of the present case for your better understanding and would try to clear doubts regarding situation.

First, patent office has not partly revoked any patent on Herceptin as with the present case. The said issue is with the patent applications filed by Genentech (Roche) viz. 3272/KOLNP/2008 and 3273/KOLNP/2008 (both filed on Aug.11, 2008). These are not yet granted, so what media has interpreted was absolutely wrong about revocation. Patent office instead has refused both applications u/s 16 (divisional application) of Indian patent Act.  To qualify as a divisional application, the application in question must be distinct invention and filed before the parent application is granted, abandoned or deemed to withdrawn.

1.      Both these patent application are divisional of 1638/KOLNP/2005, which is again divided out of IN/PCT/2000/00391/KOL (Granted as IN205534 on Apr.05, 2007). According to Indian Patent Act one cannot file the divisional application from divisional application. Therefore these applications cannot be regarded as proper divisional u/s 16(1) of the Act.

2.      Applicant concealed this fact and stated 1638 application as parent application for the both applications (viz. 3272 and 3273) and filed same with patent office. But these applications are considered to be divisional of IN/PCT/2000/00391/KOL. 391’ application was granted on Apr 05, 2007 and both these applications were filed on Aug.11, 2008, much after the grant date. Therefore they cannot be considered as timely filed as per the Act.

3.      For the sake if we consider that both these applications divided out of 1638/KOLNP/2005, but request for examination (RFE) was not timely filed for 1638 application and therefore deemed to withdrawn as of Feb.16, 2006. Therefore any divisional application filed after this date cannot be considered as divisional application according to Act.

4.      Again both these applications (3272 and 3273) cannot stand as their RFE also filed after due date ie Feb. 11, 2009. Therefore as per section 11B(1), these applications cannot be examined further.

The above objections/grounds were also communicated to the applicant before refusing the applications but hearing was not attended by applicant. Therefore both applications viz. 3272/KOLNP/2008 and 3273/KOLNP/2008 are not considered to be divisional applications within the meaning of section 16 of the Act and also they have not been properly filed complying the requirements of Acts.

Fresenius Kabi succeeds in revoking Lapatinib Salt Patent at IPAB

In an order (No. 161/2013) dated July 27, 2013, IPAB-India has revoked the patent of Lapatinib Ditosylate Salt. Fresenius Kabi Oncology Ltd had filed the revocation petition against Patent No.IN221171 entitled “Quinazoline Ditosylate Salt Compounds”, the said patent belongs to Glaxo. In a decision main arguments were focussed on obviousness, S.3(d) and S. 8 in IPAB decision.

Below is the gist of decision and few important clarifications by IPAB on some points.

Section 3(d):

Citing the recent Novartis case judgement by Hon’ble Supreme Court, IPAB stated that efficacy relates to “therapeutic efficacy” and not all advantageous or beneficial properties. More importantly considering the genesis of S.3(d) the words “therapeutic  efficacy” must receive a narrow and strict interpretation.

Patentee argued that ditosylate salt absorb much lower amounts of water when exposed to a broad range of humidities and can be prepared in a stable crystal form. And that “Due to the improved moisture sorption properties of these compounds and increase in stability they exhibit enhanced efficacy in their use as a medicament following storage when compared with the di-HCL salts disclosed in the prior art reference. But IPAB dismissed the argument and said improved moisture absorption property and hence stability of ditosylate salt cannot be considered as enhanced efficacy as per recent supreme case judgement.

 

Obviousness:

By citing F. Hoffman-La Roche Ltd v. Cipla Ltd IPAB stated it was obvious to try for person skilled in the art to choose from different salts disclosed in Exhibit B ie. substance patent of Lapatinib. Out of 19 salts disclosed in Exhibit B, two sulphonyl salts include ditosylate salts. It was submitted that when the problem to be solved was hygroscopicity, it was obvious for a person skilled in the art to try the salts disclosed in Exhibit B which would give the desired result.

Exhibit C teaches the salt of a different active ingredient which is analgesic. Once there is a suggestion that tosylate salt would solve the problem of hygroscopicity, there is definitely an encouragement to try it.

IPAB further explained that in the present case there is a clear indication in Ex.B of the tosylate compound. There is no doubt that zooming in on a correct salt is not easy, if the choice could only have been made by testing each compound one after the other with no clue available. But Ex.C gives a clue. It was reasonable to hope it might, it would not have been a blindman’s buff choice. So we are of the opinion that to the Person Skilled in The Art taught by Exhibits B and C the invention was obvious.

S.8 disclosure and non-compliance:

IPAB gave elaborated explanation for the section 8 requirement and stated that one must carefully apply the provision. S.8 of the Act is not intended to be a bonanza for all those who want an inconvenient patent removed.

The Ayyangar Report makes it clear that the purpose for introducing this provision was to ensure that it would be an advantage for our Patent Office to know the objections raised by the patent offices outside India regarding the patentablity of the invention and the amendment if any made or to be made. It also says that it would be of great use for the proper examination to know if the invention was anticipated.

IPAB also remanded patent office and said that It is unfortunate that the office has failed to understand the importance of the S.8 requirement and leaves it to the Patentee to decide what he will give. IPAB also requested patent office and Controller General to educate and instruct the officers regarding the requirements of law.

Finally IPAB rejected S. 8 ground and stated that In the present case we are rejecting the S.8 objection only because the applicant has not made out the grounds of attack by stating the facts. In this case in the Revocation application, the applicant has merely stated that S.8 has not been complied with and foreign filing particulars have not been given. Nothing more is stated. In the petition filed for receiving additional documents, the affidavit filed by the applicant merely lists the documents were downloaded. We do not think that is sufficient.

If you wish to see the whole decision, you can access the same on IPAB site at http://www.ipab.tn.nic.in/

  

Compulsory licence likely for three cancer drugs	(14/1/13)
MUMBAI, 14 JAN, 2013: The government has appointed a panel to look into issues related to compulsory licensing of drugs and whether cheaper versions of cancer medicines Trastuzumab, Ixabepilone and Dasatinib can be launched under the provision, a person with knowledge of the development said. According to the person, the health ministry has sent its proposal regarding compulsory licensing for the three drugs to the Department of Industrial Policy and Promotion (DIPP), which in turn has sought the opinion of the department of pharmaceuticals. Srikant Jena, Minister of State for Chemicals and Fertilisers, however, denied having received any note. The panel is lead by RK Jain, additional secretary and financial advisor in the health ministry, the person added. Compulsory licensing is a provision under the World Trade Organisation that allows a government to permit a company to manufacture a patented drug without the consent of the innovator company. Each of the three drugs cost over Rs 1 lakh for a month's dose. While Trastuzumab is manufactured by Roche, Ixabepilone and Dasatinib are products of Bristol-Myers Squibb. In March last year, India had allowed Hyderabad-based Natco PharmaBSE -2.06 % to make and sell a cheaper version of Bayer AG's patented cancer drug Nexavar on grounds of affordability. The move had multinational pharma companies worried about property protection. According to intellectual property lawyer Aliasgar Dholkawala, the health ministry could apply for a compulsory licence (CL) under Sec 92 of the Indian Patent Act. "The government can notify a patent for issuance of CL under Sec 92 if any of these three conditions are met: national emergency, cases of extreme urgency, or in case of public non-commercial use," Dholkawala of Wadia Ghandy and Co said. Under Sec 92, the government can issue a compulsory licence on certain patents notified in the gazette. After the same is notified by the government, any company interested in its manufacture is allowed approach the patent controller for a licence. Experts say the move could spark a fresh row in the area of intellectual property. Besides, the government is expected to release a draft report on price control for patented medicines, which may not leave much room for a compulsory licence, they add.

EU Patent, Patent Court Could Finally Be Approved In Coming Weeks

A new proposal by European Union governments could signal the end of a years-long struggle for a unified European patent and patent court. The compromise, which has the support of the European Commission (EC), appears likely to make it through the European Parliament despite pockets of resistance.

The working group of the Council of the European Union agreed on the patent package on 19 November, the EC said. The package consists of a regulation creating a European unitary patent through enhanced cooperation of 25 of the 27 member states (Spain and Italy are not participating); a separate regulation establishing a language regime for the patent; and an international agreement involving 26 EU countries setting up a single, specialised jurisdiction to hear patent cases.

Under the compromise, there will be a one-stop-shop for unitary patents at the European Patent Office (EPO) in Munich, and the patent will be effective in 25 EU countries, the EC said. After a 12-year transitional period, there will be a language regime that works in 23 languages before and after a patent registration procedure at the EPO. Requests for registrations can be filed in all EU languages, and will be processed in one of the three working languages of the EPO – English, French and German. After registration, patent claims and descriptions will be translated into all languages. The agreement will cut the translation costs for obtaining a single EU patent by 80 percent, the EC said.
The compromise creates a specialised unitary patent court, eliminating the need to litigate the same patent in different territories, the EC said. All governments agreed that the court will be seated in Paris, with a satellite court in London to handle chemical and pharmaceutical patents, and another in Munich to deal with mechanical engineering patents. All companies, no matter where established, can obtain a unitary patent, the EC said.

Unitary Patent “Will Make a Difference”
An EC impact assessment shows that the total cost of obtaining patent protection in Europe now is €36,157 euros. A unitary patent in 25 member states will cost €6,425 during the 12-year transition period, and €4,725 after that period, it says. By comparison, the total cost of a patent in the United States is €1,850.

The Council is expected to adopt the proposed compromise on 10 December, and Parliament may debate and vote on it the same week, JURI said. If the package clears the legislature, the two regulations could be adopted by 21 December, with an agreement for the patent court signed by governments on 18 February, the EC said. The package won’t become effective until EU countries ratify the international accord, it said. If that happens before 1 November 2013, the first unitary patent could be granted in April 2014, it said.

The original EC proposal is here [pdf].

Hearing in controversial Glivec case between Novartis & Union of India enters crucial stage

Saturday, November 17, 2012

Hearing in the controversial imatinib mesylate (Glivec) case between the Swiss pharma major Novartis AG and the Union of India & Others is continuing in the Supreme Court of India which is expected to conclude by the end of this month.

After several adjournments during the last more than couple of years, the final argument in the case was commenced on September 11, 2012, with representatives for Novartis being the first to present their arguments before the apex court. The court then also heard the arguments from generic companies like Cipla, Natco, Ranbaxy and Hetero, Indian government and Cancer Patients Aid Association.

According to sources, the court will now hear the responses and rebuttals from the representatives from both sides on the case. The hearing is expected to be concluded by the end of November. The two judges hearing the case may then reserve their decision, with the verdict to be announced sometime thereafter, sources said.

The Supreme Court case, between Novartis and the government of India, is the final act in a legal battle that stretches back to seven years over India's future capacity to produce low-cost generic medicines for its people, and for patients in other developing countries. In this long pending case, Novartis is challenging Section 3(d) of India's Patents Act which prohibits 'evergreening' - the practice of multinational pharma companies to extend their patent terms by making small and trivial changes to existing molecules and thereby preventing manufacture of generic drugs.

Novartis patented the molecule imatinib in 1993. After the signing of the WTO TRIPS agreement by India in 1995, Novartis filed another patent application on the mesylate salt form of imatinib in 1998 at the Indian patent office in Chennai. In 2005 India amended its patent law to comply with the WTO TRIPS agreement but also included Section 3(d), an important health safeguard that does not allow companies to get patents on new forms of old medicines.

With the Chennai Patent Office's rejection of patent after 2005, Novartis approached the Madras High Court challenging the decision of Patent Office along with questioning the relevance of section 3(d) of Indian Patent Act.

In 2007, the Madras High Court rejected Novartis' challenge to section 3(d) and held that it had no jurisdiction to determine the issue of TRIPS compatibility. In determining the issue of constitutional validity, the court held that the word "efficacy" used in section 3(d) had a definite meaning in the pharmaceutical field. The case was then transferred from the Madras High Court to the Intellectual Property Appellate Board (IPAB), which in turn rejected the application.

Novartis appealed again, this time to the Indian Supreme Court in 2009 after the IPAB rejected its appeal for a patent on the beta-crystalline form of imatinib mesylate, an anti-cancer drug.