Category Archives: India

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).

 

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).

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.

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

The Mickey Mouse Debate

Mickey Mouse has always been synonymous with Disney, and has served as their ultimate mascot.Disney Corporation has always been protective of its creations and has ensured that their copyrights and their beloved mascot, Mickey Mouse, never fall into the public domain.  Every time the first Mickey Mouse copyright is set to expire, Disney springs into action to extend the copyright term.

The debate of copyright term duration is a long standing one. Initially, US copyright law provided for a copyright term which lasted for a period of fourteen years from the date of publication. This term could be renewed for an additional fourteen years if the author was still alive at the expiry of the first term. In 1831, the Copyright Act was amended and the term was extended from fourteen years to 28 years, which could be renewed for an additional 14 years.

In 1976 the copyright act went through major changes when the first Mickey Mouse copyright was set to expire. The amendment extended the term of copyright for works copyrighted before 1978 to life of the author plus fifty years after the author’s demise and 75 years for works of Corporate.

With only 5 years left on Mickey Mouse’s copyright term in 1998, Congress again changed the duration with the Copyright Term Extension Act, 1998 (CTEA) providing retroactive extension of the copyright term.It extended the term of protection to life of the author plus 70 years, and for works of corporate authorship to 120 years after creation or 95 years after publication, whichever endpoint is earlier. According to the Act works made in 1923 or afterward will not enter the public domain till 2019 or afterward, depending on the date of production. Disney’s Mickey Mouse is set to expire on 2023 and the debate on extension is set to begin again.

The Debate

So why is there so much debate about how long creative work can be protected by copyright? Copyright provides duality of purpose which is fundamentally at odds with each other. One purpose of copyright is to educate the public culturally by disseminating cultural knowledge. The other purpose is to foster creativity by allowing authors to reap benefits from works for a limited period thus encouraging them to create more works. It is in this battle that the debate for duration of copyright finds place.

The longest debate on duration of term with respect to copyright laws is in the US. Both proponents and opponents of extension have put put forth several arguments in favour of their stand, and this debate is set to resume soon, with the effect of the CTEA expiring at the end of 2018 and the first Mickey Mouse copyright entering the public domain in 2023.

Proponents of extension have maintained that the purpose of copyright is to promote creativity and art by allowing monopoly to the creators, thus giving them an incentive to create more. According to them, by giving exclusive rights to the creator for a limited time, both the author and the public benefit. The purpose of granting exclusive rights to authors isn’t so that they recoup their initial investment, but to let them earn substantial amounts so that they can create more works. In order to achieve this, copyright term must be for a considerable period.

Proponents of extension also argue that if works fall into the public domain they will go unused. If owners know that a particular copyright is going to lapse into the public domain, they would be unwilling to utilize it further, or create derivative works, and the public could lose out.

Another argument put forth by proponents of extension is that due to increase in life expectancy and longevity of business, copyright term must also be extended.Also, with better technology, the lifespan of a created work has become virtually infinite. This means that works can be exploited longer. Therefore, proponents of extension argue that unless copyright term is extended it to match the longevity of owners, and the longevity of the work itself, it no longer becomes an incentive for authors to create more work.

Copyright is as an extension of the creator’s persona. If it gets distorted or tarnished due to lack of protection, creators are discouraged from creating more works, potentially damaging their reputation. This also means that creators will be unwilling to disseminate quality copies of work if they are soon to fall in the public domain and risk being tarnished. This would mean that the public would lose out on culturally rich works.

Opponents of extension argue that authors have always known that their works would fall into the public domain, but this has never deterred them from creating new works. Further, extension of copyright stifles creativity as another person cannot build upon the works of the owner if it has not entered the public domain. Getting permission and licenses deters new creators from building on already existing works. This means the public would miss out on better works.

Opponents also argue that the increase in life expectancy argument is invalid as copyrights are protected for the lifetime of the author. Hence, if the life expectancy has increased it means that the copyright term will automatically increase as well.

When it comes to business entities owning copyrights, longevity of the creator is irrelevant. The opponents of extension have argued that copyrights are borrowed rights from the sovereign. Copyright is not an inherent, but a statutory, right given by the sovereign. However, irrespective of copyright being a statutory right, it needs to foster creativity. When business concerns know that copyright term is limited to a shorter duration, they are discouraged from investing further or creating derivative works. For example, when concerns like Disney know that their copyright over Mickey Mouse is set to expire soon, they would stop creating further derivative works, such as theme parks, products, animated works etc,.

In 2003, a study proved that the last two major copyright changes before CTEA, the Copyright Act of 1976 and the 1988 Berne Convention, had significant effects on copyright registrations.Yet another study, conducted in 2006, proved that countries that extended the terms of copyright from the author’s life plus fifty years to the author’s life plus seventy years anytime between 1991 and 2002, saw a significant increase in movie production.This clearly shows that copyright extension is in the best interest of creativity.

The Indian Scenario

The media and entertainment industry in India is still in its nascent stage. Copyright protection under the Indian Copyright Act is for a period of 60 years from death of the author. In 2008 Yash Raj and FICCI approached the HRD Ministry to extend the copyright term to 95 years like in the CTEA.The ministry welcomed film producers’ recommendations in extension of copyright term for the Copyright Amendment Act, 2010. While Parliament may not have agreed to extending the term of a copyright to 95 years like in the US, they did amend the law dealing with copyright term of films. The amendment has allowed joint authorship of the producer and the principal director for a film. Thanks to the amendment, a principal director will have a copyright protected for 70 years, as opposed to the producer who has only 60 years. This has effectively increased the term of protection for movies from 60 years to 70 years. The momentum for increasing copyright term is just starting and India will soon get to see similar debates as faced by CTEA in the US.

About the Author : Nadine Kolliyil, an intern at Khurana & Khurana, Advocates and IP Attorneys looks into the debate surrounding copyright extension in the US, and Bollywood’s attempt to extend copyright term.

References:

Simplified account of Design Registration in India

This article is intended with covering the basic FAQs about Design registration in India. For the sake of better focusing, format of questions and answers has been adopted.

Industrial Designs are protected by different laws in different countries, i.e. some countries choose to go for Patent Registration and some go for specialized systems. Unlike USA which has chosen to protect the designs through Patents, India has chosen a sui generis system. In India, Design registration is covered under The Designs Act, 2000.

In India, functionality is protected under Patents and not Industrial Designs which are meant to protect external ornamental or aesthetic appearance such as patterns, colour, lines, shape or surface of the article.

  1. What is Design under the Design Act, 2000?

Section 2 (d) deals with this.

Design means only the features of shape, configuration, pattern or ornament or composition of lines or colour or combination thereof applied to any article whether two dimensional or three dimensional or in both forms, by any industrial process or means, whether manual, mechanical or chemical, separate or combined, which in the finished article appeal to and are judged solely by the eye, but does not include any mode or principle or construction or anything which is in substance a mere mechanical device, and does not include any trade mark, as define in clause (v) of sub-section of Section 2 of the Trade and Merchandise Marks Act, 1958, property mark or artistic works as defined under Section 2(c) of the Copyright Act, 1957.

  1. What is Article under Design Act, 2000?

Section 2 (a) deals with this.

Article means any article of manufacture and any substance, artificial, or partly artificial and partly natural and includes any part of an article capable of being made and sold separately”

  1. What are the benefits of Design Registration?

Registered Proprietor has the exclusive right to apply a registered design to the article in the class in which Design is registered. Rights obtained by Design Registration can be licensed and/or assigned. In case of infringement, damages can be claimed by the registered Proprietor.

  1. Who may apply for Design Registration?

Any person claiming to be the proprietor of any new or original design may apply for registration. A proprietor may be from India or from a Convention Country.

A proprietor may be:

  1. an author of design,
  2. a person who has acquired the design,
  3. a person for whom the design has been developed by the author, or
  4. a person on whom the design has devolved.

The application for registration of design can be filed by the applicant himself or through a professional person (i.e. patent agent, legal practitioner). However, for the applicants not residing in India, address of an agent residing in India can be used as address for service.

  1. Where to apply for Design Registration?

Applications can be filed in either the Design Office in Kolkata or the branch offices of the Patent office in Delhi, Mumbai or Chennai. For e-filing, FAQs available at https://ipindiaonline.gov.in/eDesign1/faqs/index.html can be referred.

  1. Is it necessary to have prototype article before applying for Design Registration?

No, it’s not mandatory to have prototype. However, Design must be capable of being applied to article by an Industrial Process.

  1. What is the correct time to apply for Design Registration?

Application for Design Registration must be filed before making the design available to the Public as not novel Design cannot be given registration. It is also to be noted that Design Registration is granted to whoever files the application first.

 

  1. What are the types of Applications?
  2. Ordinary application: An ordinary application does not claim priority.
  3. Reciprocity application: In case priority of foreign application is to be claimed, it has to be done within six months of filing foreign application. Such applications being filed in India are termed as reciprocal applications. This period of six months is not extendable.
  4. What is considered to be Date of Registration in Designs?

In case of ordinary applications, the date of making the application for registration is the date of registration of the Design.

In case of reciprocal applications, the date of filing the application in the convention country is the date of registration of the Design.

  1. Is there any period of pre-grant opposition for Design registration in India?

No

  1. What is time allowed for putting application in condition of grant?

In a Substantive examination, objections may be raised based on whether criteria of something being called as design as set out by definition is met or not, is Design new/original or not, is Design prejudicial to public order or morality, and is Design prejudicial to the security of India. The period allowed for removal of objections can not exceed six months from the date of filing of the application. However,   said   period   of   six   months   can   be extended  for  a  further  period  not  exceeding  three months  provided  a  request  in  Form-18  is  filed  before the expiry of initial six months. On consideration  of  response  of  the  applicant, if  the Controller  is of  opinion  that  the requirements  of Act and Rules have   not   been   met, the   fact is communicated to the applicant clearly mentioning that the application is liable to be refused for reasons to be detailed and fixing a date for hearing. If the applicant fails to appear for the hearing without any request for adjournment, the application is refused. If written submissions are filed, while the opportunity to  be  heard  is  not  availed  by  the  applicant,  no  further opportunity  to be  heard is  provided  and  the matter   is   decided   based on   the  written submissions. If the applicant complies with all the requirements laid down  under  the  Act  and  Rules,  communicated  in  the form  of  statement  of  objections,  the  application  shall be registered forthwith.

  1. How to know whether any registration already exists?

Two different forms have to be used in two different situations.

When the registration number is known:

Request can be made by any person in form 6 along with the fees and mentioning registration number of the design for which information is required.

When the registration number is not known:

Request can be made by any person in form 7 along with information in his possession. Based on such information, controller causes search to be made in class indicated therein as much as possible. Where Form 7 is accompanied by a representation or specimen of the design, such representation or specimen is to be furnished in duplicate.

  1. What are the criteria for Design Registration?

A design should:

Be new or original registration

Not been disclosed to the public anywhere by publication in tangible from or by use or in any other way prior to the filling date, or where applicable, the priority date of the application for registration.

Be significantly distinguishable from known designs or combination of known designs.

Not comprise or contain scandalous or obscene matter.

Not be a mere mechanical contrivance.

Be applied to an article and should appeal to the eye.

Not be contrary to public order or morality.

Not be prejudicial to the security of India

  1. What is the term of Protection if Design is registered?

The copyright in a registered design may be extended by a period of five years, from the  expiration  of original period of ten years. An  application  for  extension  of  copyright  shall  be filed before  the  expiry  of  the  original  period  of  ten years. A registration of design ceases to be effective on non-payment of extension fee. However, lapsed designs may be restored provided application for restoration in Form-4 with prescribed fees is filed within one year from the date of lapse stating the ground for such non-payment of extension fee with sufficient reasons. If the application for restoration is allowed the proprietor is required to pay the prescribed extension fee and requisite additional fee and finally the lapsed registration is restored.

  1. Is it possible to renew the term of the Design Registration?

No, there is no provision for renewing the term of the Design registration once a period of 15 years is over.

  1. Is Cancellation of registered Design Possible?

The registration of a design may be cancelled at any time after the registration of design.

Petition for cancellation has to be made in form 8

Following grounds can be used for the same:

    That the design has been previously registered in India or

    That it has been published in India or elsewhere prior to date of registration or

    The design is not new or original or

    Design is not registrable or

    It is not a design under Clause (d) of Section 2.

  1. Can the Refusal of Design Registration be appealed?

Yes, the jurisdiction lies with High Court.

  1. Are the abandoned applications published? Can same applicant apply for registration of same Design again?

Abandoned applications are not published by the Design Office. Another application can be made for the same design if Applicant has himself not made the Design available to the public.

  1. What are the remedies available in case of piracy of Registered Design?

In case of piracy of registered Design, a suit for injunction and/or recovery of damages may be instituted against the accused in any court not below the court of District Judge.

Section 22 of the Design Act 2000 provides the legal proceedings to be followed in case of Piracy of Registered Design.

One of the below remedies can be sought against the accused:

  • Paying to the registered proprietor of the design a sum not exceeding twenty-five thousand rupees recoverable as a contract debt provided that the total sum recoverable  in  respect  of  any one design shall not exceed fifty thousand rupees; and
  • Recovery of damages for any such contravention, and an injunction against the repetition thereof, to pay such damages as may be awarded and to be restrained by injunction accordingly

References:

http://www.ipindia.nic.in/faq-designs.htm

http://www.ipindia.nic.in/writereaddata/images/pdf/ten-steps-to-design-application.pdf

http://www.ipindia.nic.in/writereaddata/Portal/IPOGuidelinesManuals/1_30_1_manual-designs-practice-and-procedure.pdf

Simplified account of Copyright Registration in India

This article is intended with covering the basic FAQs about Copyright registration in India. For the sake of better focusing, format of questions and answers has been adopted.

  1. What is Copyright?

Copyright is a right given by the law to creators of literary, dramatic, musical and artistic works and producers of cinematograph films and sound recordings. It is important to note that Copyright does not protect the ideas but protects the expression of the ideas.

  1. What kind of works can be protected by Copyright?

The Copyright Act, 1957 protects original literary, dramatic, musical and artistic works and cinematograph films and sound recordings from unauthorized uses.

  1. What kind of works cannot be protected by Copyright?

Ideas, procedures, methods of operation or mathematical concepts as such, titles, or names, short word combinations, slogans, short phrases, methods, plots or factual information are not protected by Copyright.

  1. Who can file for Copyright registration?

Any individual who is an author or rights owner or assignee or legal heir can file application for copyright of a work.

  1. Where can applications for Copyright be filed?

Applications can be filed both online and through Physical mode. Physical applications have to be directed to:

Copyright Division.

Department Of Industrial Policy & Promotion,

Ministry of Commerce and Industry;

G-30 Super Market August Kranti Bhawan

Bhikaji Kama Palace

New Delhi- 110066

For e-filing, instructions available at http://copyright.gov.in/UserRegistration/frmLoginPage.aspx may be referred.

  1. Can both the unpublished and published works be protected by Copyright?

Yes

  1. Is quality of work important for Copyright registration?

It is the originality of the work that is mandatory for the registration and not the quality of the work.

  1. What is the procedure for Copyright Registration in India?

After application has been filed and diary number has been allocated, applicant has to wait for a mandatory period of 30 days to check if any objection is filed in the Copyright office against applicant’s claim that particular work is created by him. If such objection is filed it may take another one month time to decide as to whether the work could be registered by the Registrar of Copyrights after giving an opportunity of hearing the matter from both the parties. If no objection is filed then application goes for scrutiny from the examiners. If any discrepancy is found the applicant is given 30 days time to remove the same. Therefore, it may take 2 to 3 months time for registration of any work in the normal course.

copyright_blog

Source: http://copyright.gov.in/ 

  1. What kind works of website can be protected through Copyright?

A web-site contains several works such as literary works, artistic works (photographs etc.), sound recordings, video clips, cinematograph films and broadcastings and computer software too. Separate applications have to be filed for registration of all these works.

  1. Whether computer Software or Computer Programme can be registered?

Yes. Computer Software or programme can be registered as a ‘literary work’. As per Section 2 (o) of the Copyright Act, 1957 “literary work” includes computer programmes, tables and compilations, including computer databases. ‘Source Code’ has also to be supplied along with the application for registration of copyright for software products.

  1. What kinds of right are granted to Copyright owner?

Copyright owner has two types of rights related to his work:

Economic Rights: Economic rights include for example right of reproduction, right of performance, right of broadcasting and right of communication which are derived from right of performance, rights of translation and adaptation.

Moral Rights: These are the rights that allow owner to maintain his image. These rights allow author to claim authorship of the work and to restrain or claim damages in respect of any distortion, mutilation, modification or other act in relation to the said work which is done even after the expiration of the term of copyright if such distortion, mutilation, modification or other act would be prejudicial to his honour or reputation. It’s important to note that moral rights remain with original creator even after whole or in part assignment of the work.

  1. What is the term of Protection granted by Copyright?

Term of the protection depends on the type of work. Generally, it’s until the expiration of the 50th year after the author’s death. In case of anonymous work, it’s until 50th year after the work has been lawfully made available to the public. In case of pseudonymous work, it’s until 50th year after the work has been lawfully made available to the public, but if author leaves no doubt about the identity or reveals the identity of his or her work, the general rule applies. In case of Audiovisual (cinematographic) works, it’s 50 years after the making available of the work to the public (“release”) or if such event did not take place, then from the creation of the work. In case of applied art and photographic works, it’s 25 years from the creation of the work.

  1. Is India member of the international treaties related to Copyright?

Except, WIPO Copyright Treaty (WCT) and the WIPO Performances and Phonograms Treaty (WPPT), India is a member of most of the important international conventions governing the area of copyright law, including the Berne Convention of 1886, the Universal Copyright Convention of 1951, the Rome Convention of 1961 and the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).

  1. Which sections of the Act define what is and what is not infringement of Copyright?

Section 51 of the Act deals with the provisions related to infringement of the Copyright. Section 52 of the Act provides a detailed list of acts that do not constitute infringement. Owner of the copyright can seek criminal and civil remedies against accused infringer.

Reference:

copyright.gov.in/frmfaq.aspx