Monthly Archives: April 2014

Relief for Pfizer as IPAB stays Revocation on Drug Tolterodine

In a positive development for US drug giant Pfizer, the country’s Intellectual Property Appellate Board (IPAB) has issued an interim stay on an order stated by the Indian Patent Office removing a patent of Pfizer, for its extended release drug Tolterodine (Detrol), which is used for treating old age patients who suffer from frequent urination. On the post-grant opposition by Indian pharmaceutical company Daiichi Sankyo owned Ranbaxy Laboratories, the Assistant Controller of Patents and Designs had revoked the patent in November 2013 under section 25(2)b, 25(2)c, 25(2) and 25(2)e of the Patent Act, and subsequently removed it from the registry in December last year.

Background:

The turf war between the two multinationals started when the Chennai Patent Office revoked Pfizer’s claims on a formulation of its best-selling drug Tolterodine(Detrol).The patent on the drug was challenged by Ranbaxy Laboratories. In India, Pfizer has two patents on Tolterodine (Detrol), the first patent IN211539 was filed in August 1999, and the second (IN229260) three months later in November which cover its extended release capsule formulation. It is believed that the invention claimed in the revoked patent (IN 229260 ) was found to be “prior claimed” by another patent of Pfizer (IN 211539 ) on the same drug under Section 25(2)(c) of prior claiming. A comparison of claims of the two patents is given below. picture3The invention claimed in the revoked patent was also found to be obvious, and not involving any technical advancement compared to existing knowledge under Section 25(2)(e) of obvious over prior art. Ranbaxy relied on three prior documents i.e.; US 4800084, WO 98/03067 AND WO 96/12477. US 4800084 discloses the use of seal coat between the core and the drug layer in a multilayer medicated formulation whereas, WO 98/03067 discloses a method of use of Tolterodine in urinary voiding disorder in which various possible formulations of Tolterodine including the controlled release formulation are disclosed, but does not discuss any formulation in detail.WO96/12477 discloses a controlled release oral delivery system for oxybutynin, comprising a bead system of core and coatings. Oxybutin is a tertiary amine antiuscarinic used to treat urinary incontinence. The controller said that the “person skilled in the art would have been motivated to prepare controlled release bead for tolterodine with the teachings of preceding prior art together with common general knowledge in the art at that time of filing the application without undue experimentation”. Further, the study carried out by the patentee on ‘effect of sealcoat thickenss’ does not possess any inventive merit. The Controller further held that it is common general knowledge in the art when thickness of layer increases, release rate of the drug or permeability of water decreases. Workable range of sealcoat layer neither suggested nor described in the complete specification. Therefore, present patent do not involve any technical advancement as compare to the existing knowledge. However, the opposition board sided with the patentee and opined that inventive skill is involved in selecting quantity of the drug, core medium and compatible polymers for coating to arrive at a controlled release formulation as claimed in the instant patent IN 229260. The Assistant Controller revoked the said patent (IN 229260) of Tolterodine (Detrol) stating its obviousness and that it was prior claimed by another patent (IN211539) of Pfizer.

Further Developments:

Aggrieved by the developments, Pfizer moved to IPAB, requested for stay on the controller of patent’s order. However, when the matter came up at IPAB in March 2014, Ranbaxy’s counsel submitted that they have not been given enough time by Pfizer to prepare the counter against the appeal and the matter be adjourned, which was refuted by the latter. Considering the petition, IPAB Chairman held: “The balance of convenience is very much favourable to Pfizer and accordingly we are granting an interim stay on the assistant controller’s impugned order of November 27, 2013, which revoked the patent of Pfizer.” The order was on a miscellaneous petition of Pfizer for an interim stay. The IPAB bench also observed that Ranbaxy is open to file a counter-affidavit, seeking redressal of grievances under the applicable laws. Further in March 2014, the counsel for Pfizer, PS Raman, submitted that the controller of patents had removed the patent from the register on December 15, 2013, hardly a month after pronouncement of the revocation order on November 27, 2013. He pointed out this was done even before the limitation period for referring an appeal had expired. According to him, Pfizer had time till February 28, 2014, to appeal against the impugned order. While Pfizer informed the Board that it has served the notice to Ranbaxy on the hearing of the miscellaneous petition through courier-post on March 13, 2014, the latter in a letter dated March 21, 2014, stated that they have received the notice from the registry only on March 19, and sought a relief of adjournment. IPAB held that Ranbaxy having received the notice from the petitioner as early as March 13, 2014, had enough time to appear and argue the matter of stay petition. Hence there should not be any justification for seeking further time.

Conclusion:

Since 1991, Pfizer has been using the subject patent at the international level and filed for Indian patent in 2001, and also seen that Pfizer did succeed in pre-grant opposition. In my opinion, this revocation decision has only reduced the Tolterodine patent term by three months ( IN 229260 expires on November 2019) since the other patent IN211539 is still valid till August 2019, but since both patents covering Tolterodine claim the same invention and one of the patents is revoked as being obvious over prior art, the second patent is now susceptible to revocation under same grounds of obviousness and lack of inventive step and hence will be an inspiration for other competitors as well to attack the first patent.

About the Author: Sugandhika Mehta, Patent Intern at Khurana and Khurana and can be reached at: sugandhika@khuranaandkhurana.com

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Examination Guidelines for Pharmaceuticals Patents

There has been limited judicial consideration of how patent law applies to pharmaceutical inventions in India. Little specific guidance is available to patent examiners in assessing whether a particular pharmaceutical invention satisfies the requirements for patentability. The absence of judicial guidance in this area is problematic.

Indian Patent Office has published the Draft Guidelines on Pharmaceutical Patents to assist Indian patent examiners and patent applicants/patent agents in applying the Patents Act and Patent Rules to pharmaceutical inventions so that the Examiners and the Controllers adopt consistently uniform standards of examination. According to the Controller, a number of issues pertaining to product patenting are becoming clear through the decision of the Courts and therefore there is a need to develop such guidelines incorporating the analysis of Courts, for examination of pharmaceutical patents. These Guidelines are available over here.

The Guidelines is intended as a reference guide for examiners/patent applicants/patent agents on all aspects of patent practice, including: search and examination procedure, interpretation and application of the requirements of patentability under Indian law and relevant procedural provisions of the Patent Act, and practice and procedures in connection with patent applications filed under the PCT.

This article focuses on the important notable aspects of the Guidelines.

The Guidelines first of all categorizes the various kinds of claims the applications pertaining to pharmaceutical and allied subject matters can have:

Claims of Pharmaceutical Inventions

Patent application pertaining to pharmaceutical and allied subject matters comprises the claims relating to the following subject matters, but not limited to:

I. Product claims:

i. Pharmaceutical substances;

a. New Chemical Entities;

b. Formulations/Compositions;

c. Combinations/dosage/dose;

d. New forms of known substance such as;

Salts, Ethers and Esters; Polymorphs; Solvates, including hydrates; Clathrates; Stereoisomers; Enantiomers; Metabolites and pro-drugs; Conjugates; Pure forms; Particle size; Isomers and mixtures thereof; Complexes; Derivatives of known substance; and

ii. Kits;

iii. Product-by-process.

II. Claims for process/method of manufacturing;

III. Claims related to new property, new use of known substance or use claims, including second indications;

IV. Claims for method of treatment and/or diagnosis of human beings and animals;

V. Claims related to selection inventions.

Assessment of Novelty, Inventive Step and Industrial applicability

The assessment of novelty, inventive step and industrial applicability is similar to the patents filled in other technical domains. A claimed invention will be granted a patent only if the invention is a product and/or process.

Claimed inventions relating to the second use of already known compounds does not make the substance novel and/or inventive.

In product-by-process claims, the applicant has to show that the product defined in process terms, is not anticipated or rendered obvious by any prior art product. In other words the product must qualify for novelty and inventive step irrespective of the novelty or inventive step of the process.

A large number of illustrative examples are provided for determination of novelty and inventive step for various kinds of claimed inventions including compound (Markush) claims, combination/composition claims, product-by-process claim.

More clarifications on obviousness determination are provided, for example, the skilled person needs to eliminate hindsight analysis, reasonable expectation of success must be embedded which could motivate a skilled person, surprising (enhanced) effects cannot provide inventive step if the solution if from a limited set of alternatives which is obvious to try.

Inventions not patentable

Pharmaceutical related inventions not patentable under Section 3 (b), Section 3 (c), Section 3(d), Section 3 (e), Section 3 (i) are also discussed in the guidelines.

The patentability of pharamaceutical related inventions under section 3(d) has invoked many debates in the recent past and is discussed in detail. According to Section 3(d), an incremental invention, based upon an already known substance, having established medicinal activity shall be deemed to be treated as a same substance, and shall fall foul of patentability, if the invention in question fails to demonstrate significantly improved therapeutic efficacy with respect to that known compound. While interpreting what is “efficacy”, the Hon’ble Supreme Court held that in the context of the pharmaceutical patenting, the “efficacy” should be understood as  “therapeutic efficacy”. Also, the Supreme Court explained what would mean a “new product” in the context of Section 3(d): “…………the new product in chemicals and especially pharmaceuticals may not necessarily mean something altogether new or completely unfamiliar or strange or not existing before”. According to the Supreme Court, whether or not an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data. However, it is important to note that Supreme Court has clarified further that the test of Section 3(d) of the Act does not bar patent protection for all incremental inventions of chemical and pharmaceutical substances. The term “combination” as appearing in Section 3(d) has been explained by IPAB as “The combination mentioned in the Explanation can only mean a combination of two or more of the derivatives mentioned in the Explanation or combination of one or more of the derivatives with the known substance which may result in a significant difference with regard to the efficacy.

A number of illustrative examples are provided for section 3d, 3e, 3i etc..

Sufficiency of description, clarity and support of the claims:

Sufficiency of description, best mode, clarity and support of the claims are included in sections 10(4) and 10(5) of the Patent Act. The Guidelines provide various illustrative examples on sufficiency of microorganisms included inventions, biological material included invention.

If the invention relates to a biological material which is not possible to be described in a sufficient manner and which is not available to the public, the application shall be completed by depositing the material to an International Depository Authority (IDA) under the Budapest Treaty.

The Guidelines further explains that non-technical terms like trademarks should be discouraged and the applicant should be asked to replace them with equivalent technical terms.

In regard to the Markush claims, the Guidelines explain that claims with Markush formulas may cover innumerable compounds and may be overbroad, thus leading to conclusion of inconsistency between description and claims. Also, such formulas can lead to the question of plurality of distinct inventions. Compounds represented by different alternatives should have a technical interrelation ship. Where a single claim defines alternatives of a Markush group, the requirement of a technical interrelationship is considered met when the alternatives are of a similar nature.

Further, the functional claims (wherein the substances are defined in terms of their physiological properties/results) should be discouraged.

Unity of Invention

When there is a group of inventions in a specification they should be linked by a single concept or there should be a technical relationship among the claimed inventions, which makes the inventive contribution over the prior art.

In Markush claims the unity of invention shall be considered to be met when the alternatives claimed are of a similar nature. The Markush group of alternative chemical compounds can be regarded as being of a similar nature is subjected to the fulfillment of the following conditions:

a)They have a common property or activity,

b) All of the alternatives have a common structure, which is a significant structural element shared by all of the alternatives

The Guidelines also clarify that wherever there will be a conflict between the Guidelines and the Patent Act, the provisions of the Act will prevail.

About the Author: Ms. Harsha Rohatgi, Patent Associate, Khurana & Khurana, Advocates and IP Attorneys and can be reached at: harsha@khuranaandkhurana.com

PRINCIPLES OF ‘PRIOR ADOPTION AND USE’ VIS A VIS TRANSBORDER REPUTATION: JONES INVESTMENT CO V. VISHNUPRIYA HOSIERY MILLS

In the recent decision of Intellectual Property Appellate Board (IPAB) in the case of Jones Investment Co v. Vishnupriya Hosiery Mills, it was held that a multinational company cannot claim infringement of trademark by a local Indian company purely based on international presence, unless they can expressly establish that their presence extends to India or precedes that of the Indian company.

Facts of the case:

The appellant in this case is the Jones Investment Co. an American company who is engaged in the business of apparel, hosiery, footwear, etc. and uses the Trademark ‘Jones New York’ internationally thereto for the aforementioned goods. On the other hand, the Respondent is the Vishnupriya Hoisery Mills, a textile firm based in Erode, Tamil Nadu. The respondent applied for the registration of the trade mark ‘Jones’ for their textile products. This application was opposed by the appellant and in adjudication of the same Deputy Registrar of Trademarks dismissed the notice of the opposition on 9th March 2010. Thus being aggrieved by the decision of the Deputy Registrar, the appellants preferred this appeal in IPAB.

Arguments on behalf of the Appellants:

The counsel for the appellants mainly relied on two contentions inter alia. First, that the appellants had been using the mark ‘Jones New York’ since 1966 and thus they had acquired International reputation in the same. Further it was also contended that the appellants had registered their trade mark in India since 1997. Therefore, the registration of the trade mark with respect to same goods under the name ‘Jones’ by the respondent would cause confusion and would deceive the consumers.

Secondly, it was contended by the appellant that the respondent has not shown any substantial sale of their goods by using the impugned trade mark and the Deputy Registrar also pointed out that they have produced only meager sale. As such the respondent cannot claim reputation among the public in respect of their goods using the similar trade mark as adopted by the appellant. Also it was contended that in view of development of technology and communication the respondent cannot claim the ignorance of the international reputation of the appellant’s mark.

Arguments on behalf of the Respondent:

The counsel for the respondent submitted that the main issue involved in the case is that whether the appellants has established their use of trade mark ‘Jones New York’ in India on the date of application filed by the respondent before the Registrar for the registration of the impugned trade mark. And in response it was contended that till date the appellant is not using the trade mark ‘Jones New York’ in India. Therefore the question of transborder reputation of the appellants mark need not arise at all. The learned counsel relied on the decision of the Hon’ble Supreme Court in Milmet Oftho Industries & Ors vs. Allergan Inc reported in 2004 (28) PTC 585 among other cited cases.

Judgment:

IPAB at the outset stated that it is undisputed that the appellant till date is not using their trade mark ‘Jones New York’ in respect of their goods in India and it is their categorical statement that they proposed to use the same in India. The appellants failed to prove the use of the alleged trade mark since 1966 as they have filed their documents only from the year 1997 whereas the respondent have proved their claim of use of the trade mark since 1993 by producing relevant documents to substantiate their claim. Thus the question of confusion or deception need not arise.

The IPAB relied on decision of the Hon’ble Apex Court in Milmet Oftho Industries & Ors vs Allergan Inc. which is squarely applied to the present case that the multinational companies who have no intention of introducing their product in India should not be allowed to throttle an Indian company and the Indian company who has genuinely adopted the mark and developed product and it is first in the market cannot be prevented from using the mark.

Further the IPAB upheld the observation of the Deputy registrar that when the respondent is prior in adoption and use in India, the quantum of sales figure is immaterial. Thus the appeal was dismissed by IPAB with no order as to cost.

Conclusion:

The IPAB compared the facts and relied on Milmet and held that this was also a similar situation where the appellant company had no sales whatsoever in India under the trade mark ‘Jones New York’. Therefore, the appellant does not have any ground to ‘throttle’ the Indian business. Here it is pertinent to note that this was adjudicated only for the reason that the Appellants did not provide evidence to show that they had an established international reputation prior to 1997, whereas on the other hand the respondents substantially their presence in India since 1993. The operative test, therefore, in such cases is merely who is first in the market. Thus the IPAB has held in favour of the small firm like Vishnupriya Hosiery and against the big corporation solely in the interest of justice, equity and conscience. And if IPAB had held otherwise, it would lead to the growth of multinational corporations at the cost of small firms which is undesirable.

About the Author: Mr. Abhijeet Deshmukh, Trade Mark Attorney, Khurana & Khurana, Advocates and IP Attorneys and can be reached at: Abhijeet@khuranaandkhurana.com