Fund for Scientific advisers

The Central Government on direction of Justice JR Midha has created a Fund for Scientific Advisers in terms of Section 115 (2) of the Act.

The direction was passed during a patent litigation (Sandeep Jaidka Vs. Rohit Kapur & Ors.) in which the Court held that it would be appropriate to appoint an independent Scientific Adviser to assist this Court and give opinion with respect to the issues in dispute.

Court stated that the remuneration of the Scientific Adviser would be settled out of the funds provided by the Parliament for that purpose.

 

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Commercial Courts Act, 2015, is not “a mere piece of paper”

The Delhi High Court recently disposed of an application of the Plaintiff’s in Vifor International Ltd vs Suven Life Sciences Ltd, to file additional documents. The Court only took on record few additional documents. Two of the documents allowed are the Curriculum Vitae of the two expert witnesses sought to be examined by the plaintiff and particulars in which regard could have been given by the witnesses in their affidavits by way of examination-in-chief also. Another document that was allowed was an authorisation letter of the plaintiff in favour of its witness.

The Court was not very keen on allowing documents that can be handed over during oral proceedings. The Court was also not very keen on allowing older documents for which no reason has been given in the application for late filing thereof. The counsel for the plaintiff did not press for said documents but did reserve its right to confront the witness of the defendants with the said documents.

The Court discouraged such applications and also stated that the Parliament passed the Commercial Courts Act, 2015, intending to speed up disposal of suits. But a series of obstacles are put before the court tending to make the legislation “a mere piece of paper”. The judgment listed a series of hurdles which delayed disposal of suits and stated that the same should be avoided.

The Court said that the effort to expedite, endeavoured by the Commercial Courts Act, cannot be only by the Courts, as appears to be understood, but must be by all the stakeholders i.e. litigants as well as the counsels. The Court directed the Stakeholders to pay extra attention to,

  1. Making precise/concise pleadings spelling out basis of claim or defence and to avoid making unnecessary pleas, which add to length of pleadings and ultimately lead to unnecessary issues being framed, evidence being led, which has no relevance at the time of final adjudication;
  2. Documents they are required to file in support of their claim or defence and/or to disprove the claim / defence of other, especially at the time of filing pleadings, to avoid filing of applications as these;
  3. At the outset only, prepare an entire blue print of their case/defence, including of witnesses to be examined, by studying the law and judgments on the subject controversy, including the arguments to be ultimately addressed;
  4. It is also found that whenever applications are filed, the opposite party / counsel, out of habit, seek time for filing reply. Most of such interim applications need no reply. Moreover, the law on various aspects which come up for consideration in such interim applications, is by and large settled and any counsel worth his salt knows the outcome of such applications.

Biological Diversity Act, 2002 – OFFICE MEMORANDUM FOR POST FACTO COMPLIANCE

Indian Biological Resource usage is subject to prior permissions under the Biological Diversity Act, 2002 (BDA). The Act provides a framework for access to Indian biological resources and sharing the benefits arising out of such access and use. The Act also includes in its ambit the transfer of research results and application for intellectual property rights (IPRs) relating to Indian biological resources.

BDA requires foreigners, non-resident Indians, body corporate, association or organization that is either not incorporated in India or incorporated in India with non-Indian participation in its share capital or management to take prior approval of the National Biodiversity Authority (NBA) when they use biological resources and associated knowledge occurring in India for commercial or research purposes or for the purposes of bio-survey or bio-utilisation. Indians and Indian institutions do not require the approval of the NBA when they engage in the above mentioned activities. However they would need to inform the State Biodiversity Boards prior to undertaking such activities. However, any commercial application related to use of biological resources should be approved by the Authority.

The Ministry of Environment, Forest and Climate Change (Ministry) was made aware by the NBA that there are large number of entities/persons who are not fully aware of the provisions of the BDA, but are desirous to comply with the same. Therefore, the Ministry on September 10, 2018, brought out an office memorandum (OM), whereby the NBA was directed to hear all such cases where prior approval under Sections 3, 4, 6 or 20 of the BDA was required but the person/entity has not obtained the same, and pass appropriate orders with respect to acts that may have occurred in past, with an objective of ensuring conservation and sustainable use of biodiversity and fair and equitable sharing of benefits arising from its use.

The NBA is required to ensure that only those cases are granted approval for future activities which would have been otherwise approved in the event it had been applied for prior approval. The OM thus provides opportunity to get absolved of all the violations under the BDA that might have been caused due to past activities.

The NBA was provided a specified time period of 100 days from the date of issuance of the OM to take such decisions, including course of action for matters related to the past.

The NBA has further extended the time for the same through another office memorandum dated March 18, 2019 so as to allow such applications and decisions to be made by May 17, 2019. As the OM and the further extension provides for a limited window period to rectify the past non-compliance, it is recommended that all applications be filed for all past activities.

“Start up” definition revised

As per a recent notification by the Ministry of Commerce and industry, the definition of Start up has been revised. As per the recent notification, an entity shall be considered as a Startup:

  1. Upto a period of ten years from the date of incorporation/ registration, if it is incorporated as a private limited company (as defined in the Companies Act, 2013) or registered as a partnership firm (registered under section 59 of the Partnership Act, 1932) or a limited liability partnership (under the Limited Liability Partnership Act, 2008) in India.
  2. Turnover of the entity for any of the financial years since incorporation/ registration has not exceeded one hundred crore rupees.
  3. Entity is working towards innovation, development or improvement of products or processes or services, or if it is a scalable business model with a high potential of employment generation or wealth creation.

Provided that an entity formed by splitting up or reconstruction of an existing business shall not be considered a ‘Startup’.

A start up to be recognized as one, has to make an application online or on the mobile Application of  Department for Promotion of Industry and Internal Trade (DPIIT).

The application has to be accompanied by a copy of certificate of incorporation or registration and a write up about the nature of business etc. The DPIIT, after calling for such documents or information and making such enquires, as it may deem fit, —(a) recognise the eligible entity as Startup; or (b) reject the application by providing reasons.

Probiotic Patent of Kibow Biotech Inc. upheld by the Madras High Court

The Madras High Court dismissed a writ challenging an Intellectual Properties Appellate Board (IPAB) order No. 262/2013 in respect of revocation proceedings ORA/29/2011/PT/MUM, for the Patent No.224100.

The impugned patent was granted to Kibow Biotech Inc., based on a PCT application filed claiming priority from US Patent Application No.10.672,622 filed on 30.09.2003.

Claims of the impugned patent are directed to a composition for augmenting kidney function in a subject comprising at least one probiotic bacterium wherein said probiotic bacterium selected from Streptococcus thermpphilus at about 5 billion to about 20 billion colony forming units of said atleast one probiotic bacterium other ingredient being selected from vitamin, mineral, carbohydrate, protein and fats. A revocation was filed by La Renon, which was dismissed by the IPAB and patent upheld.

The Madras High Court upheld the IPAB’s order maintaining the patent, dismissing the revocation and held that:-

  1. The patent having been granted, the onus is on the person wishing to challenge its validity. That onus has to be discharged on a balance of probabilities. The onus of establishing invalidity on any of the grounds cannot be shifted to the patentee.
  2. The Petitioner had an opportunity to let in evidence of an expert to substantiate the grounds for revocation. However, the petitioner failed to do so. The petitioner has not produced any evidence of an expert before the Appellate Board to substantiate its plea that the invention is a mere “admixture” or that the Patent was liable to be revoked on the grounds stated in the petition filed by it.
  3. Under Section 114 of the Indian Evidence Act, 1872, there is a presumption that all judicial and official acts have been regularly performed and it will be for the party who challenges such regularity to plead and prove his case.
  4. Though the impugned patent had only 10 claims at the time of grant of patent, the petitioner had questioned all the 20 claims which were originally filed while filing the patent application. Thus, the challenge itself was vague and without proper reading of the specification and the claim
  5. For Novelty , the Court held that the petitioner attempted to piece together a number of prior documents in order to produce an anticipation of the invention which is impermissible for the purpose of defeating claims.
  6. Further, the ground relating obviousness was raised not in the pleading before Appellate Board. It was made for the first time at the time of hearing before the Appellate Board.

The Court held that the petitioner had not made out a case before the Appellate Board for revocation of the patent, and the court found no reason why the request of the petitioner should be entertained to remand the case to give it third opportunity to establish the case.

The Court also made it very clear that there is a clear distinction between the scope of review in a writ jurisdiction and an appeal. The Court held that it cannot substitute the finding of facts arrived by the Appellate Board. The Court can only examine whether there was any infirmity in the procedure adopted by the Appellate Tribunal while passing the impugned order. The Court did not find any infirmity in the procedure adopted by the Appellate Tribunal while passing the impugned order and therefore dismissed the Writ.

Patent application for formulation of Valaganciclovir refused by the IPO

A patent application of F. Hoffmann-La Roche AG, for “POWDER FORMULATION FOR VALAGANCICLOVIR” has been refused by the Indian Patent office (IPO).

The invention, as disclosed by the applicant aimed to improve the stability profile and the manufacturability of the powder dosage form and the formulation procedure was changed from a dry mix granulation to a wet mix granulation. Their product claim is reiterated as follows:

1. A solid pharmaceutical dosage form for oral administration, after being constituted in water, comprising:

  • valganciclovir hydrochloride in an amount from 10% to 90%, by weight of the total composition; and
  • fumaric acid, an amount to lower the pH of the constituted solution of valganciclovir hydrochloride to a pH of about 3.8 or below, to stabilize the valganciclovir hydrochloride in water, wherein the dosage form has following composition:

 

Components Unit Weight mg/ 120 mg
Valganciclovir HCL 55.15’
Povidone K30 2.00
Fumaric Acid 2.00
Sodium Benzoate 1.00
Sodium Saccharin 0.25
Mannitol 57.80
Tutti-Frutti Flavor 1.80

Equivalent to 50mg of Valganciclovir (as free base) on a dry basis.”

The use of fumaric acid had not been previously reported, and the applicant claimed technical advancement in the same to obtain a patent. It was also alleged by the applicant that the stability of the powder product using fumaric acid is better that product obtained using citric acid. The applicant also produced a comparison table to highlight the assay values obtained using both the acids individually.

The Deputy Controller pointed towards  teaching in the prior art that composition of valaganciclovir is stable below pH 3.8. Further, the use of an organic acid (like citric acid) having pH less than 3.8 has also been reported in prior art and the pH value of fumaric acid is 3.19.The Deputy Controller held that fumaric acid is nothing but merely an alternate organic acid available within the preferred pH range.

The Deputy controller also observed in the comparison table so produced by the Applicant, that the assay values were close, and also well within the acceptable range.

Accordingly, it was held by the Deputy Controller that there is no technical advancement achieved from the applicant’s invention and it does not have any “inventive step”. For the same reason the grant of patent was refused under Section 15 of the Patents Act.

Renewal fee under Protection of Plant Varieties and Farmers’ Rights Rules, 2003 has to be computed as per Rule 39

A Writ petition filed by Maharashtra Hybrid Seed Co Pvt. Ltd. (hereafter ‘Petitioner’) has been allowed by the Delhi High Court and it has been clarified that Rule 39 of the Protection of Plant Varieties and Farmers’ Rights Rules, 2003 (hereafter ‘the said Rules’) is a special rule relating to renewal of Plant variety registration and provides for the renewal fee to be computed. The Registrar of the Plant and Varieties has been directed to accept the renewal fee as computed under Rule 39(1)(a) for renewing the registration of the plant varieties.

The facts of the case are as follows: –

  1. The petitioner had applied for registration of two wheat varieties referred to as ‘W6001’ and ‘W6301’;
  2. The varieties were registered on 21.12.2009 vide registration No. 118/2009 and 119/2009 respectively;
  3. On 26.08.2009, the Central Government issued a notification, notifying the annual fee to be paid for registered varieties under the Act;
  4. In compliance with the said fee structure, the petitioner paid the annual fee of ₹2,000/- for each of the two registered varieties for the period 21.12.2009 to 02.09.2015;
  5. On 17.12.2015, the petitioner applied for renewal of the registrations in the prescribed Form (PV-6). The petitioner also remitted a renewal fee of ₹18,000/- for each of the two registered varieties. The said amount was computed in accordance with Rule 39 of the said Rules.
  6. On 30.12.2015, the Protection of Plant Varieties and Farmers’ Rights Authority sent a letter calling upon the petitioner to pay the renewal fee for the extended period of registration at a flat rate of ₹80,000/- per year for each variety for renewal of the registration (as per Second Schedule of the said Rules).
  7. The petitioner contested the aforesaid demand and reiterated its position that renewal fee was required to be calculated as per Rule 39(3)(a) of the said Rules, and not in accordance with the Second Schedule of the said Rules. The petitioner was afforded an opportunity of being heard in this regard and its contention was rejected by the impugned Order.
  8. The Petitioner challenged said order in a writ before the Delhi High Court.

The Court allowed the Writ and held that clarified that Rule 39 of the Protection of Plant Varieties and Farmers’ Rights Rules, is a special rule for the renewal fee to be computed. The Court held that the Second Schedule would not override the provisions of Rule 39 of the said Rules for, essentially, two reasons:-

  1. Rule 39 of the said Rules is a special rule relating to renewal of registration and by applying the maxim of generalia specialibus non derogant, that is, a special shall override the general, Rule 39 of the said Rules would override the Second Schedule.
  2. The Second Schedule is an adjunct to Rule 8 of the said Rules and provides the Schedule of fees as payable under Rule 8 of the said Rules. However, Rule 8 of the said Rules does not specifically mention payment of renewal fee. Therefore, although the Second Schedule to the said Rules provides for the renewal fee, there appears to be no provision under Rule 8 of the said Rules, which requires that fee to be paid.