Tag Archives: patent

Amendments in Patent Application Process in Singapore

The process of applying for patents in Singapore will become much easier and more efficient after Intellectual Property Office of Singapore (IPOS), in its continued efforts to ease patent application process, has introduced few changes in Patent forms 1 and 12B. According to a circular released on November 21, 2017 on IPOS website [1], these changes will be effective from 10 December 2017 [1] and will be available to Patent Applicants from that date. IPOS claims that after these changes the patent application process will be enhanced for general Applicants.

Amendments to ‘Patents form 1’ [2]

a. Patents forms 1 & 8 will be merged

This change will allow Applicants to enter details of inventors for which the patent has been applied in part 7 of the newly merged form i.e. merged ‘form 1’ & 8. There will be no need to file a separate form 8. It is a welcome move for the Applicants as they will not have to fill multiple forms. In addition to this, the Applicants will now be able to derive rights from the Inventor. Applicants can do this by filling in part 8 of the newly merged form. However, these amendments will not change the process of correcting the details of the inventors i.e. Patents Form 13 will not be applicable for such amendment or correction. Applicants will also be able to submit the details of the inventor separately by filling Patent Form 8 which will still be available for submissions.

b. A separate attachment for sequence listing

A new document will also be available for “sequence listing” for attachment at the time of filing of patent applications. A “sequence listing” is a list of biological sequences in the format prescribed by WIPO Standard ST.25 (Presentation of nucleotide and amino acid sequence listings) using controlled vocabulary (i.e. defined terms for certain features). This document will be available to patent applicants in case they do not want to include sequence listing as a part of description or claims. Also, the applicants will be able to paginate this document and will be able to indicate the page count of sequence listing document in a separate field.

In addition to this, if Applicants want to submit sequence listing as a separate reference document, not forming part of the description or claims, such document can be submitted using the mentioned “sequence listing” document type with a cover letter attached to indicate that it will serve as a reference document only.

c. A new feature of auto-population during divisional filings

Yet another efficient and productive move by the IPOS is the introduction of auto-population feature when a divisional application is being filed. This means that when an Applicant files a divisional application, relevant information from the parent application will be auto-populated for the convenience of the Applicants. Having said that, the Applicants will still be able to amend the auto-populated fields if they choose to do the same.

 Amendments to Patents ‘Form 12B’ [3]

Similar to the changes in Patents form 1, for the ease of Applicants, Patents Form 13 will also be merged with Patents Form 12B. Applicants don’t need to fill Form 13 in case they wish to make amendments to the specification when requesting for an examination review report using Patents Form 12B, and can do so by selecting the option “Written submissions and proposed amendments are filed” in Patents form B. With this selection, the Applicant will be required to submit both a clean and a marked up copy of the amendment of the specification.

Conclusion

Such amendments in the Patent Application process as mentioned above will be available from December 10, 2017. Further, these changes will ease the application process and will allow Applicants some flexibility in sequence listing, and amending details of inventors as well as amending the specification.

Author: Shilpi Saxena, Jr. Patent Associate at Khurana & Khurana Advocates and IP Attorneys can be reached at shilpi@iiprd.com.

 References:

[1] https://www.ipos.gov.sg/docs/default-source/resources-library/patents/circulars/(2017)-circular-no-8—enhancements-to-patent-application-process.pdf

[2] https://www.ipos.gov.sg/docs/default-source/resources-library/patents/patent-forms-and-fees/form-pf1—otc.pdf

[3] https://www.ipos.gov.sg/docs/default-source/resources-library/patents/patent-forms-and-fees/form-pf12b—otc477c1877c2d0635fa1cdff0000abd271.pdf

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Initial Coin Offering (ICO) and its Intellectual Property (IP) Interface

With growing importance and widespread adoption of Cryptocurrencies such as Bitcoin, Litecoin, Ethereum, Ripple among many others, Initial Coin Offerings (ICO) have become very popular over the last few years. In brief, an ICO is an unregulated means by which funds are raised for a new cryptocurrency venture or even by a technology company that integrates its offerings/products with issuance and/or transactions of cryptocurrencies. An Initial Coin Offering (ICO) is used by startups to bypass the rigorous and regulated capital-raising process required by venture capitalists (VCs) or banks, wherein in an ICO campaign, a percentage of the cryptocurrency is sold to early backers of the project in exchange for legal tender or other Cryptocurrencies as mentioned above. More information on ICO’s can be seen herehere, and here.

Having been an active part of ICOs since 2016, and have drafted over 5 ICO offering documents, and 10 white papers, we have closely observed that there has been a strong and growing correlation between subscription levels for an ICO during the initial offering and the manner in which they depict/demonstrate their Intellectual Property (IP), especially their Patent portfolio. A clear mapping between ICO entity’s product commercialization, coin offering strategy, basis of product differentiation, and how they harness the blockchain technology with respect to their Patent/IP portfolio is a strong indicator of how they create entry barriers. Investors too are gaining maturity by doing thorough due-diligence on the IP that the ICO-entity holds before they invest in the ICO through comprehensive assessment of how broad the claims are, how the claimed subject matter integrates with the blockchain platform for issuance or transaction of newly issued currencies/coins, whether claim charts have been prepared, assignment/ownership issues if any, litigation/pre-litigation outcomes, validity challenges, competitive analysis, market landscape, white-space analysis, among other common IP due-diligence parameters.

Most ICO white papers therefore pay significant attention to how they present their Patent portfolio with respect to the manner in which each feature of their blockchain based implementation would be executed such as, for instance, how digital contracts would be managed, for an IoT architecture based entity: how blockchain would enable optimization of IoT device monitoring, and for an analytics company: how data analytics can be configured to associate with blockchain network tokens. Some white papers go further to even map their patent claims with the cryptocurrency interfacing mechanisms. Although most ICOs focus on their US Patent Portfolio, companies in other major startup communities such as in Israel, UK, Germany, and Singapore are also engaging strongly in how they uniquely position their offerings to gain competitive advantage through presentation of their IP. Most white papers intend explaining what their tokens are, how they are acquired, released/spent, along with their token generation events, and IP’s that interface with each of these steps can be integrated into the relevant portion of the white paper so as to demonstrate the extent of coverage and protection that the entity has done, which is also reflective of their IP strategy.

It is therefore, in sum, crucial to develop a robust IP strategy before launching an ICO to instill higher confidence in potential investors and create a differentiator in the market.

 

Author: Tarun Khurana, Partner and Patent Attorney at Khurana & Khurana (K&K) and IIPRD can be reached at Tarun@khuranaandkhurana.com

Compulsory Licensing: An Indian Overview

Compulsory licenses are sovereign state authorizations that 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 whilethe conditions thatneed 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 suomotu 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 NatcoPharma 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-availabilityand 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 holdersand 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.

[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

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

Curious Case of Corporate Viel in Revocation Petition

This case pertains to a suit filed by Galatea Ltd. & Anr (Petitioners), against Diyora & Bhanderi Corporation (Defendants) and thirteen other defendants, for infringing of its patent IN 271425 (suit patent) for a ‘device which eliminates presence of gas bubbles from the immersion medium”. Along with the suit, the plaintiffs filed an application under order 39 Rule 1 & 2 of Civil Procedure Code, seeking interim injunction restraining the latter from using, selling or offering to sell the patented device, which was denied by the district court Vadodra. Later, it was appealed by the Plaintiff in High Court that appointed a local commissioner to make a report on investigation held in the defendants’ premises and remanded the case back to the district court.

The defendants filed written statement denying all the allegations made by plaintiff, and also filed a counter claim under section 64 (1) (e) and (f) of Patent Act, 1970 for revocation of the patent in the High Court of Ahmedabad due to lack of  novelty[1] and inventive steps[2]. The proviso to section 104, Patent Act, 1970, necessitates the transfer of the case to the High Court.

The issue that the Plaintiff raised was that revocation by means of counter-claim filed by Defendant Nos. 4 & 5 before High Court is not maintainable as revocation petition has already been filed by Defendant no. 3 before the IPAB, being the same entity as Partners in Defendant no. 3 are directors in Defendant Nos. 4 and 5.

PLAINTIFF’S CONTENTION

Plaintiff relied on the case of Saurabh Exports v. Blaze Finance & Credits (P.) Ltd[3]where the Defendants entered into an agreement with the Plaintiff under which the Plaintiff made a deposit of 15 lakhs in the company, which the defendants failed to pay and all the defendants denied their liability to repay the same. Hence, the court lifted up the corporate veil on the basis that, theDefendants’companieswere a family arrangement made to defraud the Plaintiff under the cloak of a corporate entity. This makes the company and the directors liable. Referring to this case, the Plaintiff claimed that since partners and directors of Defendant Nos. 3, 4, and 5 are same, corporate veil of Defendant nos. 4 and 5 should be lifted and counterclaim should not be maintainable as it would lead to same relief of patent invalidation being asked through two judicial entities (IPAB and High Court). Thus, the Plaintiff argued that Defendant entities are not separate but are alter-egos of each other and that multiple entities of Defendants are created to conceal improper activities conducted by them. Where the corporate charter is employed for the purpose of committing illegality or for defrauding others, the court would ignore the corporate character and will look at the reality behind the corporate veil so as to enable it to pass appropriate orders to do justice between the parties concerned.[4]

Plaintiff referred to the case of Dr. Alloy Wobben & Ors. V. Yogesh Mehra & Ors,[5]where the court held that the use of the word or” in Section 64(1) demonstrates more than one remedies but that cannot be simultaneously used.Further, it was argued by the plaintiffs that since defendant no. 3 have already filed a revocation before IPAB, the revocation petition filed by Def. Nos. 4 and 5 are not sustainable as all of them are single entity. Hence, the subsequent revocation filed before the High Court must be stopped as the Defendants cannot avail dual remedy for the same cause of action, thereby making the counter-claim non-sustainable.

DEFENDANT’S CONTENTION

Defendants first highlighted a principle of Patent Law that if validity of a patent is challenged, i.e. revocation is pending for the patent suit, then no injunction can be granted.[6] Thus, plaintiff’s interim application under order 39 rule 1 & 2 of CPC, for seeking ex- parte injunction restraining the defendants from manufacturing, selling, offering for sale any infringed device must be rejected.

Defendants submitted their arguments on two grounds:

  1. Defendants asserted that Defendant nos. 3, 4, 5 are different entities.Defendant no. 4 and defendant no. 3 are completely different entities dealing with different line of business, although partners and directors are common. They explained,“Each company is a separate and distinct legal entity and the mere fact that two companies have common shareholders or common Board of Directors, will not make the two companies a single entity. Nor will existence of common shareholders or Directors lead to an inference that one company will be bound by the acts of the other.”[7] With regard to Defendant no. 5, it is totally a different entity as it is Private Ltd Co, incorporated under Company Act, 1956 comprising of different partners. The plaintiff has itself involved defendants 4 and 5 in the present suit, resulting them to have locus-standi in the case to file a revocation petition by means of a counter-claim according to section 64 of Patent Act, 1970.
  2. Corporate veil is applicable only in certain cases such as Tax evasion, fraud, enemy character, ultra vires Act, and act against public interest, negligent activities or company avoiding legal obligations. They further emphasized that corporate veil is a rule, and lifting of corporate veil is an exception that can be done only on limited circumstances. Corporate veil should be applied only in scenarios where it is evident that company was a mere camouflage or sham deliberately created by persons exercising control over the said company for the purpose of avoiding liability.[8]Thus, lifting of corporate veil is not valid in the present case as the defendant’s business is a bona fide company incorporated having a separate juristic entity.

JUDGEMENT:

Consequently, the District court of Vadodra, decided the whole case by discussing the following two issues.

Issue 1: Whether defendant no. 3, 4 and5 are different entities or not?

Defendant no. 3 is a partnership firm, and all partners of defendant no. 3 are the directors of defendant no. 4, which is a private Ltd. Company. Thus, these two entity are not independent of each other, rather they are an alter – ego of each other. Thus, the counter claim with regard to defendant no. 4 is not maintainable. However, defendant no.5 is a Private Limited Company incorporated under Company Act, 1956, having different directors. Hence, it is completely a separate entity from defendant 3 and 4.

Issue 2: Whether the ‘Lifting of corporate veil’ applicable on the present case?

The court held that corporate veil cannot be lifted and in case of defendant no. 5, no case has been raised by the plaintiff where defendant no. 5 falls under the scope ‘corporate veil’ as corporate veil can be lifted only in certain cases as mentioned by the defendants by referring to plethora of cases.[9]The plaintiff could not put the defendant company in fissures of those specific cases. The court listed out following six legal positions where the  corporate veil can be lifted:[10]

  • ownership and control of a company were out enough to justify piercing the corporate veil;
  • the Court cannot pierce the corporate veil, even in the absence of third party interests in the company, merely because it is thought to be necessary in the interests of justice;
  • the corporate veil can be pierced only if there is some impropriety;
  • the impropriety in question must be linked to the use of the company structure to avoid or conceal liability;
  • to justify piercing the corporate veil, there must be both control of the company by the wrongdoer (s) and impropriety, that is use or misuse of the company by them as a device or façade to conceal their wrongdoing; and
  • the company may be a ‘façade’ even though it was not originally incorporated with any deceptive intent, provided that it is being used for the purpose of deception at the time of the relevant transactions.

Thereby, on discussing the above issues, the Hon’ble Court dismissed the counter-claim of defendant no. 4 for the reason that it is the same entity as of defendant no.3. But the court accepted the counter-claim submitted by defendant no.5 taking it as a separate entity from Defendant nos. 3 and 4. Thus, the court ordered for transfer of the case to High Court of Gujarat according to Section 104 of Patent Act.

[1] Section 64 (1) (e) of the Patent Act : that the invention so far as claimed in any claim of the complete specification is not new, having regard to what was publicly known or 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:

[2]Section 64 (1) (e) of the Patent Act : that 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:

[3] [2006] 133 Comp. Cas. 495

[4]Singer India v. Chander Mohan Chadha[2004] 122 Comp. Cas. 468 (SC)

[5][(2014) 15 SCC 360]

[6] TVS Motor Company Limited v. Bajaj Auto Limited, 2009 (40) PTC 689 (Mad); Standipack Private Limited v. Oswal Trading Co. Ltd., 1999 (19) PTC 479.

[7]Indowind Energy Ltd vs. Wescare (I) Ltd.& Anr, AIR 2010 SC 1793

[8] Balwant Rai Salulja V/s. Air India Ltd., AIR 2015 SC 375

[9]Saurabh Exports V/s. Blaze Finlease and Credits Pvt. Ltd.  (supra); Chander Mohan Chadha and Ors.,(supra), Delhi Development Authority; Indowind Energy Ltd. V/s. Wescare; Balwant Rai Salulja V/s. Air India Ltd.(supra)

[10]Balwant Rai Salulja V/s. Air India Ltd.,AIR 2015 SC 375

Cambodia, China Sign MoU on Cooperation in the Field of Trademark and Branding

In a further step towards the development and strengthening of Intellectual Property regime of both Cambodia and China, a Memorandum of Understanding (MoU) on Branding Cooperation between the Ministry of Commerce of the Kingdom of Cambodia and National Administration of Industry and Commerce of the People’s Republic of China was signed on September 06, 2017 [1][3]. This MoU aims at providing better facilities for trademark and brand registration in both countries.

The MoU signing ceremony took place in the city of Phnom Penh which is the capital of the Kingdom of Cambodia and was held under the presidency of HE Ouk Prachea, Secretary of State, Ministry of Commerce, High Representative of HE Peng Sosachak, Minister of Commerce, and HE Ma Zhengqi, Deputy Minister of National Administration of Industry and Trade of the People’s Republic of China. This MoU will further serve the purpose of strengthening and broadening cooperation between China and Cambodia on an equal and mutually beneficial basis in the Markets, and to also promote the growth of more brands in the respective nations. Additionally, the memorandum will protect consumers and producers’ interests.

This MoU is in continuation with the previous Memorandums [2] which have been signed between Cambodia and China for bilateral cooperation in Intellectual properties. In the press release dated September 6, 2017, on the online portal of Cambodia it is stated that, through this Memorandum both China and Cambodia will share the related documents of intellectual property and also include mutual study visits to strengthen intellectual property regime and trade protectionism. Further under this MoU, China through their experts will be helping in the training of human resources to Cambodia on brand protection and brand control. In addition, China will also in the promotion of Cambodian products exhibitions, as well as building more of Cambodia’s brand in the market.

Author: Shilpi Saxena, Jr. Patent Associate at Khurana and  Khurana Advocates and IP Attorneys can be reached at shilpi@iiprd.com.

Sources

[1] http://cambodiaip.gov.kh/NewsDetail.aspx?id=110051

[2]http://www.cambodiaip.gov.kh/DocResources/5e50267e-486b-4114-86ef-022e96df991d_c786a043-b88d-4f64-9429-60a330efdc5f-en.pdf

[3] http://www.akp.gov.kh/?p=109309

WORK PLAN FOR BILATERAL COOPERATION IN 2017-2019

WORK PLAN FOR BILATERAL COOPERATION IN 2017-2019

BETWEEN

THE NATIONAL COMMITTEE FOR INTELLECTUAL PROPERTY

RIGHTS (NCIPR)/MINISTRY OF COMMERCE (MOC)

OF THE KINGDOM OF CAMBODIA

AND

THE STATE INTELLECTUAL PROPERTY OFFICE OF THE PEOPLES REPUBLIC OF CHINA

On August 17, 2019 [1] the Intellectual Property Office of the Kingdom of Cambodia, on its online portal, released Work Plan for Bilateral Cooperation in 2017-2019 between the National Committee for Intellectual Property Rights (NCIPR)/Ministry of Commerce (MOC) of the kingdom of Cambodia and the State Intellectual Property Office (SIPO) of the people’s republic of China. The Signing Ceremony on the Work Plan for Intellectual Property Cooperation for the year 2017-2019 between Cambodia and the PRC was held on March 25, 2016 [2][3][4].

Based on the Memorandum of Understanding (MoU) on the Cooperation which was signed on March 23, 2011[5] and also based on the Work Plan for Bilateral Cooperation which was signed June 27, 2014[6] between the National Committee for Intellectual Property Rights (NCIPR)/Ministry of Commerce (MOC) of the kingdom of Cambodia and the State Intellectual Property Office (SIPO) of the people’s republic of China, both parties made a consensus on the below mentioned work plan which will strengthen the bilateral cooperation between both parties in 2017-2019 as far as the Intellectual Property of both the nations are concerned. This work plan will remain valid until December 31, 2019 [1] and may be modified in writing with mutual consent of the parties. The work plan, as stated on the website [1] is as follows:

  1. Objective

The main objective is to recognize the importance of promoting Intellectual Property cooperation between both nations i.e. the Kingdom of Cambodia & the People’s Republic of China and its effect on nation’s economy, trade, science & technology. For this, both parties have made a consensus and expressed their strong desire to further strengthen their friendship and cooperation.

  1. High-Level Dialogues

Both parties agreed that high-level dialogues between the two countries keep each party well-informed of the latest trends & developments in the other country, and also provides an opportunity for the parties to exchange their views on future-IP cooperation and IP issues or.

  1. Training

SIPO will invite 5 officials from NCIPR/MOC, once per every year from 2017-2019, to attend intellectual property training courses which will be held in China and last for one week. SIPO will cover all international travel costs (round trip economy-class flight tickets) and local expenses in China (including meals and lodging) incurred by the invited NCIPR/MOC officials.

  1. Exchange of Documentation and Information

Both the nations have agreed on the continuation of exchange of patent related documents and information through the authorized contact persons for that purpose.

  1. Information Exchange & IT systems

Both the parties have reached a consensus on pursuing cooperation of the Cloud Patent Examination System (CPES) based on the 16 accounts provided by SIPO to NCIPR/MOC.

  1. Exchange of Information

Both of the parties agreed on enhancing the exchange of experience on genetic resources, traditional knowledge and folklore, national IP strategy, information technology and dissemination of IP information.

  1. Expenses

All the actions contemplated in the work plan will be subject to the availability and priorities of the funds with each party.

Author: Shilpi Saxena, Jr. Patent Associate at Khurana & Khurana Advocates and IP Attorneys can be reached at shilpi@iiprd.com.

References :

[1] http://www.cambodiaip.gov.kh/NewsDetail.aspx?id=110050

[2] https://www.facebook.com/moc.gov.kh/posts/1160609867285223

[3] http://www.akp.gov.kh/?p=78467

[4] http://www.aseanthai.net/english/ewt_news.php?nid=1098&filename=index

[5]http://cambodiaip.gov.kh/TemplateTwo.aspx?parentId=2&menuid=175&childMasterMenuId=31&lang=en

[6]https://www.facebook.com/moc.gov.kh/photos/a.816890791657134.1073742054.689434681069413/816891918323688/

Modification in procedure regarding examination of patent applications involving the use of biological material

The Biological Diversity Act (the BD Act) was enacted with the goal to provide for conservation of Biological Diversity, sustainable use of its components and fair and equitable sharing of the benefits arising out of the utilization of biological resources. One of the provisions under the BD Act (section 6) relates to seeking prior permission from National Biodiversity Authority (NBA) before applying for any intellectual property right, if the invention is based on any research or information on a biological resource obtained from India. In the event of an intellectual property right (patent application) being filed without prior NBA permission, NBA permission may be obtained after the acceptance of the patent but before patent grant by the patent authority concerned.

It has been witnessed in a few recent Indian Patent Office (IPO) decisions that patent applications involving use of biological materials, not procured from India and sourced from commercial sources in countries like Switzerland, Spain, Japan and China, were rejected. In light of such IPO decisions, stakeholders at Mumbai and Delhi held meetings to put forward certain issues regularly faced by patent applicants regarding unwarranted objections raised by the IPO concerning requirement of permission from NBA and further delay in obtaining NBA approval.

In view of the submissions made by stakeholders, this issue has been considered by Indian Patent office and instructions/guidelines for NBA permission have been streamlined by way of the following:

S. No. Issue Modified procedure to be followed
1 Where the invention does not relate to a biological resource defined under the Biological Diversity Act 2002, such as:

(a)    Value-added   product

(b)       Bio- wastes

(c)        Synthetically prepared biological material

(a) Value Added Product:

Section 2 of Biological Diversity Act 2002 explicitly excludes value added products from the purview of “Biological resources”.

As per Biological Diversity Act, 2002:

Section 2 (c): “biological resources” means plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value, but does not include human genetic material;

Section 2 (p): “value added products” means products which may contain portions or extracts of plants and animals in unrecognizable and physically inseparable form.

Examiners/Controllers shall verify from    the   disclosure in patent specification if the claimed invention resides in the biological resource or value-added product. If the invention resides in a value-added product, then they shall avoid

2 Where the biological resource/material used in invention is not obtained /sourced from India. Section 6 (1) of the Biological Diversity Act, 2002 states,

“No person shall apply for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without

obtaining   the    previous   approval   of  the    National
Biodiversity Authority before making such application.

Provided that if a person applies for a patent, permission of the National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned; and,

Provided further that the National Biodiversity Authority shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.”

Thus, no    approval from   NBA   is  necessary when the invention is based on any research or information on a biological resource not obtained from India.Therefore, when an applicant makes unequivocal
declaration in application for patent (Form 1) that the
biological material used in the invention is neither
obtained from India nor sourced from India, then

Examiners/Controllers shall duly consider such
declaration before issuing FER and shall avoid raising an objection with respect to the requirements of NBA approval.

3. Marking of applications in the module regarding requirement of NBA approvals.
While examining the applications involving use of biological
resource, Examiners should mark these applications as
“NBA approval application” in the examination module
before sending the examination report to the Controller for
approval.
However, if the Controller is not satisfied with
requirement regarding NBA approval, he shall unmark the
application by giving reasons thereof.
4 Cases held up for grant
of patents only due to
non-submission of
NBA permission.
Where the applicant has complied with all the objections,
except submission of NBA approval, the Controller shall
mark the application in the examination module by remark
that “NBA approval pending, but in order for grant” and,
the System Administrator shall put a tag on such cases so
that these applications can be treated as if disposed of
the Controller.

IPO has further clearly stated that any false declaration on behalf of the applicant makes him liable for revocation of patent under section 64 (1) (j)/ 64(1) (p) of the Patents Act
1970 (as amended). Further, as per provisions in section 55(1) of Biological Diversity Act 2002, if the applicant contravenes or attempts to contravene or abets the contravention of the provision
of section 6 of the Biological Diversity Act 2002, he shall be liable for penal action under section 55(1) of the Act’.

With the streamlining of instructions/guidelines for NBA permission, the patent applicants can now effectively deal with the unwarranted objections raised by the IPO concerning the requirement of permission from NBA. Henceforth, the patent applicants can question the unjustifiable extension of applicability of Section 6 of the BD Act by IPO to reject patent applications even when the invention is not based on Indian biological resource and/or when the invention is one of a value-added product, bio-waste or a synthetically prepared biological material and hence, does not relate to a biological resource defined under the Biological Diversity Act 2002.

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

Enzo Biochem Inc. v. Applera Corp. – A case pertaining to Doctrine of Equivalents

On August 02, 2017, the United States Court of Appealsfor the Federal Circuit ruled in favor of Applera Corp.and Tropix Inc.in the matter of Enzo Biochem Inc., Enzo Life Sciences Inc., Yale University v. Applera Corp., Tropix Inc. The Court affirmed that the district court accurately interpreted proper construction of claims in U.S. Patent No.5,449,767 (“the’767 patent”) and correctly analyzed Enzo’s doctrine of equivalents argument. In over thirteen years of litigation between the parties, the Court has considered this present infringement action on three separate occasions.

Background

Technology as disclosed in the ‘767 patent pertains to use of nucleotide probes to detect presence of a particular DNA or RNA sequence in a sample or to identify anotherwise unknown DNA sequence. According to the ’767 patent, many procedures employed in biomedical research and recombinant DNA technology rely on use of radioactive labels such as isotopes of hydrogen, phosphorus, carbon, oriodine. The ’767patent also notes serious limitations and drawbacks pertaining to use of radioactive materials that include, elaborate safety precautions, expensive use and purchase, and short shelf-life. As an alternative to use of radioactive labels, the’767 patent elaborates on a series of novel nucleotide derivatives that contain biotin, iminobiotin, lipoic acid,and other determinants attached covalently to pyrimidine or purine ring. Further, the ’767 patent asserts that the use of modified detection approach provides detection capacities equal to or greater than procedures which utilize radio isotopes, and also overcomes other limitations and drawbacks pertaining to use of radioactive labels.

The disputed languageof claim 1 involves following limitation:

“wherein A comprises at least three carbon atoms and represents atleast one component of a signaling moiety capable ofproducing a detectable signal . . . .”

Procedural History

In 2004, Enzo filed a suitag ainst Applera alleging infringement of six patentsincluding the ’767 patent. After multiple years of litigation in 2012, an appeal to the federal court regarding invalidity issues decided on summary judgment, Enzo I, 599 F.3d 1325 (Fed.Cir.2010). The jury found Applera infringed the claims at issue and awarded $48.6million in damages. In appeal, Applera argued that the district court erred in its claim construction because claims of the ’767 patent only cover indirect detection and alternatively, if the claims cover direct detection, they are invalid for lack of written description andlack of enablement. The Federal Court agreed with Applera and reversed the district court’s claim construction, Enzo II, 780 F.3d 1149, 1150 (Fed. Cir. 2015). The Court concluded that the inventors were claiming only indirect detection and thus, held that “the district court erred in construingthe disputed claims of the patent-in-suit to cover bothdirect and indirect detection”. The Court then remanded the case to the district court to determine whether accused product infringes under proper claim construction. The district court agreed with Applera and rejected doctrine of equivalents argument raised by Enzo. Hence, Enzo Appealed.

Opinion of the Court

Firstly, the Court discussed scope of Enzo II and concluded that the district court correctly interpreted Enzo II. According to the Court, the district court rightly referred to specification of the ’767 patent and opined that specification does not support inclusion of direct detection.

Secondly, the Court discussed doctrine of equivalents. According to Enzo, Applera infringes claims under doctrine of equivalents and the district court “misconstrued” its expert declaration and improperly drew inferences in favor of Applera, rather than Enzo. Further, Enzo asserted that scope of equivalents focused on a particular subset of direct detection.

According to the Court, the district court rightly explained that the patent “describes its method of indirect detection as a superior means of detection as compared to direct detection, with ‘detection capacities equal to or greater than products which utilize’ direct detection”. The Court explained that “the specification provides additional support that claim 1 covers only indirect detection”.

The Court relied on Dolly, Inc. v. Spalding & Evenflo Cos., 16 F.3d 394, 400 (Fed. Cir. 1994), according to which “the concept of equivalency cannot embrace a structure that is specifically excluded from the scope of the claims” and noted that the same principle applies in the present case. “Including direct detection as an equivalent of indirect detection would render meaningless the claim language on which decision in Enzo II was based”. Thus, direct detection cannot be an equivalent of indirect detection in relation to these patent claims.

Conclusion

The doctrine of equivalents is generally considered when a product or process does not literally infringe a patented invention but the product or process contains elements identical or equivalent to each claimed element of the patented invention. Further, an analysis of role played by each element in context of function, way, and result of the claimed element and the product or process is required. In the present case, the court excluded direct detection from the scope of claims by referring to specification of the patent application even when the claims expressly did not exclude direct detection. Thus, the present case is an instance of difficulties pertaining to analysis of doctrine of equivalents and indicates proving doctrine of equivalents as unfeasible.

TAKEDA PHARMACEUTICAL’S PATENT ON CANCER DRUG VELCADE® UPHELD BY THE US COURT OF APPEALS FOR THE FEDERAL CIRCUIT

On July 17, 2017, the United States Court of Appeals for the Federal Circuit ruled that the U.S. Patent No. 6,713,446 (“the ‘446 patent”) covering Takeda Pharmaceutical’s cancer drug Velcade® is valid and enforceable. The appellate court decision overturned an earlier 2015 decision from a US District Court which ruled the ‘446 patent was invalid as the compound it covered was the result of an obvious process. The lawsuit came on the heels of ANDA submissions by generic companies, including Sandoz Inc, Accord Healthcare Inc, and Actavis LLC, to the FDA for a generic version of Velcade® prior to the expiration of the ‘446 patent in 2022.

VELCADE®:

Velcade® (bortezomib) is approved for the treatment of people with multiple myeloma (a cancer of the plasma cells). Velcade® is also approved for the treatment of people with mantle cell lymphoma (a cancer of the lymph nodes). The drug generated U.S. sales of $1.13 billion in 2016.

In 2003, the Food and Drug Administration (“FDA”) granted “accelerated approval” to New Drug Application No. 21-602 for VELCADE® for Injection, for the treatment by intravenous administration of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy. VELCADE® for Injection was subsequently approved in 2005 for treatment by intravenous administration of patients with multiple myeloma who had received at least one prior therapy; in 2006 for treatment by intravenous administration of patients with mantle cell lymphoma who had failed at least one prior therapy; in 2008 for frontline treatment by intravenous administration of patients with multiple myeloma; in 2012 for subcutaneous administration; and in 2014 for treatment of adult patients with multiple myeloma who had previously responded to VELCADE® for Injection therapy and relapsed at least six months following completion of prior VELCADE® for Injection treatment.

The ‘446 patent has been listed in connection with VELCADE® for Injection in the FDA’s Orange Book.

 

US District Court ruling related to VELCADE® patent:

On August 2, 2012, November 19, 2012, and December 21, 2012, Millennium Pharmaceuticals Inc filed patent infringement lawsuits in the United States District Court for the Delaware against Sandoz Inc, Accord Healthcare Inc, and Actavis LLC (collectively, “defendants”) respectively, alleging that the ANDA applications filed by the defendants infringe on claims 20, 31, 49, and 53 of the ‘446 patent. The defendants argued, and the District Court agreed, that asserted claims 20, 31, 49, and 53 of the ‘446 Patent were invalid as obvious.

Millennium Pharmaceuticals Inc, the Takeda Oncology Company, is the exclusive licensee of the ‘446 patent which covers a D-mannitol ester of bortezomib, the active ingredient in Velcade®. This active ingredient is claimed in claim 20 of the ‘446 patent:

[Claim 20] The lyophilized compound D-mannitol N-(2-pyrazine)carbonyl-L-phenylalanine-L-leucine boronate.

Claims 31, 49, and 53 of the ‘446 patent recite method of preparing the D-mannitol ester of bortezomib via lyophilization, a lyophilized cake comprising the D-mannitol ester of bortezomib, and reconstitution of the lyophilized mixture with a pharmaceutically acceptable carrier, respectively.

[Claim 31] The method of claim 23, wherein the compound of formula (1) is D-mannitol N-(2-pyrazine)carbonyl-L-phenylalanine-L-leucine boronate.

[Claim 49] A lyophilized cake comprising the compound of claim 20.

[Claim 53] The method of claim 31 further comprising (c) reconstituting the lyophilized mixture with a pharmaceutically-acceptable carrier.

Bortezomib and its esters were already described and claimed in U.S. Patent No. 5,780,454 (“the ‘454 patent”). The ‘454 patent also identified bortezomib as a very potent, promising lead candidate with the highest in-vivo activity of all the compounds disclosed in the ‘454 patent. The ‘454 patent was considered as the closest prior art document by the defendants as well as the district court.

At trial, the defendants predominately argued that the asserted claims were obvious because the ‘446 patent claims the inherent result of an obvious process-namely, that freeze-drying bortezomib with mannitol produces an ester. Specifically, the defendants argued that lyophilization is a standard formulation option and that one skilled in the art would have chosen lyophilization process in order to stabilize bortezomib. In response, Millennium Pharmaceuticals argued that a person of ordinary skill would avoid lyophilization in developing a formulation involving bortezomib because bortezomib was known to be unstable even in the dry state as a freestanding solid compound. Millennium Pharmaceuticals also argued that a person of ordinary skill would not have expected a lyophilized mannitol ester of bortezomib to provide dramatic improvements in stability, solubility and dissolution as compared to bortezomib. The district court however agreed with the defendants that lyophilization was well-known in the field of formulation and often utilized when a liquid formulation provided limited success, and that the decision to attempt a lyophilized formulation of bortezomib was routine application of a well-known problem-solving strategy. The district court also concluded that mannitol was among the “finite number of identified, predictable solutions” to freeze-drying investigational anti-cancer drugs like bortezomib, and one skilled in the art would have found it obvious to choose mannitol for the lyophilization process. As such, the asserted claims of the ‘446 patent were found invalid under 35 U.S.C. § 103.

 

US Appeals Court reverses the District Court’s obviousness determination:

The US Court of Appeals for the Federal Circuit first analyzed the District Court’s obviousness determination by framing the relevant question as whether a person of ordinary skill, seeking to remedy the known instability and insolubility and to produce an efficacious formulation of bortezomib, would obviously produce the claimed and previously unknown D-mannitol ester of bortezomib. In its analysis, the Federal Circuit found error in the District Court’s obviousness determination because (1) there is no teaching or suggestion in the prior art references to produce the claimed mannitol ester, (2) no reference or combination of references provide a reason to make the claimed mannitol ester of bortezomib, and (3) no reference shows or suggests ester formation at freeze-drying conditions, or that any such ester might solve the problems of instability and insolubility of the free acid while dissociating rapidly in the bloodstream.

The Federal Circuit agreed with the defendants that lyophilization was generally known in formulating pharmaceutical products, bulking agents were known for use in lyophilization, and mannitol was a known bulking agent. However, the Federal Circuit explained that for the compound to be obvious, the prior art must teach or suggest that lyophilization of bortezomib in the presence of mannitol would produce a chemical reaction and form a new chemical compound (i.e. mannitol ester of bortezomib), or provide a reason to make this specific new chemical compound, or describe that this new compound would solve the previously intractable problems of bortezomib formulation. The Federal Circuit also stated that “[a]lthough mannitol was a known bulking agent, and lyophilization was a known method of drug formulation, nothing on the record teaches or suggests that a person of ordinary skill should have used mannitol as part of a synthetic reaction to make an ester through lyophilization.”

With regard to the District Court’s conclusion concerning the unexpected results and commercial success of the lyophilized mannitol ester of bortezomib, the Federal Circuit made the following ruling:

“We conclude that the district court should have treated bortezomib as the closest prior art compound, and acknowledged the unrebutted evidence that the D-mannitol ester of bortezomib exhibited unexpected results compared with bortezomib, including unexpectedly superior stability, solubility, and dissolution.”

 

“The district court clearly erred in attributing Velcade®’s commercial success to bortezomib alone, as bortezomib is not a viable commercial product and had been denied FDA approval because of its instability. The D-mannitol ester was responsible for Velcade®’s successful results, for the D-mannitol ester is necessary to provide the required solubility and stability.”

Accordingly, the Federal Circuit reversed the District Court’s ruling that the asserted claims of the ‘446 patent are invalid due to obviousness. The appellate court’s ruling will help Takeda to put off the risk of generic competition until the ‘446 patent expires in 2

NPDC Supplementary Details

Patents are a major area of business proficiency nowadays and recently in India too, it has become as important as marketing, finance, corporate governance, and manufacturing economics. India’s growing R&D operations have taken a beating due to lack of in-house professionals to file patents applications. Even then, the numbers clearly indicate that there is a great deal of patenting activity going on among companies across India. Patent Specification, besides being the most important document in the entire patent registration procedure, is also considered to be one of the most complex Techno-Legal documents. Drafting of Patent Specification is a device of great importance and thus should not be left to a layman to design it. It is extremely important to use carefully selected language to describe an invention to satisfy requirements both in legal terms as well as in technical terms. Selection of the right words may prove tricky when the draft-person is an amateur. Unclear and indefinite languages used in the specification are always likely to draw competitors, or any person concerned to invalidate or oppose the patent or the patent application. And not only is the language significant, satisfying the requirements of patentability is equally vital.

And here is exactly where the National Patent Drafting Competition (NPDC) plays a crucial role in bringing greater awareness and respect for Patents in a coveted and competitive way. NPDC through its nationwide reach will aim to promote development of Patent Drafting as a Skill Set, encouraging more and more technical people to take up Patent Drafting as a Professional Competency and also identifying and honoring Top Patent Drafters in the Country. This initiative of NPDC comes with an earnest effort by IIPRD, its associates, leading sister Law Firm, Khurana & Khurana IP and Attorneys (K&K) and Sughrue Mion. Other partners serving us in this endeavour are TIFAC, PAAI, Spicy IP, IBLJ and Lex Witness.

NPDC commences on 1st of August 2017, when IIPRD and K&K will put forth on their respective websites (www.iiprd.com and www.khuranaandkhurana.com) three invention disclosures, one each in three different domains (Electronics/ Hi-Tech, Mechanical and Chemistry/Pharmaceuticals). The NPDC will be active till 20th August  2017, within which timeframe, Eligible Participants would need to write Complete Patent Specifications (along with Drawings, if applicable) which complies with the Indian Patent Act. Please note that one participant can file only one Patent Specification which will be one domain of his choice.

Complete details of the modus-operandi of the Competition can also be seen here.

Any Practitioner having a Technical/Science Background is eligible to participate in the Competition. So for instance, the Participant could be a student, a practicing Attorney, an in-house counsel, a scientist, a faculty, or any other stakeholder having a technical qualification.

In order to enable serious participants to submit their specification, a small Participation Fees of INR 1000 (USD 50) is to be submitted by each participant, which can either be paid by means of Bank Transfer or though a DD or a Cheque in favor of “IIPRD”. The Draft should reach IIPRD’s Office by 20th August 2017.

 Drafted Patent Application can be sent to Competition@iiprd.com or can be sent in Hard Copy to IIPRD’s, Greater Noida Office. In either way, drafted patent applications should be received by IIPRD on or before 20th August 2017.

Evaluation of the Drafts would be done collectively by representatives from each International Law Firm and Khurana & Khurana, IP Attorneys, coordinated by IIPRD. Their collective decision on selection of the Winners will stand final and shall not be open to change in any manner. The Winners will be decided based on a combination of numerous factors (such as flow of the Specification, Scope covered through embodiments, Claim drafting strategy and Accurary of technical coverage).

On 1st September 2017, two winners for each technology domain would be announced on the websites of IIPRD and K&K.On around 28th September 2017 (to be confirmed soon), during the 3-Days International Pharmaceutical Patent Conference being organized by IIPRD at Hotel Hilton (Andheri East) Mumbai, prize distribution of the winners would take place form 1700 hrs to 1800 hrs, wherein the first winner for technology domain would be given a price of Rupees One Lakh Only (INR 100000) or USD 2000, and the second winner for each technology domain would be given a prize of Rupees Fifty Thousand Only (INR 50000) or USD 1000.

For any of your query/question, please feel free to write to competition@iiprd.com, and/or call 0120-4296878/2342010 and speak with Mr. R. Srinivas.