Patent Opposition & Infringement

1. Patent Opposition & Infringement Dr. S. K. Mitra Kolkata

2. INVENTION NEW PRODUCT OR PROCESS involves INVENTIVE STEP (NON OBVIOUS) & CAPABLE OF INDUSTRIAL APPLICATION SKM

3. Inventions Not Patentable Frivolous or contrary to well-established natural laws Contrary to law or morality or injurious to public health Scientific principle or formulation of abstract theory New property or use of known substance Mere use of known process, machine or apparatus Substance by mere admixing Mere arrangement/rearrangement/duplication of known devices Method of agriculture/horticulture Method of treatment of human beings, animals Plants & Animals in whole or any part other than microorganisms SKM

4. Inventions Not Patentable Mathematical/Business method/Computer program per se/ Algorithms Mere scheme/Rule/Method of performing mental Act/ Playing game Presentation of information Topography of integrated circuits Invention on traditional knowledge/Aggregation or duplication of known properties of traditionally known components Related to atomic energy SKM

5. Pre-Grant Opposition Pre-grant Representation Any person before grant after publication U/S 11A(1) or (2) With the grounds available like Post-Grant Opposition Procedure: Rule 55(1) – Representation for opposition u/s 25(1) Rule 55(1A) – No Patent granted before expiry of 6 months from above publication Rule 55(2) – Consideration of representation after filing of request for examination Rule 55 (3) – Notice to the applicant Rule 55(4) – Reply statement & evidence within 3 months Rule 55 (5) & (6) – Hearing & Passing order ordinarily within One Month SKM

6. Criteria for Grants • Not opposed U/S 25(1) • Opposed but decided in favour of applicant  Not refused U/S 15 or not in contravention of any of the provisions of the Act U/S 43(1)(b) SKM

7. Post-Grant Opposition Any interested person enters within 12 months Grant Notification Procedure: Rule 55(A) –Notice of opposition u/s 25(2) in Form-7 with prescribed fees of Rs. 6,000- (Legal Entity) Rule 56 – Constitution of opposition board & Conduct Examination of the documents filed u/r 57-60 Rule 57 – Filing of written statement Rule 58 – Filing of reply statement within 2 months Rule 59 – Reply evidence by opponent within one month Rule 60 – Further evidence with leave of Controller Rule 61 – Authentication of document &Eng. Translated copy Rule 62 - Hearing with 10 days advance notice SKM

8. Grounds of Opposition • Wrongful obtaining • Prior publication • Prior claiming • (4) Prior public knowledge and use in India • (5) Obviousness • (6) Not an invention or not patentable invention • (7) Insufficiency • (8) Information regarding foreign filing not filed or false • (9) Convention application not made within 12 months • (10) Not disclosed or wrongly mentioned source/geographical origin • (11) Anticipated by knowledge, oral/otherwise SKM

9. Parallel Import Effectively Reduces the Profits of Patent Holders & the Phenomenon Lowers the Price of the Product in Situation where the Buyers Exports the Product at a Lower Price Example : A sells product for $ 5 in Country M and at $ 10 in Country N, then A is said to be Practicing Price Discrimination. Now buyers B bought the Product in Country M and Exports to Country N at $ 7. A faces situation where his Own Product sold in Country M is reducing his Profits in Country N SKM

10. Exhaustion of Intellectual Property Right This term losses control over the actions performed on it by the buyers – so, the buyer may sell it or import it to other countries without any hindrance from the Patent. Example : A has a Patent over a digital pen when he places the Patented Pen in the market subsequently he losses control over the actions performed by the buyers of the digital pen and the buyer may even sell or export the digital pen at a higher price SKM

11. Use of Technical Information without infringement • Lapsed Patent • Patent granted from countries other than India • Non-patent literature • Product not patentable under Indian Law • Compulsory licence SKM

12. Research Exemptions • Exception to Infringement – sec. 47(3) • Inventions may be used without infringement for • Research • Experiments • Education and training SKM

13. INFRINGEMENT Literallyto break a rule or agreement or to encroach. In patent parlance violation of the exclusive rights of the patentee by unauthorised making, using, offering for sale or selling a patented invention. also includesimportation of the product into India. SKM

14. INFRINGEMENT  Direct(Actively makes, uses or sells) Indirect(Actively encourages another to make, use or sell) Contributory(Selling or supplying an item for which the only use is such that it encroaches on the patented invention) SKM

15. HOW TO JUDGE NFRINGEMENT ? • Decided on the basis of claims • Immaterial variations, colourable imitations and combinations also constitute infringement • Absolute similarity is not necessary-------it is enough if “pith and marrow” of the invention has been infringed ( Birmingham Sound Reproducers v Collaro 1956 RPC 232 ) SKM

16. MECHANICAL COMBINATIONS IMMATERIAL VARIATIONS HAYWARD VS PAVEMENT LIGHT COY (1 RPC 207) Plaintiff:Owners of patent for “Improvements in pavement lights. The lights had glass moulded so as to consist of an angle or series of angles, and could divert rays of light in an inclined direction into rooms which had to be lighted Defendant:Made lights using glass moulded so as to consist of a curve. Courts held that the Defendant had infringed on the Plaintiff’s patent SKM

17. ARE THEY INFRINGERS? Private useActs done privately Not for commercial use Experimental use Roche Products Inc v Bolar Pharmaceutical Co Roche had a patent on flurazepam.HCl containing sleeping pill (Dalmane) Bolar used flurazepam.HCl to make dosage form capsules, to obtain stability data, blood serum studies etc. with a small quantity of flurazepam.HCl before the expiry of the patent term. COURTS HELD THAT BOLAR HAD INFRINGED “Bolar’s intended experimental use is solely for business reasons and not for amusement to satisfy idle curiosity, or for strictly philosophical inquiry. Bolar’s intended use of flurazepam.HCl to derive FDA required test data is thus an infringement. SKM

18. FACTORS AFFECTING DECISION TO SUE • Cost • Term of patent • Duration of Infringement • Commercial Reasons SKM

19. OTHER CONSIDERATIONS Whether infringement is only in India Loss of profit Size of infringer Multiple jurisdictions Strength of the patent Timing of action Choice of availability of counsels Financial backing SKM

20. CONTROLLING COSTS  Avoid multiple counsels  Provide all the information  Clear communication  Complete monitoring SKM

21. WHO CAN ENFORCE RIGHTS AGAINST AN INFRINGER ?  PATENTEE  ASIGNEE OF THE PATENTEE  AGENT OF THE PATENTEE  LICENSEE OF THE PATENTEE V.B.Mohd Ibrahim v Alfred Schafranek,AIR 1960 Mys 173 Fibre Glass Canada Ltd v Spun Rock Wools Ltd., AIR 1946 PC 147 SKM

22. CONDITIONS FOR ENFORCEMENT OF RIGHTS  Patent must be valid  Patent must be in force  Name of the patentee, assignee, licensee must be recorded as owner in the register of patents SKM

23. REMEDIES •  Injunction •  Delivery up •  Account of profits •  Damages SKM

24. INJUNCTION -----when ?  Prima facie case of infringement has been made out Absence of delay  Cross undertaking Balance of convenience SKM

25. RECENT PATENT INFRINGEMENT AWARDS • $125 million for a cookie recipe • (Proctor & Gamble vs Nabisco) • $56 million for an antibiotic • Pfizer vs International Rectifier) • $44 million a blood oxygenator • (Pfizer vs American Hospital Supply) • $$205 million for the design of a rock drive bit (Smith Industries vs Hughes Tool) • 873 million for the rights to an instant camera (Polaroid vs Kodak) SKM

26. DEFENCE •  Denial •  Delay tactics •  Damages have been minimal •  Counter claim for revocation of the patent • Use for experiment, research, instruction to pupils & on behalf of Govt SKM

27. BEECHAM GROUP vs BRISTOL LABORATORIES(1977 FSR 565) •  Hetacillin (Acetone adduct of ampicillin) (P2) •  Hydrolyses in the body to give Ampillicin (P1) • The claims of P2 fall outside the scope of P1. Sale of hetacillin was considered to be contributory infringement as it led to infringing production of ampicillin in the body. •  Hetacillin = Ampicillin in disguise SKM

28. The court held that such importation and sale of such substance was an act of infringement of the patented product which was temporarily masked BEECHAM GROUP vs BRISTOL LABORATORIES (1977 FSR 565) SKM

29. If the active metabolite is patented will sale of the drug infringe the Patent? Patent (P1) on Terfenadine, sold as an antihistamine had expired. MerrellDow (MD) Patented the active metabolite (P2) MD sued a competitor for selling terfenadine –Contributory infringement of P2 Patients had been swallowing terfenadine and making the active metabolite in their bodies, before P2. P1 made no reference to the active metabolite, but enabled the public to work the invention by making the active metabolite in their livers. Therefore, a valid patent should include a disclaimer to the active metabolite when prepared by ingestion and metabolism of terfenadine SKM

30. NORTH BRITISH RUBBER COY Vs MACKINTOSH & COY 11 R.P.C. 477 • Plaintiff ’s patent related to tyres for cycles comprising a • combination of • Easily detachable outside flexible tyre or cover • Inner inflatable tube of cloth and India Rubber • Dove tailed metal rim • Arched tube • Defendant’s tyres comprised a combination where • The cover had increased thickness at the sides and was made of cloth cut on the cross • The inner tube was of India rubber only • Exaggerated dovetailing of the rim • Complete tube • Court held that the Defendants had infringed SKM

31. THANK YOU SKM