Procedural Challenges in Opposition and Revocation proceedings -Essenese Obhan MHRD IP Chair Roundtable Symposium NLU, Jodhpur 17 th and 18 th March, 2012

Multiple Attacks on Validity of Patent Pre-grant opposition Post-grant opposition Revocation proceedings

Pre-Grant Opposition Who? - Any person When? - Any time after publication of application till grant Where? - Indian patent office Appeal? - No appeal for opponent

Advantages Costs: relatively low Any person Can be quick Understand the patentees case before a revocation attack Possibility of limiting scope of claims before grant

Disadvantages No response to counter-statement Cross-examination of experts- generally not allowed No additional documents or grounds (?)

Neon Labs. v TroikaaPharma Limited and Others Respondent No. 1 (TroikaaPharma Ltd.) filed the Application no. 96/MUM/2005 for "Injectable preparations of Diclofenac and its pharmaceutically acceptable salts" on On , the Petitioner filed a representation by way of opposition under Section 25(1) On , the Respondent No.1 filed a reply statement to the opposition of the Petitioner During the hearing held on , Respondent pointed out that they intended to file an amended set of claims the Respondent No. 4 (Asst. Ctrl. Of Patents) sent the amended claims to the Petitioner after the hearing vide a letter dated

Neon Labs. v TroikaaPharma Limited and Others Petitioner filed its opposition to the amended claims on The Petitioner requested by its letter dated for a personal hearing in the light of the opposition to the amended claims There was no response to these communications and therefore the Petitioner sent a letter dated objecting to the course adopted by the Respondent No.4, namely, allowing amendment of claims after the hearing was concluded

Neon Labs. v TroikaaPharma Limited and Others opportunity provided in Section 25(1) is not an empty formality…. Once the Legislature has devised such a safeguard in public interest and provided for pregrant opposition, so also, set out the manner in which the same has to be dealt with, then, we cannot place a narrow interpretation on the said provision so as to defeat the legislative mandate. The distinction made by Mr. Kadam that opportunity is restricted only to the contents of the original application and there is no requirement of giving further hearing; makes the exercise meaningless and it would be then very easy to defeat Section 25(1). In this context, it must be understood that the opposition under Section 25(1) is to the "grant of a patent"....If the opposition is raised to the grant, then, until the same is dealt with, no patent can be granted. If the original claim/application is amended, as in this case, and the amendments are also opposed, then, a personal hearing to the objector on the amended claims is required to be given if specifically requested. That is the scheme of Section 25(1) and Rule 55 which are to be considered and read together.

Patent Office: Interpreted by patent office to mean amendment to claims only treats amendments under section 15 and not under section 25

Post-Grant Opposition Who? - Person interested When? - Within one year from the date of publication of the grant of patent Where? - Indian patent office Appeal? - Yes, appealable at Intellectual Property Appellate Board

Revocation Who? - Person interested When? - Any time after the grant of patent - As a defence in an infringement suit Where? -Intellectual Property Appellate Board (IPAB) Chennai -High Court Appeal? - Yes

Advantages- IPAB Adjournments/delays strongly discouraged Additional documents can be submitted More structured

Disadvantages- IPAB No cross examination of witnesses Single technical member for all technologies

Grounds of opposition/revocation : Novelty Inventive Step Insufficiency Not an invention/not patentable

Inventive Step: Section (2)(1) (ja): inventive step means a feature of a invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art

Not Inventive: Section 64(1) (f): That 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

Windsurfer test: First: identify the inventive concept embodied in the patent Second: the court has to assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and to impute to him what was, at that date, common general knowledge in the art in question Third: identify what, if any, differences exist between the mater cited as being known or used and the alleged invention Finally, the court has to ask itself whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they require any degree of invention

Routes to proving obviousness Route 1: Mosaic of prior art documents Route 2: Missing element provided by Common General Knowledge

Insufficiency Section 64 (1)(h): that 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

Need to Determine: State of the Art – Publicly known or used in India; published anywhere Person of Skill in the Art (PoSITA) Common General Knowledge of the PoSITA

Common General Knowledge: The information which at the date of the patent in question is common knowledge in the art or science to which the alleged invention relates, so as to be known to duly qualified persons engaged in that art or science. [ British Thomson – Houston Co. Ltd v Taylor Electrical Co. Ltd (1916) 33 R.P.C. 166 at 171 ] in other words, it is part of the mental equipment necessary for competency in that art or science concerned, such as every worker in the art may be expected to have as a part of his technical equipment.[ Automatic Coil Winder, etc., Co Ltd v Taylor Electrical Instruments Ltd (1944) 61 R.P.C. 41 ]

Common General Knowledge: What is not: In my judgement it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less because it is widely circulated. Such a piece of knowledge only becomes general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art. [ British Acoustic Films 53 R.P.C 221at 250 ]

Common General Knowledge: It has never been easy to differentiate between common general knowledge and that which is known by some. It has become particularly difficult with the modern ability to circulate and retrieve information. Employees of some companies, with the use of libraries and patent departments, will become aware of information soon after it is published in a whole variety of documents; whereas others, without such advantages, may never do so until that information is accepted generally and put into practice. The notional skilled addressee is the ordinary man who may not have the advantages that some employees of large companies may have. The information in a patent specification is addressed to such a man and must contain sufficient details for him to understand and apply the invention. It will only lack an inventive step if it is obvious to such a man. It follows that evidence that a fact is known or even well-known to a witness does not establish that that fact forms part of the common general knowledge. [ Court of Appeal in Beloit Technologies Inc V Valmet Paper machinery Inc (1997) RPC 489 at pages ; also referred to in K. Manivannan v. M. Mani IPAB Order No. 55/2009 ]

Common General Knowledge in Pharma matters: Different types of dosage forms and their properties Dissolution rate of a drug affects its bioavailability Dissolution rate affected by particle size (surface area) Differing properties of different polymorphs can include different solubilities (and therefore bioavailability)

Person of Skill in the Art (PoSITA) Notional Person Average Skill in the Art to whom the patent is addressed Has read all the prior art (but does not remember any of it) Has no inventive capability Knows all the Common General Knowledge in the art Could be different for construction/ sufficiency and obviousness

PoSITA Art: Vehicular Cargo transportation (TRUCKS) Use: drives a truck? Repairs a truck? Produce: Manufacture the truck Design: Aesthetics/Capacity of the truck Research/Invent: Involved in creating new technologies for trucks

PoSITA in Pharma Cases: In the Pharma Industry – interested in formulating drugs Has a degree in Chemistry/ Pharmaceutical sciences/ Formulation science A few years experience in a lab with: – Experience in formulation and development of solid dosage forms intended for oral administration Assisted by a team of graduates and technicians Access to analytical laboratories

EP

Verathon Medical (Canada) ULC v Aircraft Medical Limited [2011] CSOH 19 Verathon Medical – proprietor of EP Verathon Medical alleged infringement of EP by Aircraft Medicals product McGrath Series 5 laryngoscope Aircraft Medical counterclaims for revocation of patent

PoSITA according to Verathon Medical-Patentee Clinicianinvolved in carrying out and supervising the intubation of patients and a Medical Device Engineer and Medical Device Engineer- a clinical technologist employed in a hospital rather than a graduate medical engineer; or if in industry: no training in anatomy and physiology; would not have used a laryngoscope and would have no design experience for it.

PoSITA according to Aircraft Medical-Defendant Clinician- newly qualified consultant anaesthetist having interest in the management of difficult airways Medical Device Engineer: works in industry with either physics, mechanical or electrical degree followed by a MSc + product design degree followed by experience in a design house + a degree in biophysics or biomedical engineering Camera technician: would know of CMOS and CCD products and how to use and position them

PoSITA as determined Not a clinical user of a laryngoscope: newly-qualified consultant anaesthetist who has an interest in airway management; medical device engineer working in industry with some knowledge of electronics and camera technology or along with a camera engineer; would know of use of cameras in some medical devices

Common General Knowledge according to Verathon Medical -Patentee Clinician: knowledge of very limited number of conventional laryngoscope blades. In UK would know macintosh blade and in the US would also know a few other blades. Not aware / experienced of other laryngoscope blade including Belscope, Bullard or other rigid fibre-optic laryngoscopes Not aware of specialist textbooks Not aware of patents, concept of indirect laryngoscopes, camera and lens in endoscopy

Common General Knowledge of a PoSITA according to Aircraft Medical-Defendant Clinician: knowledge that there had been attempts to obtain an indirect view of the glottis from the pharynx, behind the tongue Would know of Bullard and other laryngoscope, New devices discussed in meetings of DAS (Difficult Airway Society) Use of video chips at the distal end of endoscopes for gastrointestinal investigations

Common General Knowledge of a PoSITA as determined Consultant anaesthetist in UK/US –skills/use :direct laryngoscopes – Leading text books contributed to awareness of Bullard and other anatomically-shaped rigid fibre-optic laryngoscopes; – DAS Meetings contributed to awareness of new laryngoscopes including indirect laryngoscopes; Medical device engineer would be aware of use of video chips in endoscopy

EP

Claim 1: A vacuum cleaning appliance including: – cyclone units of successively higher efficiency in the capability of depositing fine dust; – in series connection; – the highest efficiency cyclone having frusto- conical part tapered away from entry; – lower efficiency cyclone unit upstream of the highest efficiency unit.

Dyson Appliances Ltd v Hoover Ltd [2001] RPC 26 First patent by Dyson had two high efficiency cyclones Huge profits in selling filter bags-industry bias Hoover product: Three parts: – SU1: cylindrical cyclone – SU2: intermediate channel-no dust collection – SU3: frusto-conical cyclone

PoSITA according to Dyson General engineer in vacuum cleaning industry with a practical turn of mind Post graduate Must be working in domestic product field Amended to: Agree that engineer must have limited knowledge of large scale industrial cyclones

PoSITA according to Hoover Engineer in vacuum cleaning industry with considerable time spent in familiarizing himself with the manufacture and operation of both gas cyclones and vacuum cleaning appliances Amended to: designer and manufacturer of vacuum cleaning appliances (not only domestic) + knowledge of theory and working of cyclones: hands on experience of cyclones including commercial cyclones

PoSITA as determined The evidence has not proved to be of much assistance in getting a clear picture of the workings of what I believe to be the relevant field, that is, vacuum cleaner industry alone PoSITA: Graduate in mechanical or electrical or both Few years practical experience in vacuum cleaner industry Not limited to only domestic appliances Does not have to possess hands on experience with cyclones and their working But will have some knowledge of cyclones as part of general engineering background including commercial cyclones

Challenges: Determining the PoSITA Identify the Common General Knowledge of the PoSITA Balancing Obviousness and Insufficiency Expert Evidence: Important not to portray the expert as person skilled in the art

Thank you Questions? -