Category Archives: Patents

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/

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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.

IPOPHL unanimously recommended for appointment as International Authority on Patent

The Intellectual Property Office of the Philippines (IPOPHL) has received unanimous international endorsement to be designated as an International Searching Authority and International Preliminary Examining Authority[1] (ISA/) under the Patent Cooperation Treaty, an agreement administered by the World Intellectual Property Organization (WIPO).

In her presentation, IPOPHL Director General Josephine Santiago noted that the IPOPHL has satisfied the requirements for designation as ISA/IPEA. The IPOPHL has[2]:

  • 110 full-time patent examiners adequately trained in search and examination;
  • full access to the minimum documentation, which include publicly available and propriety databases, such as Thomson Innovation, WIPS Global Database, EPOQUENet, among others;
  • patent examiners skilled in conducting search and examination in the required technical fields in English, one of the official languages of the PCT system;
  • a Quality Management System and stringent internal review mechanisms, including in-process quality checks, 3-person team for search report and written opinion, adoption of patent quality manual.

Santiago said[3] the Office has the competence to conduct patent prior art searches and preliminary examination of international patent applications filed under the PCT. In addition, she presented the administrative, operational and infrastructure reforms undertaken by the IPOPHL in preparation for its ISA/IPEA application and the innovative agenda and institutional partnerships of IPOPHL in support of the designation. Santiago cited the vivacious Philippine economy and the country’s achievement of having a highly successful network of Innovation and Technology Support Offices or ITSOs and universities, which becomes a potential source of patent filings. Santiago also highlighted another promising development during her presentation, which being the recent ranking of the Philippines by the UN Conference on Trade and Development (UNCTAD), being among the top 15 preferred investment destinations of multinational enterprises.

The Working Group on Patent Cooperation Treaty (PCT), sitting as Committee on Technical Cooperation (CTC), reviewed the IPOPHL’s application and unanimously endorsed it for approval by the PCT Union Assembly during the General Assembly of the WIPO Member States in October 2017.[4]

The Patent Cooperation Treaty is an international treaty that allows patent applicants to file a single application in one intellectual property office and seek protection in multiple countries. The Philippines is seeking designation as an ISA/IPEA under the treaty. There are only 22 ISAs/IPEAs worldwide.

If appointed, the IPOPHL will become the 23rd ISA/IPEA, and the 2nd in the ASEAN region. The Philippines is one of the founding members of ASEAN, which is commemorating its 50th Anniversary this year.

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

References

[1] Application made by IPOPHL was reviewed and endorsed by the Working Group (sitting as Committee on Technical Cooperation) on PCT.

[2] News5-InterAksyon. “IPOPHL unanimously endorsed for appointment as international authority on patent”. interaksyon.com. http://beta.interaksyon.com/ipophl-unanimously-endorsed-for-appointment-as-international-authority-on-patent/. (accessed 18th May, 2017)

[3] S. Sausa, Raadee. “IPOPHL endorsed as global authority on patents”. manilatimes.net. http://www.manilatimes.net/ipophl-endorsed-global-authority-patents/326961/ (accessed 18th May, 2017).

[4] Mercurio, Richmond. “Philippines seek status as international authority on patent”. PhilstarGlobal. http://www.philstar.com/business/2017/05/13/1699295/philippines-seeks-status-international-authority-patent (accessed 30th May 2017)

Patent Filing Procedure: Vietnam

Step 1: Filing:

  • Who may apply: Article 86 and 89:
  • Authors who have created inventions with their own efforts and expenses
  • Organizations or individuals who have supplied funs and material facilities to authors in the form of job assignment or hiring unless otherwise agreed by the involved parties.
  • Foreign nationals residing permanently
  • Foreign organizations having a production or trading establishment
  • Non-resident foreign nationals or organizations not having a production or trading establishment shall apply through a lawful representative.
  • Documents required: Section 100
  • Declaration for registration in the prescribed form
  • Documents, samples and information identifying the invention
  • Power of attorney (if applied through representative)
  • Documents evidencing the registration right if such right is acquired by another person
  • Documents evidencing the priority right, if it is claimed
  • Vouchers of payment of fees and charges
  • A copy of the first application certified by the registration office
  • Requirements of the registration application:
  • Description of the invention, along with scope of protection
  • The scope of protection must be described in the form of technical combinations which are necessary and sufficient to identify the scope of rights to such inventions, and compatible with the description and drawings (if any)
  • Abstract, disclosing the principal features
  • Fully and clearly disclosing the nature of the invention to the extent that such invention may be realized by a person with average knowledge in the art
  • Briefly explaining the accompanied drawings, if any
  • Clarifying the novelty, inventive step and susceptibility of industrial application of the invention
  • Filing Date: Article 108:
  • All applications shall be received by the State administrative authority.
  • The filing date shall be the one on which the application is received by the state administrative authority.
  • First to file: Article 90:
  • Where two or more applications are filed by several people to register the same invention, protection may only be granted to the valid application with the earliest date of priority or filing date among the applications that satisfy all the requirements.
  • Vietnam is a member of PCT, hence international applications are also accepted.
  • Filing fees:
  • Filed in paper form without digital database of the whole content of the application: 180 thousand VND.
  • Filed in paper form with digital database of the whole content of the application: 150 thousand VND.
  • Filed online: 100 thousand VND.
  • PCT filing, excluding fees and charges collected by the international bureau: 500 thousand VND.

Step 2: Examination:

  • The application shall be examined within 1 month from the filing date (Article 119).
  • Formal Examination: Article 109:
  • To verify the formal validity of the application, an examination process shall be conducted.
  • Substantive Examination: Article 119:
  • 12 months from the date of publication of invention. If a request for substantive examination is filed before the date of application publication, or from the date of receipt of a request for substantive examination if such request is filed after the date of application publication
  • Invalidity in the following circumstances:
  • The applicant does not fulfil the requirements of formality;
  • The subject matter of the application is not eligible for protection;
  • The applicant does not have the right to registration;
  • The application was filed in contrary to the mode of filing;
  • The applicant fails to pay the fees and charges.

Step 3: Acceptance/ Refusal:

  • The application for registration may be accepted with or without amendments.
  • Until the notice of refusal by the State administrative authority, the applicant shall have the following rights:
  • To make amendment or supplement to the application;
  • To divide the application;
  • To request for recording changes in name or address of the applicant;
  • To request for recording changes in the applicant as a result of assignment under the contract, as a result of inheritance, bequest, or under a decision of an authority;
  • Any amendment or supplement to an industrial property registration application must not expand the scope of the subject matter disclosed or specified in the application and must not change the substance of the subject matter claimed for registration in the application and shall ensure the unity of the application.
  • Fee for amending applications, including for request of supplement, separation, assignment, change (per each amendment/ application): 120 thousand VND.
  • Refusal: Article 117:

Refusal to register an application may be on the following grounds:

  • The subject matter claimed in the application does not fulfil the protection requirements;
  • The application satisfies all the conditions for the issue of a protection title but is not the application with the earliest filing date or priority date as in the case referred to in Article 90.1 of this Law.
  • The application falls within the cases referred to in Article 90.1 of this Law but a consensus of all the applicants is not reached.
  • The State administrative authority shall serve a notice of an intended refusal to grant a Protection Title, in which the reasons are clearly stated with a set time limit for the applicant to oppose to such intended refusal.
  • The State administrative authority shall serve a notice of the refusal to grant a Protection Title if the applicant has no objection or has unjustifiable objection to such intended refusal.

Step 4: Publication:

  • Article 110: An industrial property registration application which has been accepted as being valid by the State administrative authority shall be published in the Industrial Property Official Gazette.
  • An invention registration application shall be published in the 19th month as from the filing date or the priority date, as applicable, or at an earlier time at the request of the applicant.
  • Fee for publication of application, including application for amendment, supplement, separation, assignment (each application): 120 thousand VND.
  • The application for registration shall be examined as to its substance within 6 months from the date of its publication.
  • Charge for substantive examination of application (for each group of six products/services) – without information searching charge: 420 thousand VND.

Step 5: Protection Title:

  • Article 93 stipulates the validity of the protection titles:
  • It is valid throughout the territory of Vietnam.
  • The registration of Patent shall be valid up to 20 years from the date of filing. Their validity commences on the date of grant of protection.
  • Rights accruing after registration: Article 122 and 123:
  • Moral Rights:
  • To be named as authors in invention or utility patents
  • To be acknowledged as authors in documents in which inventions are published or introduced.
  • Economic rights:
  • Owners of inventions are obliged to pay remuneration to their authors, unless otherwise agreed by the parties.
  • Minimum level of remuneration:
  • 10% of the profit amount gained from the use of invention
  • 15% of the total amount received by the owner in each payment for licensing of an invention
  • To use or permit others to use the industrial property object in accordance with Article 124 and Chapter X of the law (Transfer of rights: Assignment and Licensing):
  • Manufacturing the protected product
  • Applying the protected process
  • Exploiting utilities of the protected product or the product manufactured under the protected process
  • Circulating, advertising, offering, stocking for circulation the product
  • Importing the product
  • To prohibit others from using the industrial property object in accordance with Article 125 (Right to prohibit others from using industrial property objects).
  • To dispose of the industrial property object in accordance with Chapter X of this Law (Transfer of rights: Assignment and Licensing).

Biological Diversity Act, 2002 and Patenting of Biological Inventions in India – Part I (Section – 6)

The Biological Diversity Act of 2002 (BDA) is a piece of Indian legislation which came into being in response to compliance with the Convention on Biological Diversity (CBD), to which India is a ratified member. In fact, India has taken the lead among developing and developed nations both in introducing a substantive legislation in conformance with the objectives of the CBD.

The objective of the BDA is broadly to conserve India’s biological diversity, ensure sustainable use of its biological resources, and ensure equitable sharing of benefits arising out of use of its biological resources. Though the BDA came into being in 2002, it was only in 2004 when the Rules were notified, hence, for all practical purposes, the effective implementation date of the BDA is 2004.

The BDA, in general, quite broadly covers access and use of biological resources occurring in India or knowledge associated thereto for various purposes, be it for research or commercial activity, by Indian citizens or non-citizens alike, in India or abroad.

Recognizing the importance of IPR, the BDA makes special mention of the application of the provisions of the BDA to IPR in Section 61. A careful reading of Section 6 reveals the truly wide mandate of the BDA with regard to IPR. Firstly, it is to be noted that Section 6 is not limited to Indian citizens or Indian residents (as defined in the Income Tax Act, 1961). The term “no person” used in Section 6, sub-clause 1 can be broadly interpreted to include any natural or legal person irrespective of nationality. Secondly, the application of the law is extra-territorial in that it is applicable upon IPR laws of other foreign countries also. Thirdly, it is interesting to note that the scope of the said section is not merely limited to biological material “occurring” in India. In fact, the term used is “obtained” from India, which is suggestive in its broadest implication that even exotic material would be within the ambit as long as it is obtained from India.

The language of Section 6 of the BDA leaves open a lot of questions, many of which have no definitive answers due to lack of any judicial precedents established by the judiciary of India. For instance, Section 6 states that permission of the NBA is required when IPR is applied for research or information based on a biological resource obtained from India. There is lack of clarity as to how the NBA will construe the scope of “obtained”? As the objective of the NBA is to safeguard Indian biodiversity, will “obtaining” be limited to only those biological resources which are literally sourced from within India? What about Indian biological material sourced in India but subsequently exported, and obtained elsewhere (outside of India)? Alternatively, does the term “obtained” necessarily mean that the biological resource shall also be found to be “occurring” in India? Does “occurring” mean only indigenous biological resources which are sufficiently distinct compared to their foreign counterparts? Or will it include biological resource of foreign origin which is also found in India regardless of any distinctive trait? How does one determine any time frame after which a biological resource can be considered to be “occurring” in India?

In another instance, Section 6 clearly states that no application for IPR rights is to be filed in any foreign country without prior NBA approval. The first proviso provides that in the event an application is filed, NBA permission may be obtained after the acceptance of the patent but before patent grant by the patent authority concerned. An obvious question here is whether the foreign patent office is legally bound to keep the patent grant in abeyance until NBA approval is provided?

In yet another instance, as per Section 6, the term “no person” is used. While it is clear that the term includes any Indian citizen, or a resident of India (as defined in the Income Tax Act, 1961), does it cover a foreign national operating outside India? A casual reading of the statute would suggest so, however, it puts an unnecessary burden on such a particular group to comply with Indian laws, which they may be contravening without their knowledge! This would make the jurisdictional reach of Act worldwide, whereas Section 1(2) clearly states that the Act extends to the whole of India and not elsewhere!

The definition of “biological resource” can be found in Section 2(c)2 of the BDA. It may be appreciated that the definition is quite broad, while specifically excluding value added products3 and human genetic material. It is quite clear from the definition in Section 2(c) that the legislation is principally directed towards patenting of biological inventions, which puts an additional burden, largely regulatory in nature, on the Applicant to comply with.

The gravity of non-compliance with Section 6 of the BDA can be appreciated from Sections 55(1)4, 575 and Section 586 of the Act. Briefly, under Section 55(1) and 57, the punishment for contravention of Section 6 is imprisonment for a term of up to 5 years, or a fine of up to INR 10,00,000 or more, or both. Under Section 58, such offences are cognizable and non-bailable. This is of particular significance in that the police, upon a complaint, can arrest the person concerned without prior Judge order, and bail is not a matter of right, but at the discretion of the Judge!

Under current Indian Patent Office (IPO) practice, it is observed that for patent applications, which disclose any biological material, in the First Examination Report (FER), it is almost routine to come across an objection requiring clarification as to furnishing of NBA approval in the case of use of any biological resource obtained from India. As mentioned previously, as per Section 6 of the NBA, grant of the patent would be kept in abeyance until proof of NBA approval is provided.  It should be pointed out that for patenting purposes, the application of provisions of the NBA as per the IPO is not limited merely to claimed biological resource. Instead, it encompasses use of any such resource or knowledge thereof in any part of the application. For instance, use of any biological resource for validation purposes of a claimed product would fall within the ambit of NBA!

In the case of national phase or convention applications deriving priority from a foreign country, typically a declaration may be provided stating that no biological resource obtained from India has been used in the invention. Understandably, it may be difficult for an Indian applicant to do so.

Interestingly, it is to be noted while the IPO does not require evidence of compliance with any other law of the land prior to grant of patents, it particularly requires compliance with the BDA! This “cooperation” between the IPO and the NBA is admirable in that it represents a cooperation between two different ministries, namely, The Ministry of Environment and Forests under which the NBA is a statutory autonomous body, and The Ministry of Commerce and Industry (Department of Industrial Policy & Promotion, under which the Office of the Controller General of Patents, Designs & Trademark functions.

In conclusion, under current IPO practice regime, any Applicant using any biological resource (as defined under Section 2(c) of the BDA) is suggested that he seek NBA clearance at the earliest instance in order to ensure a timely and smooth prosecution progress.

In the next part of this article, provisions of the BDA with respect to access of biological resources by Indian citizens or non-citizens, and sharing of research results generated from such biological resources will be elucidated and discussed.

About the Author: Amitavo Mitra, Sr. Patent Associate at Khurana & Khurana, Advocates and IP Attorneys. Can be reached at amitavo@khuranaandkhurana.com.

1Section 6 of BDA: (1)“ 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 seating of tile patent by the patent authority concerned

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”.

(2) “The National Biodiversity Authority may, while granting the approval under this section, impose benefit sharing fee or royalty or both or impose conditions including the sharing of financial benefits arising out of the commercial utilization of such rights”.

(3) “The provisions of this section shall not apply to any person making an application for any right under any law relating to protection of plant varieties enacted by Parliament”.

(4) “Where any right is granted under law referred to in sub-section (3), the concerned authority granting such right shall endorse a copy of such document granting the right to the National Biodiversity Authority”.

2Section 2(c) of BDA: “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.

3Section 2(p) of BDA: “value added products” means products which may contain portions or extracts of plants and animals in unrecognizable and physically inseparable form.

4Section 55(1) of BDA: “Whoever contravenes or to or abets the contravention of the provisions of section 3 or section 4 or section 6 shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to ten lakh rupees and where the damage caused exceeds tend lakh rupees such fine may commensurate with the damage caused, or with both”.

5Section 57 of BDA: (1) “Where an offence or contravention under this Act has been committed by a company, every person who at the time the offence or contravention was committed was in charge of, and was responsible to, the company for the conduct of the business of the company, as well as the company, shall be deemed to be guilty of the offence or contravention and shall be liable to be proceeded against and punished accordingly: Provided that nothing contained in this sub-section shall render any such person liable to any punishment provided in this Act, if he proves that the offence or contravention was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such offence or contravention”.

(2) “Notwithstanding anything contained in sub-section (1), where an offence or contravention under this Act has been committed by a company and it is proved that the offence or contravention has been committed with the consent or connivance of, or is attributable to, any neglect on the part of any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of the offence or contravention and shall be liable to be proceeded against and punished accordingly.

 

6Section 58 of BDA: “The offences under this Act shall be cognizable and non-bailable”.