1. 84390768v1 1 Samson Helfgott Katten Muchin Rosenman LLP New York, NY AIPLA Practical Patent Prosecution Training August 2010 PCT FILING and INTERNATIONAL PATENT PROSECUTION

2. 84390768v1 2 FOREIGN FILING DESCISIONS Why Foreign File? When to Foreign File? How to Foreign File? Strategies for Foreign Filing Cost Reduction What and Where to Foreign File? Preparing an Application for Foreign Filing – Consider a “Global” Type Patent Application

3. 84390768v1 3 WHY FOREIGN FILE? Patents are national in scope and protection - U.S. Patent only covers U.S. borders. Expansion of Foreign Commerce - Foreign competition - Foreign Markets - Offshore Manufacturing - Worldwide licensing programs Strengthening of Patent Laws in Foreign countries - Pressure from U.S. - TRIPS - part of GATT treaty - Harmonization efforts

4. 84390768v1 4 - There are at least 190 countries in the world -The cost for foreign patents is substantially more than the cost for U.S. coverage. -About 50% of U.S. applications are filed by foreigners -High Tech companies may file in 4-5 countries/regions; Biotech and Pharma may file in 120 countries. FACTS

5. 84390768v1 5 HIGH COST OF FOREIGN FILING Translation Costs Claim fees Agent Fees Government fees Examples –Japan – about $300 per page (typing and translation) –Germany – about $200 per page (translation) –Claim fees Europe – $300 for every claim above 15 (further increases in the future) Japan – $50 per claim

6. 84390768v1 6 –Lifetime costs (not including cost of writing application) –U.S. approximately - $25,000 –Europe (8 countries) approximately - $150,000 (will be less in the future using the London Protocol) –Japan approximately - $75,000

7. 84390768v1 7 1993 Costs for today’s costs multiply by 1.5 - 2 times “Patent Filing Costs Around the World,” Samson Helfgott, JPTOS, Vol. 75, No. 7 July, 1993

8. 84390768v1 8 FOREIGN FILING (National/Regional Phase) Japan Filing with translation $7,000 - $10,000 prosecution $6,000 1 - 3 yrs Canada Filingprosecution $3,000 2-4 yrs grant Korea filing with translationprosecution $8,000 4 - 6 yrs $8,000 EPC filingprosecution $8,000 - $11,000 $8,000 4 - 6 yrs England $2,500 Spain$4,500 $500 - $2,500 $400 - $2,500 Germany$4,500 $4,000France $800 - $3,000 $1,000 - $2,000 Grant Maintenance/yr. deferral 3 yrs grant Maintenance/yr. $1,000 - $3,000 Maintenance/yr. $500 - $2,000 Maintenance/yr. $700 - $2,500 grant deferral 4 yrs Translations and filing (less with London Protocol)

9. 84390768v1 9 WHEN TO FOREIGN FILE? Paris Convention - Provides a right of priority for the date of your first filing - 12 months for utility patents - 6 months for design patents - Substantially every country of the world - Covers only what was originally disclosed Example: U.S. filing (Provisional)foreign filing 5/28/09 5/28/10 priority granted 5/28/09 5/29/10 no priority granted

10. 84390768v1 10 Benefit of Priority - Prior Art dated only before Priority date can be cited - Thus, activities or publications of applicant or others during priority year do not constitute prior art - Without benefit of priority date applicant’s own activities can be used against him Term of patent calculated from actual filing date. U.S. filing foreign filing 5/28/09 5/28/10 Prior Art 20 year term

11. 84390768v1 11 DIFFERENT LAWS IN FOREIGN COUNTRIES First-to-file vs. First-to-invent - U.S. is only country to have first-to-invent standard - In U.S. an interference is declared where one inventor can prove he was first-to-invent and demonstrated diligence to reduction to practice, even though he filed later. - In foreign countries “race to patent office” - Therefore, if interested in foreign filing should file priority application (U.S. filing) ASAP - However, still need full disclosure

12. 84390768v1 12 Grace Period - U.S. (and Canada) are essentially only countries with a grace period (1 year before filing). Some have limited 6-month grace period - In all other countries any publication before actual filing (or priority date if claimed) will be prior art. - If client is interested in any foreign filing, should file in U.S. before any exploitation - Consider using Confidential Agreements if disclosure is required

13. 84390768v1 13 LOSS OF FOREIGN RIGHTS 1 Yr. Grace Period Publication No Foreign Filing U.S. Filing OR No Publication U.S. Filing 1 Yr. Priority (Paris Convention) Foreign Filing or PCT Filing

14. 84390768v1 14 Commericalization vs. Divulgation - In U.S. “publication” essentially includes “commercialization” - Thus, sales, offer for sales, secret prior use, etc. is prior art - In foreign countries “publication” essentially includes “divulgation” - Differences: a) Experimental use - Object available for public inspection but being tested In U.S. - no prior art In other countries prior art b) Offer for sale of undisclosed object In U.S. - prior art In other countries no prior art

15. 84390768v1 15 SUMMARY Foreign Filing is economically important Must file ASAP because of first-to-file overseas Must file before any disclosure since no grace period overseas Must decide on foreign filing within 1 year Foreign Filing is expensive

16. 84390768v1 16 HOW TO FOREIGN FILE? Paris Convention Route 1 year U.S. filing - costly -within 1 year you rarely have enough information on the importance of invention -within 1 year you rarely have enough information on the selection of countries -generally, the deferral of money is important for clients -often cases are dropped early on Japan Korea Canada England Germany Australia EPC

17. 84390768v1 17 FOREIGN FILING USING THE PCT 1 yr. Priority (Paris Convention) 18 mos. International Search and Optional International Exam National & Regional Filing Patent Cooperation Treaty U.S. Filing EP JP CA KR EP JP CA KR

18. 84390768v1 18 Patent Cooperation Treaty (PCT) - about 142 member countries - provides additional 18 months after priority year (30 months) before making foreign filing decisions - some countries permit 31 months - While it adds additional International Costs (about $3,000-$5,000) defers costs of national filing ($25,000-$50,000) - Preserves rights in all member countries - Gives client more time to assess importance of invention and make better decisions on foreign filing - Can file in English with US or IB as Receiving Office - During International Phase will get an International Search

19. 84390768v1 19 - Can use U.S., EPO or KR (also AU for limited technologies) for International Search -If use U.S., USPTO is now outsourcing all searches to private searching firms. However, you may get some additional references which are not prior art under U.S. law but are prior art elsewhere -Right now Korea is cheapest Searching Authority with timeliness and good quality. U.S. timeliness is improving. - If use EPO for International Search will get a second search in addition to U.S. EPO costs more but will get reduction if you proceed into EPO after the International Phase - Can optionally request Examination (Chap II) during PCT to amend claims and get Examiner’s Examination Report on Amended Claims - Many countries will accept the Search (and Examination) in place of their own Search (and Exam)

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22. 84390768v1 22 European Patent Convention (EPC) - A regional patent system covering 40 European Countries (include ext. countries) - Conducts full search and examination. Upon grant you get a bundle of patents - Operated by European Patent Organization (essentially Munich) - Can file EPC at end of Convention year or can be designated under PCT - Can file and prosecute in English language - At grant you then pay for translation, national filing fees, etc. in as many of the EPC member states as you want your patent to be issued. For example in Germany you will get a German Euro- Patent which will be just as if you went directly to Germany and got a German national patent - Upon entry into EPO must designate in which of the countries you are preserving your rights. However, designating 7 preserves all - EPO prosecution take 4-5 years

23. 84390768v1 23 EPC AdvantagesNational Advantages 1.Case can be filed and prosecuted in the English language. 1.Possible to get certain national patents rapidly for licensing and other utilization purposes. 2.Standard of invention is similar to that in the U.S. 2. Less risk than EPC where “all the eggs are in one basket”. 3.Prosecution arguments and informal interviews similar to U.S. 3. Can tailor the claim language in accordance with national requirements. 4.Deferral of high translation costs.4.Assured of at least some patents using Registration Countries, utility models patent of importation, etc. 5. Avoids national predilections.5.Can obtain a strong German patent which can serve as an accepted standard for other countries. 6.Cost savings, especially where countries may be dropped. 6. Cheaper where only 1 or 2 countries are required. 7.Additional countries initially included at minimal additional cost. 8.Permits easier addressing of “parallel import” problem. 9.Will provide uniform claims in all countries avoiding different scopes to enforce. 10. Now considered well accepted by all. USE OF EPC

24. 84390768v1 24 Other Conventions Eurasian Patent - East Europe ARIPO Patent - Africa (African Regional Industrial Property Organization) OAPI Patent - Africa (African Union Territories) GCC - Gulf States (Gulf Cooperation Council)

25. 84390768v1 25 OTHER CONVENTION COUNTRIES AP ARIPO Patent BWBotswana GHGhana GMGambia KEKenya LSLesotho LRLiberia MWMalawi MZMozambique NANamibia SDSudan SLSierra Leone SOSomalia SZSwaziland TZUnited Republic of Tanzania UGUganda ZMZambia ZWZimbabwe EA Eurasian Patent AMArmenia AZAzerbaijan BYBelarus KGKyrgyzstan KZKazakhstan MDMoldova RURussian Federation TJTajikistan TMTurkmenistan EP European Patent ALAlbania ATAustria BEBelgium BGBulgaria HRCroatia CYCyprus CZCzech Rep. DKDenmark EEEstonia FIFinland FRFrance DEGermany GRGreece HUHungary IEIreland ISIceland ITItaly LVLatvia LILiechtenstein LTLithuania LULuxembourg MCMonaco MKFormer Yugoslav Republic of Macedonia MTMalta NLNetherlands NONorway PLPoland PTPortugal RORomania SMSan Marino SKSlovakia SISlovenia ESSpain SESweden EP Extension Countries BABosnia and Herzegovina ME Montenegro RSSerbia OA OAPI Patent BFBurkina Faso BJBenin CFCentral African Republic CGCongo CICôte d’Ivoire CMCameroon GAGabon GNGuinea GQEquatorial Guinea GWGuinea-Bissau MLMali MRMauritania NENiger SNSenegal TDChad TGTogo GC GCC Patent BLBahrain KWKuwait OMOman QAQatar SASaudi Arabia AEUnited States of Emirates EP European Patent (cont’d) CHSwitzerland TRTurkey GBUnited Kingdom

26. 84390768v1 26 STRATEGIES FOR FOREIGN FILING COST REDUCTIONS Different available routes for foreign filing Combining available “tools” - Provisional Application - PCT - EPC - Paris Convention Deferral is generally to the client’s benefit - More knowledge on Invention, Competition, Markets, etc. - Cases are dropped - Use PCT wherever possible

27. 84390768v1 27 Benefits Concerns Classical Route File US as Non-provisional File PCT within year & Paris for non PCT countries Use PCT for foreign countries and continue with US non-provisional PCT search may get earlier search results that U.S. case Can get PCT search from another Patent Office Can still use PCT into US for a second U.S. case Significant upfront costs for complete U.S. preparation and prosecution Term of US patent one year less than foreign X X US non-provisional Direct for non PCT countries EP JP KR PCT 18 mos 12 mos X X X

28. 84390768v1 28 Benefits Concerns File US as Provisional but do not file the US non-provisional at 12 months File PCT within year and Paris for non PCT countries Use PCT for US and foreign filing Lower up front costs Can choose when to prosecute in U.S. May get search results before big investment Get benefit of extra year of term of U.S. Patent. All patents will expire at same time May delay prosecution in US Provisional and PCT X X US Provisional Direct for non PCT countries JP US PCT 18 mos EP X X X

29. 84390768v1 29 Benefits Concerns File US as provisional and within year file both US non-provisional and PCT, and Paris for non PCT countries Limited front end costs PCT search may get earlier result than U.S. case If use EPO for PCT search can get U.S. & EPO search before foreign filing Can still get a second US case from the PCT All patents will expire at the same time Must invest in U.S. filing without benefit of search More expenses come sooner Provisional, then Non-provisional and PCT X X US Provisional Direct for non PCT countries EP JP KR PCT 18 mos 12 mos US non-provisional X X

30. 84390768v1 30 Benefits Concerns PCT First File PCT first Cheap way to start the process Can get search before any real investment Longest time for amending claims Can file US case during International Phase, do not need to wait 30 months Will lose one year on term for all patents Delay in getting U.S. patent PCT Direct for non PCT countries 12 mos JP US EP 18 mos X X

31. 84390768v1 31 WHAT and WHERE TO FOREIGN FILE Evaluate the invention Evaluate Countries for foreign filing - General Evaluation - Patent Evaluation Many companies prepare matrix of product/country for foreign filing

32. 84390768v1 32 EVALUATING THE INVENTION Provide an analysis of the invention: - Problem to be solved - Previously suggested solutions - How the invention works - Distinguishing features of the invention Identify the type of invention that is being evaluated - Is it a basic invention? - Is it an improvement invention? - Is it an alternate embodiment to an existing invention?

33. 84390768v1 33 Determine the relationship between the invention and the client’s business - Is it directly, peripherally or unrelated to a core business? - Is the invention more significant to a competitor’s business? - What is the amount of time and money to be invested into the invention? - What is the anticipated life span of the invention? What is the purpose of obtaining the patent? - To protect technology from being used by keeping competitors away? - To improve marketing positions? - To protect customer use of the product or the technology? - Is it being filed for defensive purposes to block others from obtaining patents in certain areas?

34. 84390768v1 34 - Is it for recognition to establish a reputation or credentials? - Is it for potential use in other business relationships such as: joint venture with other companies? Licensing (one way or cross licensing?) - Is it being used to support existing licensing activities Bottom line question; If we don’t get a patent, so what?

35. 84390768v1 35 EVALUATING POTENTIAL COUNTRIES FOR FILING General evaluation of countries - Population - Market potential - Emerging of industrialized country - Industry size and growth rate - Client’s activity within country Patent Evaluation of country - The standards of patentability in the country - The type of patents available in the country - The patenting costs - Enforeability of patents in the country - Strength of the legal system - Any bias against foreign plaintiffs?

36. 84390768v1 36 COUNTRY/INVENTION SELECTION Guidance Tools - Formulas, charts, guidelines - Must be updated regularly - Must be tailored for each product

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40. 84390768v1 40 PRIORITIZING COUNTRIES 1. Protect local manufacture 2. Cover competitor’s home countries or major investment manufacturing countries 3. Cover major markets 4. Cover export sales

41. 84390768v1 41 A SUGGESTED SET OF RECOMMENDATIONS Type of Invention/ProductRecommendation System, assembly, complex machineLimited filing in industrialized countries Components and materialsBroad filing in all major countries High technology productLimited filing in industrialized countries and sourcing countries World-wide consumer productBroad filing in major market countries Industrial productLimited fling in industrialized countries Pharmaceutical/chemical productsBroad filing especially where product is easily producible Labor-intensive productLow-cost manufacturing countries

42. 84390768v1 42 The purpose of PPH is to facilitate an applicant’s acquisition of a patent at an early stage worldwide and to enhance the utilization of search and examination results among the world's major ΙΡ Offices so as to reduce the burden of examination and to enhance the quality of examination worldwide. ΡΡΗ enables an application with claims determined to be patentable in the Office of First Filing (OFF) to undergo an accelerated examination in the Office of Second Filing (OSF) with α simple procedure upon request for ΡΡΗ by an applicant. It is bilateral, i.e. can use your allowed US claims to expedite foreign prosecution, or use allowed foreign claims to expedite US prosecution. PATENT PROSECUTION HIGHWAY (PPH)

43. 84390768v1 43 First Office (OFF) OUTLINE of PPH Second Office (OSF) Application A Office Action Written Amend- ment Request for PPH Copies of office actions Corresponding Application A Provide prosecution history documents of the first office (if not available via network) Allowed Claims A’A Claims Claims X must sufficiently correspond to Allowed Claims X’ Accelerated Exam Additional Search and Examination Allowed Claims A’

44. 84390768v1 44 PPH - Requirements a.The application in the OSF validly claims priority from an application in the OFF. b.The application in the OFF has at least one claim already determined to be patentable. c.All claims in the OSF application sufficiently correspond to the claims already determined to be patentable in the OFF. d.The application in the OSF has not yet been examined.

45. 84390768v1 45 PPH – Notes The allowance must come from a National Search/Examination, not from a PCT Search/Examination The foreign application can be one derived from the basic application, i.e., a divisional Allowed foreign claims must be translated (for US) Must submit a translated claim correspondence table (for US) Copies of all O/A’s and translations (for US) IDS with references (except US patents/applications) (for US) Request for acceleration under PPH Program Any claims submitted thereafter must correspond to allowed claims from OFF Request for PPH does not carry over to any continuing application

46. 84390768v1 46 PPH – Concerns and Strategies Must complete prosecution in OFF before OSF begins prosecution, therefore: –Delays in all patent offices make use of this procedure difficult –Must accelerate prosecution in OFF and delay prosecution in OSF –When EP & JP are OFF relatively easy to accelerate. When US is OFF requesting accelerated examination is difficult and risky re: inequitable conduct –However, in JP & KR can defer examination for 3 years

47. 84390768v1 47 Some US Applicants are filing in UK (or elsewhere) as OFF (with foreign filing license), accelerating examination, and using foreign allowance for expediting US prosecution (OSF). Can also file PCT first, then enter national phase in a foreign country (e.g. England or Australia), get an early allowance in that country, then use that for PPH accelerated examination when entering national phase in U.S Can file PCT first, enter national phase at the end of the 30 (or 31) months, and see which national patent office grants first allowance, and use that as OFF for other national offices that have not started exam yet. PPH – Concerns and Strategies (cont’d)

48. 84390768v1 48 PATENT PROSECUTION HIGHWAY (PPH) US AGREEMENTS USPTO currently has agreements in place with: –JPO (Japan) –UK IPO (United Kingdom) –CIPO (Canada) –KIPO (Korea) –IPAU (Australia) –EPO (Europe) –DKPTO (Denmark) –IPOS (Singapore) –DPMA (Germany) –NBPR (Finland)

49. 84390768v1 49 STATISTICS ON USE Not used very much – about 1500 cases into US since first started in mid 2006. But use is increasing. About 95% of PPH cases using USPTO as OSF are allowed, compared to about 44% through regular filing. About 3 months to first office action. About 30% first action allowances. About 75% of PPH cases using JPO as OSF are allowed, compared to about 50% through regular filing. JPO is pushing hard for more countries to get involved and encouraging a “plurilateral treaty” of all PPH countries.

50. 84390768v1 50 PPH NOW EXTENED to PCT Can user International Search and Written Opinion or IPER, from EPO, JPO, US or KIPO Requires at least one claim that has novelty, inventive step and industrial applicability. Must conform claims to these claims (all 3 “yes”). Can still file separate a continuation or by-pass for the other claims. Can also use for domestic priority applications. Must be before prosecution started in national application.

51. 84390768v1 51 Revives value of Chapter II Preliminary Examination for EP, JP, and US national stage entries: first action allowance possible Details at http://www.uspto.gov/patents/init_events/pph/index.jsp

52. 84390768v1 52 Examples: PCT RO/-- ISA/US, EP,KR IPEA/US EP, KR WO IPER Priority Claim DO DO/US PPH Can use PCT Results for PPH in JP or EP, KR OK Can use PCT Results in domestic JP Priority Application US Application PCT RO/-- WO IPER Priority Claim OK PPH ISA/US, EP,KR IPEA/US EP, KR US Application

53. 84390768v1 53 THE NEED FOR A “GLOBAL” PATENT APPLICATION INCREASE IN FOREIGN FILING - Global Markets - More foreign manufacture - More foreign competition HIGH COST OF FOREIGN FILING - Translation costs - Claim fees - Agent fees

54. 84390768v1 54 THE NEED FOR A “GLOBAL” PATENT APPLICATION (cont.) U.S. APPLICATIONS ARE VERY LENGTHY - Satisfying 35 U.S.C. 112 - Both enablement, best mode, and written description - Satisfying CAFC Requirements - Standing up in litigation - Claim invention many ways - especially after Festo - Length to impress client - Try to do a “selling job” of obviousness in view of KSR

55. 84390768v1 55 THE NEED FOR A “GLOBAL” PATENT APPLICATION (cont.) REVISION OF APPLICATION IS NOT AN ADEQUATE SOLUTION - Time required for revision - Different attorneys for revision requires relearning - Hesitancy to make changes, especially in claims - Many countries still require translation of priority documents - Need priority application for “telex filing” - For PCT need translation of original application

56. 84390768v1 56 GENERAL RECOMMENDATIONS FOR A “GLOBAL” APPLICATION DESCRIBE THE INVENTION ONLY ONCE - Typical U.S. Applications describe it 4-5 times - Summary of Invention - Brief Description of Drawings - General Description of Invention - Best Mode of Invention - Concluding Summary DON’T TEACH THE TECHNOLOGY - Application addressed to one skilled in art - Prior art should be in IDS not applications - don’t discuss prior history of technology or prior reference

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59. 84390768v1 59 GENERAL RECOMMENDATIONS FOR A “GLOBAL” APPLICATION (cont.) AVOID OBJECTS AVOID PUFFING AVOID RECITATION OF NUMEROUS BENEFITS LIMIT NUMBER OF PAGES IN SPECIFICATION - Be Concise - Insist on Limits USE “GLOBAL” LANGUAGE - Short non-confusing sentences - Don’t use ambiguous words - Avoid indefinite language - Avoid generalizations unless part of invention - Avoid critical language unless part of invention

60. 84390768v1 60 GENERAL RECOMMENDATIONS FOR A “GLOBAL” APPLICATION (cont.) NO CROSS-REFERENCING NO INCORPORATION BY REFERENCE USE STANDARDIZED PCT FORMAT KEEP COPY ON PHYSICAL MEDIUM KEEP PARTS LIST USE SI UNITS

61. 84390768v1 61 PREPARING A “GLOBAL” APPLICATION ABSTRACT - Use reference numerals - Can be removed for U.S. if desired - Keep short BACKGROUND OF INVENTION - Use only one (1) reference - closest reference - Describe reference only briefly - Enclose copy of closest reference in all countries - Use problem/solution approach - Problem - Prior art solution from reference

62. 84390768v1 62 PREPARING A “GLOBAL” APPLICATION (cont.) SUMMARY OF INVENTION - Problem with prior art - try not to make it a simple problem in view of KSR - Solution provided by invention - Unobvious nature of invention - in view of KSR - Advantage of invention - general - Consistory statement - copy claim 1 - No objects BRIEF DESCRIPTION OF DRAWINGS - Just itemize - don’t describe - Keep Concise DESCRIPTION OF THE INVENTION - Describe only once - Describe as part of best mode

63. 84390768v1 63 PREPARING A “GLOBAL” APPLICATION (cont.) - Each time you mention an item, give alternatives at that time - Limit description of peripheral environment - Be consistent in describing elements - Use of examples is important - Use generic type of examples and then list specifics covered by generic type - Where range is recited, use example at low end, high end and mid-range - Where values are critical, must show comparisons of in range and out of range CLAIMS - Must limit foreign claims, preferably 10-15 claims - Write U.S. claims so first 10-15 useful for foreign filing

64. 84390768v1 64 PREPARING A “GLOBAL” APPLICATION (cont.) - Foreign countries have broader unity of invention than U.S., thus more than one type of claim is permitted - One independent claim for each type - Limit dependent claims to novel features - Use multiple dependencies when possible - Foreign countries like functional language, but not all like “means”, therefore use descriptive terms plus function - Insert reference numerals when preparing claims, can eliminate for U.S. DRAWINGS - Use A-4 paper and PCT margins - Prepare one set without English words - Use computerized drawings to facilitate drawing changes

65. 84390768v1 65 INTERNATIONAL ACTIVITIES Industrial Trilateral (AIPLA, IPO, UNICE, JIPA) have formulated a proposal for “Global Application” covering formalities Trilateral Patent Offices have accepted “Common Format” “Single Application” (CAF) covering formalities Substantive harmonization talks continuing by Group B+ Countries

66. 84390768v1 66 CONCLUSION APPLICATIONS CAN BE PREPARED FOR “GLOBAL” FILING CAN REDUCE INITIAL COST AS WELL AS FOREIGN FILING COST CAN PRODUCE A BETTER APPLICATION EVEN FOR U.S. FILING

67. 84390768v1 67 Contact Information for Samson Helfgott Director of Patents Katten Muchin Rosenman LLP 575 Madison Ave. New York, N.Y., 10022 (212) 940-8683 Samson.Helfgott@kattenlaw.com Disclaimer: This presentation does not constitute any specific legal or business advice.