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

Recent decision of Delhi High Court in the case of GILEAD PHARMASSET, LLC V. UNION OF INDIA & ANR

Recently, the Delhi high court on dated 30th January 2015 set aside an order of the Deputy Controller of Patents and Designs. The impugned order rejected a patent to US drug maker Gilead for its hepatitis C drug “Sovaldi” on dated 13th January 2015. The detailed judgment can be found here.

Facts of the case:

M/S GILEAD PHARMASSET, INC, USA, filed a patent application on 30/05/2003 in USA and the corresponding application was filed in India through PCT on 27/12/2005 vide application no. 6087/DELNP/2005 (“A (2’R)-2′-DEOXY-2’FLUORO-2′-C-METHYL NUCLEOSIDE”). Two Entities, NATCO Pharma Ltd. and Delhi Network of Positive People +IMAK filed applications for pre-grant opposition, under Section 25 of the Act on dated 13 March 2014 and 17 March 2014 respectively. On 13th January 2015, the Patent Office rejected Gilead’s Hepatitis C drug, sofosbuvir (Sovaldi) on the basis of it failing to clear Section 3(d) of Indian patent act 1970 which prevents evergreening of patents and provides that no new form of an existing substance shall be patented unless the new form is more effective than the old one. The copy of the decision made by Controller General of Patents can be accessed here.  Being aggrieved by the order, the GILEAD filed the present writ petition under Article 226 of the Constitution of India.

Arguments advanced by the petitioner:

It was argued by the Counsel for the applicant that while passing the impugned order, Indian Patent Office (IPO) had taken recourse to the material and objections, which were placed on record by the applicants, who had filed their applications to oppose the grant of patent to the petitioner, under Section 25 of the Act. Further it was submitted that this aspect, was clearly demonstrable from the fact that, not only the grounds taken in opposition and documents cited were considered, while passing the impugned order, but even, the typographical errors contained in the applications, filed under Section 25 of the Act, got incorporated in the said order.

It was further contended that the once notice was issued to the petitioner for a hearing under Section 14 of the Act, to consider, whether to grant a patent as requested, IPO should also have heard the petitioner regarding objections raised in the application, under Section 25 of the Act. The learned counsel contended that, while documents in opposition filed by the entities, which had preferred applications under Section 25 of the Act were supplied, no opportunity, was given, to meet the objections raised by them.

Further it was submitted that the impugned order, had created a peculiar situation whereby, while it had returned a finding that the claims presented by the petitioner represented “novelty and inventive steps”, it sustained, the challenge, under Section 3 (d) of the Act, though the applicants, which had opposed grant of patent, had raised objections, on both counts.

Arguments advanced by the Respondent

On the other hand, the opponent contended that the exercise carried out by IPO under Section 14 and 15 of the Indian Patent Act, is quite different, from that, which IPO carries out while hearing applications filed under Section 25 of the Act. Further it was submitted that, while the material and/or objections filed by opponents, which had preferred applications under Section 25 of the Act, was supplied to the petitioner, IPO did not rely upon the same, while passing the impugned order.

Decision of the Hon’ble Court:

The hon’ble court observed that while petitioner’s request for a hearing under Section 14 of the Act was pending, two pre-grant oppositions were filed. Though, the documents filed by the opponents were supplied to the petitioner, no notice was issued to the petitioner with regard to the applications filed under Section 25 of the Act. Therefore, when hearing under Section 14 was finally granted to the petitioner on 24.07.2014, there was no clarity as to the extent and scope of objections, which it was required to meet while pressing ahead with its request for grant of patent. The petitioner, at best, would have prepared itself to rebut the objections raised in the FER. Further the court observed that combining S. 25 and the S. 14 proceedings, if Gilead would have been given an opportunity to be heard on both counts, it could have save not only time, effort but also have avoided the allegation of bias.

 The court accepted the Gilead’s claim and set aside the impugned order given by IPO and remanded for a fresh decision. The court also ordered IPO to fix a date of hearing both for Sections 14 and 25 proceedings and asked to send written communication to all concerned parties including the petitioner.

 Thus it would be interesting to see the decision by IPO after fresh consideration to the facts and circumstances in view of the fact that Gilead has already entered into license agreements with Generic companies of India for the drug “Sovaldi” as per the reported news in September 2014.

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

Music Rights for Use in Films

In recent times, music copyrights and their ownership/rights to producers, artists, among other stakeholders, have been under strong discussion across geographies. We are happy to have a written piece by Gemma Harrison, a freelance writer, on her high-level take on the Copyrights in Music.

This summer, the highest grossing film at the box office was Marvel’s Guardians of the Galaxy, as notable for its music choices as for its place in the growing range of Marvel superhero films sweeping Hollywood at the moment. Guardians of the Galaxy may have grossed upwards of $550 million worldwide, but it cost a cool $170 million to produce – not including Marvel’s expansive marketing campaign – and the music choices can’t have helped with that. Peppered liberally with a range of classic tunes from the 1980s, from David Bowie to 10cc, the familiar soundtrack of Guardians of the Galaxy was extremely visible, provided key plot points, and has spawned mix tapes and tie-in merchandise since the film’s release.

From a filmmaker’s perspective, it’s evidence of Marvel’s central market position, that they were able to negotiate such extensive rights to the tracks – many of which are extremely well-known or iconic. One can only fathom at how much it must have cost them.

Licensing Music for Filmmakers

There are several types of licence that filmmakers need to acquire in order to use a pre-recorded piece of music in films. First of all, the right to use a song differs from the right to use a specific recording of the song. This is particularly key for cover versions, where the rights to the song might not belong to the band who specifically recorded the version. Alternatively, some rights are likely to belong to the record company, with others being retained by the songwriters or performers. The rights to use of the underlying composition, and the specific recording or “master recording”, may very well belong to different people, all of whom have rights which they can enforce.

Once filmmakers have discovered who owns the rights, there are three types of permissions they typically need to obtain: the right to record and distribute copies of the song, to record the music in synchronisation with the moving pictures in the film, and thirdly to perform the song publically as part of the performance of the film. It’s complicated, and convoluted, and for popular songs it can be eye-wateringly expensive. In the case of Guardians of the Galaxy, where the screenwriters deliberately wrote the music into the film as a plot point, it’s a bold and ostentatious move, signifying their vast budgets, and even more vast bargaining power.

Bridgeport Music Inc v Dimension Films, Sampling and Fair Use

In 2004, the case of Bridgeport Music Inc v Dimension Films was heard in the United States, and reached the Court of Appeal. Bridgeport was centred on the digital sampling of a two-second guitar chord from a song, looped five times, without the permission of the rights holder. The federal judge decided that a two second clip was de minimis – that it was too small to cause any real harm to the claimant, and that the claim should be dismissed on that basis.

The Court of Appeal disagreed, deciding that the owner of copyright had an exclusive right to duplicate the work in question, or any part of it, of any length. The Court said, “Get a license or do not sample. We do not see this as stifling creativity in any way.”

The decision is controversial, and has not yet been followed by other Court of Appeal circuits. The reasons for this are several: firstly, it could lead to a single note being copyrightable by a party, which is widely seen as being far too restrictive. The chilling effect of not knowing how small a section of music is covered by copyright rules could be substantial. Others have said that the decision stifles fair use policies. Since the use of the clip in Bridgeport was transformative, for non-commercial purposes, and did not harm the market for the original work or its derivatives, fair use policy should be able to give the defendants some protection.

This could have a knock-on effect for filmmakers, especially those making educational films or films reporting or commentating on the news, which are given a higher status under fair comment rules. It remains the case that filmmakers still have to be careful about using pre-recorded songs in their films, especially since the licences they would need to obtain are extensive. Given that the United States case law has yet to encounter many cases of digital sampling or the use of new technology in copyright claims, we may expect the law to remain unclear or inadequate for a few years to come.

Further reading

Amendment in Design Rules and Fee

Controller General of Patents, Design and Trade Marks, Mr. Chaitanya Prasad, has issued a Public Notice on 1 January, 2015, wherein it has been put forth that, from December 31, 2014 Official Fees for filing a new Design application as well as other proceedings of Design has been amended. It has also been mentioned that applicants have been divided into two main categories and fee shall depend on type of applicant.

Highlights of amendments in Design rules:

  • Applicants have been divided in two main categories namely: “natural person” and “other than natural person(s)” categories. Second category of applicants has been further divided in to two sub-categories 1.) “small entity” 2.) “others except small entity” and fee structure is amended accordingly.
  • New form – 24 has been introduced which has to be submitted with all new applications for claiming the status of small entity.

Addition of new clauses in Design Rules:

  • A new clause has been inserted after rule 2(c) as under:

‘(ca) “person other than a natural person”, shall include a “small entity”;’

  • Another clause has been inserted after rule 2(e) which defines definition of small entities as under:

‘(ea) “small entity” means,

  1. In case of enterprise engaged in the manufacture or production of goods, an enterprises where the investment in plant and machinery does not exceed the limit specified for a medium enterprise under clause (a) of sub-section (1) of the section (7) of the Micro, Small and Medium Enterprises Development Act , 2006 (27 of 2006); and
  2. In case of enterprise engaged in providing or rendering of services, an enterprises where the investment is not more than the limit specified for a medium enterprise under clause (b) of sub-section (1) of the section (7) of the Micro, Small and Medium Enterprises Development Act , 2006 (27 of 2006);
  • In rule 5(2) after clause (d), two new clauses have been inserted, as under :-
  1. “(e) in case an application processed by a natural person is fully or partly transferred to a person other than a natural person, the difference, if any , in the scale of fees between the fees charged from a natural person and the fees chargeable from the person other than natural person in the same matter shall be paid by the new applicant with the request for transfer.
  2. (f) in case an application processed by a small entity is fully or partly transferred to a person other than a natural person (except a small entity), the difference, if any , in the scale of fees between the fees charged from the small entity and the fees chargeable from the person other than natural person (except a small entity) in the same matter shall be paid by the new applicant with the request made for such  transfer.”,
  • In rule 6 after sub-rule (1), the following proviso has been inserted,:-

                 “Provided that in the case of small entity, every document, for which a fee has been specified,  shall be accompanied by Form-24.”

Amendments in Design Fees:

Following table gives the detailed fee structure after the amendment:

Untitled1 Untitled2

The notification can be seen here.

Belly Fireman! Rescued by Delhi High Court

In the recent decision of Delhi  High Court in the case of Reckitt Benckiser(India) Ltd v Dabur India Ltd, the Hon’ble court decided on the issue of deceptive similarity between the  television advertisement of Pudin Hara lemon fizz drink and Gaviscon

Facts of the case:

The plaintiffs is a member of  Reckitt Benckiser Group PLC who involved in the various consumer and healthcare products . It also manufactures Gaviscon which provide relief from heartburn and gastro oesophageal reflux. In the year 2006 the plaintiff started using Fireman Device for the advertising and promoting his product in the market. Fireman Device was registered in India in favour of the plaintiffs on 22nd October, 2007 in Class 5.

The defendant is the manufacturer of various Ayurvedic and non-prescription medicines such as Pudin Hara, , Hajmola, Glucose-D etc. Reckitt Benckiser alleging that the ads for Dabur’s Pudin Hara lemon fizz drink had “infringed its trademark and copyright”. The point of dispute is the image  of Fireman /fire fighter.

Issues involved/Contentions

  • In both the advertisement a person is suffering from gastro-oesophageal reflux disease/heartburn.
  • Both the advertisements show fire burning inside the oesophagus.
  • Then a person consumes medicine & the medicine converts into the image of a fireman which extinguishes the fire by sprinkling the product on the stomach walls.

Delhi High Court decision

Trademark infringement

After comparing the advertisement, the Delhi High court concluded that Dabur’s fireman device was not deceptively similar to the registered mark. The mark appears to be different in terms of colour, representation and number. Therefore there was no likely hood confusion and no infringement had occurred.

Passing off

The defendant product i.e  Pudin Hara Lemon Fizz  is sold in Indian market since April, 2010 whereas the plaintiff product i.e Gaviscon was introduced in Indian market in November 2011.Hence Reckitt Benckiser could not establish goodwill  in India prior to Dabur and the element of misrepresentation was also missing. So, Dabur had not committed the tort of passing off.

 Copyright infringement

The court concluded that there were several dissimilarity between both  the advertisement  in respect of their  colour, representation and image of fireman device. The court relied on the Supreme Court decision in RG Anand v Delux Films (1979 SCR (1) 218) to reiterate the established principle that only the manner of expression of ideas is protected under copyright law (not the ideas themselves). Thus, the court held that there had been no copyright infringement.

 The court has, however, said that if there is any modification in the television Commercial Ad, Dabur would need to take necessary permission from the court.

About the Author: Ms. Pallavi Sharma, Trademark Attorney at Khurana and Khurana, Advocates and IP Attorneys and can be reached at:pallavi@khuranaandkhurana.com

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