Tag Archives: patents

Growing efficiency of Patent Prosecution in India – Comparative Study (2015 through 2017)

Patents have been a very functional and important aspect of Intellectual Property Rights (IPRs). They are also one of the oldest laws of IPR that have been prevalent in India since 1856. However, after lot of repeals and amendments, the final draft was introduced as Patent Act, 1970, which came into force in 1972. This Act and Patent Rules also went through a lot of amendments, the last amendment being in March -2016, in furtherance to the establishment of the National IPR policy.

One key objective of these developments in the IPR field has been to increase and strengthen the IPR laws, and also to enhance the procedure of Patent registration. However, these changes and amendments have not only given incentives to the inventors to get their works patented, but have also built up their faith in the administrative bodies (Patent office) that are involved in the grant/issuance of Patents.

As is known, the Indian Patent Office is spread over four locations, namely Delhi, Mumbai, Kolkata and Chennai that administer the laws concerning protection of inventions in the country by way of grant of exclusive rights in the form of Patents to the Applicants for a limited period.

Following are the charts of the First Examination Reports (FERs) that have been issued in the year 2015, 2016 and 2017.

graph1

 Fig 1: FER issued in 2015 against each category

graph2

Fig 2: FER issued in 2016 against each category

graph3

Fig.3: FER issued in 2017 against each category

graph4

Fig.4: Comparative graph showing FER issued during three years

By perusing the above graphs, it is quite evident that the offices have largely worked at par in the year 2015 and 2016. However, in the year 2017, Patent offices have shown considerable surge in the issuing of examination reports when compared to previous years. Therefore, it can be safely inferred that the recent amendments and developments in the Indian Patent laws have brought about a positive change in functioning of the Patent prosecution, thereby building trust and faith of the inventors as well as of Applicants who file their Patent Applications in India, thereby complying with the National IPR policy.

 

NUMBERS OF FERs ISSUED IN EACH PATENT CATEGORY (MONTHLY)

EVALUATION OF THE YEAR – 2015

graph5

Fig. 5 : Number of FERs issued in Electrical/Electronics Domain in 2015

graph6

Fig.6:  Number of FERs issued in Biotechnology Domain in 2015

graph7

Fig. 7: Number of FERs issued in Chemistry Domain in 2015

graph8

Fig. 8: Number of FERs issued in Mechanical Domain in 2015

 

EVALUATION OF THE YEAR – 2016

graph9

Fig. 9: Number of FERs issued in Electrical/Electronics Domain in 2016

graph10

Fig. 10: Number of FERs issued in Biotechnology Domain in 2016

graph11

Fig. 11: Number of FERs issued in Chemistry Domain in 2016

graph12

Fig. 12: Number of FERs issued in Mechanical Domain in 2016

 

EVALUATION OF THE YEAR – 2017

graph13

Fig. 13: Number of FERs issued in Electrical/Electronics Domain in 2017

graph14

Fig. 14: Number of FERs issued in Biotechnology Domain in 2017

graph15

Fig. 15: Number of FERs issued in Chemistry Domain in 2017

graph16

Fig. 16: Number of FERs issued in Mechanical Domain in 2017

As would be appreciated from the above charts, the number of FERs issued in 2015 in each category of patents i.e. electronics, Mechanical, Chemistry and Biotechnology as shown in Figs.5-8 is less than 500 Applications in each month, which is very low, considering that there are Four Patent Offices in India taking care of the geographical extent of the country. The graphs in Figs. 9-12 depict FERs issued in 2016, which shows moderate increase in the number of FERs being issued compared to 2015. It is pertinent to note that in the period of January to March 2017, the Offices showed the same performance as that of 2016. There were very few issuances of FERs in the month of April and May 2017 in all the four categories, probably due to implementation of the new Amended Patent Rules. However, the period from June to December 2017 has shown a huge rise in the number of Applications that has been examined by respective Patent Offices. The graphs, as provided in Figs. 13-16 show a considerable growth in the issuance of FERs as compared to the previous years. However, the efficiency of Delhi Patent Office and Chennai Patent Office has not increased significantly and these two offices seem to be largely consistent. The Mumbai Patent Office and the Kolkata Patent Office are positive examples of how the Patent Rule amendments have enhanced the competitiveness with respect to swift issuance of FERs.

 

        CONCISE COMPARISON OF ISSUANCE OF FERs in 2015, 2016 AND 2017

 

Group
2015
2016
2017
Electrical
7186
7179
19734
Biotechnology
1498
1512
4179
Chemistry
6563
5116
15088
Mechanical
4338
5406
12888
Total
19,585
19,213
51,889


graph17

In the year 2017, 51,889 Examination Reports have been issued, while in the year 2016 and 2015, 19,213 and 19,585 FERs were issued, respectively. Therefore, the Patent Offices have demonstrated more than 2.5 times improvement in its competitiveness in a single year.

 

GRANTED PATENT

graph19

Fig. 17: number of patents granted in biotechnological domain

graph20

Fig. 18: number of patents granted in Electrical domain

graph21

Fig. 19: number of patents granted in Mechanical domain

graph22

Fig. 20: number of patents granted in Chemistry domain

By looking at fig. 17, it can be observed, with respect to the Biotechnological domain, that in the year 2015, IPO has only granted 174 patent applications, whereas 2016 witnessed a growth of about 50%, which makes it issuance (grant) of 264 patents. But IPO showed tremendous growth in granting patent to 486 applications in the year 2017.

Fig. 18 depicts number of Patents granted in 2015, 2016 and 2017 in respect of Electrical Domain, which shows that Patents granted in the year 2015 and 2016 were at par with a little variance in number of granted Patents, which was 350 and 381, respectively. It is evident from the graph that the number of Patents granted in the year 2017 is twice of what was granted in the previous years, i.e. 652 applications.

Number of Patents granted in 2015, 2016 and 2017 in Mechanical domain has been provided in fig. 19. It is pertinent to note that IPO in the year 2017 has granted 2091 Patents which is 42% and 44% more than Patent granted in the year 2015 and 2016 respectively.

Further, Fig. 20 shows the number of Patent granted in the span of three years in the field of Chemistry, which clearly shows a progressive growth of the work of IPO from the year 2015 to the year 2017. It can be observed that IPO only granted Patents to 1176 applications in 2015, which increased to 1932 applications in the year 2016 and lastly IPO raised its bar to grant Patent to 2643 applications in 2017.

graph23

Fig.17 to 20-show number of Patents granted in 2015 to 2017 in each categories i.e. Biotechnological, Mechanical, Electrical and Chemistry. It can be observed that among all the three years, the number of patents issued was lowest in year 2015 followed by year 2016. Moreover, year 2017 has witnessed highest number of Patents that has been granted. This progressive growth of IPO in granting Patent hints towards a better and successful future in the field of invention and would be a strong incentive for inventors as well as foreign investors to invent and invest in India.

Author: Pratistha Sinha, Trademark Associate at  Khurana&Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at pratistha@iiprd.com.

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An Article On Shamnad Basheer V. Union Of India And Ors.

It is common to witness infringement cases in the intellectual property law sector but rarely there are suits which point out to the defects in the system managing the grant and working of patents, trademarks or other intellectual property rights.

In the case of Shamnad Basheer v. Union of India and Others[1], a writ-petition was filed against the defaulting patentees as well as the Patent Office as both of them were not complying with the statutory requirements.

Facts leading to the case

Section 83 (g) of the Patents Act, 1970 clearly mentions that “patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public”.

To fulfil such an object, Section 146 of the abovementioned Act specifies that a periodical statement as to the extent to which the patented invention has been worked on a commercial scale in India has to be submitted by every patentee as well as licensee. The Controller has the power under the same section to order any patentee (or licensee) to do the same.

But the real scenario seems to be very different as was pointed out by Professor (Dr.) Shamnad Basheer (the Petitioner in the case) through a number of arguments and evidences that neither the ‘commercial working statement’ has been submitted by many Patentees nor any action is taken against them by the Controller of Patents.

Issue

    1. Manifest failure to comply with Section 146 of the Patents Act, 1970 as well as no action initiated under Section 122 of the same Act against the patentees who did not follow the procedure mentioned under Rule 131[2] of the Patent Rules, 2003.

 

  1. Whether information provided under section 146 of the said Act “Confidential” nature of licensees and sub-licensees.

Arguments by the Petitioner

    • Annual Report (2012-13) of the Office of the Controller General of Patents, Designs, Trademarks and Geographical Indications clearly indicated that out of 43920 patents granted in the year 2012-13, only 27946 of them submitted Forms (Form-27) as required by Section 146 and Rule 131 (mentioned above). The fact that only 6201 patents out of them were found to be commercially working in the territory of India shows that neither the Patent Office nor the patentees consider following the general principles of law.

 

    • Furthermore, the Petitioner presented a query as was raised in front of the Patent office under Right to Information Act (RTI), 2005 which was basically an inquiry as to whether any action was taken against those Patentees or licensees who did not submit the Form-27? The answer was in negative indicating that no action had been taken against the defaulters.

 

    • An interesting point that was further raised was that when NATCO Pharma was granted compulsory license (in relation to a patent numbered 215758 o 9th March, 2012), it was ordered to report accounts of sales to the Controller on a quarterly basis, on or prior to the 15th of each succeeding month but when a query related to the same was raised before the Controller General of Patents, Designs, Trademarks and Geographical Indications on 19th January, 2015, no details were available in the concerned office.

 

    • Furthermore, it was informed to the Petitioner by the Controller of Patents and Designs that Form-27 is filed by Patentees only and many Patentee such as M/s Telefonaktiebolaget LM Ericsson state in the column wherein they are required to furnish information regarding licensees that “As all the licenses are confidential in nature, the details pertaining to the same shall be provided under specific directions from the Patent Office.”

 

Court’s Order

According to the Delhi High Court the information regarding licensees (and sub-licensees) cannot be termed as confidential as all information regarding the grant of patent is already available on the website of the Patents Office and failure to disclose such information by the Patentees would mean non-compliance with the requirements of Section 146 of the Patents Act, 1970 and thus, making such patentees liable for action.

Furthermore, It is pertinent to point out that the Delhi High Court had opined on 10.01.2018 that no information that is required to be filled in Form 27 is ‘confidential’. This was negated on 07.02.2018 stating that information cannot be held ‘not confidential’ as it would be voilative of section 146.

The case has been pending in the Court since 2015 and the Court has directed the Patent Office to provide a proposed modified Form27. Few of the recommendation have also been sent by stakeholders. (read here)

Observation

The systematic failure is a topic seldom touched upon in India as already mentioned in the beginning of the article. The fact being that the internal process of an institution is not thoroughly monitored due to which the persons availing facilities get a way to skip the statutory requirements as laid down by the legislature. Hence, it has become all the more important that people should be made aware that they have certain duties related to the rights they receive from an institution and non-compliance with such duties entails action against them.

One such institution is the Patent Office(s) which grants Patent. The basic purpose of granting a Patent is not to provide exclusive rights to the Patentee over his invention but to ensure that the invention is commercialized for the welfare of the public at large. Hence, submission of ‘commercial working document’ as mandated by the Patents Act, 1970  should not be ignored either by the Patent office or by the Patentee otherwise the whole concept of grant and protection of an invention would come down to nothing.

This case was a progressive step taken to ensure that the common man as well as the institutions understand their responsibility in a field (that is, Intellectual Property Rights) which is in its budding stage in India.

Author: Priya,  intern at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at swapnils@khuranaandkhurana.com.

References:

[1] W.P.(C) 5590/2015.

[2] Form and manner in which statements required under Section 146(2) to be furnished.

Patent Landscapes: An Effective Tool for Business and IP Strategy

A Patent landscape is a conglomerate of patent information that provides the most up to date analysis of – who is patenting in any chosen area of technology, what is the innovative focus of companies, businesses and nations; how has a particular technology evolved over a period of time, what has been the filing history and strategies of technology leaders, and of many other pertinent aspects, particularly targeted to direct business benefits.In a complete patent landscape analysis, patent assets(including granted patents, published applications, and unpublished applications) are mapped and analyzed from which important legal, business, and technology information can be derived.

Information derived from a patent landscape analysis is applied within an organization to generate novel technology, to identify possible companies or technologies to license or acquire, to identify orphan patents and thus opportunities for monetization, to design around others’ technology to evade litigation, or to strategically direct research and development toward the open spaces in the patent landscape and steer clear of tracts that are already hemmed-in by densely competing patent activity.

Appropriate approaches are employed to present data to the client in an effective manner such that the client is enabled to ascertain areas of interest quickly and get clear visibility as to which patents are owned by the client, its competitors and other parties. One common approach of presenting data is to organize whole of the data in a spreadsheet, with an area of interest to the client being marked as flagged record.A detailed and non-overlapping hierarchical representation of technology gives an added benefit and clarity to the client. Inclusion of non-patent data and market research is also critical to a comprehensive patent landscape to provide context to the presented patent data.

Top assignee and inventor trendsrender insight into which large companies, startups, universities, and others are most focused in each technology, product, or application area. This information comes in handy to identify potential partners, customers, licensees, and acquisition candidates.Details associated with mergers and acquisitions prove to be a vital piece of information for client as technology transfer and strategic alliances often result from the information covered under sections of mergers and acquisitions.

Patent claims in each technology, product, or market area can be examined and mapped against products for legal analysis pertaining to validity, patentability, or freedom to operate.Effective patent landscape maps or pictorial representations can be analyzed for research, discovery and “white space” opportunities. These graphic visualizations can also be useful for communication and marketing tools – especially to non-patent experts and investors.

A patent landscape can serve an excellent tool for the client, only if it closely addresses the issues important for the client’s business or IP strategy. The landscape should be of adequate granularity to be valuable. A good patent landscape study must always aim to capture the right kind of information and draw out insights from the analyzed information while keeping the end objective of the client as the base.

About the author: Tanu Goyal, Patent Associate at IIPRD and can be reached at: tanu@khuranaandkhurana.com

United States district court upholds the validity of two Horizon Pharma patents covering VIMOVO®

Horizon Pharma plc, an Irish specialty biopharmaceutical company, on 27 June 2017, reported that the United States district court for the district of New Jersey upheld the validity of two Horizon Pharma patents covering VIMOVO®, a pain relief treatment for arthritis patients, and that the ANDA applicants viz. Lupin Limited, Dr. Reddy’s Laboratories and Mylan Inc. would infringe at least one of the two patents with their proposed generic version of VIMOVO®.

What is VIMOVO®?

            VIMOVO® is a fixed dose combination of naproxen, a nonsteroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium, a proton pump inhibitor (PPI). VIMOVO is used to relieve signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing stomach (gastric) ulcers in people who are at risk of developing gastric ulcers with NSAIDs.

            The two Horizon Pharma patents which cover VIMOVO® and have now been upheld as valid by the US district court are:

  1. US6926907B2 – expires in February 2023. The US’907 patent claims a pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of an acid inhibitor and a non-steroidal anti-inflammatory drug (NSAID), which unit dosage form provides for coordinated release of the acid inhibitor and the NSAID.
  2. US8557285B2 – expires in May 2022. The US’285 patent claims a pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of: (a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating; and (b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher; wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium.

            On April 21, 2011, July 25, 2011, and June 28, 2013, Horizon Pharma filed patent infringement lawsuits at the New Jersey District Court against Lupin Limited, Dr. Reddy’s Laboratories and Mylan Inc., seeking adjudication for patent infringement by these companies of one or more claims of the US‘907 and US’285 Patents. The infringement lawsuit came after these companies filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (FDA) seeking regulatory approval to market a generic version of VIMOVO before the expiration of the US‘907 patent in February 2023 and the US’285 patent in May 2022. At trial, the ANDA applicants alleged that the claims of the US‘907 and US’285 patents, listed in the Orange Book for VIMOVO were invalid.

            The announcement from Horizon Pharma came on the same day the U.S. district court for the district of New Jersey ruled in favor of Horizon Pharma and upheld the validity and enforceability of the patents at issue. Horizon Pharma says the outcome of the infringement lawsuit will prevent the launch of generic VIMOVO, which is being developed by Indian drug makers Lupin Limited and Dr. Reddy’s Laboratories as well as American generic drug maker Mylan Inc., in the United States.

Compulsory licensing

Compulsory licenses are sovereign state authorizations which enable a third party to make, use, or sell a patented product without the consent of the patent holder. Provisions pertaining to compulsory licensing are provided for under both the Indian Patent Act, 1970, as well as the international legal agreement between all the member nations of WTO – the TRIPS. In India, Chapter XVI of the Indian Patent Act, 1970 deals with compulsory licensing while the conditions which need to be fulfilled for the grant of a compulsory license are laid down under Sections 84 and 92 of the Act.

In accordance with Section 84(1) of the Indian Patent Act, 1970, after three years from the grant of a patent, any interested person may make an application for a compulsory license on the grounds that the patented invention:

(a) Does not satisfy the reasonable requirements of the public;

(b) Is not available to the public at a reasonably affordable price; and

(c) Is not worked in the territory of India.

In addition to the aforementioned grounds, according to Section 92 of the Act, compulsory licenses can also be issued suo motu by the Controller of Patents pursuant to a notification issued by the Central Government if there is either a “national emergency” or “extreme urgency” or in cases of “public non-commercial use”. The said section enables the Government of India to notify to the public of such extreme circumstances, whereupon, any person interested can apply for a compulsory license and the Controller in such case may grant to the applicant a license over the patent on such terms and conditions as he thinks fit.

The patentee, however, has the right to be heard in the compulsory licensing application process.

India’s first ever compulsory license was granted by the Patent Office on March 9, 2012, to Hyderabad-based Natco Pharma for the production of generic version of Bayer’s Nexavar, an anti-cancer agent used in the treatment of liver and kidney cancer. It was established in the Bayer vs Natco case that only 2% of the cancer patient population had an easy access to the drug and that the drug was being sold by Bayer at an exorbitant price of 2.8 lakh INR for a month’s treatment[1]. Further, on the ground that Nexavar was being imported within the territory of India, the Indian Patent Office issued a compulsory license to Natco Pharma, which assured that the tablets would be sold for Rs. 8,880/- per month. It was settled that 6% of the net sales of the drug would be paid to Bayer by Natco Pharma as royalty.

In the second case of Compulsory licensing in India, the Controller rejected BDR Pharmaceuticals’ application for compulsory license (made on March 4, 2013) for BMS cancer drug, SPRYCEL[2]. The Controller rejected the compulsory license application made by BDR for stating that BDR has failed to make prima facie case for the making of an order under section 87 of the Act. Controller in the said case observed that BDR Pharmaceuticals had not made any credible attempt to procure a voluntary license from the Patent holder and the applicant has also not acquired the ability to work the invention to the public advantage.

In the most recent case of compulsory licensing in India, Lee Pharma, a Hyderabad based Indian pharma company, filed an application for compulsory license (dated 29.06.2015) for the patent covering AstraZeneca’s diabetes management drug Saxagliptin. In order to make a prima facie case, Lee Pharma strived to show that their negotiations for a voluntary license with the patent owner were not rewarding as they did not receive any response from the Patent owner within a reasonable period. The grounds alleged by Lee Pharma were that:

  • the patentee has failed to meet the reasonable requirements of the public,
  • the patented invention is not available to the public at a reasonably affordable price, and
  • the patented invention is not worked in India.

However, all the three grounds of Lee Pharma were rejected by the Controller General and the Compulsory license application was refused[3]. The application was rejected on the basis that Lee Pharma failed to demonstrate what the reasonable requirement of the public was with respect to Saxagliptin and further failed to demonstrate the comparative requirement of the drug Saxagliptin vis-a-vis other drugs which are also DPP-4 inhibitors. Further, Controller General held that all the DPP-4 inhibitors were in the same price bracket and the allegation that Saxagliptin alone was being sold at an unaffordable price was unjustified. The Controller General also stated that Lee Pharma failed to show the exact number of patients being prescribed the patented drug and how many of them were unable to obtain it due to its non-availability and consequently it was difficult to hold whether manufacturing in India was necessary or not.

Considering the last two compulsory license cases in India, it is clear that the provisions of compulsory license cannot be misemployed to diminish the rights of the patent holders and that the basic jurisprudence governing the subject of compulsory license lies in balancing the conflicting interest of the patentee’s exclusive rights and making the invention available at an affordable price to third parties in case of need.

About the author: Tanu Goyal, Patent Associate at IIPRD and can be reached at: tanu@khuranaandkhurana.com

[1] http://thefirm.moneycontrol.com/story_page.php?autono=1132015

[2]https://iiprd.wordpress.com/2013/11/13/indian-patent-office-rejects-compulsory-licensing-application-bdr-pharmaceuticals-pvt-ltd-vs-bristol-myers-squibb/

[3] http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/india-rejects-compulsory-license-application-of-lee-pharma-against-astrazenecas-saxagliptin/articleshow/50652935.cms

Cambodia’s Intellectual Property

What is new in store for Cambodia’s Intellectual Property?

 

There are some recent developments in Cambodia as far as the IP of the country is concerned [1]. Out of these developments two of them have been major.

 

The first amendment came into existence on November 25th2016 [2]. The change was that the Cambodian kingdom Government to the Geneva (1999) Act submitted its instrument of Accession related to the Hague Agreement which is concerned with the global Registration of Industrial Designs [3].The above mentioned Geneva (1999) Act became effective on February 25th 2017 in Cambodia and enables the Hague System users to assign Cambodia in an application of international design.

 

The second amendment came into existence on January 23rd 2017[4] when Cambodia signed an agreement of validation with the European Patent Organization (EPO) and became the first country in Asia to do so. This change will be effective once it is incorporated and adopted into the law of kingdom of Cambodia, possibly by July 1st 2017. Based on this amendment, the European Patent applicants will be able to submit in future a request for validation in the kingdom of Cambodia, where the European Patent will have the same value and effect as a Cambodian national patent application and will be subjected to national law. The 2 major amendments discussed above will now be discussed in more detail below.

 

  1. Cambodia Following the Hague System

After submitting its instrument of Accession related to The Hague Agreement by the Cambodian kingdom Government to the Geneva (1999) Act, Cambodia is now a part of Hague system. This enables the Hague System users to assign Cambodia in an application of international design. The 1999 Act came into effect in Cambodia on February 25th 2017. Just like the Madrid protocol for trademarks, this system enables the applicants for obtaining multiple registrations on the basis of one single International application filed with World Intellectual Property Organization (WIPO) [5].

There are few other South-East Asian countries other than Cambodia which are a part of the Hague convention which includes inter alia Brunei and Singapore [6]. This move by Cambodian government has and in future will motivate other nations to also become a part of the Hague convention; as such a step is an economy booster for the participant country.

 

  1. Cambodia-EPO Validation Agreement

History was made on January 25th 2017, when the kingdom of Cambodia became the first Asian nation to sign an agreement of validation with the Patent Organization of Europe (EPO). This agreement will be effective possibly from July 1st 2017 as mentioned above and will be a part of Cambodian law. There are 38 European countries (“member states”) which are member of the EPO till date [7]. The EPO was set up for facilitating the members with a single procedure for granting of patents. There are, from 2010, some non-member nations with which the EPO has signed agreements of validation. These non-members are Tunisia, Republic of Moldova, Morocco, and now Cambodia. According to this agreement, once an applicant for a patent with WPO submits a request for validation in each or one of the chosen validation countries, the patent application can be extended to these validation states. In these validation states the European Patent will have the same value and effect as a national patent application and will be subjected to national law. Such a step by the Cambodian government will allow a boost in the businesses.

About the Author :Shilpi Saxena, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys. Can be reached at abhijeet@khuranaandkhurana.com

References

[1] WATANABE. “Trends in Development and Issues Related to IP Systems in Three GMS Countries: Cambodia, Lao PDR and Thailand.” Trends in Development and Issues Related to IP Systems in Three GMS Countries: (n.d.): n. pag. InndsstIintUDteevEolofPImnetnetrAnnadtIisosnuaeslRReelaltaetdiOtonIsPASnysdtEAmrse Ian TShtrueedGieMs,S R Ciotusnutrmiees􀊢ikWanATAUNAnBiEv􀊣ersi9t5, 2011.

[2] “Cambodia Joins the Hague System.” WIPO – World Intellectual Property Organization.Wipo, 25 Nov. 2016.

[3] “The Hague Notification No. 131 Hague Agreement Concerning the International Registration of Industrial Designs Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs.” TREATY/HAGUE/131: [Hague Agreement] Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs | Accession by the Kingdom of Cambodia. WIPO, 25 Nov. 2016.

[4] Office, European Patent. “Cambodia First Asian Country to Recognise European Patents on Its Territory.” EPO – Cambodia First Asian Country to Recognise European Patents on Its Territory. EPO, 23 Jan. 2017.

[5]”Hague – The International Design System.” WIPO – World Intellectual Property Organization.WIPO, n.d.

[6] “WIPO Singapore Office.” WIPO – World Intellectual Property Organization.WIPO, n.d.

[7]”European Patent Convention.” Wikipedia. Wikimedia Foundation, 31 May 2017.

 

 

Expedited examination and non-expedited (normal) examination: Who can file request for examination?

With effect from May 16, 2016 (effective date for Patent (amendment) rules, 2016), provision of expedited examination was introduced in the Patent system of India. This article does not intend to discuss the different timelines within which request for examination has to be filed in different situations, rather article is restricted to the eligibility of person who can file such requests. Specifically, article intends to highlight the difference between person who is eligible for non-expedited examination and expedited examination.

Section 11B (1) of the Patent Act, 1970 provides that no application for a patent shall be examined unless the applicant or any other interested person makes a request in the prescribed manner for such examination within the prescribed period.

According to section 2 (t), interested person is defined as including a person engaged in, or in promoting, research in the same field as that to which the invention relates.

Rule 24 (B) and rule 24 (C) provide procedures for the non-expedited (normal) examination and expedited examination respectively.

Rule 24 (B) (3) provides that  applicant as well any interested person can request for non-expedited examination, however in latter case, only intimation is given to such interested person, and examination report is shared with the applicant only.

Rule 24 (C)(1) deals with eligibility of person who can request for non-expedited examination.

Rule 24 (C)(1):

An applicant may file a request for expedited examination in Form 18A along with the fee as specified in the first schedule only by electronic transmission duly authenticated within the period prescribed in rule 24B on any of the following grounds, namely:-

(a) that India has been indicated as the competent International Searching Authority or elected as an

International Preliminary Examining Authority in the corresponding international application; or

(b) that the applicant is a startup.

Rule 24 (C)(2) provides for conversion of non-expedited examination to expedited examination.

Rule 24 (C)(2):

A request for examination filed under rule 24B may be converted to a request for expedited examination under sub-rule (1) of rule 24C by paying the relevant fees and submitting requisite documents as required under sub-rule (1). (Emphasis added).

As seen in section 11 (B)(1), there is no categorical difference provided in the eligibility to request for expedited and non-expedited examination (that interested person cannot request for expedited examination). But there is no parallel sub-rule as like 24 (B)(3) in rule 24 (C) and also rule 24 (C)(1) also puts restriction of applicant.

However, what if interested person submits documents available in the public domain to convert a non-expedited examination to expedited examination (by paying the required fees)? Though it is not categorically given that it cannot be done, language of 24 (C)(1) which restricts eligibility to applicant and absence of parallel provision as like 24 (B)(3) in rule 24 (C)indicates that interested person cannot convert non-expedited examination to expedited examination even after paying fees and submitting documents available in public domain that a particular applicant is eligible for expedited examination.

However it would be interesting to see if Indian Patent Office (IPO) faces such question and how it tackles the same.

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

NEPAL’S IP LAW: AN ENCAPSULATION

Intellectual property law in Nepal is comparatively new and it enjoys the extension provided for under the TRIPS agreement to the least developed country. The Patents, Designs and Trademarks are protected under one head, and the governing act/ legislation is known as “The Patent, Design and Trade Mark Act, 2022 (1965)” (hereinafter referred to as “Act”).

Trademarks

Section 2: Definitions: Unless the subject or the context otherwise requires in this Act:

“Trade-mark” means word, symbol, or picture or a combination thereof to be used by any firm, company or individual in its products or services to distinguish them with the product or services of others.

FILING PROCEDURE:

Step 1: Filing

  • Who may apply: Section 17:
  • Any person desirous to register the trademark of his business shall submit an application to the Department in the format specified in Schedule 1(C).
  • Document: Four specimens of the Trade Mark sought to be registered.
  • Fees: NPR 2000.

Trademark Application in Nepal can be filed in a single class only. Mutli-class Application cannot be filed.

Step 2: Investigation:

  • Section 18: When an application is received by the department, it conducts necessary investigation/examination and provides an opportunity of being heard to the applicant in case of any concerns/objections.
  • Examination is done with regard to distinctiveness, possibility of distinctiveness and conflicting trademarks.

Step 3: Grant/ Refusal:

  • If the department is satisfied with the application for registration, it shall register the trademark in the name of the applicant and grant him a certificate. Registration fees: NPR 5000.
  • It may conduct further inquiry/ investigation.
  • The mark shall not be registered/ registration is liable to be cancelled when the subject mark:
  • Hurt the prestige of individual/ institution
  • Adversely affect public conduct or morality
  • Undermine the national interest
  • Undermine the reputation of another’s trademark
  • Found to have already been registered in the name of another person.
  • If the registered trademark is not used within 1 year from the date of registration, the department may cancel the registration after conducting necessary inquiries.
  • The term of the registered trademark shall be 7 years from the date of registration.

Step 4: Publication:

  • Section 21A: The department shall publish the trademarks registered under section 18. Such publication is made in the Trademark Journal.
  • Anyone who has any objection to the same shall file a complaint to the department within 3 months from the date of such publication in Trademark Journal.
  • Necessary actions shall be taken by the department after conducting inquiries.

Step 5: Renewal and Cancellation

  • Renewal: Section 23B:
  • A trademark holder needs to renew the registration within a period of 35 days from the date of expiration of the term for which he is entitled to use the same.
  • The prescribed form is Schedule 2(F) and the fee is NPR 500 each time.
  • When the time limit of renewal expires, renewal may be done within 6 months from the date of expiry of the time limit for the same along with a fee of NPR 1000.
  • A trademark can be renewed indefinitely for a period of 7 years each time after a payment of renewal fee.

 

Patents

Section 2: “Patent” means any useful invention relating to a new method of process or manufacture, operation or transmission of any material or a combination of materials, or that made on the basis of a new theory or formula.

FILING PROCEDURE:

Step 1: Filing:

  • Who may apply: Section 3 and 4:
  • Any person desirous of having any patent registered in his name shall submit an application to the Department in the format prescribed in Schedule 1(A) containing the following particulars, along with all evidences related to the same in his possession:
  • Name, address and occupation of the inventor (person inventing the patentable subject matter)
  • If the applicant is not the inventor, then information as to how and in what manner has he acquired title thereto from the inventor
  • Process of manufacturing, operating or using the patent
  • If the patent is based on any theory or formula, then the same needs to be mentioned.
  • Maps or drawings, if any.
  • Application fees: NPR 2000

Step 2: Investigation:

  • Section 5: On receipt of an application for registration, the Department shall conduct all investigation or study to ascertain two things:

(a)  Whether the patent claimed in the application is a new invention or not

(b)  Whether it is useful to the general public or not.

 

  • Section 6: The Department shall not register any patent under this Act in the following circumstances:

(a) In case the patent is already registered in the name of any other person, or

(b) In case the applicant him/herself is not the inventor of the patent sought to be so registered nor has acquired rights over it from the original inventor, or

(c) In case the patent sought to be registered is likely to adversely effect the public health, conduct or morality or the national interest, or

(d) In case it is contradictory to the prevailing laws (the registration of the patent) will constitute a contravention of existing Nepal law.

The Examination/Investigation is of two kinds namely;

  1. Formality Examination- It is done to determine whether the application for patent fulfills the requirements of the same.
  2. Substantive Examination- It is done to determine the patentability of the invention, whether;

–  The claimed product/process is patentable or not.

–  The claimed invention is new i.e passes the test of Novelty.

–  The claimed invention is capable of Industrial Application.

– The invention involves a ‘innovative step’

Step 3: Grant/ Refusal:

  • If the Department is satisfied with the findings under Section 5, it shall register the patent in the name of the applicant.
  • In case, the Application does not fulfill the statutory requirements, a notice to the applicant is sent regarding the Rejection of Application.
  • Section 7: Issue of registration certificate:
  • When the registration of the patent is granted, the Department shall issue a certificate of registration in the name of the applicant in the format prescribed in Schedule 2(A).
  • The fee for the same is NPR 10,000.
  • Section 8: The term of the patent granted shall be 7 years from the date of registration.

Grounds of refusal/ cancellation of registration: Section 6:

  • The patent is already registered in the name of other person
  • The applicant is not the inventor of the subject matter of the patent and has not acquired rights over it from the original inventor
  • The patent sought adversely affects public health, conduct or morality, or national interest
  • The patent sought is contradictory to existing Nepalese laws.
  • The applicant will be provided a reasonable opportunity of being heard before the department cancels the registration of the patent.

Step 4: Publication:

  • Section 7A: All patents registered under the Act, except those that are kept secret in the national interest, shall be published in the Nepalese Gazette by the department.
  • In case of objections, the complaint may be filed within 35 days from the date of seeing or copying the Patent, and thereafter, the Department shall conduct necessary inquiries and take further action. The fee for complaints and objections is NPR 1000.
  • In case anyone wants to see or copy the particulars, maps or drawings of a patent, he can do so by paying the prescribed fee of NPR 750.

Step 5: Renewal

  • Section 23B: Renewal:
  • A patent holder shall renew the registration within a period of 35 days from the date of expiration of the term for which he is entitled to use the same.
  • The prescribed form is Schedule 2(D) and the fee for
  1. First time: NPR 5000
  2. Second time: NPR 7500.
  • When the time limit of renewal expires, it may be done within 6 months from the date of expiry of the time limit for the same along with a fee of NPR 1000.
  • A patent can only be renewed twice for a period of 7 years at a time.

 

FILING CONVENTION PATENT APPLICATIONS IN NEPAL:

Nepal being party to Paris Convention since June 2001, an applicant desirous of filing patent application in Nepal claiming priority from one or more convention countries based on same invention may file such application within 12 months from the date of earliest priority. Pertinently, Nepal is not a member of PCT (Patent Cooperation Treaty).

 

Designs

Section 2:

“Design” means the form or shape of any material manufactured in any manner.

FILING PROCEDURE:

Step 1: Filing:

  • Who may apply: Section 12 and 13:
  • A person desirous to register the design of any article manufactured or caused to be manufactured, shall submit an application in the format specified in Schedule 1 (B) to the Department.
  • The applicant shall also furnish four copies of such design and maps, and drawings and particulars thereof.
  • Fees: NPR 1000.

Step 2: Examination

This involves “Formality check” and “Substanstive check” –

  1. Formality Check- An application is submitted to check if the statutory formalities and procedural requirements are fulfilled.
  2. Substantive Check- After the formality check, a substantive examination is carried out, weather ;

–  There is existence of a prior application or registration of the same.

–  Such design will hurt the prestige or interest of an individual or institution or conduct of public or morality of undermines national interest.

If either of the above mentioned points are

Step 3: Grant/ Refusal:

  • Section 14: On receipt of the application filed by any person under Section 13, the Department shall register the design in the applicant’s name and issue a certificate of registration in the format specified in Schedule 2(A). i.e If it has passed the stage of Examination.
  • In case, the Application is rejected, a Notice of Rejection is sent to the Applicant.
  • Registration fees: NPR 7000.
  • The term of a registered design is five years from the date of registration.
  • Renewal: Section 23B:
  • A design holder shall renew the registration within a period of 35 days from the date of expiration of the term for which he is entitled to use the same.
  • The prescribed form is Schedule 2(E) and the fee for
  1. First time: NPR 1000
  2. Second time: NPR 2000.
  • When the time limit of renewal expires, it may be done within 6 months from the date of expiry of the time limit for the same along with a fee of NPR 1000.
  • A design can only be renewed twice for a period of 5 years at a time.

Step 4: Publication:

  • Section 21A: The department shall publish the designs registered under section 14, along with their particulars of renewal or cancellation.
  • Anyone who has any objection to the same need to file a complaint to the department within 35 days from the date of such publication.
  • Post receiving the complaint, Department takes necessary actions after conducting inquiries.

Step 5: Renewal/ Cancellation

Grounds of refusal/ cancellation: Design is liable to be refused or cancelled, if the design or design registration, as the case may be:

  • Hurt the prestige of individual/ institution
  • Adversely affect public conduct or morality
  • Undermine the national interest
  • Found to have already been registered in the name of another person.
  • The design holder will also get an opportunity to show cause as to why his registration must not be cancelled.

REVOCATION OF PATENTS ACCORDING TO INDIAN PATENT ACT, 1970: INSIGHT

This article focuses on the revocation proceedings which is one of the mechanisms available for annulations of Patents in India.

  1. What is revocation of a patent?

When a patent has been sealed or granted, it is not always the case that the patent shall stay unhindered by any third party till the life of the patent. The patent can be challenged by certain people on different grounds, and a method to cause the same is by filing a revocation petition/ post-grant opposition proceedings. This article focuses on the revocation proceedings.

  1. Why does one file a revocation petition?

As the Patent Act does not presume Patents granted to be valid, rights granted on such Patents cannot be absolute. Third parties which are required to seek permission from Patentee for practicing any of the exclusive rights bestowed upon him are also given a chance to challenge the validity of the Patents. This challenge can be instituted on own as well as on Patentee asserting infringement of Patent rights.

  1. Who can file a revocation petition?

As per Section 64 of the Patent Act, 1970, the following persons can file the petition in the High Court:

  • any person interested[1];
  • the Central Government
  • the person making the counter-claim in a suit for the infringement of a patent
  1. Where can a revocation petition be filed?

Thus, a revocation petition can be filed in the Intellectual Property Appellate Board by the interested person or the Central Government, or it can be filed as a counter-claim in a suit for infringement at the High Court.

To bring in the aspect about jurisdiction of suits of infringement and the corresponding revocation petitions, Section 104 of the Patents Act, 1970 states that no suit of infringement can be brought before a court inferior to the District Court having jurisdiction to try the suit and in the event of a counter-claim for revocation of the patent made by the defendant, such suit for infringement and the said counter-claim must be transferred to the High Court.

  1. What are the grounds under which a revocation petition can be brought?

Under Section 64, the following are the said grounds:

  1. the invention, so far as claimed in any claim of the complete specification, was claimed in a valid claim of earlier priority date contained in the complete specification of another patent granted in India;
  2. the patent was granted on the application of a person not entitled to apply therefor;
  3. the patent was obtained wrongfully in contravention of the rights or the petitioner or any person under or through whom he claims;
  4. the subject of any claim of the complete specification is not an invention;
  5. the invention so far as claimed in any claim of the complete specification is not new, having regard to what was publicly known to publicly used in India before the priority date of the claim or to what was published in India or elsewhere in any of the documents referred to in Section 13;
  6. the invention so far as claimed in any claim of the complete specification is obvious or does not involve any inventive step, having regard to what was publicly known or publicly used in India or what was published in India or elsewhere before the priority date of the claim;
  7. the invention, so far as claimed in any claim of the complete specification, is not useful;
  8. the complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed, that is to say, that the description of the method or the instructions for the working of the invention as contained in the complete specification are not by themselves sufficient to enable a person in India possessing average skill in, and average knowledge of the art to which the invention relates, to work the invention, or that it does not disclose the best method of performing it which was known to the applicant for the patent and for which he was entitled to claim protection;
  9. that the scope of any claim of the complete specification is not sufficiently and clearly defined or that any claim of the complete specification is not fairly based on the matter disclosed in the specification;
  10. that the patent was obtained on a false suggestion or representation;
  11. that the subject of any claim of the complete specification is not patentable under this Act;
  12. that the invention so far as claimed in any claim of the complete specification was secretly used in India, otherwise than as mentioned in sub-section (3), before the priority date of the claim;
  13. that the applicant for the patent has failed to disclose to the Controller the information required by section 8 or has furnished information which in any material particular was false to his knowledge;
  14. that the applicant contravened any direction for secrecy passed under section 35
  15. that leave to amend the complete specification under section 57 or section 58 was obtained by fraud.
  16. that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention;
  17. that the invention so far as claimed in any claim of the complete specification was anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere.
  1. Does revocation restrict itself to Section 64?

It is important to note that section 64 does not restrict grounds to be used in revocation to only those provided in section 64 whereas section 25 (2) setting out grounds used in post-grant opposition proceedings is restrictive in nature.

  1. What are the other provisions concerning revocation?

Under Section 65, if a patent is claimed to be related to atomic energy, a revocation petition can be filed against it. Such patent shall not be granted under the Atomic Energy Act, 1962 and shall be revoked. Under Section 66, if the Central Government is of the opinion that a patent or the mode in which it is exercised was mischievous to the State or prejudicial to the public, after giving an opportunity to the patentee to be heard, it may make such declaration in the Official Gazette and the patent shall stand revoked.

Moreover in the Enercon (India) Ltd and Ors. v Enercon Gmbh (2014) 5 SCC 1 , it was laid down by the Supreme Court that when post grant opposition proceedings are instituted by a party, he cannot institute a revocation petition or counter-claim of revocation proceeding against the same patent.

  1. “‘Person interested’ under Section 64 would mean a person who has a direct, present and tangible commercial interest which is injured or affected by the continuance of the patent on the register. (Ajay Industrial Corporation v Shiro Kanao of Ibaraki City AIR 1983 Del 496)”

About the Author :  Ms. Anjana Mohan, Symbiosis Law School, Pune, intern at Khurana and Khurana, Advocates and IP Attorneys. Views expressed in this article are solely of the intern and do not reflect the views of either of any of the employees or employers. Queries regarding this may be directed to swapnil@khuranaandkhurana.com or swapnils@khuranaandkhurana.com.

Merk’s patent valid but Teva’s Nasonex generic non-infringing

In Merck Sharp & Dohme Corp.  (hereinafter referred to be as “Merck”) v. Teva Pharms. United States, Inc. (hereinafter referred to be as “Teva”) decided on November 16, 2016, Teva’s application of Abbreviated New Drug Application (hereinafter referred to as “ANDA”) no. 205149 had triggered Merck to file infringement suit against Teva in respect of US patent number 6127353 (hereinafter referred to be as “353” patent) which is currently listed against NDA number of New Drug Application (hereinafter referred to as “NDA”) number 020762. The‘353 patent is set out to expire in April 03, 2018 with Pediatric Exclusivity. NDA 020762 was approved for ‘NASONEX’ having MOMETASONE FUROATE (hereinafter referred to as “MMF”) as active ingredient in the dosage form EQ 0.05MG BASE/SPRAY. Merck further stated in its complaint that Teva’s ANDA application contained certification (PARA IV) that US patent no. 6127353 is invalid and unenforceable and will not be infringed by Teva producing its generic, the complaint also stated that Teva refused to allow Merck access to its ANDA application or samples.

Anhydrous Mometasone Furoate (“MFA”) was earlier patented by Merck in the early 1980s. MFA and MFM are the polymorphs. On July 3, 2014, plaintiff i.e. Merck brought this action alleging infringement. Merck filed an amended complaint on August 17, 2015, which Teva answered on August 31, 2015. Independent claims 1 and 6 and dependent claims 9-12 of the ‘353 patent titled ‘Mometasone furoate monohydrate, process for making same and pharmaceutical compositions’ were asserted by Merck.

Independent claim 1 and claim 6 have been reproduced below for the reference:

Claim 1:

9.alpha.,21-dichloro-16α-methyl-1,4-pregnadiene-11β,17α-diol-3,20-dione-17-(2′-furoate) monohydrate.

Claim 6:

A pharmaceutical composition comprising mometasone furoate monohydrate in a carrier consisting essentially of water.

Teva’s ANDA contains MFA as the active ingredient and has shelf life of 2 years. Merck did not allege the inclusion of MFM in the pre-formulation active ingredient of Teva’s formulation.

Teva had challenged the ‘353 patent on the grounds of double patenting with U.S. Patent 6,180,781 (hereinafter referred to be as ‘781’) and lack of subject matter description. Court rejected both the arguments and found the Patent to be valid. To ascertain whether Teva’s ANDA product contains any MFM during shelf life, Teva presented six different batches of its product to Merck. Merck’s expert, Dr. Victor Young (“Dr. Young”), testified in favor of Merck by placing a high premium on his ability to visually distinguish between MFM and MFA using a microscope. Teva’s expert, Dr. Leonard Chyall (Dr. Chyall), however, contended that protocol required visual observation to be paired with a more accurate method of measurement. Court observed that “Dr. Chyall has offered up a reasonable criticism of such findings. At bar, Dr. Chyall’s testimony is more credible and consistent”. Finally the court ordered in favor of Merck for the issues of validity but declared Teva’s product to be non-infringing the ‘353 patent. In the form 10K submitted with Securities and Exchange Commission on February 26, 2016, Merck apprehended decline the sale of Nasonex after the entry of generics. Here is their take ‘For example, a court has ruled that a proposed generic form of Nasonex does not infringe the Company’s U.S. patent for Nasonex. If the generic form of Nasonex receives marketing approval in the United States, the Company will experience a loss of Nasonex sales.’

About the Author :  Ms. Rashmi, intern at Khurana and Khurana, Advocates and IP Attorneys. For any queries, please write to swapnil@khuranaandkhurana.com.