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

Obtaining a Certificate of Recognition from DIPP for IPR benefits

“A start-up would now require only a certificate of recognition from the Department of Industrial Policy and Promotion (DIPP) and would not be required to be examined by the inter-ministerial board, as was being done earlier. This is one rapid change that we have brought in,” said  Nirmala Sitharaman, Minister of Commerce and Industry in New Delhi at the ‘Start-up India States’ Conference’ in  2016.

This has been done to improve the ease of doing business by entrepreneurs, when earlier there was a complex and elaborate process of approaching the inter-ministerial board to procure the IPR benefits. After May 16, 2016, Start-Ups have been made eligible for expedited examination of Patent Applications.

This post particularly discusses the procedure of obtaining a ‘Certificate of Recognition’ from Department of Industrial Policy and Promotion (DIPP) before and after filing the Application of Patent.

Procedure to be followed varies depending on whether Start-Up has applied for Patent (and the application is published) or has not applied yet.

Type 1:

The procedure below is only for applicants who have NOT filed the application of patent.

The Application form is available on http://www.startupindia.gov.in/registration.php

Click on Startup India Services > Startup Recognition > Application.

  1. Fill the required information regarding the following ;
      a. Name of the Entity;
      b. Nature of the Entity – Private Limited Company/Limited Liability Company/Registered Partnership
      c. Incorporation/Registered No.
      d. Date of Incorporation/Registration
      e. Address of Registered Office
      f. Details of authorized representative
      g. Details of Directors/Partners
  2. Either of the following supporting documents are required to be filed in the Application for the Certificate.
      a. Letter of Recommendation, in a form specified by the DIPP from an incubator recognized by Government of India  ;or
      b. Letter of support by any incubator which is funded, in relation to the project, from Government of India or State Government as a part of specified scheme to promote innovation ; or

A panel of facilitators has been constituted for providing assistance and support in filing applications for Intellectual Property Rights (IPR), wherein, Department of Industrial Policy and Promotion (DIPP) would bear the facilitation cost. The list of the Incubators is available on ; –http://startupindia.gov.in/uploads/pdf/List_of_facilitators_for_patents.pdf

      c. Letter of Recommendation, in a form specified by the DIPP from an incubator established in post-graduate college in India; or.
      d. Letter of funding from the Government of India or any State Government as a part of specified scheme to promote innovation; or – If the Government of India or State Government has provided funds as a part of any scheme to promote innovation to the applicant, a Letter of Funding by GOI or State Government is admissible as a legit document to be submitted.
      e. Letter of funding of not less than 20 percent in equity by any Incubation Fund/Angel Fund/Private Equity Fund/Accelerator/Angel Network duly registered with Securities Exchange Board of India that endorses innovative nature of the business – If SEBI has funded,  not less than 20% in equity by any above mentioned Funds which endorses the innovative nature of the business of the entity to the applicant, A Letter of Funding by SEBI can be submitted.
      f. Letter of recommendation from Industry association recognized by DEPARTMENT OF INDUSTRY POLICY AND PROMOTION – A Recommendation  Letter can be obtained by any Industry Association or Organisation which is recognized by DIPP.

The list of Industries/Organisations which can provide for the letter of Recommendation  are available on www.startupindia.gov.in .

Click on Information> List of Industry Association/Organisations for Recommendation Letter.

  1. Incorporation or Registration Certificate- Company/ Partnership Incorporation/LLP/ Registration Certificate is MANDATORY to be submitted.
  2. A Brief note or a supporting document regarding the innovativeness of the idea of the product or services offered by the entity.
  3. With respect to tax benefits, note that, if you opt for tax benefits, your application will go to the Inter–Ministerial Board for evaluation, which may take time. If your aim is only to obtain benefits related to IPR, you can refrain from choosing the tax benefits option.

The FORMAT for the above mentioned “Letter of Recommendation,  Letter of Support from Incubator, Letter of Funding from SEBI, Recommendation letter from Industry Association/Organisation”  is available on http://www.startupindia.gov.in/startup-recognition.php

An application for a certificate is processed within a period of 10-25 working days from the date of Application, if accepted, the certificate is available to be procured.

Type 2:

The points below discuss the procedure for obtaining a Certificate of Recognition for applicants who have filed for patent and the same is published.

  1. Visit http://startupindia.gov.in/uploads/pdf/List_of_facilitators_for_patents.pdf and fill in the details requested in the form as mentioned above.
  2. Against Nature of Recommendation, Select “Patent filed and published in the Journal by the India Patent Office in areas affiliated with the nature of business being promoted”.
  3. Against “Supporting document based on the nature of recommendation selected above”, upload journal extract of publication of your patent application.
  4. Upload Incorporation/ Registration Certificate.
  5. Against “Brief note on innovativeness of products /services offered by the entity”, upload a document in PDF format that provides details relating to the nature of business of your company and why products /services offered by your company is innovative.
  6. As mentioned above, with respect to tax benefits, note that, if you opt for tax benefits, your application will go to the Inter–Ministerial Board for evaluation, which may take time. If your aim is only to obtain benefits related to IPR, you can refrain from choosing the tax benefits option.
  7. Submit the application upon self-certification.

PENALTY FOR FALSE REGISTRATION:
If the application is found to be obtained, without uploading the document or uploading any other document or a forged document, the concerned applicant shall be liable to a fine which shall be fifty per cent of paid up capital of the startup but shall not be less than Rs. 25,000/- (Rupees Twenty Five Thousand only).

 

NEPAL’S IP LAW: AN ENCAPSULATION

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

Trademarks

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

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

FILING PROCEDURE:

Step 1: Filing

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

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

Step 2: Investigation:

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

Step 3: Grant/ Refusal:

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

Step 4: Publication:

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

Step 5: Renewal and Cancellation

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

 

Patents

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

FILING PROCEDURE:

Step 1: Filing:

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

Step 2: Investigation:

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

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

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

 

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

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

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

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

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

The Examination/Investigation is of two kinds namely;

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

–  The claimed product/process is patentable or not.

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

–  The claimed invention is capable of Industrial Application.

– The invention involves a ‘innovative step’

Step 3: Grant/ Refusal:

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

Grounds of refusal/ cancellation of registration: Section 6:

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

Step 4: Publication:

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

Step 5: Renewal

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

 

FILING CONVENTION PATENT APPLICATIONS IN NEPAL:

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

 

Designs

Section 2:

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

FILING PROCEDURE:

Step 1: Filing:

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

Step 2: Examination

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

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

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

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

If either of the above mentioned points are

Step 3: Grant/ Refusal:

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

Step 4: Publication:

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

Step 5: Renewal/ Cancellation

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

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

Effect of Union Budget, 2017 on the R&D/ Intellectual Property Practices in India

Union budget that was highly waited for (after demonetization) had gained more attention also due to preponing to February 01, 2017.

As a matter of fact, every year budget has certain impact on various industries including IP industry and R&D sectors. In this article, we will try to analyze possible effects of 2017 budget on R&D/Intellectual Property (IP) Practices in India. Though there were no special funds/incentives proposed for R&D, budget did have certain announcements for indirect effect on the IP practices.

  1. With intent made clear in budget 2015 itself, in 2017 Hon’ble Finance Minister Arun Jaitley proposed that corporate income tax for smaller companies with annual turnover upto INR 50 CR be reduced to 25%.

In 2016, FM had proposed that companies with turnover less than INR 5 CR would have to pay tax less by 1% and new manufacturing companies who do not avail of any exemption would be charged only 25%.

 This move will make sure that medium size companies do not pay more tax as compared to larger companies as observed in 2015-2016, wherein 2.85 lakh companies making profit of less than INR 1 CR had to pay effective tax rate of 30.26% while 298 companies making profit of more than 500 CR paid effective tax rate of 25.90%.

This reduction in tax rate is likely to give smaller companies flexibility to invest saved 5% in R&D activities.


  1. FM also believes pushing digital transactions further would enable small and micro enterprises to access formal credit. He also made clear that Small Industries Development Bank of India (SIDBI) will be encouraged by government to refinance credit institutions which provide unsecured loans at reasonable interest rates to borrowers based on their transaction history. This is likely to give higher chances of eligibility to IP driven companies not having strong collateral.

  2. Focus on startups in 2016 seems to be continued in 2017 as well. Among the schemes announced for start-ups, eligibility for start-ups for expedited examination of Patent Applications was a great move. In 2017, government aiming to heavily utilize technology for pushing initiatives such as SWAYAM (providing opportunities for a life-long learning) and DIGIGAON (providing telemedicines, education and skills through digital technology), start-ups would never want to miss an opportunity to contribute through innovative ideas for the facilitation of implementation of schemes.

  3. In another move to encourage start-ups, in 2016 it was announced that 100% deduction would be available for any 3 consecutive assessment years out of 5 years beginning from the year in which the eligible start-up is incorporated with the condition that total turnover of eligible start-up should not exceed Rs. 25 Crore in any of the previous years beginning on or after the 1st day of April, 2016 and ending on the 31st day of March, 2021. In 2017 budget, period of 5 years has been changed to 7 years.

  4. Research and Development Cess Act, 1986 is proposed to be repealed. Reduction in tax cost to the extent of 5% (R&D cess) on technology imports. Subsequently, service tax at 15% to be paid in full.

  5. On a disappointing note, there seems to be no separate incentive for R&D.

All in all, though there seem to be some encouraging proposals nothing substantial is coming to the way of IP fraternity as was provided in last year budget in the light of Make in India Regime. But this is not totally surprising as on all fronts, budget seems to be a cautious approach (understandable in light of other measures such as demonetization and GST being radical).

Comparative Advertisement: A Perspective

Ms. Sakshi Jhalani, Intern, Khurana & Khurana, Advocates and IP Attorneys looks into the fundamentals of Comparative Advertisement vis-avis Trade Mark Rights in India.

Advertising is indeed a crucial step in determining future of any product. It is the most successful and proven way to attract the attention of the potential consumers in the market. Since, the consumers have a wide variety of products to choose from, often the advertisers resort to a practice of comparing their products from that of the competitors. While this is an acceptable practice, many times in order to gain more pecuniary benefits and mileage, competitors end up using such tactics which either misleads the customers or amounts to denigration of other’s product. Comparative advertisement is a unique practice, where a manufacturer compares his goods or service from that of his competitors for the purpose of promotion and increased sale of his goods.

Comparative advertisement can be divided into two categories, puffery and denigration. Imagine a producer making superlative claims indicating his product is best so as to influence the public into buying it. Now, if the same claim is made through degrading the image of an identifiable competitive product, it crosses the limited scope of puffery leading to denigration of the product. This might not only amount to defamation of the competitor’s product, but also mislead the consumers since most of the time to producers does not have a valid ground to claim that other product is not good.

Though advertisements were considered a part of form of speech but, they did not constitute as ‘free speech’ since it was done merely for the purpose of commercial gain.[1] This position was reversed in the case of Tata Press vs. Mahanagar Telephone Nigam Ltd., where the court held that advertisements is not only profiting the producers but there is a free flow of information in free market economy fulfilling the greater goal of public awareness.[2]By virtue of this judgement, advertisements were held constitutive of ‘commercial speech’ under the ambit of Article 19(1)(a) of the Constitution.

Even though advertisements have been given constitutional protection under free speech, there cannot be blanket protection given to advertisements merely on the ground of public awareness. It needs to be checked that these advertisements are neither deceptive, nor they are disparaging the competitor’s goods. Initially, matters relating untrue or misleading advertisements were governed under Section 36A of the Monopolies and Restrictive Trade Practices Act, 1969 (‘MRTP Act’), which dealt with ‘unfair trade practices’. However, the MRTP Act was repealed by Section 66 of the Competition Act, 2002. But, this did not leave traders remediless since the definition of ‘unfair trade practices’ was incorporated parimateria under Section 2(1)(r) of the Consumer Protection Act, 1986 (‘CP Act’). The scope of CP Act was limited to the extent of providing recourse to the consumers only, it did not include manufacturers, sellers or service providers.

The absence of a proper statutory instrument for advertisers to address their grievances led to the creation of a self-regulatory body called Advertising Standards Council of India (‘ASCI’). The principles laid down by ASCI ensured that this practice of comparative advertisement is conducted in a fair way taking into consideration the interests of all the associated groups involved. It make sure that the manner in which the comparison is laid out is not in a way that provides the producers with an undue advantage over the competitor’s product. It also ensured that the comparisons are accurate and are based on the facts so as to not deceive the potential consumers.

Even though ASCI laid down reasonable and fair guidelines, it lacked effective implementation and faced problems when infringement is caused by the actions of non-members. The problems covering such infringements are better addressed by Section 29(8) and 30(1) Trademarks Act, 1999 (‘the Act’). While Section 29(8) deals with infringement of trademarks when done through advertisements, section 30(1) provides with an exception when such use of marks is done according to the “honest practices” in industrial and commercial matters. When a producer is using the method of comparative advertisement for promoting his/her goods or services, it might lead to dilution, tarnishment or blurring of the trademarks of the competitors. The Act protects the interests of such producers, whose marks are likely to get denigrate because of unfair actions of the competitors.

Honest practices, dilution, disparagement, all these essentials are not clearly defined under the Act, but can be traced through various judgments throughout the course of time. In the case of Reckitt & Colman f India Ltd. vs. M.P. Ramchandram&Anr, the court dealt with the component of puffery as a part of comparative advertisement for the first time. This case involved manufacturers of two clothing detergents ‘Robin Blue’, the plaintiff and ‘Ujala’ the defendant. It was contended by the plaintiff that the defendant in his advertisement, had on purpose used a bottle similar to that of plaintiff’s product. The defendant also mentioned in his advertisement that the plaintiff’s product was inefficient and was uneconomical.[3] The court in this case held relied on the case of De Beers[4] and held that a producer can declare his goods to be the best, or even better than his competitors even if the statement is untrue. But, while making such comparison he cannot state that his competitor’s goods are bad, even if that is true. He cannot make any statement which might lead to disparagement of his competitor’s goods.

Another landmark case that dealt with the meaning of word disparagement is Pepsi Co. vs. Hindustan Coca Cola Ltd. Pepsi Co. alleged infringement of trademark as Coca Cola, vide its advertisement has disparaged the products of Pepsi Co by calling Pepsi “Bacchon Wala Drink”. Further Coca Cola also used a bottle with same colour combination as that of Pepsi with the name “Peppi” written on it. The court while analyzing the meaning of disparagement held that, an advertisement is considered to be defaming if it is undervaluing, bringing discredit or dishonor upon the competitor’s product.[5]

Further clarity is laid down by the court in the recent 2015 judgment of Havells vs. Amritanshu, where the advertisement in dispute dealt with the Hevells’s and Eveready’s LED bulbs. The question in issue was whether for an advertisement to be an ‘honest’ one, does the comparison between the producer’s and the competitor’s product must involve all the features. The Delhi high court in this case held that if an advertiser is highlighting only a special feature of his/her product, that makes it distinct from that of his competitor’s, he/she is allowed to do so as long as the comparison is true. The failure to compare all features of a product while comparing will not amount to disparagement. The court in this case also laid down certain tests to be applies for the purpose of comparative advertising. The tests include, standard used in deciding a case of comparative advertisement, test of ‘honest’ advertising as per section 29(8) and 30(1), and test of a ‘misleading advertisement’.

The status of comparative advertisement in foreign countries like U.K. and USA is more liberal when compared to India. Where the practice of comparative advertisements is a common trend, the producers are generally not allowed to make any superlative claims with respect to their products without providing for any evidence. They are also allowed to compare their products with the competitors’ and mention that the other’s product is not as good as theirs provided they make a valid and reasonable claim. In my opinion, such trend should be adapted in India as well, as making superlative claims about their products without them being true fails the main purpose of protecting the consumers from deceptive practices of traders. Also, if the claim made by the producer with respect to his competitor’s product is true, it should be allowed since, it will provide consumers with a valid reason to choose between a better product, and in long-run promotes healthy trade practice as it will help the competitor to improve the quality of his goods.

About the Author: Ms. Sakshi Jhalani, Intern, Khurana & Khurana, Advocates and IP Attorneys.

References :

[1]HamdaedDawakhana vs. Union of India, AIR 1960 SC 554.

[2](1995) 5 SCC 139.

[3]1999 PTC (19) 741.

[4]1975 (2) AII ER 599.

[5]2001 (21) PTC 722.

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

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

  1. What is revocation of a patent?

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

  1. Why does one file a revocation petition?

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

  1. Who can file a revocation petition?

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

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

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

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

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

Under Section 64, the following are the said grounds:

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

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

  1. What are the other provisions concerning revocation?

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

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

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

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

Section 3 (K) of Indian Patent Act: Case Study

Ms. Anjana Mohan, intern at Khurana and Khurana, Advocates and IP Attorneys attempts to analyze case study related to section 3 (k) of Patent Act, 1970.

ACCENTURE GLOBAL SERVICE GMBH (Appellants) V

ASSISTANT CONTROLLER OF PATENTS &

DESIGN AND THE EXAMINER OF PATENTS (Respondents)

CITATION- OA/22/2009/PT/DEL and Miscellaneous Petition No. 118/2012 in OA/22/2009/PT/DEL

HON’BLE JUDGES/CORAM:

Prabha Sridevan, J. (Chairman) and D.P.S. Parmar, Member (T)

Bibliographic Details:

Patent Application number 01398/DELNP/2003
Title Distributed Development Environment For Building Internet Applications By Developers At Remote Locations.
Applicant Accenture global services limited
Date of filing 01/09/2003
Date of publication of application 27/05/2005
Date of First Examination  Report 29/01/2008
Matter coming to IPAB 26/09/2012

As focus of the article is on section 3 (k), it has been reproduced below. For those who are new to this topic, section 3 of the Indian Patents Act, 1970 bars patent eligibility of some inventions.

Section 3 (k):

A mathematical or business method or a computer programme per se or algorithms

The appellants filed a PCT National phase application No. 01398/DELNP/2003 dated 01/09/2003 with 22 claims based on a PCT application No. PCT/US02/04964. On 03.02.2004 Form 13 was filed and claims were suo moto reduced to 18 and claims 19-22 were deleted.

In the First Examination Report (FER) dated 29/01/2008, based on the amended claims following objections, Inter-alia, were raised:-

  1. Claims 1-18 are not patentable in light of certain prior arts (US 5907704, US 6145119, US 5911075, US 5966535 and US 6014666).
  1. Claims in essence fall within the sense of section 3(k) of the Patent Act, 1970 (as amended).

During the hearing, the appellants submitted revised set of the claims, a new Claim 19 was also added without seeking amendment under section 57 and principle claim 1 is amended.

Appellant alleged that respondent’s order issued is influenced by incorrect facts and without application of mind and should be subjected to correction as Respondent indicated in the impugned order that the method claims were deleted by the Applicant only after raising of the objection by the Patent Office and have therefore on their own concluded that the objections raised by the Patent Office were correct and valid.  Appellant indicated fact that the method claims had been deleted from the present set of claims even before the filing a request for examination and only system claims were examined by the Examiner.

In the appeal it was found that allegations of appellant were true and board found it sufficient to say that the respondent has not applied his mind based on the existing facts.

Appellant alleged that ‘Applicable Standards’ relied on by the respondent to refuse the patent are neither mentioned in the Indian Patent Act nor in the Patent Office Manual or in guidelines by the Indian Courts in such matters.

Respondent had relied on below standards:

“1. A hardware implementation performing a novel function is not patentable if that particular hardware is known or is obvious irrespective of the function performed.

  1. If the novel features of the invention resides in a set of instructions (programme) designed to cause the hardware to perform the desired operations without special adoption of the hardware or modification of the hardware, then the matter claimed either alone or in combination is not patentable.”

IPAB agreed to such allegations.

IPAB also observed that passing the impugned order without giving appellant opportunity to amend the claims caused violation of the principle of natural justice and it is unsustainable in law.

Court did not go into the details of the merit of the case, even though appellant had submitted the argument relating to the merits, as it remanded the case back to the respondent.

Later, when invention was analyzed on merits, Indian Patent Office passed an order on May 10, 2013 to grant the application with below observation:

‘the invention as claimed is not software per se but , a system is claimed which is having the improvement in web services and software. the invention since not falling in the category of section 3(K), viz software per se , objection is waived and patent is granted’

 

India: Do we need Patent Term Extension and Non-Patent Exclusivities for Pharmaceuticals?

India, though in a phase of rapid economic development, still has the bane of poverty. In this country, around 22% of the population is Below the Poverty Line [1], and hence most of the nation’s policies are oriented towards the poor. India’s IP Policy is no different, as the IP legislature in India is mostly oriented towards giving the general public an easy and inexpensive access to medicines. Indian IP policy drafters have used every flexibility in the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS), to which India is a signatory, for this purpose.

The curious case of drug development

The process of development of the drugs to treat the diseases and ailments is pretty much painstaking. A drug regulatory authority, (e.g. The US Food and Drug Administration-US FDA; Central Drugs Standard Control Organization-CDSCO in India) monitors and governs the testing of the New Chemical Entities (NCEs) through pre-clinical and clinical trials to prove their safety and efficacy to treat an ailment. Several NCEs fail at some or the other stage, rendering all the money and efforts in vain. The amount of money invested in each NCE is of the order of billions of dollars. [2] The time period it takes for the development of the NCEs as approved ‘Drugs’ typically ranges from 10-15 years [2]. The chances of a candidate making it through this whole of the process, to the desk of the pharmacy, are merely 2% [2]. So, in this precarious situation, the 20 years of patent protection granted to the drug products is not sufficient to recover the huge investment made in the R&D of the product. So, the pharma companies usually demand the extension of the protection of their monopoly over the drug product. This Patent Term Extension (PTE) is granted by the Patent Office of the region or country.

Now, these clinical trials generate data regarding the therapeutic activity and safety of the drug. So, if a generic player wants to launch the same drug, it will need this data to prove that its generic version of the drug is ‘equivalent’ to the innovator’s product. Since the innovator companies invest huge amounts of time, money and efforts into generating this data, they demand exclusivity of this data. This Clinical Trial Data Exclusivity is under the discretion of the drug regulatory authority and regardless of the existence of a valid patent on the subject matter. If granted, it gives an additional layer of protection to the innovator drug product.

In the following paragraphs, we will discuss the Patent Term Extension and Clinical Trial Data Exclusivity provisions present in the US and European, legislature, in comparison with the Indian scenario. Several other countries also provide these provisions, but we will limit our discussion to these three jurisdictions.

 

Patent Term Extension

In the US, according to the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, 1984 [3], the patent term can be extended up to 5 years, however, the total patent term (including extension) should not be more than 14 years after the date of approval of the product by FDA. This period may be extended by a period of another six months of Pediatric Exclusivity.

The European Patent Office similarly provides an extension of protection in this regards, by giving the Supplementary Protection Certificate (SPC). [4] The SPC allows extending the Patent term by 5 years. however, the total patent term (including extension) should not be more than 15 years after the date of approval of the product by the European Medicines Agency. Additional 6 months’ protection is given to medicinal preparation to treat children (Pediatric Formulations). This extension is not applicable to orphan drugs [11]

Non-Patent Exclusivities:

The US FDA grants different types of Non-Patent Exclusivities [5] [6]

  1. 5 years for a New Chemical Exclusivity (NCE) for the Active Ingredient approved for the first time
  2. 180 days exclusivity for the generic player who first files and maintain an ANDA (Abbreviated New Drug Application) with Paragraph IV certification, which requires the applicant to prove either that he will not be infringing the innovator’s patent or that the innovator’s patent is invalid/not enforceable.
  • 3 years of New Clinical Study Exclusivity for submission of “reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application [or the supplemental application] and conducted or sponsored by the applicant”. For example, in case of preparation of a drug previously approved, which differs in the route of administration, drug delivery system, dosing regimen, modification of the drug such as salt or ester, which won’t affect the pharmacological actions of the drug. The exclusivity period would start from the date of NDA approval of the same drug. This is for the Active Ingredient has been approved before in another application.
  1. 5 additional years in case of antibiotics that treat some serious condition, for products that have obtained Qualified Infectious Disease Products (QIDP) designation under the Generating Antibiotics Incentives Now (GAIN) Act.
  2. 7 years for an orphan drug, i.e. the drug for the treatment of the rare diseases
  3. 6 months of Pediatric Exclusivity which gets added to the existing Patents and exclusivities.

The table below summarizes these exclusivities in relation to whether innovator and/or generic players can avail them.

Table 1. Scheme of Exclusivities granted by the US FDA

Sr. No. Description  NDA Applicant  ANDA Applicants
1 New Chemical Entity (NCE) 5 years NA
2 New Clinical Investigation (NCI) (Same drug, different route of administration or another form of the same drug, e.g. salt form) 3 years NA
3 First Abbreviated New Drug Application, under Para (IV), with applicant successfully proving the innovators patent invalid, or not infringing, or in case the infringement suit is not filed within 45 days of application NA 6 months
4 Antibiotics with Qualified Infectious Disease Product (QIDP) designation to treat serious conditions 5 additional years NA
5 Drugs to treat rare disease (Orphan Drugs) 7 years NA
6 Pediatric preparation 6 additional months NA

The European Medicines Agency, after 2005,started the 8+2(+1) formula which dictates that the innovator will be getting 8 years’ data exclusivity, and 2 years of market protection, during which no generic can be placed on the market, and an additional 1 year exclusivity for the new indication which shows significant clinical benefit (same as NCI in the US). Prior to this rule, there was a distinction for nationalized procedure and centralized procedure. The following table indicates the exclusivity period based on the application date and type.

Date of submission of application For Centralized Procedure For Nationalized Procedure
Before

20.11.2005 (CP)

30.10.2005 (NP)

10 years’ data exclusivity 6a or 10b years’ data exclusivity
After

20.11.2005 (CP)

30.10.2005 (NP)

8 years data exclusivity

+2 years market protection

(+1 year market protection for the new indication showing significant clinical benefit)

a – Austria, Denmark, Finland, Ireland, Portugal, Spain, Greece, Poland, Czech Republic, Hungary, Lithuania, Latvia, Sweden, Slovakia, Malta, Estonia, Cyprus, Bulgaria, Romania, Norway, Iceland, and Liechtenstein. (‘6-year countries’)

b – Belgium, Germany, France, Italy, Netherlands, Sweden, United Kingdom, Luxembourg. (’10 year countries’)

In addition to this, the orphan drugs get 2 more years of exclusivity. [7], [11]

India

India has not, as of yet, implemented such provisions, because-

  1. Granting of the PTE and Non-Patent Exclusivities would require the establishment of the Patent Linkage system in effect, which is not there at present, and India is not planning to do it in the near future, because India has not, as of yet, entered into any trade agreement which requires such provisions.
  2. The TRIPS agreement also does not require members to grant such benefits to the innovators, this means that India is in no obligations to grant PTE and Non-Patent Exclusivities. [8] Whatever pressure is there on Indian policymakers to implement such benefits, are there due to the Trade Agreements like the Trans-Pacific Partnership (TPP), Regional Comprehensive Economic Partnership (RCEP). These agreements constitute to a new regime called as TRIPS Plus, which is lobbied by the big pharma companies of the developed countries. Currently, India is not signatory to any of such agreements.
  3. If at all these provisions are implemented, they would severely delay the entry of generic versions of the drugs into the market. India, being a developing country, simply cannot afford granting PTE and DE to every request, at the expense of access to the poor.
  4. On the same lines, the Indian Pharma sector is largely thriving on the generic players, so the industry is hardly affected by the absence of provisions for PTE and DE.

These provisions have long been sought by the Big Pharma lobby of the developed nations, by criticizing India’s ‘weak’ IP policies. Companies like Bayer, Novartis have tried to tweak with the legislature for the same purpose. [9] Several generic pharma companies and access-to-medicines activists like Médecins Sans Frontières (Doctors without Borders) have constantly warned India about the effects of such provisions, saying that India will no longer remain the ‘Pharmacy of the world’. [10]

Implementing these would be advantageous only to the innovator companies, and millions will be stripped off their right to live a healthy life. This is being sugarcoated to say that these provisions will boost the trade and innovation in India. On the other hand, if these provisions are not introduced, India will be under constant pressure to do so at the earliest, but it won’t kill anyone. Now it is up to the policy makers whom they are going to put first.

About the Author: Mr. Swapnil Chandwade intern at Khurana and Khurana, Advocates and IP Attorneys. In case of any queries, feel free to reach on swapnil@khuranaandkhurana.com.

References:

  1. http://data.worldbank.org/country/india
  2. http://www.nature.com/nrd/journal/v9/n3/full/nrd3078.html
  3. http://www.fda.gov/newsevents/testimony/ucm115033.htm
  4. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31992R1768
  5. http://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm447307.pdf
  6. http://www.orangebookblog.com/files/nonpatent_exclusivity.pdf
  7. http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/05/WC500143122.pdf
  8. https://indiankanoon.org/doc/1123372/
  9. https://iiprd.wordpress.com/2010/05/17/bayer-vs-cipla/
  10. http://www.thehindu.com/sci-tech/health/If-India-signs-RCEP-it-will-not-be-the-pharmacy-of-the-world-MSF/article14422200.ece
  11. Chakrabarti, G., 2014. Need of data exclusivity: Impact on access to medicine. Journal of Intellectual Property Rights, 19(5), pp.325-336.

First Symposium of IIPRD in 2017

After successfully conducting several symposiums in 2016, IIPRD is coming up with one-day seminar on software and electronics patent portfolio with focus on preliminary preparation, prosecution, and litigation in India and US.  While the programme is being organized in Pune on February 23, the one in Bengaluru will be hosted February 24.

The seminar is being arranged by IIPRD along with Khurana and Khurana, Advocates and IP Attorneys and Sughrue Mion.

With speakers like Chid Iyer-partner of International Law Firm of Sughrue Mion, Anubhav Kapoor-Tata Technologies’ General Counsel and Company Secretary, Vinod Khurana-Senior Partner at IIPRD and Khurana & Khurana, IP Attorneys, Irfan Modi-Senior IP Law Attorney at IBM India, Subhadip Sarkar- Senior Director and manages Intellectual Property at Cognizant Technology Solutions, Mr. R. Lakshminarayanan- Head of Intellectual Property Rights (IPR) Management in Samsung R&D India, Mr. Ajay Panwar- having 11 years of experience in the field of IP with domain expertise in software and electronics, Tarun Khurana- having over 14 years of experience in a broad range of IP subject matters, and Co-Founding Partner and Patent Attorney of Khurana & Khurana, Abhishek Pandurangi- partner at Khurana & Khurana, having over a stretch of 7 years as an IP practitioner, entrepreneur, legal expert and a trainer, one cannot afford to miss same. This event turns out to be great opportunity for IP Groups, R&D experts, In-House IP/Legal Counsels, Patent Agents & Attorneys in the field of Practice, Patent Litigators, and Professionals in Legal Domain related to Software,Information Technology, Instrumentation, Electronics, Electrical, Embedded, Mobile Technology, IoT, and Telecom Domains.

Fee per delegate is INR 5,000 for Indians and is INR 10,000 for foreign applicants.

For more details about profiles of partners, programme outline, speakers, why and how to apply, please see http://www.iiprd.com/iiprd-symposium-23rd-february-2017-24th-february-2017/.

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