U.S. District Court Confirms Validity of Patent For UCB Pharma’s Vimpat®

UCB Pharma, a Belgian pharmaceutical company, announced on 14th August 2016 that the U.S. District Court for the District of Delaware confirmed the validity of its U.S. reissued patent RE38551 related to anti-epileptic drug Vimpat® (lacosamide). The patent challenge was brought by generic drug makers who had questioned the validity of the UCB’s patent which is scheduled to expire in March 2022.

Vimpat®, one of four key products for UCB Pharma, generated net sales of 379 million euros ($423.7 million) in the first half of 2016. Vimpat® is indicated for use alone or as add-on therapy in the treatment of partial-onset seizures in patients with epilepsy who are 17 years of age or older.

In 2013, UCB had sued numerous generic drug companies, including New York-based generics maker Argentum Pharmaceuticals, after they applied ANDA application to market a generic version of Vimpat® in the United States. In late May, Argentum Pharmaceuticals won an inter partes review of UCB’s patent by the USPTO’s Patent Trial and Appeal Board (PTAB).

The Delaware district court has ruled that UCB’s patent covering the epilepsy drug Vimpat® is valid. The Court upheld the validity of the UCB’s patent after issuing a sealed opinion on the patent. The court’s favorable decision for UCB now guarantees patent protection for Vimpat® until 2022.

Anna S. Richo, executive vice president and general counsel for UCB stated “We are pleased with Delaware Chief Judge Stark’s decision”. “This confirms the strength of our intellectual property for Vimpat®”.

The decision is currently under seal and will be released following an order from the court.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:antony@khuranaandkhurana.com.

Movie Titles and their Protection in India

Ms. Shreya Shrivastava, an intern at Khurana & Khurana, Advocates and IP Attorneys looks into the aspect of protection of Movie titles in India along with the parameters to avail the same.

What’s in a name? That which we call a rose by any other name would smell as sweet.” Turns out this quote by William Shakespeare does not hold true for the Producers of motion pictures. A name is an identity for a person, product, company, books or movies.

When it comes to choosing a title for a movie, film makers are very particular about the uniqueness and suitability. A title that is catchy and distinctive finds a place in the minds of the audience instantly and thus lots of money and efforts are put into achieving the right one.

The conventional practice followed by the film producers is to get the plot or titles registered with the film industry associations like Indian Motion Picture Producers’ Association;Film Writers’ Association; Television Producers’ Guild of India; Association of Motion Pictures and Television Program Producers and Film and Western India Film Producers Association. These associations are working consistently to endorse and encourage the production of motion pictures and to protect the commercial interest of films produced in India. Before registering a title, the association usually verifies the registration of same or deceptively similar title with other associations. However such registration has no effect on any legal proceedings, it only establishes precedence in the adoption title.

Under Indian Copyright Act, protection is conferred on literary works, dramatic works, musical works, artistic works, cinematograph films and sound recording but not to titles alone. Thus copying of a title alone and not the plot of the movie, the characters, songs etc does not fall under the ambit of copyright protection. It is common, rather it is imperative, to give title to literary or entertainment works. The literary work produced by the author or the work of entertainment produced by a producer needs a name. It is only then that such work would be identified. The term ‘literary title’ is used to encompass the titles of books, periodicals, newspapers, plays, motion pictures, television series, songs, phonograph records, cartoon features and the like.[1]

Movie titles in India may be registered under Class 41 of the Trademarks Act 1999. Movie titles can be bifurcated into two heads, that is, titles of series of movies, like for instance ‘Munna bhai MBBS’ and ‘Lage raho munnabhai’ and title of a single movie. In case of a single movie title, it must be established that the title has acquired secondary meaning amongst the public at large. The test of secondary meaning for literary titles is basically to determine whether in the minds of a significant number of consumers, the title in question is allied with a single source of the literary work.

In Kanungo Media (P) Ltd. v. Rgv Film Factory And Ors.[2] Kanungo media had produced a Bengali documentary movie titled Nisshabd, which had won numerous awards in various significant film festivals but was not released commercially. The plaintiff challenged the use of their highly acclaimed film title Nisshabd by the defendant for its upcoming Bollywood movie. The Court held that while the title of a literary work could be protected under the trademark law, in order to prove likelihood of confusion, it would be vital to establish consumer recognition and secondary meaning. The Court denied the relief of injunction based on the fact that the plaintiff’s film has not acquired secondary meaning. Also plaintiff approached the court very late after huge expenses had been made by defendant in advertising, promoting the movie and other marketing strategies and thus there was delay in filing the suit.

In Biswaroop Roy Choudhary v. Karan Johar[3] , Producer Biswaroop Roy filed a suit in the High Court seeking permanent injunction to restrain Karan Johar from using the title “Kabhi Alvida Naa Kehna”. The title had been filed by Karan Johar with the Association of Motion Pictures and TV Program Producers and the Film and Television Producers Guild of India also. The court dismissed the petition on the grounds that where words or phrases in common parlance are sought to be used with exclusivity, the Court should take care to determine which of the parties has ended its journey or traversed appreciably longer way in the use of such words as a trademark or as a title.[4]

In the case of Warner Bros. Entertainment Inc. and Anr v. Harinder Kohli and Ors.[5], the plaintiffs of the registered Trademark ‘HARRY POTTER’ alleged infringement of Trademark and sought a permanent injunction from the use of the title ‘Hari Puttar’, which was registered with Indian Motion Picture Producers’ Association and the Guild and was ready for commercial release. The Court dismissed the case due to the fact that the Harry Potter films meet the entertainment needs of an exclusive audience who can distinguish between films based on a Harry Potter book and a film which is a Punjabi comedy. Confusion of Hari Puttar with the plaintiff’s popular trademark Harry Potter was unlikely and also on grounds of delay.

It is thus clear from the above case decisions of the court that by mere registering a movie title either with any of the independent trade associations or as a trademark with the Registry may not be enough of the protection in title rights. Even though registering it is advisable but in order to establish one’s right over the title it is imperative that consumer recognition and secondary meaning is adduced to it. In order to do that, one has to actually use the trademark. Even if the work has not been released, a sufficient amount of pre-release publicity of the title may cause a title to acquire recognition sufficient for protection. Relevant evidence from which secondary meaning for a literary title may be inferred as a question of fact include: (1) the length and continuity of use; (2) the extent of advertising and promotion and the amount of money spent; (3) the sales figures on purchases or admissions and the number of people who bought or viewed plaintiff’s work; and (4) the closeness of the geographical and product markets of plaintiff and defendant.[6] Also, delayed approach to the court to enforce one’s right in the titles can also be of loss to the plaintiff.

Any cinematographic work is identified by its title for decades. People conceptualize the idea behind the work by associating it with the title and hence it is becoming a perquisite to register it in order to protect and preserve the commercial interest in the film. The registration not only provides exclusive right over the title but also restrains the unauthorized use or adoption by another.

[1] McCarthy on Trademarks and Unfair Competition, Third Edition (1995) Vol. I

[2] 138 (2007) DLT 312

[3] 131 (2006) DLT 458, 2006 (33) PTC 381 Del

[4] Supra

[5] 2008(38)PTC185(Del)

[6] Kanungo Media (P) Ltd. vs Rgv Film Factory And Ors. 138 (2007) DLT 312

India’s First IP Crime Unit Launched in Telangana State

Piracy is one of the major evil Indian IP industry is facing for decades and the same is growing day by day rooting into the system causing irreparable loss to the economic reputation of the country. As per the report by Ernst & Young, Indian films industry has sustained loss of around USD 959 (Rs. 4,411 Crores) million and 5, 71,896 jobs in the year 2008 due to piracy.[1] Further various incidents regarding piracy in the film industry seems to be increasing and recently the incident related to the online leak of movie “UDTA PUNJAB” before two days of its release had made headlines. However Indian Judiciary has taken timely steps to control the piracy by passing John Doe orders wherein identities of the Defendants are not known but the whole site suspected providing the pirated versions is blocked. UDTA PUNJAB is not the only movie which is victim of the piracy, there are numerous movies that falls prey of piracy, some of which are reported while others go unnoticed. Latest incidents of piracy in the Bollywood industry have been in headline every now and then, which palpably is a sheer discouragement to the IPR holder as well as economic system of the country. Even Telangana Film Chamber of Commerce recently claimed that there were 14,000 sites and 89,000 illegal downloads of the movies causing loss in millions of rupees.[2] The issue related to piracy and infringement of IPR in India ultimately impacts its economic reputation which is not at all desirable.

Reportedly, in order deal with the menace of piracy, Telangana Intellectual Property Crime Unit (TIPCU) is launched as India’s first unit to deal with the Intellectual Property Crime. It is set up under the cyber crime wing of the CID to deal with complaints pertaining to online piracy particularly illegal download and spread of movies. Pertinently, TIPCU being first of its kind of state level unit in India seems to be vigilant step by the state government in setting up a special unit dedicated to tackle with the serious and organized intellectual property crime such as piracy, with prime focus on offences committed using an online platform. Modeled upon UK’s Police Intellectual Property Crime Unit (PIPCU), TIPCU’s main task will be to monitor online piracy and recommend blocking of websites providing pirated contents, identify the perpetrators and pursue action. Reportedly, TIPCU’s will also prosecute the pirates and choke their revenue sources. The taskforce is expected to start work in the next few months. It will have representatives from cyber crime police, state IT ministry, internet service providers, the Telugu film industry, legal experts and financial experts.[3] Further TIPCU is also expected to deal with the measure to control illegal online activities, including child pornography. Thus it seems that the horizon of the unit is duly kept wide in order to confront all the wrongs being carried out through online platforms with special focus on piracy. It is a commendable step by the Telangana Government which inculcates deterrence among the wrong doers who indulge in such illegal activities of piracy. Thus units like TIPCU are essential to curb the menace of the Piracy and intellectual property infringement in India, which ultimately helps retain confidence among the authors/creators/ owner towards their Intellectual Property rights in India. Now the actual effective working of the unit is expected to speak louder than words and help clear the menace of piracy issue. Further, it is the need of the hour to have such units throughout India, as the piracy is the issue that is also being faced by the Bollywood as that of the Tollywood. Launch of TIPCU has already set a trend across other Indian states to have such units established which would actively help curbing the menace of piracy in India.

About the Author: Mr. Abhijeet Deshmukh, Trade Mark Attorney, Khurana & Khurana, Advocates and IP Attorneys and can be reached at: Abhijeet@khuranaandkhurana.com

[1] http://www.financialexpress.com/archive/piracy-a-serious-threat-to-indian-film-industry/592752/


[3] https://www.telanganastateofficial.com/tipcu-telangana-intellectual-property-crime-unit-formed/

CO2 Solutions Wins Patent Challenge Against Akermin in Denmark

CO2 Solutions Inc, a leader in the field of enzyme-enabled carbon capture technology, has successfully defended its broad intellectual property (IP) rights to its enzyme-enabled carbon capture technology in a case brought against it by U.S.-based Akermin Inc. in Denmark.

Based in Quebec City, CO2 Solutions Inc. is an innovator in the field of enzyme-enabled carbon capture and has been actively working to develop and commercialize the technology for stationary sources of carbon pollution. CO2 Solutions’ technology lowers the cost barrier to Carbon Capture, Sequestration and Utilization (CCSU), positioning it as a viable CO2 mitigation tool, as well as enabling industry to derive profitable new products from these emissions. CO2 Solutions has built an extensive patent portfolio covering the use of carbonic anhydrase, or analogues thereof, for the efficient post‐combustion capture of carbon dioxide with low‐energy aqueous solvents.

The Danish PTO’s decision came in response to a challenge filed by Akermin Inc., a U.S. company that had intended to utilize similar CO2 capture technology for a biogas-related project in Denmark, known as ENZUP. CO2 Solutions had notified Akermin’s Danish ENZUP partners of their impending infringement of the CO2 Solutions’ registered Utility Model BR 2014 00144, subsequent to which Akermin Inc. filed a request for re-examination with the Danish PTO for invalidating the CO2 Solutions’ utility model.

The Danish Patent and Trademark Office (DKPTO), after reexamination, upheld the validity of the issued claims in the CO2 Solutions’ registered Utility Model BR 2014 00144 entitled “System For CO2 Capture Using Packed Reactor and Absorption Mixture with Micro-particles including Biocatalysts”. In the re-examination decision, the DKPTO held the claimed subject matter was novel and distinct over the prior art, and maintained all the claims of the registered utility model in un-amended form.

Independent Claim 1 of DK 2014 00144 (U1) reads as follows:

A system for capturing CO2 from a CO2-containing gas comprising a packed reactor configured for contacting the CO2-containing gas with an absorption mixture within, the absorption mixture comprising a liquid solution and micro-particles, the micro-particles comprising a support material and biocatalysts supported by the support material and being sized and provided in a concentration such that the absorption mixture flows through the packed reactor and that the micro-particles are carried with the liquid solution to promote dissolution and transformation of CO2 into bicarbonate and hydrogen ions, thereby producing a CO2-depleted gas and an ion-rich mixture comprising the micro-particles.

“This decision is the third in Denmark upholding all of our intellectual property claims in the face of vigorous opposition by Akermin and other ENZUP partners,” stated Evan Price, President and Chief Executive Officer of CO2 Solutions.

“The decision clearly confirms our ownership of the IP related to enzyme-enabled carbon capture, the most economical and cleanest commercial technology available to date for this purpose. While we offered the ENZUP partners a single commercial license for use of the CO2 Solutions’ IP in their project, it appears that, pursuant to this decision, Akermin has indefinitely ceased operations and the ENZUP project itself, in Denmark, has been cancelled. CO2 Solutions welcomes initiatives to implement carbon capture technology, but shall defend the Corporation’s IP wherever we observe actual or imminent infringement on our rights, as we have done successfully in Denmark.” Evan Price further stated.

With 70% of global energy demand currently met through the burning of carbon-based fuels, and the demand predicted to double by 2035, the world faces a growing challenge that includes reducing climate change causing carbon dioxide (CO2) emissions while not damaging a fragile global economy that is sustained by these abundant fossil fuels. Additionally, substantial opportunities exist for the utilization of CO2 in a broad range of industrial applications from enhanced oil recovery, to beverage carbonation, pulp and paper production, greenhouses, and chemical production, many of which also provide a carbon sequestration opportunity.
CO2 Solutions is addressing these challenges as the leader in the field of enzymatic CO2 capture. CO2 Solutions’ patented technology allows for the low-cost capture of CO2 from stationary emissions sources such as oil production operations, power and steam plants and metals production facilities, while leveraging existing solvent-based gas scrubbing approaches already known to industry. In turn, CO2 Solutions is positioning CO2 capture and sequestration as a viable climate change mitigation tool as well as enabling industrial customers requiring CO2 to lower their acquisition costs for existing and new applications.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:antony@khuranaandkhurana.com.

Jurisdiction for Trademark and Copyright Suits after Bombay High Court’s Decision

It’s really not settling down when it comes to jurisdiction of infringement of trademarks and copyrights. In INDIAN PERFORMING RIGHTS SOCIETY LTD. Versus. SANJAY DALIA AND ORS: (2015) 10 SCC 161 decided on July 01, 2015, Hon’ble Supreme Court (SC) dealt with the extent to which section 62 of the Copyright Act,1957 and section 134 of the Trademark Act, 1999 provide the convenience to Plaintiff in terms of instituting suit for infringements. SC agreed that both section 62 and section 134 are inclusive in nature, and provide additional forum to the plaintiff to sue defendant at places where plaintiff is residing or carrying on business or personally works for gain in addition to places provided by the section 20 of CPC i.e. places where defendant is residing or carrying on business or personally works for gain or where cause of action has arisen. But SC made it clear that section 62 and section134 do not give plaintiff authority to institute a suit at subordinate place if no cause of action has arisen there and cause of action has arisen at the place of registered office. By observing so, SC made it clear that section 62 and section 134 are not interpreted to the detriment of Defendant.

After this decision by SC, in ULTRA HOMES CONSTRUCTION PVT. LTD Versus PURUSHOTTAM KUMAR CHAUBEY & ORS FAO (OS) 494/2015 & CM 17816/2015 decided on January 20, 2016, Hon’ble division bench of Delhi High court held that, plaintiff being a corporation (which includes a company), can sue at additional places as discussed below:

Jurisdiction for Trademark

According to this decision, plaintiff cannot choose to file suit at the place of Principal office in case it has subordinate office and cause of action has arisen at such place. An in-depth analysis of inclusive nature of the section 62 and section 134 and effect of the above mentioned two decisions on the jurisdictions available to plaintiff was done by IIPRD.

In decision given on June 15, 2016 in respect of SUIT NO. 516 of 2013 and SUIT NO. 632 of 2014, Hon’ble Bombay High Court decided that Dalia decision by SC does not take away the privilege of the plaintiff to file suit at the place of principal place of business or registered office even if it has subordinate place and cause of action has arisen at such place or defendant resides or carries on business there. To support his views, Justice Patel of Bombay HC relied on the discussion of SC on “carries on business”, where SC observed that registered office of a company is the principal place of business as generally it is place where controlling powers are exercised. Justice Patel said that Dalia decision intended to avoid only abuse that can result when cause of action has arisen at the place of registered office of plaintiff and he chooses to file a suit at such a place where he has subordinate place and neither cause of action has arisen nor defendant resides or carries on business there.

With the contrary decisions of DB of Delhi High Court and Bombay High Court on whether plaintiff has the privilege to file suit at the place of its registered office when it also has a subordinate place and cause of action has arisen at such a place, the position remains unsettled. It would be interesting to note stand of the Supreme Court on the same.

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

Update On Pune Office: Change of Address

Kind Attention..!

This is to update our Patrons that in the wake of our growing client demand, we have changed our Pune office address to a new one which is more centrally located in the heart of city facilitating our patrons, existing and future ones in Pune, Maharashtra and surrounding region to reach us easily and in a hassle free manner.

Kindly note our new Address for PUNE Office as below:

Khurana & Khurana, Advocates and IP Attorneys
Office No. 206, 2nd Floor, Citymall,
University Road, Ganesh Khind,
Shivaji Nagar, Pune – 411007, Maharashtra, India
Tel: +91-(020) 65223365
E-Mail id: info@khuranaandkhurana.com


Post Prosecution Pilot Program (P3): A Commendable Decision by USPTO

On Monday 11 July, USPTO announced a new pilot program (P3), intended to boost the prosecution efficiency. Under the P3 program, an applicant can file a request for consideration after final rejection, statement that he is willing and available to participate in the event, along with copy of response to a final rejection, and optionally proposed non-broadening amendment to the one or more claims. The program provides an opportunity to the applicant to make an oral prosecution to a panel of examiners, and then receive a written decision from the panel.

Duration of the initiative:

The P3 pilot is scheduled to start from 11 July 2016 and will continue till earlier of 12 January 2017 or receipt of 1,600 compliant requests by USPTO. There are multiple technology centres involved in this initiative and one or more of them shall stop accepting further requests as soon as their counter reaches 200.


To participate in the P3 pilot program, applicant has to file a request within 2 months from the mailing date of final rejection, and before applying a notice of appeal. USPTO is providing facility to the applicant, to present an oral presentation to a panel of 3 examiners, during the conference. To apply for P3 Pilot program the requirements are as follows:

  • A request form to apply under P3 pilot program;
  • A statement within the Request Form that the applicant is willing and available to participate in a P3 conference with the panel of examiners;
  • A response under 37 C.F.R. 1.116 comprising no more than 5 pages of arguments (exclusive of amendments) to final rejection; and
  • Optionally a proposed non-broadening amendment to one or more claims.

There is no fee required to participant in the program. The goal of the P3 pilot program is to reduce the number of appeals take to patent trial and appeal board. It will also hopefully reduce the request for continued examination (RCE) filing after final rejection.

The USPTO is also requesting comments from the public, and suggestion to improve the prosecution process. The patent office plans to evaluate the public feedback to the pilot program so as to achieve its goals. Comments and suggestion can be sent by email on: afterfinalpractice@USPTO.gov, or by post to: USPTO, mail stop comments patents, office of commissioner for patents, P.O. Box 1450, Alexandria, VA 22313 – 1450. View the USPTO Notice for more details.

About the Author: Saurabh Kumar Jain, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: Saurabh@khuranaandkhurana.com.

Patent Cooperation Treaty National Phase Entry in India: 31 months Period: Effect of Patent (Amendment) Rules, 2016

Under Patent Cooperation Treaty (PCT), applicant gets varying period of 30-34 months to enter different states with National Phase applications. In the case of India, this period is 31 months. Decisions have been given by Hon’ble High Courts of India regarding extendible or non-extendible nature of this period of 31 months.

In the case of NOKIA CORPORATION VS DEPUTY CONTROLLER OF PATENTS AND DESIGNS decided by Hon’ble MADRAS HC, Indian application was filed as National Phase Entry on August 18, 2009 claiming a priority from an earlier US application 11/622, 147 dated January 11, 2007. Indian Patent Office rejected to accept the patent application by resorting to rule 20 (3) of the Patents Rules, 2003 which mandates to file Indian National Phase Application within 31 months from the priority date which in the current case was August 11, 2009. After returning the documents to attorneys on August 21, 2009, online application was filed on September 10, 2009, which was accorded application No. 5322/CHENP/2009. Along with patent application, petitions under Rule 137 and 138 for condoning the delay in filing National Phase application were also filed, and also request for personal hearing was made. According to the petitioner, National Phase application could be filed within 31 months, along with the request for one month extension of time, under Rule 138, if necessary petition under Rule 137 for Condonation of irregularity was filed before expiry of prescribed period of one month. Patent office rejected to condone the delay by holding that it will be detrimental to public at large. Madras HC held that in case, an application is moved for extension of time by one month or shorter period, it is required to be decided on merit by taking into consideration facts and circumstances of each case. Court went on to stay that it is the discretion of the Controller to extend the period on facts and circumstances of the case, but it was not correct on the part of the Deputy Controller to have rejected the application, by treating it to be not maintainable, as having been filed after expiry of prescribed time under rule 20 of the Patents Rules 2003. In short, court declared that that if applicant shows sufficient cause for the delay, national phase application could be filed within 32 months from the priority date.

After this decision, two different cases related to 31 months were decided by Hon’ble Delhi HC.

In the case of 5402/DELNP/2011, reason for missing timeline of 31 months was mentioned by agents as the non-receipt of the instructing emails due to limitations of the agent’s IT systems in place at that time. Petitions under rule 137 and rule 138 were filed for condoning the delay, obviating the irregularity and extending the deadlines to complete the procedures.

 The petitions were rejected by controller for below reasons:

Reasons for rejecting petition under rule 137:

  1. Condonation can’t be allowed to result in detriment to the interest of any person.
  2. Provisions were applicable to amendments only and not for condoning the delay in filing National Phase application.

Reason for rejecting petition under rule 138:

  1. Application for extension was not made before expiry of prescribed period of time.

Controller decided that condoning the delay would be to the detriment of the public and by resorting to rule 22, Patent Rules, 2003, held that subject matter of the patent application had fallen in the public domain.

Controller also held that the delay in the current case was unintentional, hence articles 48 of the PCT was not attracted as it allows condonation of delay in the case of unavoidable loss or delay in mail and not in the case of unintentional delay.

In the case of 1494/DELNP/2010, reason for not meeting deadline of 31 months was mentioned as docketing error on the part of US Attorney. Petitions under rule 137 and 138 were filed even in this case. In this case also, controller rejected to accept the patent application after the expiry of 31 months and held that subject matter had fallen in the public domain. Controller cited similar grounds as that of the 5402/DELNP/2011 case.

In both cases i.e. 5402/DELNP/2011 and 1494/DELNP/2010, Hon’ble Delhi High Court chose not to rely on the earlier Madras High Court decision and instead relied on Nippon case decided by Delhi HC which had strictly interpreted provisions related to 48 months period during which request for examination is to be filed. Delhi high court declared that in case of the application for which this deadline is missed, application is to be treated as withdrawn and not existent in the law and no amendment of priority date should be allowed in case of such application. Though Nokia case was specific to 31 months period, case was not relied upon in these two cases as it was older than Nippon case, and was decided by Madras court against the latter which was decided by Delhi High Court within jurisdiction of Delhi IPO falls.

Before introduction of the 2016 amendment rules, the picture was unclear as practices of different high courts were different and much was dependent on the discretion of the controller.  Now with the 2016 amendment of rule 138 of the Patent Rules, 2016, possible of extension of 31 months time period has been expressly barred. Rule 138 gives list of timelines in case which, extension cannot be sought. Before amendment, this section was not listing period of 31 months time period as one the non-extendible timelines but now includes the same.

With this change, applicant and their agents are required to docket the applications with more care.

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

Choosing India as International Search Authority (ISA) and International Preliminary Examining Authority (IPEA): Who Can and Who Cannot

It is long since October 15th, 2013, that India started to work as International Search Authority (ISA) and International Preliminary Examining Authority (IPEA).  Agreement between the Indian Patent Office (IPO) and the International Bureau (IB) of the World Intellectual Property Organization (WIPO) in respect of the same can be accessed here. With the introduction of Patent (Amendment) Rules, 2016, that took effect from May 16, 2016, India has brought in provision for Expedited Examination of Patent applications for which request may be made on any of the following grounds, namely:-

 (a) that India has been indicated as the competent ISA or elected as an IPEA in the corresponding international application; or

(b) that the applicant is a startup.

So as to better understand the eligibility to request for expedited examination, it is important to understand which states can choose India as competent ISA and IPEA. In the above referred agreement, article 3 that deals with Competence of Authority makes it clear that the India shall act as ISA and IPEA for any international application filed with the receiving Office of, or acting for, any Contracting State specified in Annex A provided other requirements are fulfilled. Annex A states that India; and any State that the India will specify can choose India as competent ISA and IPEA. As India has not specified any other state than India that can choose India as ISA and IPEA, as on now India is the only state with the receiving Office of, or acting for which international application may be filed in order to select India as competent ISA and IPEA.

So as per the existing scenario, for Indian Applicants, any of the Austrian Patent Office (AT), Australian Patent Office (AU), European Patent Office (EP), China Intellectual Property Office (CN), United States Patent & Trademark Office (US), Swedish Patent Office (SE) and India (IN) can be chosen as competent ISAs and IPEAs but India can be chosen as ISA and IPEA only for international applications filed with the receiving Office of, or acting for India.

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

Federal Circuit Rules 180-Day Post-Licensure Notice is Mandatory in Biosimilar Litigation

In Amgen v. Apotex (No. 2016-1308), the US Court of Appeals for the Federal Circuit on July 5, 2016 affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing of a biosimilar product begins, regardless of whether the applicant provided the § 262(l)(2)(A) notice of USFDA review.

            In Amgen v. Apotex, the Federal Circuit rejected Apotex’s contention that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” procedure of the Biologics Price Competition and Innovation Act (“BPCIA”), expanding on its decision in Amgen v. Sandoz that the 180 days notice provision under § 262(l)(8)(A) is mandatory in all circumstances, whether or not the applicant engages in the patent dance.


            The biologic product at issue is Amgen’s Neulasta® (pegfilgrastim). Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. Pegfilgrastim treatment that can help patients make white blood cells after receiving cancer treatment. After Apotex filed a Biologic License Application (BLA) seeking FDA approval to market a biosimilar version of Neulasta® (pegfilgrastim), the parties began the BPCIA’s patent information exchange process, known as the “patent dance”, and as a result, Amgen concluded that two patents U.S. Patent Nos. 8,952,138 and 5,824,784 will be infringed by Apotex’s biosimilar version of Neulasta®. Those infringement claims are being litigated in the U.S. District Court for the Southern District of Florida, although the ‘784 patent has been dropped since it expired.

            Apotex sent Amgen a letter on April 17, 2015, stating that it was “providing notice of future commercial marketing pursuant to § 262(l)(8)(A), though Apotex lacked an FDA license.” Amgen sought a preliminary injunction to “require Apotex to provide … notice if and when it receives a marketing license from FDA and to delay any commercial marketing for 180 days from that notice.” The district court granted that motion, citing the Federal Circuit’s decision in Amgen v. Sandoz that notice cannot be given before the biosimilar product is approved. Apotex appealed.

What is Biosimilar Patent Dance:

            The US Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called “Patent Dance” which describes the process by which the biosimilar applicant and the reference product sponsor (“RPS”) exchange patent-related information for resolving any patent disputes before a biosimilar product can enter the US market.  This procedure has strict timing and sequencing requirements and involves several rounds of information exchanges between the reference product sponsor and the biosimilar applicant. Some of the key steps of this process include:

  • Within 20 days after the FDA has accepted its abbreviated application, the biosimilar applicant must provide the reference product sponsor with confidential access to the biosimilar application and relevant manufacturing information for the proposed biologic.
  • Within 60 days of receiving these materials, the reference product sponsor must provide to the biosimilar applicant: (1) a list of patents it believes are infringed, and (2) identify which, if any, of these patents it would be willing to license to the biosimilar applicant.
  • Within 60 days of receipt of the patent list, the biosimilar applicant must provide the reference product sponsor a statement describing, on a claim-by-claim basis, the factual and legal basis as to why each patent is invalid, unenforceable, and/or not infringed. Within this same 60 day period, the biosimilar applicant may provide to the reference product sponsor a counter list of patents that the biosimilar applicant believes could be subject to a claim of patent infringement.
  • Within 60 days of receiving these materials, the reference product sponsor must provide a reciprocal statement describing, on a claim-by-claim basis, the factual and legal basis that each patent will be infringed, as well as a response to any statement regarding validity and enforceability.
  • The parties then have up to 15 days to negotiate in good faith to arrive at a list of patents, if any, that should be subject to a patent infringement action.

– If the parties reach agreement, then the reference product sponsor must bring an infringement action within 30 days for each patent on the negotiated list.

– If the parties do not reach agreement, the biosimilar applicant must notify the reference product sponsor of the number of patents it will provide in a second list, and the parties then simultaneously exchange within 5 days of this notice a list of patents that each party believes should be the subject of the infringement litigation. Within 30 days after this exchange, the reference product sponsor must bring an infringement action on all the patents on the simultaneously exchanged lists.

The Federal Circuit’s decision in the Amgen v. Apotex case:

            Two provisions of the BPCIA were at play in the Federal Circuit’s decision.  First, under § 262(l)(2)(A), the biosimilar applicant initiates the statutory “patent dance” by providing a copy of its biosimilar application and information about how its product is manufactured.  Second, under § 262(l)(8)(A), the applicant must provide a notice to the innovator 180 days before the first commercial marketing of the biosimilar product.

            In Amgen v. Apotex, Apotex argued that it had followed the patent dance procedure and made its (2)(A) disclosures to Amgen, and that the (8)(A) notice of commercial marketing is only mandatory if the applicant failed to provide the information required by (2)(A).

            The Federal Circuit rejected this argument and upheld the district court’s grant of an injunction to Amgen.  The court held that (8)(A) is mandatory in all circumstances, whether or not the applicant engages in the patent dance.

            The Federal Circuit looked to the text of the law, finding that the “language of (8)(A) is categorical”, and there is “no other statutory language that effectively compels a treatment of (8)(A) as non-mandatory.”  The court further noted that § 262(l)(8)(A) “contains no words that make the applicability of its notice rule turn on whether the applicant took the earlier step of giving the § 262(l)](2)(A) notice that begins the patent dance (i.e. information-exchange) process,” and stood by its holding in Amgen v. Sandoz that the statute is “‘a standalone notice provision’ not dependent on the information-exchange processes that begin with (2)(A).” The court held that “the (8)(A) notice must be a notice given after FDA licensure of the biosimilar product, not before, and that pre-licensure notices are of no legal effect for purposes of (8)(A)”. The court explained that the 180 days period gives the reference product sponsor a period of time to assess and act upon its patent rights.

            In sum, the Federal Circuit concluded that a biosimilar applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.

The Federal Circuit’s order can be found at the following link:


About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: antony@khuranaandkhurana.com.


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