High court of Delhi granted permanent injunction in trademark infringement of pharmaceutical products

In two separate proceeding, Merck KGA successfully brought permanent injunction against LA LIFESCIENCE and EMIL PHARMACEUTICAL for trademark infringement “EXFLAM/EMFLAM” and “COSOME” respectively.

Plaintiff had filed the present suit for permanent injunction restraining infringement of trademark and rendition of accounts, damages and delivery up, etc. against the defendant in the High Court of Delhi. Judge Mr. S.P.GARG handed down these two decisions.

“EXFLAM” and “EMFLAM” are under registration Nos. 471455 & 467598. It is pleaded that the defendant is engaged in the manufacture and sale of pharmaceutical and medicinal preparations and had adopted the trademark “LAFLAM” with respect to its medicinal preparations.

“COSOME” is under trademark registration No. 147029. It is pleaded that the defendant is also engaged in the manufacture and sale of pharmaceutical and medicinal preparations and had adopted the trademark “COZOLE” with respect to its medicinal preparations.

While delivering the decision in theses 2 cases, court considered “whether rival marks are deceptively similar and are likely to cause confusion in the mind of unawary purchasers. The purchasers are not expected to be well-versed with the chemical compositions of the medicinal preparations. It is well settled that while considering whether a mark is likely to deceive or to cause confusion, the question has to be approached from the point of view of a man of average intelligence and imperfect recollection”.

Also court said - citing ‘Cadila Health Care Ltd. v. Cadila Pharmaceuticals Ltd.’, 2001 (5) SCC 73, the Supreme Court after considering a large number of judgments of Foreign Courts and Indian Courts cautioned that strict measures to prevent confusion and lesser degree of proof is required for a Plaintiff to prove infringement in pharmaceutical cases if the marks are similar.

Finally court concluded that in these instant cases, the defendant’s mark in respect of medical preparations is phonetically and visibly similar to the registered trademark of the plaintiffs. It is, therefore, evident that the defendant has infringed the registered trademark of the plaintiffs’ and has passed of his goods as those of the plaintiffs.

International applications filed to the Indian Patent Office as Receiving Office may be filed electronically using ePCT

On 3 November 2014, the Indian Patent Office, in its capacity as receiving Office, notified the International Bureau, that it is prepared to receive and process international applications in electronic form (e-PCT)with effect from 15 November 2014. Standard fees such as transmittal fees, filing fees, search fees have to be paid (see PCT Applicant’s Guide, Annex C (IN)). But interestingly online payment is not available. One can file – international applications, subsequently filed documents for international applications, to the extent supported by the relevant software. In case of failure of the electronic systems when an international application is filed with it, the Office will use all means available, such as fax or e-mail, to inform the applicant about procedures to follow as alternatives. It’s another good initiative by Indian patent office to streamline the process, albeit many difficulties in online filing system at IPO. Hope for seamless system in future..

Next on target…..Patented Drugs !!!

It seems 2014 would be in very much focus with respect to affordability of medicine as Indian Government is considering bringing the patented drugs under price control. According to news, after sitting on it for years, the government is finally initiating steps to regulate the price of patented medicines and medical devices, a move that may provide relief to patients suffering from life-threatening diseases.

A committee comprising representatives from the health ministry, pharmaceuticals department, the drug price regulator and department of industrial policy and promotion is scheduled to meet early next month to discuss at least three options, said an official familiar with the development. While negotiated price mechanism, that was recommended by an earlier panel and junked, is one of the options, the inter-ministerial committee will also explore the possibility of reference pricing and differential pricing.

Under a system of reference pricing, the domestic price is linked to those in comparable markets. In case of differential pricing, the government can fix separate prices for its procurement programme and for purchase by others, including individual buyers.

Various countries, including developed ones, use various tools to regulate prices, India controls prices of only a handful of medicines and patented ones are not covered, often resulting in complaints of over-pricing. During the period of a patent, only one company, which has invented the medicine has rights to manufacture it and uses its monopoly rights to fix the price.

Although a proposal to regulate the price of patented medicines was floated several years ago, the government has refused to move forward. In fact, an internal committee of the department of pharmaceuticals had recommended a negotiated price mechanism for government purchases and for use by insurance companies. The proposal was to link the domestic rate with those at which governments in the UK, France, Canada, Australia and New Zealand purchase drugs from the company that holds the patent. The actual price was to be linked to the purchasing power in India.

But, this mechanism was only going to apply to 23% of the market, leaving a vast majority outside the proposed regime and opening the proposal to criticism.

 

indian patent office considering disclosure of inn in pharma patent applications

According to the news published in economic times indian patent office is considering mandatory disclosure of inn (international non proprietary names) in patent application for pharmaceuticals.

This is another first of its kind provision patent office wants to include as nobody in the world even considered. The motive behind this consideration is to help examiners, generic industry and public as large as well. They said it would bring more clarity in identifying the pharmaceutical substance in the claimed product. Also it would help to weed out frivolous inventions by filing opposition to the same.

But on the other side body represntating the multinationals has opposed this move. According to them it is another burden  to innovator companies to comply with as they already dealing with section 8 and section 3d requirements. Another point of contention was that it is not always possible to innovator to disclose inn of exact compound, for example at the time of filing basic substance patent. Because hundreds of compounds are disclosed and claimed in patent when these compounds are in pre clinical or even in earlier phase. So it is not possible to exact disclose which one would be the active substance or pharmaceutical product.

The consultation was held on oct 9, where all four patent office and some law firms discused this issue. Patent office has also asked for the submissions regarding the same. Lets wait and watch what would be the next course of action by indian patent office against multinational companies, as ipo is already under pressure by these companies for not complying TRIPS.

Indian patent office starts functioning as ISA and IPEA

Indian patent office (IPO) has now started functioning as International Search Authority (ISA) and International Preliminary Examining Authority (IPEA) under the PCT from 15th October 2013. IPO will search and examine patents filed under the Patent Classification Treaty (PCT). This is a major development and in itself is a huge responsibility for the Indian Patent Office.

The PCT, which currently has 17 nations acting as ISAs and IPEAs, enables inventions to be protected in each of the 148 contracting states. Indian Patent Office has certain advantages like reasonably low official fees charged for different categories as compared to other nations which are designated as ISA and IPEA. Also being the only English speaking nation in the Asian region to be recognized as an ISA/IPEA would mean that several international applications received by WIPO under the Patents Cooperation Treaty would be sent to the Indian Patent Offices for search and preliminary examination purposes.

Fees and Charges to be charged by IPO while functioning as ISA and IPEA:-

Kind of fee or charge Amount (Indian rupees)

Search fee (Rule 16.1(a))                                             10000 (2500)1

Additional fee (Rule 40.2(a))                                       10000 (2500)1

Protest fee (Rule 40.2(e) and 68.3(e))                          4000 (1000)1

Late furnishing fee (Rule 13ter.1(c) and 13ter.2)        4000 (1000)1

Preliminary examination fee (Rule 58.1(b)):

– where the international search report

was issued by the Authority                                         10000 (2500)1

– in other cases                                                             12000 (3000)1

Late payment fee for preliminary examination [amount as set out in Rule 58bis2]

Additional fee (Rule 68.3(a)):

– where the international search report

was issued by the Authority                                         10000 (2500)1

– in other cases                                                             12000 (3000)1

Cost of copies (Rules 44.3(b), 71.2(b) and 94.2)/page   4   
1 - individual entity

But this major leap forward comes with daunting challenge of dealing with the backlog of applications. Already IPO is running very much behind its schedule, it is interesting to see the developments and efforts that would be taken by IPO to deal with the situation. 

 

Claims Involving the Skills of the Physician Fall under Method of Treatment Claims and therefore Unpatentable Subject Matter

In most of the Jurisdictions, claims related to method of treatment and allied human surgical processes are not patentable including Europe, Canada, India etc. Lots of debate is going on what actually the scope of these treatments, what areas come under treatment scope and how claims should be drafted to avoid objection of unpatentable subject matter.

Last month, Federal court-Canada handed down interesting decision in Novartis Vs Cobalt case. Federal court rejected the obviousness ground but dismissed the patent on basis of unpatentable subject matter asserted by Cobalt. This particular case is related to Zoledronic acid and product covered therein. Cobalt seeks approval by way of a Notice of Compliance from the Minister of Health to market a generic version of Novartis ACLASTA drug in Canada. Novartis brought an application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt Pharmaceuticals Company for its drug containing zoledronic acid until the expiry of Canadian Patent No. 2,410,201.

As to validity, Cobalt asserted mainly two grounds for the revocation of patent:

1. Obviousness; and

2. Is the subject matter ineligible for patent protection – is it a method of medical treatment?

I would summarize mainly on later part as court rejected the cobalt’s former allegation as to obviousness.

THE CLAIMS OF THE '201 PATENT 

The claims at issue - claims 1 to 36 - can be considered as being in different groups; each with a general claim, followed by more specific claims.

There are 5 types of claims in the Patent:

a. Claims 1-9 are Swiss-type claims, in that they relate to the use of ZA in the manufacture of a medicament;

b. Claims 10-18 are use claims, in that they relate to the use of ZA;

c. Claims 19-27 are claims to a compound (i.e. ZA);

d. Claims 28-36 are claims to a pharmaceutical composition containing ZA; and

e. Claims 37-39 are claims to a kit containing ZA.

Claim construction related to the claims 10 to 18 particularly, together with a rewritten claim 16 are considered to determine whether they fall under medical treatment claims or not?

Claim features were –

      Claim 10: -use of zoledronic acid

-to treat abnormal bone turnover

-intermittent administration of about at least one year

Claim 11: - administration about one year

Claim 12: - intravenous administration

Claim 13: - dosage from about 2 mg to about 10 mg

Claim 14: - dosage of about 5 mg

Claim 15: - condition is osteoporosis

Claim 16 - once-a-year administration intravenously, 5 mg dose, for osteoporosis

Main arguments were whether such claims were directed to a method of medical treatment or for a vendible product having real economic value. According to the previous case laws vendible product claims are patentable subject matter if they are directed to product having economic value.

But federal court rejected Novartis argument regarding vendible product claims and said these claims are actually directed to method of medical treatment because patent claiming a dosage range within which the physician is to exercise skill and judgment was not a vendible product; and thus, not patentable. Claims where actual involvement of physician comes are directed to treatment claims as it is the physician who has to apply his skills to decide the dose, dosage frequency, route of administration depending on the condition of patient.

The '201 patent specifically states that the mode of administration and dosage “may be selected by the attending physician taking into account the particulars of the patient, especially age, weight, life style, activity level, hormonal status (e.g. postmenopausal) and bone mineral density as appropriate”. (page 11, emphasis added)

Further at page 11, the '201 patent states that the “dose mentioned above is typically administered intermittently, with a period of at least 6 months between doses. The period between bisphosphonate administrations may be longer, e.g. conveniently once per year, once per 18 months, or once every 2 years, or even longer, or any period in between.”

Page 12 of the '201 patent describes dosages that depend on the potency of the bisphosphonates and that dosages may be administered in a divided manner, such as 4 mg one day, and a further 1 mg a few days later.

Finally court held that it is in reality, however contrived the wording of the claim may be, a method of medical treatment under Canadian law, unpatentable.

Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Company et al., 2013 FC 985
 

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….