dr. stephen cherkez p.a. intellectual property tase ...events.eventact.com/ivc/analizacourse/dr...

Dr. Stephen Cherkez P.A.Intellectual Property

TASE presentation –January 1, 2014

1

INTRODUCTION

PATENTS HAVE A PROFOUND EFFECT ON THE PHARMACEUTICAL INDUSTRY, ITSCOMPETITIVE LANDSCAPE AND DRUG’S RETURN ON INVESTMENT.

AROUND PATENT EXPIRY DATE, ETHICAL AND GENERIC PHARMACEUTICALCOMPANIES JOCKEY FOR POSITIONS AND FIGHT FOR THE GENERIC LAUNCH DATE.

THE PHARMA MARKET INVESTMENT DECISIONS DEPEND ON THE ANALYSIS OFTHE IP PORTFOLIOS AND REGULATORY ASPECTS.

A DIFFERENCE OF 1-2 YRS IN THE GENERIC ENTRY DATE TRANSLATES INTOBILLIONS OF DOLLARS GAIN OR LOSS.

A CORRECT ANALYSIS IS A MULTI-DISCIPLINARY TASK: PATENTS AND PATENTLITIGATION OUTCOME, REGULATORY, CHEMICAL, ETC.

IN THIS TWO-HOUR LECTURE WE WILL TRY TO PROVIDE A SHORT GUIDE ON THE“RULES OF THE GAME” AND THE ANALYSIS OF THE IP LANDSCAPE. PATENTS – WHY, WHAT AND HOW PATENT LITIGATIONS IN THE PHARMACEUTICAL INDUSTRY THE PHARMACEUTICAL REGULATORY PROCESS BRAND EVERGREENING PATENT STRATEGIES GENERIC PATENT STRATEGIES

Dr. Stephen CherkezIntellectual Property

PATENTS HAVE A PROFOUND EFFECT ON THE PHARMACEUTICAL INDUSTRY, ITSCOMPETITIVE LANDSCAPE AND DRUG’S RETURN ON INVESTMENT.

AROUND PATENT EXPIRY DATE, ETHICAL AND GENERIC PHARMACEUTICALCOMPANIES JOCKEY FOR POSITIONS AND FIGHT FOR THE GENERIC LAUNCH DATE.

THE PHARMA MARKET INVESTMENT DECISIONS DEPEND ON THE ANALYSIS OFTHE IP PORTFOLIOS AND REGULATORY ASPECTS.

A DIFFERENCE OF 1-2 YRS IN THE GENERIC ENTRY DATE TRANSLATES INTOBILLIONS OF DOLLARS GAIN OR LOSS.

A CORRECT ANALYSIS IS A MULTI-DISCIPLINARY TASK: PATENTS AND PATENTLITIGATION OUTCOME, REGULATORY, CHEMICAL, ETC.

IN THIS TWO-HOUR LECTURE WE WILL TRY TO PROVIDE A SHORT GUIDE ON THE“RULES OF THE GAME” AND THE ANALYSIS OF THE IP LANDSCAPE. PATENTS – WHY, WHAT AND HOW PATENT LITIGATIONS IN THE PHARMACEUTICAL INDUSTRY THE PHARMACEUTICAL REGULATORY PROCESS BRAND EVERGREENING PATENT STRATEGIES GENERIC PATENT STRATEGIES

2



3

WHAT IS A PATENT?

IN SIMPLE WORDS, A PATENT IS KIND OF A “CONTRACT” BETWEEN AN INVENTOR ANDTHE STATE.

THIS IS SUPPOSED TO BE A WIN-WIN SITUATION, IN WHICH THE INVENTOR GETSMONOPOLISTIC RIGHTS AND PROTECTION, THE PUBLIC GETS TO LEARN DETAILSABOUT THE INVENTION FROM DAY ONE AND BY THE END OF THE PATENT (20 YRS) THEINVENTION BECOMES FREE FOR ALL TO USE (IT IS CALLED “PUBLIC DOMAIN”). ON THEONE HAND THE SCIENCE PROFITS FROM THIS ARRANGEMENT, BUT ON THE OTHERHAND IT IS HAMPERED BY THE EXCLUSIVITY.

THE MODERN DAYS PHARMA LITIGATION AND THE SO CALLED “PATENT LIFECYCLESTRATEGIES” (MORE LATER) ARE IN FACT ATTEMPTS OF THE INVENTOR COMPANIES TOESCAPE THE “CONTRACT” AND PREVENT THE PUBLIC FROM ENJOYING ITS PART OF THECONTRACT, NAMELY FREE USE OF THE INVENTION AFTER THE EXPIRY OF ITS BASICPATENT.

MANY OF THE PATENTS COVER INVENTIONS WHICH ARE IMPROVEMENTS OF PREVIOUS,OLDER INVENTIONS. THEY “STAND ON THE SHOULDERS” OF ANOTHER INVENTION.

THE PATENT SYSTEM IN ITS PRESENT FORM IS A WONDERFUL WAY TO DISSEMINATEINFORMATION ON WHAT IS “COOKING” AND PROVIDE KNOWLEDGE WHICHENCOURAGES NEW INVENTORS TO PUSH THE INNOVATION EVEN FURTHER.

THE “ART” HERE IS HOW TO DO IT WITHOUT INFRINGING THE OLDER PATENTS


IN SIMPLE WORDS, A PATENT IS KIND OF A “CONTRACT” BETWEEN AN INVENTOR ANDTHE STATE.

THIS IS SUPPOSED TO BE A WIN-WIN SITUATION, IN WHICH THE INVENTOR GETSMONOPOLISTIC RIGHTS AND PROTECTION, THE PUBLIC GETS TO LEARN DETAILSABOUT THE INVENTION FROM DAY ONE AND BY THE END OF THE PATENT (20 YRS) THEINVENTION BECOMES FREE FOR ALL TO USE (IT IS CALLED “PUBLIC DOMAIN”). ON THEONE HAND THE SCIENCE PROFITS FROM THIS ARRANGEMENT, BUT ON THE OTHERHAND IT IS HAMPERED BY THE EXCLUSIVITY.

THE MODERN DAYS PHARMA LITIGATION AND THE SO CALLED “PATENT LIFECYCLESTRATEGIES” (MORE LATER) ARE IN FACT ATTEMPTS OF THE INVENTOR COMPANIES TOESCAPE THE “CONTRACT” AND PREVENT THE PUBLIC FROM ENJOYING ITS PART OF THECONTRACT, NAMELY FREE USE OF THE INVENTION AFTER THE EXPIRY OF ITS BASICPATENT.

MANY OF THE PATENTS COVER INVENTIONS WHICH ARE IMPROVEMENTS OF PREVIOUS,OLDER INVENTIONS. THEY “STAND ON THE SHOULDERS” OF ANOTHER INVENTION.

THE PATENT SYSTEM IN ITS PRESENT FORM IS A WONDERFUL WAY TO DISSEMINATEINFORMATION ON WHAT IS “COOKING” AND PROVIDE KNOWLEDGE WHICHENCOURAGES NEW INVENTORS TO PUSH THE INNOVATION EVEN FURTHER.

THE “ART” HERE IS HOW TO DO IT WITHOUT INFRINGING THE OLDER PATENTS

4

HOW DID IT ALL START?OLD AND MODERN PATENT HISTORY

FIRST “PATENTS” FLORENCE-ITALY – 1421 - THREE YEAR PATENT FOR A BARGE WITH HOISTING

GEAR. VENICE – 1474 – NEW AND INVENTIVE DEVICES – GRANTS RIGHT TO PREVENT

OTHERS FROM USING THEM.MODERN PATENT HISTORY PARIS CONVENTION – 1883. FIRST NOTION OF CLAIMING PRIORITY. FILING AN

APPLICATION IN ONE MEMBER STATE PRESERVES THE RIGHT FOR ONE YEARTO FILE IN ANY OTHER MEMBER STATE. MOST STATES ARE SIGNATORIES. PARISCONVENTION DATE

PATENT COOPERATION TREATY – PCT 1970, AMENDED 1979 (ADMINISTERED BYWIPO – MORE THAN 140 COUNTRIES)

EUROPEAN PATENT CONVENTION - EPC 1973 (ADMINISTERED BY THEEUROPEAN PATENT ORGANISATION - EPO)

REGIONAL – EP, ARIPO (AFRICAN REGIONAL INTELLECTUAL PROPERTYORGANIZATION), OAPI (ORGANISATION AFRICAINE DE LA PROPRIETEINTELLECTUELE), EAPO (EURASIAN PATENT ORGANIZATION)

WTO VS PATENTS – URUGUAY ROUND


FIRST “PATENTS” FLORENCE-ITALY – 1421 - THREE YEAR PATENT FOR A BARGE WITH HOISTING

GEAR. VENICE – 1474 – NEW AND INVENTIVE DEVICES – GRANTS RIGHT TO PREVENT

OTHERS FROM USING THEM.MODERN PATENT HISTORY PARIS CONVENTION – 1883. FIRST NOTION OF CLAIMING PRIORITY. FILING AN

APPLICATION IN ONE MEMBER STATE PRESERVES THE RIGHT FOR ONE YEARTO FILE IN ANY OTHER MEMBER STATE. MOST STATES ARE SIGNATORIES. PARISCONVENTION DATE

PATENT COOPERATION TREATY – PCT 1970, AMENDED 1979 (ADMINISTERED BYWIPO – MORE THAN 140 COUNTRIES)

EUROPEAN PATENT CONVENTION - EPC 1973 (ADMINISTERED BY THEEUROPEAN PATENT ORGANISATION - EPO)

REGIONAL – EP, ARIPO (AFRICAN REGIONAL INTELLECTUAL PROPERTYORGANIZATION), OAPI (ORGANISATION AFRICAINE DE LA PROPRIETEINTELLECTUELE), EAPO (EURASIAN PATENT ORGANIZATION)

WTO VS PATENTS – URUGUAY ROUND 5

PRE-REQUISITES FOR PATENT GRANT

PATENT PROSECUTION AND REQUIREMENTS FOR OBTAINING AGRANT ARE NOT A SIMPLE MATTER, AND THIS IS NOT THE PLACE TOENTER DETAILS. MORE ON THIS IN THE SECOND LECTURE.

SUFFICE IT TO SAY THAT THE TWO CENTRAL REQUIREMENTS ARE: INVENTIVE STEP - NOVELTY: THE SUBJECT MATTER WAS NOT

DESCRIBED AS SUCH IN THE OPEN OR PATENT LITERATURE. NON-OBVIOUSNESS: THIS IS THE TRICKY ISSUE – THE INVENTION

COULD NOT HAVE BEEN OBVIOUS TO A PERSON SKILLED IN THE ARTBASED ON THE STATE OF THE ART KNOWLEDGE.

THESE ARE ALSO THE USUAL GROUNDS FOR PATENT CHALLENGE INLITIGATIONS.


PATENT PROSECUTION AND REQUIREMENTS FOR OBTAINING AGRANT ARE NOT A SIMPLE MATTER, AND THIS IS NOT THE PLACE TOENTER DETAILS. MORE ON THIS IN THE SECOND LECTURE.

SUFFICE IT TO SAY THAT THE TWO CENTRAL REQUIREMENTS ARE: INVENTIVE STEP - NOVELTY: THE SUBJECT MATTER WAS NOT

DESCRIBED AS SUCH IN THE OPEN OR PATENT LITERATURE. NON-OBVIOUSNESS: THIS IS THE TRICKY ISSUE – THE INVENTION

COULD NOT HAVE BEEN OBVIOUS TO A PERSON SKILLED IN THE ARTBASED ON THE STATE OF THE ART KNOWLEDGE.

THESE ARE ALSO THE USUAL GROUNDS FOR PATENT CHALLENGE INLITIGATIONS.

6

WHY DO YOU NEED A PATENT IN EVERY COUNTRY?

A PATENT IS A TERRITORIAL RIGHT EVERY COUNTRY HAS ITS OWN PATENT LAW AND ITS OWN JUDICIARY

SYSTEM. IN ORDER TO GAIN PATENT RIGHTS IN A SPECIFIC COUNTRY YOU NEED TO

FILE , PROSECUTE AND OBTAIN GRANT IN THAT COUNTRY. AS EACH NATIONAL PATENT IS PROSECUTED VIS-À-VIS THE LOCAL PATENT

OFFICE, OFTENTIMES THE PATENTS GRANTED IN DIFFERENT COUNTRIES AREDIFFERENT. SOMETIMES ONE GETS A PATENT IN ONE COUNTRY ANDREJECTION IN ANOTHER. OTHER TIMES THE CLAIMS ARE DIFFERENT.

THE PRESENT SYSTEM IS COSTLY, TIME-CONSUMING AND CONFUSING. SEEFURTHER SLIDE – HARMONIZATION.

A STEP IN THE GOOD DIRECTION IS THE PCT SYSTEM AND THE REGIONALPATENTS – SEE FURTHER SLIDE – PCT APPLICATIONS AND REGIONALPATENTS.


A PATENT IS A TERRITORIAL RIGHT EVERY COUNTRY HAS ITS OWN PATENT LAW AND ITS OWN JUDICIARY

SYSTEM. IN ORDER TO GAIN PATENT RIGHTS IN A SPECIFIC COUNTRY YOU NEED TO

FILE , PROSECUTE AND OBTAIN GRANT IN THAT COUNTRY. AS EACH NATIONAL PATENT IS PROSECUTED VIS-À-VIS THE LOCAL PATENT

OFFICE, OFTENTIMES THE PATENTS GRANTED IN DIFFERENT COUNTRIES AREDIFFERENT. SOMETIMES ONE GETS A PATENT IN ONE COUNTRY ANDREJECTION IN ANOTHER. OTHER TIMES THE CLAIMS ARE DIFFERENT.

THE PRESENT SYSTEM IS COSTLY, TIME-CONSUMING AND CONFUSING. SEEFURTHER SLIDE – HARMONIZATION.

A STEP IN THE GOOD DIRECTION IS THE PCT SYSTEM AND THE REGIONALPATENTS – SEE FURTHER SLIDE – PCT APPLICATIONS AND REGIONALPATENTS.

7

NATIONAL APPLICATIONS

FIRST STEP: FILING A NATIONAL APPLICATION IN THE INVENTOR’S NATIVECOUNTRY (OR IN ANOTHER, LIKE US) AND GETTING A ONE YEAR PARISCONVENTION PRIORITY TO FILE IN OTHER COUNTRIES OR REGIONS OR PCT.

THIS IS THE CHEAPEST AND FASTEST FILING ALTERNATIVE US PATENT LAW ALLOWS YOU TO FILE A PROVISIONAL OR A NON-

PROVISIONAL APPLICATION (THE “NORMAL” KIND OF APPLICATION). THE PROVISIONAL APPLICATION IS IN FORCE FOR ONE YEAR AND CONFERS

ALL THE PARIS CONVENTION RIGHTS AS A NON-PROVISIONAL. IT IS FILED BUT NOT EXAMINED UNTIL IT IS CONVERTED INTO A NON-

PROVISIONAL. UNLIKE THE NON-PROVISIONAL, THE PROVISIONAL IS NOT PUBLISHED. IN THE EVENT THE CONVERSION TO NON-PROVISIONAL DOES NOT OCCUR,

THE PROVISIONAL EXPIRES AND NOBODY KNOWS ABOUT IT. THE PROVISIONAL ACTUALLY CONFERS ONE MORE YEAR OF PATENT LIFE,

THAT IS 21 YEARS INSTEAD OF 20.


FIRST STEP: FILING A NATIONAL APPLICATION IN THE INVENTOR’S NATIVECOUNTRY (OR IN ANOTHER, LIKE US) AND GETTING A ONE YEAR PARISCONVENTION PRIORITY TO FILE IN OTHER COUNTRIES OR REGIONS OR PCT.

THIS IS THE CHEAPEST AND FASTEST FILING ALTERNATIVE US PATENT LAW ALLOWS YOU TO FILE A PROVISIONAL OR A NON-

PROVISIONAL APPLICATION (THE “NORMAL” KIND OF APPLICATION). THE PROVISIONAL APPLICATION IS IN FORCE FOR ONE YEAR AND CONFERS

ALL THE PARIS CONVENTION RIGHTS AS A NON-PROVISIONAL. IT IS FILED BUT NOT EXAMINED UNTIL IT IS CONVERTED INTO A NON-

PROVISIONAL. UNLIKE THE NON-PROVISIONAL, THE PROVISIONAL IS NOT PUBLISHED. IN THE EVENT THE CONVERSION TO NON-PROVISIONAL DOES NOT OCCUR,

THE PROVISIONAL EXPIRES AND NOBODY KNOWS ABOUT IT. THE PROVISIONAL ACTUALLY CONFERS ONE MORE YEAR OF PATENT LIFE,

THAT IS 21 YEARS INSTEAD OF 20.

8

REGIONAL APPLICATIONS ANOTHER ALTERNATIVE TO NATIONAL AND PCT APPLICATIONS IS FILING A

REGIONAL APPLICATION THIS IS POSSIBLE IN: EPC – INCLUDING ALL THE EUROPEAN COUNTRIES ARIPO (AFRICAN REGIONAL INTELLECTUAL PROPERTY ORGANIZATION),

INCLUDING SOME OF THE AFRICAN COUNTRIES OAPI (ORGANISATION AFRICAINE DE LA PROPRIETE INTELLECTUELE),

INCLUDING THE FRENCH SPEAKING AFRICAN COUNTRIES EAPO (EURASIAN PATENT ORGANIZATION) WHICH INCLUDES THE FORMER

SOVIET REPUBLICS THE ADVANTAGES ARE CLEAR - ONE FILING AND ONE PROSECUTION. DISADVANTAGES – COSTS HIGHER THAN A NATIONAL FILING AND NEED FOR

FILING IN EACH NATIONAL JURISDICTION AFTER GRANT UNLIKE PCT – THERE IS SUCH A THING AS A EUROPEAN PATENT, BUT IT IS

WORTHLESS WITHOUT THE NATIONAL FILINGS.


ANOTHER ALTERNATIVE TO NATIONAL AND PCT APPLICATIONS IS FILING AREGIONAL APPLICATION

THIS IS POSSIBLE IN: EPC – INCLUDING ALL THE EUROPEAN COUNTRIES ARIPO (AFRICAN REGIONAL INTELLECTUAL PROPERTY ORGANIZATION),

INCLUDING SOME OF THE AFRICAN COUNTRIES OAPI (ORGANISATION AFRICAINE DE LA PROPRIETE INTELLECTUELE),

INCLUDING THE FRENCH SPEAKING AFRICAN COUNTRIES EAPO (EURASIAN PATENT ORGANIZATION) WHICH INCLUDES THE FORMER

SOVIET REPUBLICS THE ADVANTAGES ARE CLEAR - ONE FILING AND ONE PROSECUTION. DISADVANTAGES – COSTS HIGHER THAN A NATIONAL FILING AND NEED FOR

FILING IN EACH NATIONAL JURISDICTION AFTER GRANT UNLIKE PCT – THERE IS SUCH A THING AS A EUROPEAN PATENT, BUT IT IS

WORTHLESS WITHOUT THE NATIONAL FILINGS.

9

PCT APPLICATIONS

THE PCT IS A CENTRALIZED FILING PROCEDURE ONE CAN FILE A PCT APPLICATION IN THE WAKE OF A NATIONAL

APPLICATION OR INSTEAD OF A NATIONAL APPLICATION. THE PCT SYSTEM ALLOWS FILING ONE PATENT APPLICATION

AFFORDING PRIORITY FOR MOST WORLD COUNTRIES ANDREGIONALS (SEE FURTHER) AND POSTPONING THE DECISION ONWHEN AND WHAT TO FILE FOR LATER. PCT ALSO CARRIES OUTEXAMINATIONS AND PRODUCES REPORTS WHICH ARE VERY USEFULTO THE INVENTOR.

DRAWBACK – HIGH COSTS – HIGHER THAN A NATIONAL ORREGIONAL APPLICATION.

COMMON FALLACY:“WORLD (PCT) PATENT “ - THERE IS NO SUCHTHING – YET.


THE PCT IS A CENTRALIZED FILING PROCEDURE ONE CAN FILE A PCT APPLICATION IN THE WAKE OF A NATIONAL

APPLICATION OR INSTEAD OF A NATIONAL APPLICATION. THE PCT SYSTEM ALLOWS FILING ONE PATENT APPLICATION

AFFORDING PRIORITY FOR MOST WORLD COUNTRIES ANDREGIONALS (SEE FURTHER) AND POSTPONING THE DECISION ONWHEN AND WHAT TO FILE FOR LATER. PCT ALSO CARRIES OUTEXAMINATIONS AND PRODUCES REPORTS WHICH ARE VERY USEFULTO THE INVENTOR.

DRAWBACK – HIGH COSTS – HIGHER THAN A NATIONAL ORREGIONAL APPLICATION.

COMMON FALLACY:“WORLD (PCT) PATENT “ - THERE IS NO SUCHTHING – YET.

10

PCT FLOW-CHARTINTERNATIONAL SEARCH AUTHORITY (ISA) WRITTEN OPINION

IPRP = INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY


11

PATENT PROSECUTION HIGHWAY(PPH)

122006 Cross filing Applications among IP5 Offices

RIGHTS OF THE PATENT OWNER

CONTRARY TO THE COMMON BELIEF, A PATENT DOES NOTCONFER THE INVENTOR THE RIGHT TO PRACTICE HISINVENTION.

IN FACT, SOME INVENTIONS ARE BASED ON EARLIER PATENTSAND CANNOT BE PRACTICED WITHOUT A LICENSE FROM THEOTHER PATENTEE.

SUCH SITUATIONS MAY BE SOLVED BY CROSS-LICENSE. A PATENT ONLY CONFERS THE RIGHT TO PREVENT OTHERS

FROM MAKING, USING, SELLING OR DISTRIBUTINGTHEPATENTED INVENTION WITHOUT PERMISSION.

PERMISSION MAY BE GRANTED IN RETURN FOR A ROYALTYOR OTHER FORM OF PAYMENT.


CONTRARY TO THE COMMON BELIEF, A PATENT DOES NOTCONFER THE INVENTOR THE RIGHT TO PRACTICE HISINVENTION.

IN FACT, SOME INVENTIONS ARE BASED ON EARLIER PATENTSAND CANNOT BE PRACTICED WITHOUT A LICENSE FROM THEOTHER PATENTEE.

SUCH SITUATIONS MAY BE SOLVED BY CROSS-LICENSE. A PATENT ONLY CONFERS THE RIGHT TO PREVENT OTHERS

FROM MAKING, USING, SELLING OR DISTRIBUTINGTHEPATENTED INVENTION WITHOUT PERMISSION.

PERMISSION MAY BE GRANTED IN RETURN FOR A ROYALTYOR OTHER FORM OF PAYMENT.

13

WHAT CAN YOU DO WITH A PATENT?

OWNING A PATENT IS NOT MUCH DIFFERENT FROM OWNINGA PROPERTY, LIKE A HOUSE.

YOU CAN SELL A PATENT, LICENSE IT (SIMILARLY TORENTING), PUT IT IN ESCROW (LIKE A MORTGAGE), OR USE ITAS COLLATERAL AT THE BANK.

MOREOVER, UNLIKE A HOUSE, YOU CAN LICENSE THE PATENTTO SEVERAL CLIENTS IN PARALEL (NON-EXCLUSIVELICENCING). OF COURSE, THE PRICE IS DIFFERENT BETWEENEXCLUSIVE AND NON-EXCLUSIVE LICENSING.

HOWEVER, YOU CAN ONLY SELL A PATENT ONCE AND THENYOU LOSE THE OWNERSHIP AND THE PATENT IS REASSIGNED.THE INVENTORSHIP THOUGH, REMAINS YOURS.


OWNING A PATENT IS NOT MUCH DIFFERENT FROM OWNINGA PROPERTY, LIKE A HOUSE.

YOU CAN SELL A PATENT, LICENSE IT (SIMILARLY TORENTING), PUT IT IN ESCROW (LIKE A MORTGAGE), OR USE ITAS COLLATERAL AT THE BANK.

MOREOVER, UNLIKE A HOUSE, YOU CAN LICENSE THE PATENTTO SEVERAL CLIENTS IN PARALEL (NON-EXCLUSIVELICENCING). OF COURSE, THE PRICE IS DIFFERENT BETWEENEXCLUSIVE AND NON-EXCLUSIVE LICENSING.

HOWEVER, YOU CAN ONLY SELL A PATENT ONCE AND THENYOU LOSE THE OWNERSHIP AND THE PATENT IS REASSIGNED.THE INVENTORSHIP THOUGH, REMAINS YOURS.

14

PATENT TERM EXTENSIONS

THE WAXMAN-HATCH ACT (1984) PERMITS LIMITED EXTENSIONS TOCOMPENSATE FOR MARKET TIME LOST DURING THE DRUGAPPROVAL PROCESS (FDA).

THE EXTENSION CANNOT EXCEED 5 YRS AND THE REMAINING PATENTTERM AFTER APPROVAL MAY NOT EXCEED 14 YRS.

THE PRE-CONDITION IS THAT THE APPLICANT SHOULD HAVEEXERCISED DUE DILLIGENCE IN OBTAINING THE REGULATORYAPPROVAL

EXTENSION UNDER 35 U.S.C. § 156 (WAXMAN HATCH) EXTENSION UNDER 35 U.S.C. § 155 EXTENSION UNDER PRIVATE LAW (NOT CODIFIED)


THE WAXMAN-HATCH ACT (1984) PERMITS LIMITED EXTENSIONS TOCOMPENSATE FOR MARKET TIME LOST DURING THE DRUGAPPROVAL PROCESS (FDA).

THE EXTENSION CANNOT EXCEED 5 YRS AND THE REMAINING PATENTTERM AFTER APPROVAL MAY NOT EXCEED 14 YRS.

THE PRE-CONDITION IS THAT THE APPLICANT SHOULD HAVEEXERCISED DUE DILLIGENCE IN OBTAINING THE REGULATORYAPPROVAL

EXTENSION UNDER 35 U.S.C. § 156 (WAXMAN HATCH) EXTENSION UNDER 35 U.S.C. § 155 EXTENSION UNDER PRIVATE LAW (NOT CODIFIED)

15



16

PHARMACEUTICALREGULATORY PROCESS

ROOTS AND SHORT HISTORY

A DRAMATIC TRAGEDY FACILITATED THE PASSAGE OF STRONGER REGULATORYLAWS:

THE ANTIBIOTIC SULFANILAMIDE WAS INTRODUCED IN THE 1930S. THEDRUG WAS A MAJOR MEDICAL ADVANCE IN THE TREATMENT OF INFECTIOUSDISEASES. HOWEVER, SULFANILAMIDE IS RELATIVELY INSOLUBLE ANDTHEREFORE WAS ONLY AVAILABLE IN A PILL FORM THAT WAS DIFFICULT TOADMINISTER TO SMALL CHILDREN. IN 1937, A CHEMIST AT THE S.E.MASSENGILL COMPANY, IN AN EFFORT TO OBTAIN A SOLUBLE FORM OF THEDRUG, DISSOLVED A BATCH OF SULFANILAMIDE IN THE TOXIC INDUSTRIALSOLVENT DIETHYLENE GLYCOL. THE COMPANY MARKETED THE OBTAINED“ELIXIR” RESULTING IN AT LEAST 358 POISONINGS AND 107 DEATHS, MOSTLYOF CHILDREN.

THE THALIDOMIDE INCIDENT (THOUGH NOT APPROVED BY THE FDA THANKSTO DR. KELSEY) WAS ANOTHER CATALYST TO TIGHTER PHARMACEUTICALLEGISLATION (KEFAUVER).


A DRAMATIC TRAGEDY FACILITATED THE PASSAGE OF STRONGER REGULATORYLAWS:

THE ANTIBIOTIC SULFANILAMIDE WAS INTRODUCED IN THE 1930S. THEDRUG WAS A MAJOR MEDICAL ADVANCE IN THE TREATMENT OF INFECTIOUSDISEASES. HOWEVER, SULFANILAMIDE IS RELATIVELY INSOLUBLE ANDTHEREFORE WAS ONLY AVAILABLE IN A PILL FORM THAT WAS DIFFICULT TOADMINISTER TO SMALL CHILDREN. IN 1937, A CHEMIST AT THE S.E.MASSENGILL COMPANY, IN AN EFFORT TO OBTAIN A SOLUBLE FORM OF THEDRUG, DISSOLVED A BATCH OF SULFANILAMIDE IN THE TOXIC INDUSTRIALSOLVENT DIETHYLENE GLYCOL. THE COMPANY MARKETED THE OBTAINED“ELIXIR” RESULTING IN AT LEAST 358 POISONINGS AND 107 DEATHS, MOSTLYOF CHILDREN.

THE THALIDOMIDE INCIDENT (THOUGH NOT APPROVED BY THE FDA THANKSTO DR. KELSEY) WAS ANOTHER CATALYST TO TIGHTER PHARMACEUTICALLEGISLATION (KEFAUVER).

17


MILESTONE REGULATORY LEGISLATION

LEGISLATION AND REGULATION ARE TWO DIFFERENT THINGS

MILESTONE LEGISLATION THE DRUG IMPORTATION ACT OF 1848 PURE FOOD AND DRUG ACT OF 1906 FEDERAL FOOD, DRUG AND COSMETIC (FD&C) ACT 1938 (post-sulfanilamide) KEFAUVER-HARRIS AMENDMENTS OF 1962 (post-thalidomide) CONTROLLED SUBSTANCES ACT OF 1970 WAXMAN-HATCH ACT 1984 PRESCRIPTION DRUG USER FEE ACT 1992 FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997 BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2002 PUBLIC HEALTH AND SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002


LEGISLATION AND REGULATION ARE TWO DIFFERENT THINGS

MILESTONE LEGISLATION THE DRUG IMPORTATION ACT OF 1848 PURE FOOD AND DRUG ACT OF 1906 FEDERAL FOOD, DRUG AND COSMETIC (FD&C) ACT 1938 (post-sulfanilamide) KEFAUVER-HARRIS AMENDMENTS OF 1962 (post-thalidomide) CONTROLLED SUBSTANCES ACT OF 1970 WAXMAN-HATCH ACT 1984 PRESCRIPTION DRUG USER FEE ACT 1992 FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997 BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2002 PUBLIC HEALTH AND SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002

18


MORE RECENT US PHARMACEUTICAL REGULATORY LEGISLATION

MEDICARE PRESCRIPTION DRUG IMPROVEMENT AND MODERNIZATION ACTOF 2003 (AMENDMENTS TO WAXMAN-HATCH – ORANGE BOOK LISTINGS, ONE30 MONTHS STAY ONLY)

PEDIATRIC RESEARCH EQUITY ACT OF 2003 FEDERAL FOOD, DRUG AND COSMETIC ACT (FD&C) OF 2006 FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT (FDAAA) OF 2007 QI (QUALIFYING INDIVIDUAL) PROGRAM SUPPLEMENTAL FUNDING ACT OF

2008 (ANTIBIOTICS IN THE ORANGE BOOK) FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT (FDASIA)

– USER FEES, PEDIATRIC DRUG DEVELOPMENT AND SYNTHETIC DRUG ABUSE “BIOLOGICS PRICE COMPETITION AND INNOVATION ACT OF 2009” – FOLLOW-

ON BIOLOGICS (KNOWN ALSO AS FOBs OR BIOSIMILARS) PRESERVE ACCESS TO AFFORDABLE GENERICS ACT (DRAFT) – PROHIBITS “PAY

FOR DELAY” – (HERBERT KOHL) (IN CONGRESS BUT NOT YET HR) 2011-2012


MEDICARE PRESCRIPTION DRUG IMPROVEMENT AND MODERNIZATION ACTOF 2003 (AMENDMENTS TO WAXMAN-HATCH – ORANGE BOOK LISTINGS, ONE30 MONTHS STAY ONLY)

PEDIATRIC RESEARCH EQUITY ACT OF 2003 FEDERAL FOOD, DRUG AND COSMETIC ACT (FD&C) OF 2006 FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT (FDAAA) OF 2007 QI (QUALIFYING INDIVIDUAL) PROGRAM SUPPLEMENTAL FUNDING ACT OF

2008 (ANTIBIOTICS IN THE ORANGE BOOK) FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT (FDASIA)

– USER FEES, PEDIATRIC DRUG DEVELOPMENT AND SYNTHETIC DRUG ABUSE “BIOLOGICS PRICE COMPETITION AND INNOVATION ACT OF 2009” – FOLLOW-

ON BIOLOGICS (KNOWN ALSO AS FOBs OR BIOSIMILARS) PRESERVE ACCESS TO AFFORDABLE GENERICS ACT (DRAFT) – PROHIBITS “PAY

FOR DELAY” – (HERBERT KOHL) (IN CONGRESS BUT NOT YET HR) 2011-2012

19

WAXMAN-HATCH (1984) AND THE PARAGRAPH IVPROCESS

PATENT CERTIFICATIONS: PAR I – NO PATENT FILED PAR II – PATENT HAS EXPIRED PAR III – PATENT WILL EXPIRE PAR IV - PATENT CHALLENGE - INVALIDITY, NON-INFRINGEMENT OR UNENFORCEABLE

21 CFR 314.94(A)(12)(I)(A)(4) LITTLE viii STATEMENT - APPLICANT NOT SEEKING APPROVAL FOR A CLAIMED INDICATION

(CARVING OUT) NO RELEVANT PATENT STATEMENT - NO PATENTS IN ORANGE BOOK AND ANDA APPLICANT NOT

AWARE OF ANY EXISTING PATENTS (NOT LISTED)

PARAGRAPH IV PROCESS ONCE A PAR. IV ANDA HAS BEEN FILED AND NOTICE SERVED, THE BRAND HAS 45 DAYS TO SUE THE

ANDA FILER(S) WITHIN THE PAR. IV FRAMEWORK. ONCE THE NOTICE IS FILED, FDA CANNOT APPROVE THE ANDA UNTIL THE GENERIC EITHER

SUCCESSFULLY DEFENDS THE SUIT OR UNTIL 30 MONTHS (THE “30 MONTHS STAY”) EXPIRES,WHICHEVER COMES FIRST.

IN THE EVENT NO LITIGATION WAS TIMELY FILED, THE BRAND STILL HAS THE OPTION TO SUE INCOURT, BUT THIS TIME, NO STAY.


PATENT CERTIFICATIONS: PAR I – NO PATENT FILED PAR II – PATENT HAS EXPIRED PAR III – PATENT WILL EXPIRE PAR IV - PATENT CHALLENGE - INVALIDITY, NON-INFRINGEMENT OR UNENFORCEABLE

21 CFR 314.94(A)(12)(I)(A)(4) LITTLE viii STATEMENT - APPLICANT NOT SEEKING APPROVAL FOR A CLAIMED INDICATION

(CARVING OUT) NO RELEVANT PATENT STATEMENT - NO PATENTS IN ORANGE BOOK AND ANDA APPLICANT NOT

AWARE OF ANY EXISTING PATENTS (NOT LISTED)

PARAGRAPH IV PROCESS ONCE A PAR. IV ANDA HAS BEEN FILED AND NOTICE SERVED, THE BRAND HAS 45 DAYS TO SUE THE

ANDA FILER(S) WITHIN THE PAR. IV FRAMEWORK. ONCE THE NOTICE IS FILED, FDA CANNOT APPROVE THE ANDA UNTIL THE GENERIC EITHER

SUCCESSFULLY DEFENDS THE SUIT OR UNTIL 30 MONTHS (THE “30 MONTHS STAY”) EXPIRES,WHICHEVER COMES FIRST.

IN THE EVENT NO LITIGATION WAS TIMELY FILED, THE BRAND STILL HAS THE OPTION TO SUE INCOURT, BUT THIS TIME, NO STAY.

20

ANDAs ARE FILED BY GENERICS WITHIN THE FRAMEWORK OFAMENDED WAXMAN-HATCH BASED CODE AND REGULATIONS.

ANDA ELIGIBILITY – PRODUCT MUST FULFIL THE FOLLOWINGCONDITIONS:

SAME INGREDIENT AS IN THE ETHICAL PRODUCT (NDA) BIOEQUIVALENT SAME ROUTE OF ADMINISTRATION SAME DOSAGE FORM SAME STRENGTH SAME CONDITIONS OF USE


ANDAs

ANDAs ARE FILED BY GENERICS WITHIN THE FRAMEWORK OFAMENDED WAXMAN-HATCH BASED CODE AND REGULATIONS.

ANDA ELIGIBILITY – PRODUCT MUST FULFIL THE FOLLOWINGCONDITIONS:

SAME INGREDIENT AS IN THE ETHICAL PRODUCT (NDA) BIOEQUIVALENT SAME ROUTE OF ADMINISTRATION SAME DOSAGE FORM SAME STRENGTH SAME CONDITIONS OF USE

21

ORANGE BOOK IS A FDA PUBLICATION. IT IS THE LEGAL SOURCE OF PATENT LISTINGS, EXCLUSIVITIESAND USE CODES

THE FULL NAME OF THE ORANGE BOOK IS: “APPROVED DRUG PRODUCTS WITH THERAPEUTICEQUIVALENCE EVALUATIONS”

LISTING – WHAT PATENTS CAN BE LISTED AND WHAT NOT, FOLLOWING AUGUST 18, 2003CAN BE LISTED:THE NDA FILERS MAY FILE UNDER AMENDED RULE 314.53(b)(1) PATENTS RELATED TO:

DRUG SUBSTANCE (ACTIVE INGREDIENT AND POLYMORPH)DRUG PRODUCT (FORMULATION AND COMPOSITION)METHOD OF USE (CLAIMING INDICATIONS OR OTHER CONDITIONS OF USE)

CANNOT BE LISTEDPROCESS PATENTSMETABOLITESINTERMEDIATESPACKAGING

DE-LISTING AND RE-LISTING THE LEGAL RELEVANCE OF THE ORANGE BOOK LISTINGS LEADS TO LEGAL SQUIRMISHES OVER

THE FDA OR BRAND DE-LISTINGS AND RE-LISTINGS


ORANGE BOOKWHAT CAN BE LISTED AND WHAT NOT, FOLLOWING AUGUST 18, 2003

(MEDICARE ACT)

ORANGE BOOK IS A FDA PUBLICATION. IT IS THE LEGAL SOURCE OF PATENT LISTINGS, EXCLUSIVITIESAND USE CODES

THE FULL NAME OF THE ORANGE BOOK IS: “APPROVED DRUG PRODUCTS WITH THERAPEUTICEQUIVALENCE EVALUATIONS”

LISTING – WHAT PATENTS CAN BE LISTED AND WHAT NOT, FOLLOWING AUGUST 18, 2003CAN BE LISTED:THE NDA FILERS MAY FILE UNDER AMENDED RULE 314.53(b)(1) PATENTS RELATED TO:

DRUG SUBSTANCE (ACTIVE INGREDIENT AND POLYMORPH)DRUG PRODUCT (FORMULATION AND COMPOSITION)METHOD OF USE (CLAIMING INDICATIONS OR OTHER CONDITIONS OF USE)

CANNOT BE LISTEDPROCESS PATENTSMETABOLITESINTERMEDIATESPACKAGING

DE-LISTING AND RE-LISTING THE LEGAL RELEVANCE OF THE ORANGE BOOK LISTINGS LEADS TO LEGAL SQUIRMISHES OVER

THE FDA OR BRAND DE-LISTINGS AND RE-LISTINGS

22

NON-PATENT REGULATORY EXCLUSIVITIES – EXTEND MARKET PROTECTION BEYONDTHE PATENT TERM

FIRST TO FILE: FIRST ANDA PATENT CHALLENGER 180 DAYS EXCLUSIVITY AGAINST OTHER ANDA FILERS EXCLUSIVITY TRIGGERED BY EARLIER OF FIRST COMMERCIAL MARKETING OR COURT

DECISION AMENDED BY MEDICARE ACT

NCE NEW CHEMICAL ENTITY EXCLUSIVITY NDA (INCLUDING 505(B)(2)) FOR A DRUG NO “ACTIVE INGREDIENT” (INCLUDING ESTER OR

SALT) OF WHICH HAS BEEN APPROVED IN ANY OTHER NDA NP NEW PRODUCT (NEW CLINICAL INVESTIGATIONS) EXCLUSIVITY

NDA OR SUPPLEMNTAL NDA INCLUDING NEW CLINICAL INVESTIGATIONS PED PEDIATRIC EXCLUSIVITY

TIMELY SUBMISSION OF STUDIES IN PEDIATRIC PATIENTS UPON WRITTEN REQUEST OF FDAFOR DRUGS THAT ARE APPROVED OR IN APPROVAL PROCESS

ODE - ORPHAN DRUG EXCLUSIVITY FIRST NDA OR BLA APPROVED FOR A RARE DISEASE WHICH AFFECTS LESS THAN 200,000

PERSONS IN THE US INNOVATIVE BIOLOGICS

BIOLOGIC INNOVATORS GET 12 YRS EXCLUSIVITY –(BPCIA). THIS MAY CHANGE TO 7 YRS.


EXCLUSIVITIES(FITZPATRICK)

NON-PATENT REGULATORY EXCLUSIVITIES – EXTEND MARKET PROTECTION BEYONDTHE PATENT TERM

FIRST TO FILE: FIRST ANDA PATENT CHALLENGER 180 DAYS EXCLUSIVITY AGAINST OTHER ANDA FILERS EXCLUSIVITY TRIGGERED BY EARLIER OF FIRST COMMERCIAL MARKETING OR COURT

DECISION AMENDED BY MEDICARE ACT

NCE NEW CHEMICAL ENTITY EXCLUSIVITY NDA (INCLUDING 505(B)(2)) FOR A DRUG NO “ACTIVE INGREDIENT” (INCLUDING ESTER OR

SALT) OF WHICH HAS BEEN APPROVED IN ANY OTHER NDA NP NEW PRODUCT (NEW CLINICAL INVESTIGATIONS) EXCLUSIVITY

NDA OR SUPPLEMNTAL NDA INCLUDING NEW CLINICAL INVESTIGATIONS PED PEDIATRIC EXCLUSIVITY

TIMELY SUBMISSION OF STUDIES IN PEDIATRIC PATIENTS UPON WRITTEN REQUEST OF FDAFOR DRUGS THAT ARE APPROVED OR IN APPROVAL PROCESS

ODE - ORPHAN DRUG EXCLUSIVITY FIRST NDA OR BLA APPROVED FOR A RARE DISEASE WHICH AFFECTS LESS THAN 200,000

PERSONS IN THE US INNOVATIVE BIOLOGICS

BIOLOGIC INNOVATORS GET 12 YRS EXCLUSIVITY –(BPCIA). THIS MAY CHANGE TO 7 YRS.

23

CONGRESS ENACTED FEDERAL REGULATIONS THAT ALLOW INDIVIDUALS TO EXPRESSTO THE FDA GENUINE CONCERNS ABOUT THE SAFETY, SCIENTIFIC, OR LEGAL ISSUESREGARDING A PRODUCT ANY TIME BEFORE, OR AFTER, ITS MARKET ENTRY.12 UNDERTHESE REGULATIONS, ANY PERSON OR ENTITY, INCLUDING A PHARMACEUTICALCOMPANY, MAY FILE A CITIZEN PETITION WITH THE FDA REQUESTING THAT THE FDATAKE, OR REFRAIN FROM TAKING, ANY ADMINISTRATIVE ACTION.

THIS DEMOCRATIC PROCESS IS ABUSED: A PARTY COULD EMBARK ON A STRATEGY OFFILING BASELESS CITIZEN PETITIONS WITH THE INTENT AND EFFECT OF USING THETIME IN WHICH IT TAKES THE FDA TO RESPOND TO THE PETITION (I.E., THE PROCESS,RATHER THAN THE OUTCOME) TO DELAY GENERIC ENTRY.

CONGRESS PASSED THE FDAAA, WHICH WAS ENACTED ON SEPTEMBER 27, 2007. THEFDAAA ADDS NEW SECTION 505(Q) TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT(FDCA) AND GOVERNS CERTAIN CITIZEN PETITIONS AND PETITIONS FOR STAY OF FDAAGENCY ACTION. IMPORTANTLY, SECTION 505(Q)(1)(A) PROVIDES THAT THE FDA MAYNOT DELAY APPROVAL OF AN ANDA APPLICATION BECAUSE OF ANY REQUEST TO TAKEANY FORM OF ACTION RELATED TO THE PENDING ANDA UNLESS “A DELAY IS NECESSARYTO PROTECT THE PUBLIC HEALTH.”


CITIZEN PETITIONS

CONGRESS ENACTED FEDERAL REGULATIONS THAT ALLOW INDIVIDUALS TO EXPRESSTO THE FDA GENUINE CONCERNS ABOUT THE SAFETY, SCIENTIFIC, OR LEGAL ISSUESREGARDING A PRODUCT ANY TIME BEFORE, OR AFTER, ITS MARKET ENTRY.12 UNDERTHESE REGULATIONS, ANY PERSON OR ENTITY, INCLUDING A PHARMACEUTICALCOMPANY, MAY FILE A CITIZEN PETITION WITH THE FDA REQUESTING THAT THE FDATAKE, OR REFRAIN FROM TAKING, ANY ADMINISTRATIVE ACTION.

THIS DEMOCRATIC PROCESS IS ABUSED: A PARTY COULD EMBARK ON A STRATEGY OFFILING BASELESS CITIZEN PETITIONS WITH THE INTENT AND EFFECT OF USING THETIME IN WHICH IT TAKES THE FDA TO RESPOND TO THE PETITION (I.E., THE PROCESS,RATHER THAN THE OUTCOME) TO DELAY GENERIC ENTRY.

CONGRESS PASSED THE FDAAA, WHICH WAS ENACTED ON SEPTEMBER 27, 2007. THEFDAAA ADDS NEW SECTION 505(Q) TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT(FDCA) AND GOVERNS CERTAIN CITIZEN PETITIONS AND PETITIONS FOR STAY OF FDAAGENCY ACTION. IMPORTANTLY, SECTION 505(Q)(1)(A) PROVIDES THAT THE FDA MAYNOT DELAY APPROVAL OF AN ANDA APPLICATION BECAUSE OF ANY REQUEST TO TAKEANY FORM OF ACTION RELATED TO THE PENDING ANDA UNLESS “A DELAY IS NECESSARYTO PROTECT THE PUBLIC HEALTH.”

24

ONE OF THE PREFERRED BRAND STRATEGIES FOR EVERGREENING IS THE PRACTICE OF CHANGING THEFORMULATION OR THE PRESENTATION OF AN APPROVED REFERENCE LISTED DRUG (RLD) JUST AHEADOF A PLANNED GENERIC LAUNCH AND DE-LISTING THE RLD (MOVING TARGET STRATEGY).

A RECENT EXAMPLE IS WARNER CHILCOTT’S DORYX. MYLAN PHARMACEUTICALS FILED AN ANTITRUSTCOMPLAINT ACCUSING WARNER CHILCOTT OF ENGAGING IN PRODUCT HOPPING IN CONNECTIONWITH ITS DORYX PRODUCT. WARNER CHILCOTT MADE A NUMBER OF CHANGES TO ITS DORYXPRODUCT IN ORDER TO "MANIPULATE THE FDA REGULATORY PROCESSES TO DELAY AND/OR PREVENTGENERIC COMPETITION TO DORYX. WARNER CHILCOTT CONVERMARKETPLACE FROM CAPSULES TOTABLETS. THIS MOVE, RENDERED ITS PROPOSED GENERIC VERSION OF THE CAPSULES OBSOLETE AS ACAPSULE CANNOT SERVE AS A SUBSTITUTE FOR A TABLET RLD. IN 2006, DEFENDANTS RELEASED ASTUDY FOR THE ADMINISTRATION OF DORYX WITH APPLESAUCE AND SOUGHT A CORRESPONDINGLABELING CHANGE THAT REQUIRED GENERIC MANUFACTURERS TO DEVELOP TABLETS THAT COULDBE ADMINISTERED BY BREAKING THE TABLETS INTO PIECES AND SPRINKLING THE PIECES OVERAPPLESAUCE. THIS SCHEME DELAYED MYLAN'S DEVELOPMENT OF ITS GENERIC DORYX TABLETSANYWHERE FROM 6 TO 12 MONTHS.

THE FTC FILED A MOTION, WHICH WAS ACCEPTED. IN THE PAST, THREE COURTS HAVE CONSIDERED CLAIMS THAT NEW PHARMACEUTICAL PRODUCTS

CONSTITUTED ILLEGAL 'PRODUCT SWITCHING' IN VIOLATION OF THE ANTITRUST LAWS." TWOCOURTS HAVE DISMISSED THE COMPLAINT AND ONE PERMITTED THE CASE TO PROCEED (THISLATTER CASE REPORTEDLY SETTLED FOR $250 MILLION AFTER ONE DAY OF TRIAL).


PRODUCT HOPPING

ONE OF THE PREFERRED BRAND STRATEGIES FOR EVERGREENING IS THE PRACTICE OF CHANGING THEFORMULATION OR THE PRESENTATION OF AN APPROVED REFERENCE LISTED DRUG (RLD) JUST AHEADOF A PLANNED GENERIC LAUNCH AND DE-LISTING THE RLD (MOVING TARGET STRATEGY).

A RECENT EXAMPLE IS WARNER CHILCOTT’S DORYX. MYLAN PHARMACEUTICALS FILED AN ANTITRUSTCOMPLAINT ACCUSING WARNER CHILCOTT OF ENGAGING IN PRODUCT HOPPING IN CONNECTIONWITH ITS DORYX PRODUCT. WARNER CHILCOTT MADE A NUMBER OF CHANGES TO ITS DORYXPRODUCT IN ORDER TO "MANIPULATE THE FDA REGULATORY PROCESSES TO DELAY AND/OR PREVENTGENERIC COMPETITION TO DORYX. WARNER CHILCOTT CONVERMARKETPLACE FROM CAPSULES TOTABLETS. THIS MOVE, RENDERED ITS PROPOSED GENERIC VERSION OF THE CAPSULES OBSOLETE AS ACAPSULE CANNOT SERVE AS A SUBSTITUTE FOR A TABLET RLD. IN 2006, DEFENDANTS RELEASED ASTUDY FOR THE ADMINISTRATION OF DORYX WITH APPLESAUCE AND SOUGHT A CORRESPONDINGLABELING CHANGE THAT REQUIRED GENERIC MANUFACTURERS TO DEVELOP TABLETS THAT COULDBE ADMINISTERED BY BREAKING THE TABLETS INTO PIECES AND SPRINKLING THE PIECES OVERAPPLESAUCE. THIS SCHEME DELAYED MYLAN'S DEVELOPMENT OF ITS GENERIC DORYX TABLETSANYWHERE FROM 6 TO 12 MONTHS.

THE FTC FILED A MOTION, WHICH WAS ACCEPTED. IN THE PAST, THREE COURTS HAVE CONSIDERED CLAIMS THAT NEW PHARMACEUTICAL PRODUCTS

CONSTITUTED ILLEGAL 'PRODUCT SWITCHING' IN VIOLATION OF THE ANTITRUST LAWS." TWOCOURTS HAVE DISMISSED THE COMPLAINT AND ONE PERMITTED THE CASE TO PROCEED (THISLATTER CASE REPORTEDLY SETTLED FOR $250 MILLION AFTER ONE DAY OF TRIAL).

25

REGULATION THROUGH LITIGATION REFERS TO CHANGES INREGULATION BROUGHT ABOUT BY LITIGATION.

THIS HAPPENS MOST OF THE TIMES WHEN THE REGULATION IS NOTCLEAR ENOUGH OR AMBIVALENT AND THE INTERESTED PARTIES SUETHE REGULATORY AGENCIES OR EVEN TAKE CASES TO THE SUPREMECOURT (CERTIORARI), IN ORDER TO CLARIFY ISSUES AND BRINGABOUT WANTED CHANGES IN THE WAY THE REGULATION ISINTERPRETED AND APPLIED.

AN EXTENSION TO THIS PRACTICE IS A SERIES OF LITIGATIONSINITIATED BY THE STATES AGAINST VIRTUALLY THE ENTIREPHARMACEUTICAL INDUSTRY ALLEGING FRAUD IN THE REPORTINGOF PRICES, TRYING TO LOWER DRUG PRICES. COURTS HAVE RULEDAGINST THIS PRACTICE.


“REGULATION THROUGH LITIGATION”

REGULATION THROUGH LITIGATION REFERS TO CHANGES INREGULATION BROUGHT ABOUT BY LITIGATION.

THIS HAPPENS MOST OF THE TIMES WHEN THE REGULATION IS NOTCLEAR ENOUGH OR AMBIVALENT AND THE INTERESTED PARTIES SUETHE REGULATORY AGENCIES OR EVEN TAKE CASES TO THE SUPREMECOURT (CERTIORARI), IN ORDER TO CLARIFY ISSUES AND BRINGABOUT WANTED CHANGES IN THE WAY THE REGULATION ISINTERPRETED AND APPLIED.

AN EXTENSION TO THIS PRACTICE IS A SERIES OF LITIGATIONSINITIATED BY THE STATES AGAINST VIRTUALLY THE ENTIREPHARMACEUTICAL INDUSTRY ALLEGING FRAUD IN THE REPORTINGOF PRICES, TRYING TO LOWER DRUG PRICES. COURTS HAVE RULEDAGINST THIS PRACTICE.

26



27

CLAUSEWITZ SAID: “DIPLOMACY IS THE CONTINUATION OF WAR BY OTHER MEANS”. BY PARAPHRASE, LITIGATION IN THE PHARMACEUTICAL INDUSTRY IS THE

CONTINUATION OF THE PROCESS WHICH STARTS WITH THE INVENTION AND ITSPATENTING.

THE LIFECYCLE OF AN INVENTIVE DRUG STARTS WITH DEVELOPMENT AND PATENTINGAND THROUGHOUT THE LIFECYCLE NEW LAYERS OF PATENTS AND REGULATORYBLOCKS ARE ADDED IN ORDER TO DELAY AS MUCH AS POSSIBLE THE DREADED DAY OFPATENT EXPIRY AND GENERICIZATION.

LITIGATION PLAYS AN IMPORTANT PART IN THE PROFIT MAXIMIZATION STRATEGY,ESPECIALLY TOWARDS THE END OF THE PATENTED PRODUCT’S LIFE.

THE OUTCOME OF THE LITIGATIONS IS VERY IMPORTANT TO ALL PLAYERS IN THE FIELD,ETHICALS, GENERICS AND INVESTORS ALIKE.

PREDICTING (OR MORE CORRECTLY GUESSING) THE OUTCOME OF A LITIGATION IS THERESULT OF THOROUGH ANALYSIS BASED ON KNOW-HOW, PRECEDENTS AND A LOT OFWORK.


PATENT LITIGATIONSIN THE

PHARMACEUTICAL INDUSTRY

CLAUSEWITZ SAID: “DIPLOMACY IS THE CONTINUATION OF WAR BY OTHER MEANS”. BY PARAPHRASE, LITIGATION IN THE PHARMACEUTICAL INDUSTRY IS THE

CONTINUATION OF THE PROCESS WHICH STARTS WITH THE INVENTION AND ITSPATENTING.

THE LIFECYCLE OF AN INVENTIVE DRUG STARTS WITH DEVELOPMENT AND PATENTINGAND THROUGHOUT THE LIFECYCLE NEW LAYERS OF PATENTS AND REGULATORYBLOCKS ARE ADDED IN ORDER TO DELAY AS MUCH AS POSSIBLE THE DREADED DAY OFPATENT EXPIRY AND GENERICIZATION.

LITIGATION PLAYS AN IMPORTANT PART IN THE PROFIT MAXIMIZATION STRATEGY,ESPECIALLY TOWARDS THE END OF THE PATENTED PRODUCT’S LIFE.

THE OUTCOME OF THE LITIGATIONS IS VERY IMPORTANT TO ALL PLAYERS IN THE FIELD,ETHICALS, GENERICS AND INVESTORS ALIKE.

PREDICTING (OR MORE CORRECTLY GUESSING) THE OUTCOME OF A LITIGATION IS THERESULT OF THOROUGH ANALYSIS BASED ON KNOW-HOW, PRECEDENTS AND A LOT OFWORK.

28

PATENT INVALIDATION

GROUNDS FOR PATENT INVALIDATION NOVELTY GROUNDS EXPRESS ANTICIPATION BY A PREVIOUS ART REFERENCE INHERENT ANTICIPATION – USING PRIOR ART WILL INHERENTLY

PRODUCE THE DISCLOSED ELEMENT OBVIOUSNESS GROUNDS SUBJECT OF A CLAIM IS NOT AN INVENTION INSUFFICIENT DISCLOSURE THE CLAIMS ARE NOT SUBSTANTIATED BY THE DESCRIPTION DOCTRINE OF EQUIVALENCE INEQUITABLE CONDUCT DOUBLE PATENTING OBVIOUSNESS TYPE DOUBLE PATENTING – NOT PATENTABLY DISTINCT

FROM EARLIER CLAIMS PROSECUTION LACHES


GROUNDS FOR PATENT INVALIDATION NOVELTY GROUNDS EXPRESS ANTICIPATION BY A PREVIOUS ART REFERENCE INHERENT ANTICIPATION – USING PRIOR ART WILL INHERENTLY

PRODUCE THE DISCLOSED ELEMENT OBVIOUSNESS GROUNDS SUBJECT OF A CLAIM IS NOT AN INVENTION INSUFFICIENT DISCLOSURE THE CLAIMS ARE NOT SUBSTANTIATED BY THE DESCRIPTION DOCTRINE OF EQUIVALENCE INEQUITABLE CONDUCT DOUBLE PATENTING OBVIOUSNESS TYPE DOUBLE PATENTING – NOT PATENTABLY DISTINCT

FROM EARLIER CLAIMS PROSECUTION LACHES

29

PATENT LITIGATIONSPATENT-RELATED LITIGATIONS OTHER THAN PATENT

INVALIDATION

INFRINGEMENT LITIGATION WILLFUL OR NOT WITHIN THE PAR. IV FRAMEWORK OR OUTSIDE IT

INDUCED INFRINGEMENT INJUNCTIONS – STOPPING TRADING OF INFRINGING DRUGS, STOPPING

IMPORT OF APIs PRODUCED BY INFRINGING PROCESS DECLARATORY JUDGMENTS SUING THE PATENT OFFICE FOR WRONG DETERMINATIONS FDA-RELATED LITIGATIONS:

SUING FDA FOR WRONG DECISIONS, OR SUING TO OBLIGE IT TO TAKE A CERTAIN PATH ORANGE BOOK LISTINGS, DELISTINGS FIRST TO FILE CASES FORFEITURE CASES


INFRINGEMENT LITIGATION WILLFUL OR NOT WITHIN THE PAR. IV FRAMEWORK OR OUTSIDE IT

INDUCED INFRINGEMENT INJUNCTIONS – STOPPING TRADING OF INFRINGING DRUGS, STOPPING

IMPORT OF APIs PRODUCED BY INFRINGING PROCESS DECLARATORY JUDGMENTS SUING THE PATENT OFFICE FOR WRONG DETERMINATIONS FDA-RELATED LITIGATIONS:

SUING FDA FOR WRONG DECISIONS, OR SUING TO OBLIGE IT TO TAKE A CERTAIN PATH ORANGE BOOK LISTINGS, DELISTINGS FIRST TO FILE CASES FORFEITURE CASES

30

PATENT INFRINGEMENT

PATENT INFRINGEMENT: MANUFACTURING, IMPORTING, USING,SELLING OR OFFERING PATENTED TECHNOLOGY WITHOUT LICENSEFROM THE PATENTEE.

INDIRECT INFRINGEMENT OR CONTRIBUTORY INFRINGEMENT: ATHIRD PARTY SUPPLIES A PRODUCT WHICH CAN ONLY BE USED INTHE CLAIMED DEVICE.

ACTIVE INDUCEMENT OF INFRINGEMENT: THE INDIRECT INFRINGERENCOURAGES THE DIRECT INFRINGER. EXAMPLE: API SUPPLIERSUGGESTING AND INITIATING AN INFRINGING ACTIVITY .

FOR AN INFRINGEMENT TO TAKE PLACE, EVERY ELEMENT ORLIMITATION OF AT LEAST ONE CLAIM MUST HAVE BEEN INFRINGED.


PATENT INFRINGEMENT: MANUFACTURING, IMPORTING, USING,SELLING OR OFFERING PATENTED TECHNOLOGY WITHOUT LICENSEFROM THE PATENTEE.

INDIRECT INFRINGEMENT OR CONTRIBUTORY INFRINGEMENT: ATHIRD PARTY SUPPLIES A PRODUCT WHICH CAN ONLY BE USED INTHE CLAIMED DEVICE.

ACTIVE INDUCEMENT OF INFRINGEMENT: THE INDIRECT INFRINGERENCOURAGES THE DIRECT INFRINGER. EXAMPLE: API SUPPLIERSUGGESTING AND INITIATING AN INFRINGING ACTIVITY .

FOR AN INFRINGEMENT TO TAKE PLACE, EVERY ELEMENT ORLIMITATION OF AT LEAST ONE CLAIM MUST HAVE BEEN INFRINGED.

31

PATENT LITIGATIONSDRUG COMPANY FINES AND SETTLEMENTS

IN RECENT YEARS, DRUG COMPANIES HAVE PAID HUGE FINES AND SETTLEMENTSFOR VARIOUS

THE LARGEST FINE IMPOSED THAT FAR LAST JULY'S $3 BILLION JUDGMENT AGAINSTGLAXOSMITHKLINE (GSK) FOR ILLEGALLY MARKETING THE ANTIDEPRESSANTSPAXIL AND WELLBUTRIN, WITHHOLDING HEALTH RISKS DATA OF THE DIABETESMEDICATION AVANDIA AND OTHER WRONGDOINGS - ACCOUNTED FOR JUST 11PERCENT OF ASSOCIATED REVENUE. IT SEEMS THAT THESE FINES ARE CONSIDEREDBY THE PHARMACEUTICAL INDUSTRY AS AN ACCEPTABLE PART OF DOING BUSINESS.

BY CONTRAST, IN MOST INDIVIDUAL CASES OF FRAUD ALL PROFITS ARE TYPICALLYCONFISCATED AND THE FRAUDSTER GOES TO PRISON..

ON A COMICAL NOTE, A JUDGE PASSED A RULING TO SHAME RATHER THANFINANCIALLY PUNISH THE CEO OF A CATHETHER COMPANY SELLING A CATHETHERWITHOUT FDA APPROVAL: THE CEO AGREED TO WEAR A T-SHIRT SAYING “I WASCONVICTED OF VIOLATING THE FDCA”.

OTHER CASES: PFIZER – $2.3 BILLION FOR MISBRANDING BEXTRA ABBOT - $1.5 BILLION FOR ILLEGAL PROMOTION OF DEPAKOTE.


IN RECENT YEARS, DRUG COMPANIES HAVE PAID HUGE FINES AND SETTLEMENTSFOR VARIOUS

THE LARGEST FINE IMPOSED THAT FAR LAST JULY'S $3 BILLION JUDGMENT AGAINSTGLAXOSMITHKLINE (GSK) FOR ILLEGALLY MARKETING THE ANTIDEPRESSANTSPAXIL AND WELLBUTRIN, WITHHOLDING HEALTH RISKS DATA OF THE DIABETESMEDICATION AVANDIA AND OTHER WRONGDOINGS - ACCOUNTED FOR JUST 11PERCENT OF ASSOCIATED REVENUE. IT SEEMS THAT THESE FINES ARE CONSIDEREDBY THE PHARMACEUTICAL INDUSTRY AS AN ACCEPTABLE PART OF DOING BUSINESS.

BY CONTRAST, IN MOST INDIVIDUAL CASES OF FRAUD ALL PROFITS ARE TYPICALLYCONFISCATED AND THE FRAUDSTER GOES TO PRISON..

ON A COMICAL NOTE, A JUDGE PASSED A RULING TO SHAME RATHER THANFINANCIALLY PUNISH THE CEO OF A CATHETHER COMPANY SELLING A CATHETHERWITHOUT FDA APPROVAL: THE CEO AGREED TO WEAR A T-SHIRT SAYING “I WASCONVICTED OF VIOLATING THE FDCA”.

OTHER CASES: PFIZER – $2.3 BILLION FOR MISBRANDING BEXTRA ABBOT - $1.5 BILLION FOR ILLEGAL PROMOTION OF DEPAKOTE.

32

“PAY FOR DELAY” SETTLEMENTS, AUTHORIZED GENERICSAND THEIR LEGALITY

PAY-FOR-DELAY: THE FEDERAL TRADE COMMISSION (FTC) FIGHTS THE COMMONPRACTICE IN THE US PHARMACEUTICAL INDUSTRY WHEREIN THE ORIGINATORSTRIKES A DEAL WITH ONE OR MORE GENERICS TO DELAY THE GENERIC ENTRY, WHILEPROVIDING THE GENERICS WITH SOME BENEFIT, NOT NECESSARILY MONEY.

MORE THAN 100 PAY-FOR-DELAY DEALS HAVE BEEN SIGNED SINCE 2005. A RULING IN A PAY-FOR-DELAY CASE AGAINST SCHERING-PLOUGH (NOW OWNED BY

MERCK) STATED THAT WHEN A BRAND-NAME DRUG MANUFACTURER PAYS A GENERICRIVAL TO DROP ITS CHALLENGE TO THE BRAND-NAME DRUG PATENT, THE SETTLEMENTIS PRIMA FACIE EVIDENCE OF AN ILLEGAL RESTRAINT OF TRADE. THE DECISIONINCREASES THE LIKELIHOOD THAT THE U.S. SUPREME COURT WILL HAVE TO TAKE UPTHE ISSUE.

THE US SUPREME COURT DECIDED IN JUNE 2013 IN FTC vs. ACTAVIS TO REVERSE THEDECISION OF THE LOWER COURT. WITH A 5:3 MAJORITY, THE COURT DECIDED THATWHILE REVERSE PAYMENTS ARE NOT INHERENTLY ILLEGAL, THEIR ANTICOMPETITIVEEFFECTS DO RENDER THEM SUSCEPTIBLE TO ANTITRUST SCRUTINY.

AUTHORIZED GENERICS: A RECENT DECISION STATES THAT AG ARE LEGAL


PAY-FOR-DELAY: THE FEDERAL TRADE COMMISSION (FTC) FIGHTS THE COMMONPRACTICE IN THE US PHARMACEUTICAL INDUSTRY WHEREIN THE ORIGINATORSTRIKES A DEAL WITH ONE OR MORE GENERICS TO DELAY THE GENERIC ENTRY, WHILEPROVIDING THE GENERICS WITH SOME BENEFIT, NOT NECESSARILY MONEY.

MORE THAN 100 PAY-FOR-DELAY DEALS HAVE BEEN SIGNED SINCE 2005. A RULING IN A PAY-FOR-DELAY CASE AGAINST SCHERING-PLOUGH (NOW OWNED BY

MERCK) STATED THAT WHEN A BRAND-NAME DRUG MANUFACTURER PAYS A GENERICRIVAL TO DROP ITS CHALLENGE TO THE BRAND-NAME DRUG PATENT, THE SETTLEMENTIS PRIMA FACIE EVIDENCE OF AN ILLEGAL RESTRAINT OF TRADE. THE DECISIONINCREASES THE LIKELIHOOD THAT THE U.S. SUPREME COURT WILL HAVE TO TAKE UPTHE ISSUE.

THE US SUPREME COURT DECIDED IN JUNE 2013 IN FTC vs. ACTAVIS TO REVERSE THEDECISION OF THE LOWER COURT. WITH A 5:3 MAJORITY, THE COURT DECIDED THATWHILE REVERSE PAYMENTS ARE NOT INHERENTLY ILLEGAL, THEIR ANTICOMPETITIVEEFFECTS DO RENDER THEM SUSCEPTIBLE TO ANTITRUST SCRUTINY.

AUTHORIZED GENERICS: A RECENT DECISION STATES THAT AG ARE LEGAL

33

TROLLSABUSIVE PATENT LITIGATION

In the patent world, “Trolls“ (troll is a Norwegian scary mythological being)are firms or persons filing litigations against rich companies in an attempt tocash in on the nuisance potential the litigations present.

As litigations are bad for the stock value and entering litigation is costly andenergy consuming, it is sometimes preferable to settle with the “troll” thanfight him.

Many attempts have been made to prevent this practice, but so farunsuccessfully. Recently (October 2013) a judge blasted a “patent troll” callingthe case “a sham” and the troll agreed to drop its suit. However, in absence ofproper legislation, the judges have a hard time stopping the trolls. A lowerCourt decision to desist was reversed on appeal.

Recently, the House of Representatives has passed H.R. 2655 titled “LawsuitAbuse Reduction Act of 2013 attempting to curb this practice. Should theCongress approve it, sanctions and compensations will become mandatory.


In the patent world, “Trolls“ (troll is a Norwegian scary mythological being)are firms or persons filing litigations against rich companies in an attempt tocash in on the nuisance potential the litigations present.

As litigations are bad for the stock value and entering litigation is costly andenergy consuming, it is sometimes preferable to settle with the “troll” thanfight him.

Many attempts have been made to prevent this practice, but so farunsuccessfully. Recently (October 2013) a judge blasted a “patent troll” callingthe case “a sham” and the troll agreed to drop its suit. However, in absence ofproper legislation, the judges have a hard time stopping the trolls. A lowerCourt decision to desist was reversed on appeal.

Recently, the House of Representatives has passed H.R. 2655 titled “LawsuitAbuse Reduction Act of 2013 attempting to curb this practice. Should theCongress approve it, sanctions and compensations will become mandatory.

5

PATENT LITIGATIONNUMBER OF LITIGATION CASES BY INDUSTRY

(Source: PricewaterhouseCoopers)


35

PATENT LITIGATIONDAMAGES PAID



36

PATENT LITIGATIONLITIGATION SUCCESS RATE



37

PATENT LITIGATIONANDA SUCCESS RATE

NEW JERSEY AND DELAWARE MOST FAVORED ANDA DISTRICTS


38

PATENT LITIGATIONTOP DEFENDANTS AND PLAINTIFFS



39

BRAND LIFE-CYCLE EXTENSION STRATEGIES ALSO KNOWN AS “TOTAL PRODUCT STRATEGIES”,

“EVERGREENING” OR “LIFECYCLE MAXIMIZATION” BRANDS STAND TO LOSE 15-30 % OF THEIR REVENUE ON FIRST

GENERIC’S LAUNCH AND UP TO 75-90% ON MULTIPLE LAUNCH, SOTHE INCENTIVE FOR LCM IS VERY STRONG

THE GENERIC PENETRATION INCREASES EVERY YEAR, WITH USPENETRATION REACHING 54% (OR 61% INCLUDING APPROVEDGENERICS) AND EU PENETRATION VARYING ACCORDING TOCOUNTRY FROM 5-65%.

LCM ACTIVITIES BEGIN VERY EARLY BUT BECOME MOREAGGRESSIVE TOWARDS THE END OF PATENT’S LIFE.

BRAND LCE TACTICS ARE IMPROVING ALL THE TIME AND ADAPTTO CHANGING LEGISLATION AND GENERIC TACTICS

BRANDS SPEND $50-400 MILL DOLLARS PER PRODUCT FOR LCE AN IMPORTANT PART OF THE LCM BUDGET IS USED FOR

LOBBYING FOR NEW LEGISLATION FAVORING BRANDS,PLACATING GENERIC LEGISLATION, PATENT LAW, ETC

LITIGATIONS AND PATENTING ACTIVITY ARE THE LARGEST LCMBUDGET ITEM

MULTIPLE STRATEGIES ARE EMPLOYED FOR EACH PRODUCT

Source: Combating Generics: Pharmaceutical Brand Defense for 2007


ALSO KNOWN AS “TOTAL PRODUCT STRATEGIES”,“EVERGREENING” OR “LIFECYCLE MAXIMIZATION”

BRANDS STAND TO LOSE 15-30 % OF THEIR REVENUE ON FIRSTGENERIC’S LAUNCH AND UP TO 75-90% ON MULTIPLE LAUNCH, SOTHE INCENTIVE FOR LCM IS VERY STRONG

THE GENERIC PENETRATION INCREASES EVERY YEAR, WITH USPENETRATION REACHING 54% (OR 61% INCLUDING APPROVEDGENERICS) AND EU PENETRATION VARYING ACCORDING TOCOUNTRY FROM 5-65%.

LCM ACTIVITIES BEGIN VERY EARLY BUT BECOME MOREAGGRESSIVE TOWARDS THE END OF PATENT’S LIFE.

BRAND LCE TACTICS ARE IMPROVING ALL THE TIME AND ADAPTTO CHANGING LEGISLATION AND GENERIC TACTICS

BRANDS SPEND $50-400 MILL DOLLARS PER PRODUCT FOR LCE AN IMPORTANT PART OF THE LCM BUDGET IS USED FOR

LOBBYING FOR NEW LEGISLATION FAVORING BRANDS,PLACATING GENERIC LEGISLATION, PATENT LAW, ETC

LITIGATIONS AND PATENTING ACTIVITY ARE THE LARGEST LCMBUDGET ITEM

MULTIPLE STRATEGIES ARE EMPLOYED FOR EACH PRODUCT

Source: Combating Generics: Pharmaceutical Brand Defense for 2007 41

GENERICCOMPETITOR-BLOCKING STRATEGIES

PROCESSES PATENTING ALL THE PRACTICAL SYNTHETIC PROCESSES FOR THE API API PROPERTIES PATENTING THE AMORPHOUS API WHEN THE CRYSTALLINE API IS

ALREADY PROTECTED (VALGANCICLOVIR, CANDESARTAN CILEXETIL) PATENTING ALL THE PRACTICAL STABLE POLYMORPHS AND

PROCESSES FOR THE SEMINAL POLYMORPH, IF ANY PATENTING THE API WITH LOW LEVEL OF IMPURITY AND

REQUESTING PHARMACOPOEIAL MONOGRAPH UPDATE TO THENEW PURITY

ANALYTICAL METHODS PATENTING A SPECIFIC METHOD OF ANALYSIS AND ITS MARKER,

AND REQUESTING PHARMACOPOEIAL MONOGRAPH UPDATE TOINCLUDE THIS METHOD

FORMULATIONS PATENTING THE PRACTICAL BIOEQUIVALENT FORMULATIONS

PROCESSES PATENTING ALL THE PRACTICAL SYNTHETIC PROCESSES FOR THE API API PROPERTIES PATENTING THE AMORPHOUS API WHEN THE CRYSTALLINE API IS

ALREADY PROTECTED (VALGANCICLOVIR, CANDESARTAN CILEXETIL) PATENTING ALL THE PRACTICAL STABLE POLYMORPHS AND

PROCESSES FOR THE SEMINAL POLYMORPH, IF ANY PATENTING THE API WITH LOW LEVEL OF IMPURITY AND

REQUESTING PHARMACOPOEIAL MONOGRAPH UPDATE TO THENEW PURITY

ANALYTICAL METHODS PATENTING A SPECIFIC METHOD OF ANALYSIS AND ITS MARKER,

AND REQUESTING PHARMACOPOEIAL MONOGRAPH UPDATE TOINCLUDE THIS METHOD

FORMULATIONS PATENTING THE PRACTICAL BIOEQUIVALENT FORMULATIONS

43

INTENSIFICATION OF THE BRAND-GENERIC LITIGATIONS

Source: Paragraphfour.com

Thank you!

45

dr. stephen cherkez p.a. intellectual property tase ...events.eventact.com/ivc/analizacourse/dr...

Documents