Part 3 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

This is third and last part of the three part series dedicated to the discussion on the comparison of the Patent Term Extension laws of Europe and the United States of America (USA). While part one of three, which discussed the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, was more a kind of introductory one, second part took care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and this part is giving comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

This table is continuation of the table 1 from part 1 and part 2

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About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Part 2 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

This is second part of the three part series dedicated to the discussion on the comparison of the Patent Term Extension laws of Europe and the United States of America (USA). While part one of three, which discussed the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, was more a kind of introductory one, this part takes care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and third and last part of the series will give comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

This table is continuation of the table 1 from part 1

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About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Part 1 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

Many people love comparing and contrasting and I am one of those (at least for study purposes). This time, I am comparing Patent Term Extension laws for Europe and the United States of America (USA). Though there are other provisions that may extend the life of patent such as patent term adjustment to compensate the delays due to patent offices, and paediatric exclusivity, I am specifically focusing on the patent term extension intended when the patent owner loses patent term during the early years of the patent because the product cannot be commercially marketed without approval from a regulatory agencies. Though Patent Term Extension laws in both the USA and Europe serve the same purpose, you will agree with me when I say that there are notable differences in the provisions of both. Products eligible for extension of patent term are not limited to human drug products, but this blog focuses more on them, somewhere references may also be found to medical devices, food additives, or color additives, animal drug products, and plant protection products. Unless otherwise specified, details discussed in this blog are related to human drug products/medicine products.  In the table 1, the Patent Term Extension laws for Europe and the USA are compared for easy understanding. Table 2 is for regulations governing Supplementary Protection Certificate and Table 3 is for calculation of extension period for the USA. As the discussion of this topic is quite lengthy one, I thought it fit to post it in series of three. While part one of three, which discusses the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, is more a kind of introductory one, part two will take care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and third and last part of the series will give comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

Table 1: Comparison Patent Term Extension laws for Europe and the USA

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Table 2: Regulations governing Supplementary Protection Certificate
 

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Table 3*: Calculation of extension period for the USA
 

*This table is for other than animal drug or veterinary biological products. Term of the patent shall be extended from the original expiration date of the patent, which shall include any patent term adjustment (PTA) granted under section 154 (b)

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The patent term extension of a patents that were issued before September 24, 1984, where the regulatory review period began and ended before September 24, 1984, were only function of the regulatory review period could be extended for more than five years.

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Recent Patent Litigation Cases (2014-15): India

Patent Litigation in India has steadily increased over last 2-3 years. Dramatic swift has been observed in the innovator’s perspective from the mere aspect of invention to gaining patent protection for their respective invention. Patent owners have adopted aggressive approach towards their patent protection and enforcing their proprietary rights as businesses, are now well-positioned in the realm of patent litigation.  The patent owners are not at all hesitant to challenge the validity of patent rights of their rivals. There has also been gradual increase in the understanding of the complex patent infringement and validity issues.

We will now deal with some of the recent and important patent litigation cases in India.

Merck vs. Glenmark over “Sitagliptin”

In an interesting note, Hon’ble Supreme Court of India on Special Leave Petition filed by Glenmark stayed the Delhi High Court order which passed injunction against Glenmark for the generic drug Sitagliptin till 28th April 2015. Merck Sharp & Dohme filed an application for an ad interim injunction restraining the respondent/defendant Glenmark Pharmaceuticals from using its patented product Sitagliptin (Indian Patent No. 209816) at the Supreme Court. The Delhi high court conclusively held that all the three ingredients (Prima facie, Irreparable injury and balance of convenience) for passing the order of injunction were established by MSD and hence injuncted Glenmark from manufacturing and selling of Zita and Zitamet.

Ericsson vs. Xiaomi

In December 2014, Ericsson had filed a suit against Xiaomi in India for the alleged infringement of the 8 standard-essential patents. The Delhi High Court granted an ex-parte injunction on the sale, manufacture, advertisement, and import of Xiaomi’s devices.

Xiaomi claimed that its latest devices in the Indian market (as of December 2014), the Mi3, Redmi1S and Redmi Note 4G, contained Qualcomm chipsets, which implemented technologies licensed by Ericsson. Xiaomi subsequently challenged the injunction before a Division Bench of the Delhi High Court, which issued temporary orders to allow Xiaomi to resume the sale, import, manufacture, and advertisement of its mobile devices subject to the following conditions:

  • Xiaomi would only sell devices having Qualcomm chips.
  • Xiaomi would deposit Rs. 100 towards royalty for every device it imported to India from the date of the launch of the device in India toJanuary 5, 2015. This amount was to be kept in a fixed deposit for three months during the proceeding of the case.

Novartis vs. Cipla

In another patent litigation case, Delhi High court barred Indian generic drugmaker Cipla from making or selling generic copy of Novartis’s “Onbrez” by giving temporary injunction to Novartis. Citing famous Roche vs Cipla case, the court observed that Novartis has a strong prima facia case and as the validity of the patent is not seriously questioned, there is a clear way out to grant injunction. Further, the court observed that Cipla did not provide any figures about the “inadequacy or shortfall in the supply of the drug.” Earlier Cipla lunched its generic version of Indacarterol in October claiming “urgent unmet need” for the drug in india.

Without going conventional way, Cipla, also approached the Department of Industrial Policy and Promotion (DIPP) to exercise its statutory powers under Section 66 and Section 92 (3) to revoke Indian Patents IN222346, IN230049, IN210047, IN230312 and IN214320 granted to Novartis AG for the drug Indacaterol. Cipla argued on the basis of 3 main points i.e. “epidemic” or a “public health crisis” of COPD, unable to manufacture the same in India by Patentee and high cost of patented drug.

Vringo Vs. ZTE

In January 2014, Vringo and Vringo Infrastructure filed a patent infringement suit in the Delhi High Court against ZTE, over the alleged infringement of its patent IN200572.

In February 2014, the Delhi High court granted an ad-interim ex-parte injunction restraining ZTE from importing, selling, advertising, installing or operating devices that comprise the infringing components. The High court also appointed local commissioners to inspect ZTE’s premises and instructed customs authorities to detain ZTE’s shipments that may contain such devices and to notify Vringo. In March 2014, ZTE appealed against the injunction, which was vacated on August 5 the same year with ZTE being ordered to deposit Rs. 17.85 crore to the court.

The suit is sub judice now. As of August 2014, ZTE had filed for the revocation of IN200572 on grounds of it not being innovative as well as for violating some statutory provisions under Section 64 of the Indian Patents Act.

Reference: http://inpublic.globenewswire.com/2014/09/02/VRINGO+PROVIDES+UPDATE+TO+SHAREHOLDERS+HUG1853040.html

Vringo vs. Asus

In April 2014, Vringo filed a patent infringement suit against AsusTek Computer Inc. in Delhi High Court. As per public updates issued by Vringo to its shareholders, Vringo has alleged the infringement of patent IN223183 entitled “Method and system for providing wireless communication using a context for message compression” by Asus in India.

Asus had claimed that in the context of IN 223183 it was using technology licensed to it by Google. In August 2014, Google filed a request to become a party to the proceedings.

Vringo had requested for an injunction on Asus’ use of the technology in India. The injunction has not been granted yet. No further information about the lawsuit is publicly available.

Reference: http://inpublic.globenewswire.com/2014/09/02/VRINGO+PROVIDES+UPDATE+TO+SHAREHOLDERS+HUG1853040.html

SYMED Labs vs. Glenmark Pharmaceuticals

In another case of SYMED Labs vs. Glenmark Pharmaceuticals, Symed Labs Ltd. had sued Glenmark Pharmaceuticals Laboratories before the Delhi High Court for allegedly infringing two of its patents: IN213062 & 213063. First patent was granted for “Novel intermediates for Linezolid and related compounds” while the ‘063 patent was granted for “A novel process for the preparation of linezolid and related compounds. While declaring the judgment on 9th Jan 2015, the judge convinced that the Plaintiff has got good prima facie case in favour of SYMED. Further the judge decided that protection to the patent processes ought to be granted to the Plaintiff as damages will not be an efficacious remedy. Thus, there will be irreparable loss and injury because of the long uninterrupted use of patents, the balance of convenience also lies in favour of the Plaintiff. Thus the judge granted an ad interim injunction restraining Glenmark from manufacturing, selling, offering for sale, advertising or directly or indirectly dealing in the production of Linezolid manufactured in a manner so as to result in infringement of the Plaintiff’s registered Patents.

Maj. (Retd.) Sukesh Behl & Anr. vs Koninklijke Phillips

In this litigation case, Sukesh Behl made a counter claim for revocation of the suit Patent No. 218255 under Section 64(1)(m) of the Patents Act, 1970 (for short “the Patents Act”) for non-compliance of the provisions of Section 8. Earlier in another suit Koninklijke Phillips sought for permanent injunction restraining Sukesh Behl from infringing its patent and for other incidental reliefs. While delivering the judgement, the judge answered the question of whether the failure to comply with the requirement of Section 8 of the Patents Act would invariably lead to the revocation of the suit patent under Section 64(1)(m) of the Patents Act, the word “may” employed in Section 64(1) indicates that the provision is directory and raises a presumption that the power of revocation of patents conferred under Section 64(1) is discretionary. Citing Chemtura case, the judge hold that the power to revoke a patent under Section 64(1) is discretionary and consequently it is necessary for the Court to consider the question as to whether the omission on the part of the plaintiff was intentional or whether it was a mere clerical and bonafide error. Finally, the judge dismiss the plea of Sukesh Behl for revocation of said patent under section 64 (1)(m).

Enercon vs. Dr. Aloys Wobben

In this land mark decision, Hon’ble Supreme Court of India addressed the multiplicity of patent proceeding cases with respect to Invalidation, opposition and revocation. Dr.Aloys Wobben has filed around 19 infringement suits before the High Court and Enercon India Limited have filed around 23 “revocation petitions” before the Appellate Board, praying for the revocation of the patents held in the name of the Dr. Wobben. The respondents had also filed “counter claims” to the “patent infringement suits” filed by the appellant.  Even though some revocation petitions have been settled by the IPAB, the same issues were being re-agitated by Enercon before the High Court. The Supreme Court of India following rules – firstly, if “any person interested” has filed proceedings under Section 25(2) of the Patents Act, the same would eclipse all similar rights available to the very same person under Section 64(1) of the Patents Act. This would include the right to file a “revocation petition” in the capacity of “any person interested” (under Section 64(1) of the Patents Act), as also, the right to seek the revocation of a patent in the capacity of a defendant through a “counter-claim” (also under Section 64(1) of the Patents Act). Secondly, if a “revocation petition” is filed by “any person interested” in exercise of the liberty vested in him under Section 64(1) of the Patents Act, prior to the institution of an “infringement suit” against him, he would be disentitled in law from seeking the revocation of the patent (on the basis whereof an “infringement suit” has been filed against him) through a “counter-claim”.  Clearly, this judgement laid a smooth road for complex patent litigation practices in India.

It would be interesting to note the developments that would take place in the Patent protection scenario in India and the gradual increase in the patent litigation cases in India.

About the Author: Mr Sitanshu Singh, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:Sitanshu@khuranaandkhurana.com

ROLE OF DOCUMENTATION IN PROTECTING TRADITIONAL KNOWLEDGE

Domestic and International laws prohibit patenting of traditional knowledge of any local community. However, the traditional knowledge, such as unique plants and their use is being usurped by unscrupulous players by patenting them in different countries. Only way to stall such moves is by providing prior art evidences proving that the knowledge was already available and practiced. Documentation of old references/books, therefore plays an important role in protecting the traditional knowledge.  The challenge exists with protecting the undocumented or the traditional knowledge available in local/ancient scripts.  In some cases, the traditional knowledge are also available in local stories, legends, folklore, rituals and songs, which are not property documented.

Importance of documentation can be appreciated by the fate of a patent application number CA2454171, filed by a US multinational firm, Metaproteomics LIc, at the Canada Intellectual Property Office. The application was titled “Curcuminoid compositions exhibiting synergistic inhibition of the expression and/ or activity of Cyclooxygenase-2″. The priority date of the application no CA2454171 was 17-Jul-2001 that was published on 30-Jan-2003. It claimed the usefulness of turmeric, apple, basil, kalamegha and licorice for the treatment of inflammation, psoriasis, gastritis and as anti-inflammatory to be novel.  The Traditional Knowledge Digital Library (TKDL), a unit of Council of Scientific & Industrial Research (CSIR), submitted prior art evidences in the form of references in books from 18th century to the 20th century citing evidences that turmeric, apple, basil, kalamegha and licorice have been used alone or in combination with a few other ingredients for the treatment of inflammation, psoriasis, gastritis and as anti-inflammatory in the Indian systems of medicine. The books that were used by TKDL for citing prior art of evidences includes  Khazaain-al-Advia,  Muheet-e-Azam, Vaidyamanorama, RasayogaSagara, Rajanighantauh, Bhavaprakasa, Siddhabhesajamanimala and Ilaaj-al-Amraaz.

By presenting these prior art references, India was successfully able to foil the firm’s bid to patent the medicinal use of turmeric.Based on TKDL evidences filed for the application no. CA2454171, CIPO declared the application as ‘Dead’ on 28-Sep-2012.

The Traditional Knowledge Digital Library has been playing a crucial role in protecting traditional Indian knowledge. The chronology to build up of the TKDL and their related activities is as under:

In Nov 2002, internationally recognized specifications and standards for setting up of Traditional Knowledge (TK) databases and registries based on TKDL specifications was formed that included TK experts from China, Philippines, India.

Access Policy Issue Committee (APIC) was constitution in August 2002, their responsibilities included:

  • Frame policies on accessing TKDL database
  • Decide on matters relating to dissemination of TKDL
  • Meet defensive and positive objectives of TKDL

In March 2003, the data abstraction work on 36,000 Ayurveda formulations for creating TKDL in five languages, i.e. English, German, Spanish, French and Japanese was completed. It was followed by a demo CD containing a sample of 500 formulations in October 2003.

A meeting held in June 2004 with the Health and Family Welfare Minister on providing access to TKDL database to European Patent Office (EPO). EPO requested access to TKDL in July 2005.

An approval on access to TKDL database was granted to International Patent Offices (IPOs) by Cabinet Committee on Economic Affairs in June 2006.The Access Agreement was sent to EPO in July 2006.

The US Patent and Trademark Office (USPTO) requested for access to TKDL database in December 2006. USPTO agreed in principle to TKDL Access Agreement in May 2009.

TKDL Access Agreement concluded with Canadian Intellectual Property Office (CIPO) in Sep 2010.

An international conference was held in Mar 2011 on ‘Utilization of the Traditional Knowledge Digital Library (TKDL) as a Model for the Protection of Traditional Knowledge’ that was organised by World Intellectual Property Organization (WIPO) and Council of Scientific & Industrial Research (CSIR).

First Amending Agreement to TKDL Access Agreement with EPO concluded in Jul 2012 and with CIPO in Aug 2012.

Similar to India’s TKDL, several other countries are creating libraries of their traditional knowledge, which is being actively used by patent authorities while deciding the patentability of new applications.

As can be observed from the activities of different organization working to protect the traditional knowledge from being patented, the primary issue lies with undocumented traditional knowledge or the documents existing in local languages.  Government institutions interested to protect the traditional knowledge of the local communities need to create a proper team for proactively documenting the undocumented practices/traditional knowledge. They should interact with local communities including tribal who poses huge traditional knowledge, collect the evidence of early uses and document it as per the specified format.  The instructions, such as Archaeological Survey of India can be used effectively to validate the early usage or to establish the claims of traditional knowledge.

References from:-http://www.csir.res.in/%5Ccsir%5Ctkdl%5Cmilestones.asp

About the Author: Mr Rakesh Kumar Gupta, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: Rakesh@khuranaandkhurana.com

Improving Regulatory Transparency for New Medical Therapies Act

A new act passed in the U.S. house of representative: What will it protect? Patent exclusivity, non-patent exclusivity, or both? Anything else also it deals with?

The bill titled ‘A bill to amend the Controlled Substances Act with respect to drug scheduling recommendations by the Secretary of Health and Human Services, and with respect to registration of manufacturers and distributors seeking to conduct clinical testing, and for other purposes’ was passed on March 16th, 2015, in the U.S. House of Representatives, by voice vote H.R. 639, for an act which may be cited as ‘‘Improving Regulatory Transparency for New Medical Therapies Act’’.

The first comment which I give on this bill is, it will protect both Patent exclusivity and non-patent exclusivity in case of New Chemical Entities (NCEs) which that required scheduling decisions by the Drug Enforcement Administration (DEA) under the Controlled Substances Act (CSA) before the drug products could be placed on the market. How? Before I explain this, I would like to take you with me to the events in the recent past, which made essential to pass this bill.

But even before that read this:

Form FDA 356h without which NDA applications for controlled substances can’t be filed with FDA, prevents commercial marketing for controlled substances till they are scheduled by the DEA under the CSA, developers of controlled substances claim. If this is the case, what happens if FDA approves NDA before they are scheduled under CSA? When all important NCE exclusivity is triggered for that NCE? On the date of NDA approval by FDA itself? Or FDA waits till they are scheduled under CSA? Let’s find out what FDA should do on this (and also what it has done before). Let’s untravel to the past.

For three drug products having controlled substances as the Active Pharmaceutical Ingredient, Lacosamide tablets (VIMPAT, NDA no- N022253, approval date- October 28, 2008) by UCB INC and Perampanel tablets (FYCOMPA, NDA no- N202834, approval date- October 22, 2012) and Lorcaserin HCl tablets (BELVIQ, NDA no- N022529, approval date- June 27, 2012) by EISAI INC, NCE exclusivity was triggered by FDA on the date of approval. Yes, even before UCB INC and EISAI INC could place the drug on the market. For three products referred above dates on which they could be actually be marketed were June 09, 2009, January 02, 2014 and June 07, 2013 respectively. This led to UCB INC and EISAI INC filing citizen petitions to FDA, petition numbers FDA-2013-P-1397-0001 and FDA-2013-P-0884-0001 respectively. This was not surprising because, (erroneous) triggering of NCE exclusivity before one can market the drug was leading to reduction in the all valuable NCE period. For a blockbuster drug, this can lead to significantly high monetary loss. Though I do not intend to discuss importance of NCE exclusivity in depth here, would like to appreciate the importance of the same by drawing your attention to the fact it is the only exclusivity (amongst both patent and non-patent exclusivities) which blocks submission of ANDA and 505 (b) (2) applications at least for four years once it is triggered (those who knew this, please consider it as a reminder). It means shortening of NCE exclusivity caused due to erroneous triggering can lead to early entry of generics into the market. In fact, in case of Lacosamide, shortening of NCE exclusivity has lead to early filing of ANDA applications for its generic version.

In the petition dated July 25, 2013, filed by Eisai, it requested FDA to trigger NCE exclusivity only when FDA approves labeling incorporating the final schedule permits commercial marketing of the products. It also claims that FDA’s letters approving the products as safe and effective reinforce this requirement, stating “when the scheduling is finalized, you will need to make appropriate revisions to the package insert, the patient package insert and the carton and the immediate-container labels through supplementation of your NDA”.

Further in its petition, Eisai provided two solutions to resolve the issue at hand:

  1. First what FDA can opt is , if a Changes Being Effected (“CBE”) supplement is used to reflect DEA’s scheduling decision, “the day the CBE supplement is submitted with the necessary label changes is the day the sponsor can commercially market the product, and accordingly, should be the date for triggering the NCE exclusivity period, or
  2. FDA could determine that the date for triggering the NCE exclusivity period is the date the DEA scheduling order becomes effective as this is the date when a CBE supplement could be submitted to permit the sponsor to commercially market the product.

And in the petition dated November 18, 2013, UCB adopted the same rationale and requested FDA to start clock running on the NCE exclusivity from the date which it could actually enter the market.

In reply, FDA issued Citizen Petition Denial Response dated April 30, 2014 to Eisai and UCB, being firm by its stand that NCE exclusivity will be triggered only on the date at which FDA approves NDA. In doing so it gave reference of § 505(j)(5)(F)(ii) which deals with ANDA applications and § 505(c)(3)(E)(ii) (505(b)(2) which deals with 505(b)(2) application, which provides for the start of NCE on the date of the approval.

What followed this is, Eisai filed suit dated August 08, 2014, Eisai filed a Complaint in the U.S. District Court for the District of Columbia alleging that FDA erroneously triggered periods of 5-year NCE exclusivity for its two products at issue.

Meanwhile aggrieved by the slow speed of DEA to provide scheduling decisions, Eisai filed petition to Order Scheduling of FYCOMPA on August 19, 2013, which was denied by the U.S. Court of Appeals for the D.C. Circuit on October 22, 2013.

While litigation between Eisai and FDA is still pending, the bill “Improving Regulatory Transparency for New Medical Therapies Act” has been passed, which was first introduced on February 2, 2015.

This act with three sections has amended Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), Section 351 of the Public Health Service Act (42 U.S.C. 262), Section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b), Section 571(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360 ccc(d)), Section 572 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc–1), Section 573(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc–2(c)) while dealing with ‘EFFECTIVE DATE OF APPROVAL’. These amendments seem to favor NCE developers. In order to improve practices related to ‘SCHEDULING OF NEWLY APPROVED DRUGS’, this bill has amended Section 201 of the Controlled Substances Act (21 U.S.C. 811). To ensure that no one who deserves patent exclusivity should miss out it, ‘EXTENSION OF PATENT TERM’ related procedures have also been taken care in the same section of the act (section no-2) along with ‘EFFECTIVE DATE OF APPROVAL’ and ‘SCHEDULING OF NEWLY APPROVED DRUGS’. Amendments to the 35 U.S. Code § 156 while dealing with ‘EXTENSION OF PATENT TERM’ touch the period during which application for Patent Term Extension may be submitted (within the sixty-day period beginning on the ‘covered date’), definition of which (covered date) has newly been inserted.

While section 1 of gives the title, section 3 offers provisions related to ‘ENHANCING NEW DRUG DEVELOPMENT’ by introducing amendments to Section 303 of the Controlled Substances Act (21 U.S.C. 823).

Once this bill is enacted, we can expect Orange book page for Perampanel and Lorcaserin HCl to display NCE exclusivities expiring on January 02, 2019 and June 07, 2018, respectively, beginning on the date when they actually could be marketed (unless FDA determines to offer the advantages to only those applicants who file their NDA after the date of the enactment).

Reference:

http://www.fdalawblog.net/

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Supreme Court stayed the Delhi High Court order of injunction against Glenmark over the Generic drug “Sitagliptin”

Reportedly, Hon’ble Supreme Court of India on Special Leave Petition filed by Glenmark stayed the Delhi High Court order which passed injunction against Glenmark for the generic drug Sitagliptin till 28th April 2015. The Delhi high court on dated 20th March 2015 set aside an order of single judge bench of Delhi High Court which rejected the injunction application by MSD against Glenmark. This article aims to analyze the Delhi High Court judgment by the Division bench in detail. The detailed judgment can be found here.

Facts of the case:

Merck Sharp & Dohme (hereafter “MSD”) aggrieved by the dismissal of its application for an ad interim injunction restraining the respondent/defendant Glenmark Pharmaceuticals (hereafter “Glenmark”) from using its patented product Sitagliptin (Indian Patent No. 209816) filed an appeal. MSD filed an application before single bench Delhi High Court for permanent injunction, restraining infringement of the patent, damages, rendition of accounts and delivery up. The suit patent relates to a drug which lowers blood sugar levels in Type 2 Diabetes Mellitus (“T2DM”) patients. Glenmark opposed the application for ad interim injunction and relied on documents produced during the hearing. The learned Single Judge rejected the injunction application. Aggrieved by the dismissal of interim injunction Merck sought to obtain an interim injunction against Glenmark seeking to restrain Glenmark from selling its Generic products Zita (generic version of Januvia) and Zitamet (generic version of Janumet, combination of sitagliptin+metmorphin).

Argument advanced by the Appellant (MSD): 

The learned Senior Counsel, Mr. T.R. Andhyarujina for MSD argues, that its drug Sitagliptin is the first in its class of compounds that inhibits the enzyme Di Peptidyl Peptidase-IV (“DPP-IV”). The learned counsel argued that the suit patent is infringed because Sitagliptin and any of its acceptable salts are covered by its claims, thus resulting in the making, using or offering for sale, importing into India etc. of Sitagliptin or any of its salts or any form amounting to infringement of the suit patent. It was further argued that Glenmark, by manufacturing, selling, offering for sale and advertising the pharmaceutical combinations Sitagliptin Phosphate Monohydrate under the brand Zita and Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride under the brand name Zitamet infringes the suit patent and all its claims. It was underlined that Sitagliptin Phosphate Monohydrate cannot be prepared without manufacturing the active ingredient Sitagliptin molecule. Therefore, the use of Sitagliptin claimed by IN 209816 to prepare Sitagliptin Phosphate Monohydrate by Glenmark infringes the suit patent. MSD argued that its non-disclosure of applications (which were not pursued by it) was an inessential detail which should not have clouded the debate on whether Glenmark infringed its suit patent. It was submitted that the subject of the European Patent, and the application No. 5948/DELNP/2005 (filed on 18.06.2004 – in respect of the Phosphoric Acid Salt of a DPP-IV inhibitor that claimed Dihydrogenphosphate salt of Sitagliptin and was abandoned under Section 21(1) on 23.08.2010) could not have been the basis for refusing ad interim injunction. In India, on account of Section 3(d) and the interpretation of the expression “efficacy” by courts, MSD abandoned the phosphate salt application.

The learned counsel for MSD argued that Glenmark’s US Process Patent No. US8334385 is for “Process for the preparation of R. Sitagliptin and its pharmaceutical salts”. It was further contended that this patent clearly admits that Sitagliptin is developed for the treatment of T2DM and is the active free base. It also gives the full description of the process for preparing Sitagliptin freebase in the patent specification which is Scheme 6 in Merck’s patent. The claim of Glenmark’s patent is for a crystalline salt of Sitagliptin. The learned counsel relied upon the disclosures made to the suit patent IN 209816 to state that the basic invention for which patent protection was sought was Sitagliptin “with pharmaceutically acceptable salts thereof”. It is submitted that this is clearly stated in claims 1, 15, 17 and 19. Thus learned counsel stressed that Glenmark”s ZITA (Sitagliptin Phosphate Monohydrate) and ZITA-MET (Sitagliptin Phosphate Monohydrate and Metformin) infringe the suit patent because Sitagliptin is made and used by Glenmark in ZITA and ZITA-MET when it makes salt Sitagliptin Phosphate Monohydrate. It was underlined that the phosphoric acid salt of Sitagliptin was disclosed in the suit patent itself as one of the pharmaceutically acceptable salts.

Arguments advanced by the Respondent:

 The counsel for the respondent argued that the suit patent is obvious and does not involve an inventive step over and above previous disclosures in the prior art. It was further argued that the suit patent is anticipated by prior arts European Patent 1406622 and WO/01/34594.

Further it was argued by the Counsel for the respondent that the suit patent drug Sitagliptin as well as Sitagliptin Hydrochloride are unstable compounds possessing incapability of commercial production and industrial use.

The respondent argued that the claim goes much beyond the limited disclosures in the specification, and thus the claim is overbroad or an impermissible Markush claim that creates a false monopoly. It was also contended that the patent monopoly is too broad to be workable as it includes possibly 4.9 billion compounds and such elastic claims cannot be sustained.

It was argued that the complete specification of the suit patent does not sufficiently and fairly describe the invention and the method by which it is to be performed, since the patent does not describe the preparation of the Sitagliptin free base or Sitagliptin phosphate monohydrate, but only its hydrochloride salt.

Further it was argued that MSD did not comply with its obligation under Section 8 of the Act to disclose patent applications made for the “same or substantially the same invention” – it did not disclose 5948/DELNP/2005 (for Sitagliptin Phosphate Monohydrate), 1130/DELNP/2006 (Sitagliptin Phosphate Anhydrate), 2710/DELNP/2008 (Sitagliptin plus Metformin) or subsequent international applications for these compounds either. It was also argued that such suppression and concealment – contrary to statutory obligations – results in the invalidity of the patent, and at any rate, militates against the grant of an interim injunction that is premised on good faith and complete disclosure.

It was argued by the respondent that the suit patent by the plaintiff’s own admission is different from its product. The only exemplified salt being Sitagliptin Hydrochloride, no other salt can be claimed or covered in the impugned salt patent and the plaintiff, by its own admission equivocally, through several documents admitted that the suit patent is distinct and different from the Sitagliptin Phosphate Monohydrate (SPM) as well as its combinations with Metformin Hydrochloride. Urging that the latter two products are the subjects of separate patents, Glenmark highlighted that this is clear admission that they are not covered by the suit patent. In this respect, the details of the plaintiff’s application, i.e. 5148/DELNP/2005, especially, Claim no.1 and International Patent US 2004027983, again claim no.1 are relied upon. The said salt, i.e. SPM was also claimed to possess tremendous advantages over free base and previously disclosed hydrochloride salt. MSD‟s said patent application no. 5948/DELNP/2005 for SPM was specifically abandoned.

Conclusion:

Considering the arguments advanced by both the parties, the court evaluated the three grounds Prima facie case, irreparable injury and balance of convenience for passing interim injunction as below:

1) The court on the first ingredient held that prima facie case had been established by MSD for the fact that Glenmark uses Sitagliptin free base as the active component in its chemical formulation.

2) The court on the issue of whether the claimant would suffer irreparable injury in the absence of interim injunction or not, held in affirmative. The court rejected the argument of Glenmark that injunction should not be granted as the monetary compensation may be granted. On the contrary court opined that prices may not recover after the patentee ultimately prevails, even if it is able to survive the financial setback (or “hit”) during the interim, which may take some time.

3) On the issue of balance of convenience the court held in favor of MSD. On the issue of price difference between the commercial products by MSD and Glenmark is not so startling as to compel the court to infer that allowing Glenmark to sell the drug, at lower prices would result in increased access. However, the court observed that Permitting Glenmark to operate would not necessarily result in lowering of market prices. Hence according to court the balance of convenience lies in favor of MSD.

The court conclusively held that all the three ingredients for passing the order of injunction were established by MSD and hence injuncted Glenmark from manufacturing and selling of Zita and Zitamet.

About the Author: Meenakshi Khurana, Partner at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: meenakshi@khuranaandkhurana.com

E- Filing of Application for Registration of Geographical Indications in India

Controller General of Patents, Designs and Trademarks issued public notice dated 11 March 2015 launching electronic filing of application for registration of Geographical Indication (GI) in India. Now the application for registration of GI can be submitted online to the Registrar of GI through the official portal at www.ipindia.gov.in or www.ipindia.nic.in. The payment for the same can be done through net banking, Credit cards and Debit Cards. Pertinently the same digital signature already registered for Trade mark, Patents or Design can be used for login and authentication into e-filing system of GI.

Source: http://www.ipindia.nic.in/iponew/publicNotice_11March2015.pdf

First time in India – Free IPR Clinic for Indian Startups – by Khurana & Khurana Advocates & IP Attorney

Even though Intellectual Property Rights (IPR), Innovation and knowledge protection is emerging to be a key driver in businesses, very few startups have the proper information and understanding of IPR, let alone the approach to forming an optimal IPR strategy for their business.

 Thus, as a leader and torch bearer in the IPR services Industry, we, Khurana & Khurana Advocates & IP Attorneys have decided to shoulder the responsibility of strengthening the IPR arsenal of Startups in India by conducting two weeks of free IPR clinics for startups, and use all our experience in dealing with Startups and Individual Inventors in providing customized solutions, counseling and guidance to budding entrepreneurs of India.

 The first IPR clinic session will start with the Mumbai office of Khurana & Khurana from 16th to 30th of March, 2015 where Khurana & Khurana IPR Consultants & Experts will conduct one to one interactive and solution based counseling on IPR strategy, approach and budgeting. With no fees or any other criteria involved in registration, the sessions will be conducted on a first come first serve basis.

 Having 2000+ clients, 4 offices in India, and 60+ experts, team Khurana & Khurana under the leadership of the partners Mr. Vinod Khurana, Mr. Tarun Khurana, Mrs. Meenakshi Khurana & Mr. Abhishek Pandurangi has always extended arms to Startup innovation and encouraged knowledge and transparency in the IPR ecosystem, and the Free Startup IPR clinics shall be yet another chapter in this story.

For registration please contact: Parvez Kudrolli at parvez@khuranaandkhurana.com / 9820519769 / 022-65281005

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