Category Archives: Patents

Intellectual Property of Singapore Launches ‘Patents Open Dossier’

In a bid to continue the growth of Intellectual Property regime in Singapore, the Intellectual Property of Singapore (IPOS) has launched the Patents Open Dossier (POD) on July 24, 2017 [1] [3]. The recently launched POD is an online database, which provides a single point of access for individuals/innovators to access published patent documents.

This POD service have been added to and is available on IP2SG, which is the online e-service portal [2] of IPOS, which enables the public with simple access to a collection of selected published patent documents under Section 27 of the Patent Act and which are not restricted for inspection pursuant to Patents Rule 93(4) and 93(5). These documents comprises of Inventor search reports, the office actions and responses for published patent applications lodged on or after 14 Feb 2014 under the positive grant system, among many others [3].

After the launch of POD, individuals are now able to analyze, view, monitor and manage the patent profiles, which are of interest to them. There are several other advantages of this POD, which are:

  • Reduced time and cost for an individual to extract and analyze patent information of their interest;
  • Enabled work sharing between different IP offices via a single platform for search and examination results; and
  • Enhanced transparency of patent system through easy and increased accessibility of file prosecution histories.

Also, as an administrative concession, the individuals will no longer be needed to furnish any published search and examination results established by IPOS under the positive grant system when they file a Patent Prosecution Highway (PPH) request in the Office of Second Filing. The effective date for IPOS to be a participating Office under the initiative will be announced on a later date.

As a central agency in providing its Intellectual Property consultations and networking for the current & future growth of Singapore IP regime, the IPOS remains at the forefront of the latest IP developments happening globally. With the launch of POD, IPOS joins the ranks of the IP5 Offices, namely, the US Patent and Trademark Office (USPTO), European Patent Office (EPO), Japan Patent Office (JPO), Korean Intellectual Property Office (KIPO) and the State Intellectual Property Office (SIPO) that have developed a Global Dossier Initiative with the same purpose [1].

Below is the list of documents that are accessible and available for download on the POD platform [4]:

  1. Search Report
  2. Examination Report
  3. Written Opinion
  4. Search and Examination Report
  5. Written Submission in response to Written Opinion
  6. Examination Review Report
  7. Amendment and Correction of Specification
  8. Amendment and Correction of Abstract
  9. Patents Form and Common Forms (With the exception of Form CM10 and

Form CM12 and their related correspondence)

  1. Notification relating to the request made on Patents Form and Common Forms

(With the exception of Form CM10 and Form CM12 and their related correspondence)

Documents not available on Patents Open Dossier [4] are as below:

  1. Cover Letter
  2. Supporting Documents and Statements
  3. Statutory Declarations or Affidavit
  4. Certificate of grant of patent 

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/media-events/happenings/ViewDetails/launch-of-patents-open-dossier/

[2] https://www.ip2.sg/RPS/WP/CM/SearchSimpleP.aspx?SearchCategory=PT

[3] https://in.linkedin.com/company/ipos-international

[4] https://www.ipos.gov.sg/docs/default-source/resources-library/patents/circulars/(2017)-circular-no-5—launch-of-open-dossier-and-patents-formalities-manual.pdf?sfvrsn=0

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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/

GROUNDLESS THREAT OF PATENT INFRINGEMENT

Introduction

Infringement proceedings involve high costs of litigation in defending the same with the possibility that any temporary injunction granted in the due course thereof would lead to revenue loss, loss of employment and several other impediments to the business. Moreover, embroilment in infringement proceedings or the mere possibility thereof leads to disrepute of the business. Thus, keeping in mind the serious effects and consequences associated with infringement proceedings for which no person should unnecessarily be subjected to baseless threats of infringement, groundless threats of Infringement has been kept as a civil wrong or offence.

Groundless Threat of Infringement

Groundless threat, also connoted to as unjustified/wrongful threat is a threat whereby the owner or any person (depending on the statute) threatens another with legal proceedings without basing the threat on any reasonable basis. IP laws provide protection to the victims of unjustified threats, by preventing the person(s) making the threats from doing the same. Examples of such provisions in IP statutes include Section 60 of the Copyright Act, 1957, Section 142 of the Trademark Act, 1999 and Section 106 of the Indian Patents Act, 1970.

Relief under Patents Act, 1970: –

The Court has the power to grant relief in cases of groundless threat of patent infringement under Section 106 of the Indian Patents Act, 1970. The scope of this provision includes a threat given by any person (who is entitled to or interested in a patent or not)  to any other person by circulars or advertisements or by communication, oral or in writing with proceedings for infringement of a patent. It is important to note that a mere notification of the existence of a patent does not constitute a threat of proceeding within the meaning of this section. The person aggrieved thereby may bring the suit praying for the following reliefs:

  • a declaration to the effect that the threats are unjustifiable;
  • an injunction against the continuance of the threats; and
  • such damages, if any, as he has sustained thereby.

 

LG Electronics India Pvt. Ltd. v. Bharat Bhogilal Patel & Others[1]

 

In this case the plaintiff approached the Hon’ble Delhi High Court on the premise that complaint preferred by Defendant No. 1, Bharat Bhogilal Patel, against the Plaintiff before Defendant No.2, Customs Office, on the basis of which said Customs department is acting upon and interdicting the goods imported by the plaintiff without approaching the Court in accordance with Patents Act, 1970 amounts to groundless threats. The defendant claimed to have obtained a patent in respect of “Process of manufacturing engraved design articles on metals or non-metals”.

Upon receiving show cause notice from defendant no. 2 Customs department, the plaintiff requested for the documents pertaining to the impugned patent and on perusing the same, found that the claims of CS(OS) No.2982/2011 Page No.3 of 10 the impugned patent allegedly lacked novelty as well as any inventive step. Accordingly, plaintiff filed revocation petition before the Intellectual Property Appellate Board (IPAB) challenging validity of the impugned patent. The Customs department continued interdicting the consignments of the plaintiff despite having been informed of the pendency of revocation proceedings. Subsequently, the case came up for hearing and the Court passed interim order in favour of plaintiff, staying the operation of complaint of Defendant No. 2 the Customs office.

Clause 4 of IPR (Imported Goods) Enforcement Rules, 2007: –

“It is pertinent to mention that while the mandatory obligations under Articles 51 to 60 of the TRIPS dealing with border measures are restricted to Copyright and Trade Marks infringement only, the said Rules deal with Patents, Designs and Geographical Indications violations as well, in conformity with the practice prevailing in some other countries, notably EU countries. While it is not difficult for Customs officers to determine Copyright and Trade Marks infringements at the border based on available data/inputs, it may not be so in the case of the other three violations, unless the offences have already been established by a judicial pronouncement in India and the Customs is called upon or required to merely implement such order. In other words, extreme caution needs to be exercised at the time of determination of infringement of these three intellectual property rights”.

Order passed by the Court: –

The Court explained the role of Customs officer in view of clause 4 of IPR rules and under para 95 of the judgement, “I do not agree with the statement made in the written statement by the Defendant No.2 Custom department that unless the stay orders are passed in the Revocation petition, they can proceed with the complaint filed by the owner of patent despite of any merit or demerit in the Revocation proceedings”.

The Court further explained the aspects of groundless threat and stated that “the custom shall act on the notice of the court, therefore if any proprietor or the right holder issues a notice to the custom officials and the custom officials act upon the same by causing restricting the imports of consignments of any party without the determination (prima facie or otherwise) of the factum of infringement of patent by the appropriated designated authority which is civil court under the governing law, then such notice by the right holder to the third party which is customs and the actions thereof by the customs either in the form of notice to that party or otherwise calling upon the party to explain its stand which no such position exists in law are all unnecessary illegal threats to that party”.

Conclusion

From the above discussion, it is clear that complaint to Customs and show cause notice sent by Customs Authority without adjudication of quantum of infringement by Civil Court amounts to groundless threat of patent infringement in light of clause 4 of aforesaid IPR (Imported Goods) Enforcement Rules, 2007.

Authors: Avadhi Joshi and Pratik Das, Legal Interns, Khurana & Khurana, Advocates and IP Attorneys and can be reached at info@khuranaandkhurana.com

References :

[1] 2012 (51) PTC 513 (Del) available at https://indiankanoon.org/doc/48055807/

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

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.

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

Revised Guidelines for Examination of Computer-related Inventions (CRIs)

On 30th June 2017, the Office of the Controller General of Patents, Designs, and Trade Marks (CGPDTM) published Revised Guidelines for Examination of Computer-related Inventions (CRIs) that are applicable with immediate effect. The revised guidelines have replaced the Guidelines for Examination of CRIs, published on 19th February, 2016. The revised guidelines are short and precise as compared with the previous versions and have relaxed the criteria for patentability of the CRIs.

The heart of the 2016 guidelines was a three stage test to examine a CRI application, according to which the Examiners may:

  • Properly construe the claim and identify the actual contribution
  • If the contribution lies only in mathematical method, business method or algorithm, deny the claim
  • If the contribution lies in the field of computer programme, check whether it is claimed in conjunction with a novel hardware and proceed to other steps to determine patentability with respect to the invention. The computer programme in itself is never patentable. If the contribution lies solely in the computer programme, deny the claim. If the contribution lies in both the computer programme as well as hardware, proceed to other steps of patentability.

Therefore, the requirement of a novel hardware was apparent under the three step test laid in 2016 guideline. The revised guidelines have however done away with this test. The revised guidelines focus on substance over form and states:

If, in substance, claims in any form such as method/process, apparatus/system/device, computer program product/ computer readable medium belong to the said excluded categories, they would not be patentable. Even when the issue is related to hardware/software relation, the expression of the functionality as a method is to be judged on its substance. It is well-established that, in patentability cases, the focus should be on the underlying substance of the invention, not the particular form in which it is claimed. The Patents Act clearly excludes computer programmes per se and the exclusion should not be allowed to be avoided merely by camouflaging the substance of the claim by its wording.

The revised guidelines further discuss determination of excluded subject matter relating to CRIs. According to the revised guidelines, it is important to ascertain from the nature of the claimed CRI whether it is of a technical nature involving technical advancement as compared to the existing knowledge or having economic significance or both, and is not subject to exclusion under Section 3 of the Patents Act.

Further, the sub-section 3(k) excludes mathematical methods or business methods or computer programme per se or algorithms from patentability. Computer programmes are often claimed in the form of algorithms as method claims or system claims with some means indicating the functions of flow charts or process steps. It is well-established that, while establishing patentability, the focus should be on the underlying substance of the invention and not on the particular form in which it is claimed.

What is important is to judge the substance of claims taking whole of the claim together. If any claim in any form such as method/process, apparatus/system/device, computer program product/ computer readable medium falls under the said excluded categories, such a claim would not be patentable. However, if in substance, the claim, taken as whole, does not fall in any of the excluded categories, the patent should not be denied.           

Hence, along with determining the merit of invention as envisaged under Sections 2(1) (j), (ja) and (ac), the examiner should also determine whether or not they are patentable inventions under Section 3 of the Act.

Thus, it can be inferred that the revised guidelines focus on substance over form instead of novel hardware requirement. That is, while examining an application its substance is considered and a claim is taken as whole, if it does not fall in any of the excluded categories, the Examiner can proceed with other steps to determine patentability with respect to the invention.

Various stake holders associated with the software industry and Associated Chambers of Commerce & Industry of India (ASSOCHAM) have been lobbying for such a change. ASSOCHAM trough a communication to the Prime Minister’s Office, urged the Prime Minister to bring out appropriate amendments to the 2016 guidelines and simplify the criteria in pursuance of becoming a leading global player in areas of research and development (R&D) and software products.

In the view of the foregoing, it can be concluded that as the CGPDTM has done away with the requirement of novel hardware, the patentability criteria is eased out. This not only facilitates the patentability of CRIs but also attracts big software MNCs and startups to invest in the area of development of software technologies.

About the Author: Ms. Prigya Arora, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys. Can be reached at prigya@iiprd.com

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.

Exclusions in Patentable Subject Matter in Malaysia

Malaysia’s Patent Act similar to other countries jurisdictions excludes certain subject matter from protection under patent. Such subject matter is defined under section 13(1) of Malaysia’s Patent Act.

The Malaysian patent law uncovers some of the non-patentable subject matter relevant to the life sciences industry in Malaysia. This non-patentable subject matter in Malaysia affects the life sciences industry. Some of the related examples are: discoveries and scientific theories; plant or animal varieties or essentially biological processes for the production of plants or animals; methods of treatment of human or animal body by surgery or therapy, and diagnostic methods practiced on the human or animal body. [1]

The Malaysian IP office (MyIPO) for its Interpretation and application of sections 13(1)(a) and 13(1)(b)  is highly influenced by European Patent Convention (EPC) 2000 and European guidelines for the lawful protection of biotechnological inventions.

Section 13(1)(a)

It relates in general to discoveries. Although, Malaysian patent law does not provide protection for discovery of new species, but it is possible to protect the composition/methodology of an extract obtained from new species, if it fulfills the patentability requirements.[2]

Section 13(1)(b)

It states that flora or fauna varieties or essentially biological processes for their production, other than man-made living microorganisms as well as microbiological processes and products of such processes, cannot be patented. To provide protection for new plant species, likely to Europe, Malaysia has also followed a “sui generis system”. Thus, since October 2008, the “Protection of New Plant Varieties Act 2004” is in force. [2] [3]

Practical observation on MyIPO’s interpretation and application under section 13(1)(b) in lieu with animal varieties shows that it is highly influenced by European Patent Convention 2000 and the directive 98/44/EC. [2]

Solutions

EPC 2000 provisions were followed by MyIPO to interpret and apply the provisions of section 13(1)(d) for treatment and diagnosis methods which would be beneficial for the pharmaceutical and medical. The section 13(1)(d)’s subject matter interpretation for exemption under protection has been expanded in Chapter IV, point 3.5 of MyIPO’s Guidelines for Patent Examination (October 2011).

Under section 13(1)(d), it’s been stated that all non-therapeutic treatment methods are patentable whereas surgical or therapy based treatment methods are exempted from protection. It covers all the cosmetic methods and methods which are practiced on human or animal body. Cosmetic methods includes straightening/waving of hair or any other cosmetic application on human body for the cosmetic purpose. [4]

Additionally, technical methods of measuring/recording human characteristics which have an industrial application can also be protected under MyIPO. MyIPO doesn’t allow the biological characters to be patentable. For example, artificial manufacturing of prosthetic limbs, different diagnostic scanning approaches are allowed to be protected under law. Furthermore, diagnosis approaches which involve alive organism for analyzing information that produces intermediate results and does not directs a treatment decision also patentable. [4] [5]

Similar to EPO, MyIPO believes the theory that curing any disease is same as its treatment by therapy, based upon this theory MyIPO excludes the prophylactic methods from the patentable subject matter. [3] [4]

Rooted from European Patent Convention provisions, MyIPO does not exempt apparatuses used in treatment or diagnosis from a patentable subject matter which implies that surgical, therapeutical or diagnostic equipments can be claimed. Through this insight, substances/compositions used for treating a disease if claimed are patentable. [2] [4]

Inspite of the fact that generally “treatment methods” claims are not patentable in Malaysia, still it’s possible to acquire protection over such methods through Malaysian IPO. Malaysian IPO permits to pursue patent over few types of purpose-limited products. These purpose limited products uses medical usage of claims. [4]

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

REFERENCES

[1] Ramachandran, Sumah. “PATENT PROTECTION IN MALAYSIA – A BASIC GUIDE.” PATENT PROTECTION IN MALAYSIA (n.d.): n. pag. http://www.bioeconomycorporation.my. BIOTECHCORP, 23 Dec. 2011.

[2] Office, European Patent. “The European Patent Convention.” Article 53 – Exceptions to Patentability – The European Patent Convention, Convention on the Grant of European Patents – (European Patent Convention), Part II – Substantive Patent Law, Chapter I – Patentability. Espacenet, n.d.

[3] “Malaysia.” Malaysia: Protection of New Plant Varieties Act 2004 (Act 634). WIPO, n.d. Web.

[4] Rights, Journal Of Intellectual Property, and Asif E. “Exclusion of Diagnostic, Therapeutic and Surgical Methods from Patentability.” Exclusion of Diagnostic, Therapeutic and Surgical Methods from Patentability 18.May 2013 (2013): 242-50. Journal of Intellectual Property Rights, 8 Apr. 2013.

[5] RAMACHANDRAN, Suman. “PATENT REGISTRATION PROCEDURE IN MALAYSIA.” BIOTECHCORP, 10 July 2009. Web.