Opposition proceeding to patent and anticipation

Patents: 

Patents . OPPOSITION PROCEEDING TO GRANT OF PATENT AND ANTICIPATION Experimental Design and Patents (930001) Presented by Nidhi Lathia M.Pharm SEM- III Department of Pharmaceutics Atmiya Institute of Pharmacy, Rajkot

Opposition [Section 25-28]: 

Opposition [Section 25-28] Where an application for a patent has been published and a patent has/has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on any specified ground. There are specific grounds that can be raised in an opposition proceeding. 2 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Opposition [Section 25-28]: 

Opposition [Section 25-28] Earlier, person making such representation was not a party to proceedings. Now, with amendment, one can be given opportunity to be heard, if application is made (rule 55). Based on the prima facie of the case, Controller may accept the opposition and refuse to grant the patent or reject the application and grant the patent . At any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of a patent, any person interested may give notice of opposition. 3 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Types of opposition: 

Types of opposition Pre grant opposition Post grant opposition 4 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Pre grant opposition [Section 25 (1)]: 

Pre grant opposition [Section 25 (1)] Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground. Pre-grant opposition has to be filed within six months from the date of publication of the application or till the grant of a patent, setting out facts upon which applicant relies ( until the expiry of this deadline, no patent will be granted ). Fee: No fee 5 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Form and content [Rule 55(1)] There is no prescribed form for pre grant opposition however the representation shall be in writing and shall comprise of following particulars; Statement regarding opposition Evidence regarding opposition; (if any) Request for hearing (optional) Appeal An applicant can go for an appeal against the decision of the controller. Such an appeal can be filed before the Intellectual Property Appellate Board (IIPAB), Chennai. 6 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Grounds for pre-grant opposition by way of representation u/s 25(1): 

Grounds for pre-grant opposition by way of representation u/s 25(1) Wrongfully obtaining Prior publication / prior claiming Prior claiming in India Prior public knowledge or public use in India Obviousness and lack of inventive step Not an invention or the invention not patentable Insufficient description of the invention Failure to disclose information or furnishing false information relating to foreign filing 7 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Convention application not filed within the prescribed time Incorrect mention of source/geographical origin of biological material Invention anticipated with regard to traditional knowledge of any community, anywhere in the world No ground other than the statutory grounds as above can be taken for opposing the Grant of Patent under section 25(1) 8 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Procedure for opposition u/s 25 (1): 

Procedure for opposition u/s 25 (1) 9 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Case study - The Gleevec Case: 

Case study - The Gleevec Case Novartis AG, Switzerland Vs Natco Pharma Ltd., India “ Crystal Modification of N-Phenyl-2-Pyrimidineamine derivative, processes for its manufacture and its use” Application No. : 1602/MAS/1998 Patent filed in India : 17 th July 1998 (at patent office, Chennai) 10 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Novartis claimed Switzerland priority for the above mentioned invention on 18 th July 1997. Upon publication, the grant of patent was opposed by way of representation u/s 25(1) by Natco Pharma Ltd., India on 26 th May, 2005 and they also requested for hearing. The grounds for opposition were: Anticipation by prior publication Lack of inventive step Non-patentability u/s 3(d) of the Patents Act Wrongfully claiming the priority. 11 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Applicant filed the reply statement with evidence on 25 th July, 2005 and also asked for hearing. The Controller conducted the hearing and considered various grounds for opposition in the light of submissions by both the parties and concluded as follows: The title compound commercially, called imatinib mesylate , was already known in the US Patent No.5521184 (1993 Patent). The 1993 Patent disclosed methanesulphonic acid as one of the salt –forming groups and also states that the required acid additions salts were obtained in a customary manner. 12 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Claims 6 to 23 of the 1993 Patent claimed a pharmaceutically acceptable salt of the base compound. Another Document, “Nature Medicine” (5 th May, 1996) also described the title compound. Also the compound , imatinib mesylate salt, inherently existed in the β-crystalline form, which is most stable form of the salt. This fact was also clear from the results of laboratory experiments conduced by two reputed government institutions, Indian Institute of Chemical Technology, Hyderabad Indian Institute of Technology, Delhi 13 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Hence, the claims of the application for the product and process in respect of the title compound stood anticipated by prior publication. As per section 3(d), any salt or polymorph or derivative of the known substance is not patentable unless such salt or polymorph or derivative shows enhanced efficacy of the substance. The affidavit submitted by the technical expert on behalf of the applicant demonstrated that the relative bioavailability of the free salt with that of β-crystal form of imatinib mesylate differ only by 30% and accounted this difference to their solubility in water. 14 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Thus, the specification did not bring out any improvement in the efficacy of the β-crystal form over the known substances ; rather it stated that the base compound could be used equally in the treatment of diseases or in the preparation of pharmacological agents wherever the β-form is used. Thus, the product claim amounted to a mere discovery of the new form of the known substance. The application filed in India has claimed the Swiss priority dated 18 th July,1997, but Switzerland was not a Convention country on that date. It became the Convention country in September,1998 only. 15 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Hence, no priority of Swiss application could be claimed in respect of the Indian application. Decision: In view of the above findings and arguments made by both the parties during the hearing, the Learned Controller ruled that the Patent Application no.1602/MAS/1998 cannot proceed for grant of patent. The decision of the Controller has been appealed against by the applicant and the matter is currently sub-judice 16 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Post grant opposition [Section 25 (2)Rule 55-63]: 

Post grant opposition [Section 25 (2)Rule 55-63] At any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of a patent, any person interested may give notice of opposition to the Controller in the prescribed manner. The post grant opposition has to be filed within one year from the date of grant. Statutory fees: Particular Natural person (INR) Other than natural person (INR) Notice of opposition 1500 6000 17 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Form and content Notice of opposition shall be in form 7 (in duplicate)[Rule 55A] Written statement setting out nature of the interest (in duplicate) [Rule 57] Evidence regarding opposition Statutary fees Request for hearing (optional) Appeal An applicant can go for an appeal against the decision of the controller. Such an appeal can be filed before the Intellectual Property Appellate Board (IIPAB), Chennai. 18 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Form no. 7 for post grant opposition [Section 25(2)]: 

Form no. 7 for post grant opposition [Section 25(2)] 19

Grounds for post-grant opposition by way of representation u/s 25(2): 

Grounds for post-grant opposition by way of representation u/s 25(2) Wrongfully obtaining Prior publication / prior claiming Prior claiming in India Prior public knowledge or public use in India Obviousness and lack of inventive step Not an invention or the invention not patentable Insufficient description of the invention Failure to disclose information or furnishing false information relating to foreign filing 20 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Convention application not filed within the prescribed time Incorrect mention of source/geographical origin of biological material Invention anticipated with regard to traditional knowledge of any community anywhere in the world 21 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Procedure for opposition u/s 25 (2): 

Procedure for opposition u/s 25 (2) Nidhi Lathia-opposition proceeding to grant of patent and anticipation 22

Case study: 

Case study Stoplik services pvt. ltd. Vs Panacea biotech ltd. “ A process for the preparation of a therapeutic anti-inflammatory and analgesic composition containing Nimesulide for use transdermally ” Application No. : 454/BOM/1998 Patent No. : 183458 Patent application filed on : 14 th July, 1998 23 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Opposition was lodged by Panacea biotech ltd. on the ground of; prior publication prior public knowledge obviousness not an invention Comparison of the alleged invention 183458 with the Sri Lanka’s Patent 11012 and Nigerian Patent RP 12829 clearly shown that it do not pass the test of the Novelty . 24 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… Further Panacea Biotech Ltd. mentioned that Sri Lankan Patent No. 11012 dated on 24 th July 1996 was granted on 20 th September 1996 while Nigerian Patent Application No. RP 12829 dated on 5 th September 1996 was sealed on 3 rd March 1997. The opponents succeed on the ground of obviousness and lack of inventive step. The grant of Patent on application for Patent No. 183458 was refused and the applicants have to pay Rs.17,000 towards the cost as per schedule Annexure. 25 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Case study : 

Case study Hindustan Lever Ltd. Vs Kay laboratories “A method for making a plant growth nutrient/stimulant” Application No. : 1988 PTC 31 Mum 26 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… An Application for patent for the above mentioned invention was filed by Hindustan Lever Limited. The acceptance of the application was notified in the Gazette of India part III, Section 2 dated 14-12-1982 after a serial number, 150203 was accorded to it. This invention relates to the method for making a plant growth nutrient/stimulant which comprises subjecting plant waxes like rice bran wax, camauba wax or sugarcane wax. Next step is saponification Saponified non saponified matter Nidhi Lathia-opposition proceeding to grant of patent and anticipation 27

Contd… : 

Contd… Then non- saponified matter is separated and recovered from the said mixture by selective extraction is an organic solvent as the said plant growth nutrient/stimulant , and optionally converting said nutrient/stimulant into a stable aqueous emulsion in a conventional manner. The opponents ground for opposition; relied upon scientific publications expert’s evidence . properties of unsaponified products is not a fit subject matter for the grant of a valid patent, prior publication The opposition succeeds on this ground and it is ordered that the patent shall not be granted. Nidhi Lathia-opposition proceeding to grant of patent and anticipation 28

Wrongfully obtaining [Section 26]: 

Wrongfully obtaining [Section 26] If the work is of any other person or any part of the patent; than one may oppose it. In cases of "obtaining" Controller may treat the patent as the patent of opponent. Request under section 26(1) shall be made on Form 12 within three months from the date of the order of the Controller and shall be accompanied by a statement setting out the facts upon which the petitioner relies and relief he claims. Nidhi Lathia-opposition proceeding to grant of patent and anticipation 29

Form 12: 

Form 12 Nidhi Lathia-opposition proceeding to grant of patent and anticipation 30

Case study: 

Case study GlaxoSmithKline Vs Nichols Paxil ® Paroxetine hydrochloride Year : 2006 Court : United States District Court for the Eastern District of Pennsylvania 31

Contd…: 

Contd… GSK violated the law by wrongfully maintaining or attempting to maintain a monopoly on Paxil ® . There were four different actions by GSK that gave rise to antitrust liability: GSK pursued unjustified patent litigation to delay the entry of generic competition in the market for Paxil ® GSK committed fraud on the U.S. Patent Office, wrongfully obtaining patents that prevented competition 32

Contd…: 

Contd… GSK committed fraud on the U.S. Food and Drug Administration by improperly listing patents in the Orange Book GSK marketed Paxil ® in a manner that violated the antitrust laws through its anti-competitive wielding of monopoly power in the Paxil ® market. The case settled for $65 million on behalf of consumer. 33

Anticipation: 

Anticipation It is a patent defense that must be based on a single prior art reference. For a claim to be anticipated , each claim element must be disclosed, either expressly or inherently, in a single prior art reference, and the claimed arrangement or combination of those elements must also be disclosed , either expressly or inherently, in that same prior art reference. It requires only one step to prove, if a single prior art reference is available. 34 Nidhi Lathia-opposition proceeding to grant of patent and anticipation

Contd…: 

Contd… If a single document teaches all elements of a patent, in the same arrangement, the single prior art reference can invalidate the target patent. Nidhi Lathia-opposition proceeding to grant of patent and anticipation 35

Not an anticipation: 

Not an anticipation The invention is not anticipated i.e. novelty of an invention is not destroyed in certain exceptional conditions, specially provided in the Act in Sections 29-34. Prior Publication (S. 29) Previous communication to Government (S. 30) Prior Public Display etc. (S. 31) Prior Public Working (S. 32) Use and Publication after provisional specifications (S. 33) No anticipation if circumstances are only a described in Sections 29, 30, 31 and 32 (S. 34) Nidhi Lathia-opposition proceeding to grant of patent and anticipation 36

Prior Publication [Section 29]: 

Prior Publication [Section 29] The invention claimed in the complete specification will not be considered as anticipated by a specification accompanying an application in India, which was published before the 1 st day of January, 1912. A prior publication of an invention before its priority date will not be deemed as anticipation, if the patentee or the applicant proves that the matter was obtained from him/inventor/assignor without their knowledge that the publication was done without their knowledge Nidhi Lathia-opposition proceeding to grant of patent and anticipation 37

Contd…: 

Contd… The application for patent was therefore made immediately after learning that the publication had happened. This provision will not apply if the invention was commercially worked in India, otherwise for the purpose of reasonable trial before the priority date of the claim by the inventor, patentee or applicant, their assignor or assignee or some one else having their consent. Nidhi Lathia-opposition proceeding to grant of patent and anticipation 38

Previous communication to Government [Section 30]: 

Previous communication to Government [Section 30] The invention will not be deemed as anticipated by its communication to the government or to any person authorized by the government to investigate the invention or its merits, or of anything done in consequence of such communication for the purpose of the investigation. Nidhi Lathia-opposition proceeding to grant of patent and anticipation 39

Prior Public Display [Section 31]: 

Prior Public Display [Section 31] If the application for the patent is made by the inventor or his assignee not later than twelve months after the opening of the exhibition (notified by the Central Government) where the invention is first displayed and published by the applicant or used with his consent, it will not be deemed as anticipated. The use of the invention (so displayed) by an unauthorized person during the period of exhibition also will be deemed as non-anticipation. Nidhi Lathia-opposition proceeding to grant of patent and anticipation 40

Prior Public Working [Section 32]: 

Prior Public Working [Section 32] This deals with public working of an invention claimed in a complete specification for a reasonable trial because the nature of the invention is such that it was necessary to do so. This type of public working will not be deemed as anticipation if performed within one year before the priority date by the patentee, applicant (or assignor) or by any person with their consent. Nidhi Lathia-opposition proceeding to grant of patent and anticipation 41

Use and publication after provisional specifications [Section 33]: 

Use and publication after provisional specifications [Section 33] An invention in an application should not be considered as anticipated by public use and/or publication of the invention in India or elsewhere after the corresponding filing date of the provisional specification or the prior application in a convention country for which a priority is claimed. Nidhi Lathia-opposition proceeding to grant of patent and anticipation 42

No anticipation [Section 34]: 

No anticipation [Section 34] Notwithstanding anything contained in this Act, the Controller shall not refuse to grant a patent, and a patent shall not be revoked or invalidated by reason only of any circumstances which, by virtue of section 29 or section 30 or section 31 or section 32, do not constitute an anticipation of the invention claimed in the specification. Nidhi Lathia-opposition proceeding to grant of patent and anticipation 43

References: 

References Draft manual of patent practice and procedure the patent office. 3 rd ed., Controller general of patents, designs & trade marks; India: 2008. pp 175-210. www.lexorbis.com www.mcbride-law.com www.ipfrontline.com Nidhi Lathia-opposition proceeding to grant of patent and anticipation 44

Questions… ? : 

Questions… ? 45

Slide 46: 

“Smile is an inexpensive way to change your look as there is no patent on smile…”