Tag Archives: patent

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

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WORK PLAN FOR BILATERAL COOPERATION IN 2017-2019

WORK PLAN FOR BILATERAL COOPERATION IN 2017-2019

BETWEEN

THE NATIONAL COMMITTEE FOR INTELLECTUAL PROPERTY

RIGHTS (NCIPR)/MINISTRY OF COMMERCE (MOC)

OF THE KINGDOM OF CAMBODIA

AND

THE STATE INTELLECTUAL PROPERTY OFFICE OF THE PEOPLES REPUBLIC OF CHINA

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

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

  1. Objective

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

  1. High-Level Dialogues

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

  1. Training

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

  1. Exchange of Documentation and Information

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

  1. Information Exchange & IT systems

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

  1. Exchange of Information

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

  1. Expenses

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

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

References :

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

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

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

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

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

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

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

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

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

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

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

(a)    Value-added   product

(b)       Bio- wastes

(c)        Synthetically prepared biological material

(a) Value Added Product:

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

As per Biological Diversity Act, 2002:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Background

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

The disputed languageof claim 1 involves following limitation:

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

Procedural History

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

Opinion of the Court

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

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

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

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

Conclusion

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

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

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

VELCADE®:

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

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

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

 

US District Court ruling related to VELCADE® patent:

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

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

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

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

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

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

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

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

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

 

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

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

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

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

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

 

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

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

NPDC Supplementary Details

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

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

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

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

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

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

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

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

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

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

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)

Teva held responsible for Induced Infringement of Eli Lilly’s Blockbuster drug ALITMA

In Teva Parenteral Medicines, Inc.; APP Pharmaceuticals LLC; Pliva Hrvatska D.O.O.; Teva Pharmaceuticals USA, Inc.; and Barr Laboratories, Inc. (hereinafter referred to be as Defendants/Appellants/Teva) Vs. Eli Lilly & Co. (hereinafter referred to as Plaintiff/Appelle/Eli Lilly) decided by United States Court of Appeals for the Federal Circuit (CAFC) on January 12, 2017, Plaintiff had filed Hatch Waxman suit against defendant to prevent them from launching generic version of the lung cancer drug whose rights are reserved with the plaintiff. The decision from CAFC came after an appeal from the United States District Court for the Southern District of Indiana in No. 1:10-cv-01376-TWPDKL, Judge Tanya Walton Pratt.

Eli Lilly owns a patent US 7772209 (hereinafter referred to as US‘209) issued in 2010, relating to method of treatment administering the chemotherapy drug pemetrexed disodium (hereinafter referred to as “pemetrexed”) (used to treat certain types of lung cancer and mesothelioma) after pretreatment with two common vitamins—folic acid and vitamin B12 (reduce the toxicity of pemetrexed in patients). Eli Lilly markets pemetrexed under the brand name ALIMTA®.

In 2008-2009, Defendants notified Eli Lilly that they had submitted ANDA seeking approval to market generic version of ALIMTA®. After issuance of US’209 patent, Teva sent additional notice that they had filed Para IV certifications, declaring that US’209 patent was invalid, unenforceable, or would not be infringed. Subsequent to which Eli Lilly alleged Teva of induced infringement. Eli Lilly asserted that Teva’s generic drug would be administered with folic acid and vitamin B12 pretreatments and thus will result in infringement of the 209 patent.

Eli Lilly asserted claims 9, 10 (dependent on claim 1), Independent claim 12, and its dependent claims 14, 15, 18, 19, and 21 of the US’209 patent at trial.

Independent claims 1 and 12 have been reproduced below for reference:

Claim 1:

A method of administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.

Claim 12:

An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:

  1. a) administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;
  2. b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and
  3. c) administration of pemetrexed disodium.

It is important to note that current case involves issue of induced infringement i.e. a type of indirect infringement that may be committed under section 271 (b) (dealing with infringement of Patents).

In June 2013, Defendants conditionally conceded induced infringement under then-current law set forth in Akamai Technologies, Inc. v. Limelight Networks, Inc. (Akamai II) which at that time was the subject of a petition to the Supreme Court for a writ of certiorari. The parties’ stipulation included a provision reserving Defendants’ right to litigate infringement if the Supreme Court reversed or vacated Akamai II.

District court had rejected contentions of the defendant that Patent was invalid for obviousness or obviousness-type double patenting and also due to indefiniteness of the term vitamin B12.

Defendants filed an appeal on invalidity. While that appeal was pending, the Supreme Court reversed Akamai II, holding that liability for inducement cannot be found without direct infringement, and remanding for CAFC court to possibly reconsider the standards for direct infringement. In view of that development, the parties in this case filed a joint motion to remand the matter to the district court for the limited purpose of litigating infringement. CAFC granted the motion.

The district court held a second bench trial in May 2015 and concluded in a decision issued on August 25, 2015 that Defendants would induce infringement of the US’209 patent. This was after considering the effect of Akamai V decision, which had broadened the circumstances in which others’ acts may be attributed to a single actor to support direct infringement liability in cases of divided infringement.

Defendants appealed.

Below given factors are taken into consideration while deciding cases of induced infringement:

  • Whoever actively induces infringement of a patent shall be liable as an

Infringer;

  • There cannot be indirect infringement without direct infringement;
  • Patentee needs to prove alleged infringer knew or should have known his actions would induce actual infringements; and
  • Standard of proof required by Patentee to claim relief under induced infringement is ‘preponderance of the evidence’.

It was agreed by parties that Defendants’ proposed product labeling would be materially the same as the ALIMTA® product labeling and consists of two documents: the Physician Prescribing Information and the Patient Information. District court found that both the documents included instructions regarding the administration of folic acid—the step that the district court found would be performed by patients but attributable to physicians.

According to Akamai V, where no single actor performs all steps of a method claim, direct infringement only occurs if the acts of one are attributable to the other such that a single entity is responsible for the infringement. The performance of method steps is attributable to a single entity in two types of circumstances:

  • when that entity “directs or controls” others’ performance, or

 

  • when the actors “form a joint enterprise.”

In Akamai V, CAFC had held that directing or controlling others’ performance includes circumstances in which an actor:

(1) “conditions participation in an activity or receipt of a benefit” upon others’ performance of one or more steps of a patented method, and

(2) “establishes the manner or timing of that performance.”

District court found taking folic acid in the manner recited by the asserted claims is a critical and necessary step to reduce potentially life threatening toxicities caused by the Pemetrexed amounts to receive the benefit of the patented method.

Regarding first of the two pronged test, the court found, based on the product labeling, that taking folic acid in the manner specified is a condition of the patient’s participation in the Pemetrexed treatment. Regarding the second prong, the court found that physicians would prescribe an exact dose of folic acid and direct that it be ingested daily. Hence court held all steps of the asserted claims would be attributable to physicians.

Court further observed that the mere existence of direct infringement by physicians, while necessary to find liability for induced infringement, is not sufficient for inducement but there has to be also specific intent and action to induce infringement. Court went on to find intent on the part of physician for the inducement and held that there was no error in district court’s decision. Some important observations of court have been mentioned below.

CAFC made two important observations as below:

  • The intent for inducement must be with respect to the actions of the underlying direct infringer, here physicians.

 

  • Second, it is not required to show evidence regarding the general prevalence of the induced activity. When the alleged inducement relies on a drug label’s instructions, the question is not just whether those instructions describe the infringing mode,..but whether the instructions teach an infringing use such that we are willing to infer from those instructions an affirmative intent to infringe the patent. Court further observed that the label must encourage, recommend, or promote infringement and it is irrelevant that some users may ignore the warnings in the proposed label.

Court went on to observe a label that instructed users to follow the instructions in an infringing manner was sufficient even though some users would not follow the instructions, but vague instructions that require one to look outside the label to understand the alleged implicit encouragement do not, without more, induce infringement.

On the issue of invalidity on the indefiniteness of the term “vitamin B12”, CAFC hold that a person of ordinary skill in the art would understand the scope of the claim term “vitamin B12” with reasonable certainty. Applying Nautilus (outcome of this decision) in this case did not lead CAFC to a different result from the district court’s conclusion on the question of indefiniteness.

Regarding issue of invalidity due to obviousness, CAFC was not convinced that the district court committed clear error in concluding that Defendants failed to carry their burden of proving that it would have been obvious to a person of ordinary skill to use vitamin B12 pretreatment to reduce Pemetrexed toxicities.

Thus CAFC affirmed district court decision.

About the Author :  Ms. Rashmi Goswami, WOS-C at TIFAC, intern at Khurana and Khurana, Advocates and IP Attorneys and can be reached at swapnil@khuranaandkhurana.com

Analysis of the rejection of Lumacaftor (Polymorph) patent application in India

We have been receiving requests from our Pharma clients/readers of the blog for the analysis of the decision/ facts that led to rejection of Lumacaftor (Polymorph) patent application in India since last year.

Here is our take:

Details of the Patent Application and important dates:

Patent application number in India 2056/KOLNP/2010
Title of the invention SOLID FORMS OF 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL) BENZOIC ACID
Applicant VERTEX PHARMACEUTICALS INCORPORATED
International application number/ International filing date PCT/US2008/08545/

 

04/12/2008

Priority Application Number/ Priority date US61/012,162

 

07/12/2007

National phase Filing date 04/12/2008
Publication date 03/09/2010
Request for examination date 25/11/2010
Pre-Grant Opposition under section 25 (1) 19/02/2011
First examination report Date 20/08/2014
Date of communication of outstanding objections 01/03/2016
Date of hearing after failure to put the application in condition of allowance 18/03/2016
Date of decision of rejection 31/03/2016

Application Area:

Lumacaftor is given with another active ingredient Ivacaftor in the treatment of cystic fibrosis which is caused by F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Facts of the case:

First Examination Report (FER) was issued on 20/08/2014 which not only objected claims based on the prior arts cited in International Preliminary Report on Patentability (IPRP) corresponding to PCT application but also used section 3 (d), 3 (i), 3 (n) of the Patents Act, 1970, and procedural grounds for objection.

As the FER was issued on 20/08/2014 (before 16/05/2016), period of twelve months was allowed to put the application in condition of allowance. Controller found the application not to be in condition of allowance even after 12 months and communicated the objections on 01/03/2016. Finally, hearing was held on 18/03/2016.

As reported in the decision of controller dated 31/03/2016, “There were nine (09) objections mentioned in the hearing letter including major technical objections on the grounds of novelty, inventive step and non-patentability of the claimed subject matter u/s 3(d) of the ‘Act’.”

Section 3 (d) has been reproduced below for the reference:

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

Analysis of the rejection decision:

Dr. I. S. Bhattacharya, attorney of the applicant, who attended the hearing, relied on the technical data filed as affidavit along with reply statement in respect of pre-grant opposition already filed under section 25(1) for the instant application to argue that form 1 of Lumacaftor ought to be considered be Novel and Inventive. She asserted that better pharmacokinetic properties / superior bioavailability of the formulation of claimed polymorphic Form I compared to the hydrochloride salt of the compound were enough to win the Patent.

Controller in response declined to accept the arguments on the ground ‘Anything beyond the disclosure of complete specification is not acceptable’ as the technical data was not part of the complete specification yet. The technical details were also rebuffed on the ground that different pharmacokinetic properties / superior bioavailability results were natural results of comparison of Form I (free solid) with hydrochloride salt of the same compound. He further opined that better bioavailability does not necessarily lead to better efficacy.

Based on these grounds, controller went on to reject the Patent Application under section 15.

Controller also took into consideration the pre-grant opposition that had also been filed under section 25(1) by Indian Pharmaceuticals Alliance, Mumbai for the instant application. Controller did not conduct a separate hearing under section 25 (1) as the grounds and prior arts were incorporated in the hearing letter and were heard on 18/03/2016. Controller accepted the petition under section 25 (1) while refusing the grant of the patent application no. 2056/KOLNP/2010.

Reference:

http://ipindiaservices.gov.in/decision/2056-KOLNP-2010-16971/2056-KOLNP-2010.pdf