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FarmaPatent arastirma ve Danismanlik http//www.fa
rmapatent.com.tr
FARMASÖTIK BULUSLARDA PATENT, RUHSATLANDIRMA VE
HUKUKI UYGULAMALAR SEMPOZYUMU 31 Mayis 1
Haziran 2012 Türkiyede Ilaç Patenti
Uygulamalari Dr.Ecz.Pinar Bulut
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Ilaçlar Fikri Mülkiyet Korumasi
Frank Daelemans Presentation
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Türkiye Patent Mevzuati
Paris Sözlesmesi 1925
WIPO Katilim 1976
TPE Kurulus 24 Haziran 1994

1995 WTO üyesi (TRIPs) 1995 Patent Yasasi
(Ilaçlar için patent hakki)
1879 Patent Yasasi Ilaçlara patent hakki yok.
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UYGULAMALAR (TPE)
Ürün patentleri , Proses Patentleri
Bolar hakki (ruhsat
basvurusu istisnasi) 551 KHK 75-f- Ilaçlarin
ruhsatlandirilmasi ve bunun için gerekli test ve
deneyler de dahil olmak üzere, ruhsat
konusu bulusu içeren deneme amaçli fiiller.
Ikinci endikasyon 551 KHK Md.6- Patent
Verilemeyecek Konular ve Buluslar e - Insan veya
hayvan vücuduna uygulanacak cerrahi ve tedavi
usulleri ile teshis usulleri. (. hüküm bu
usullerin herhangi birinde kullanilan terkip ve
maddeler ile bunlarin üretim usullerine
uygulanmaz )
Zorunlu lisans Patentli bulusun kullanilmamasi
 Patentlerin ana konusunun bagimliligi Kamu
yarari söz konusu olmasi.
Ciprofloxacin (sarbon) Oseltamivir (kus
gribi)

Anti-cancer drug Nexavar (sorafenib
tosylate) Bayer refused Natcos plea to grant
voluntary license in December 2010. ? compulsory
license (2012) .. in India for just 3 of the
patented drug's price in return for paying 6
royalty on sales to Bayer.
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UYGULAMALAR (Saglik Bakanligi)
Veri imtiyazi(6 yil) gt 1 Ocak 2005 (1
Ocak 2000de kismen)
Jenerik ruhsat basvurularinin orijinal firmalar
tarafindan ögrenilebilmesi

• Ruhsatlandirma Yönetmeligi .. bilgilerin
  gizliligi kurali dosyadaki bilgi ve belgelerin
  baskalarinin incelemesine açilmasinin
  engellenmesi .. ile sinirli olup anilan kural,
  ruhsat sahiplerinin, ruhsatli ürünleri referans
  gösterilerek yapilan kisaltilmis ruhsat
  basvurularinin varligi hakkinda
  bilgilendirilmelerine engel degildir.
• .. davacilarin ruhsati referans gösterilerek
  kisaltilmis ruhsat basvurusu yapilip yapilmadigi,
  yapilmis ise, bunlarin sayisi ve kimler
  tarafindan yapildigina iliskin evrak kayit
  bilgilerinin verilmesi ..

Patent Ruhsat Baglantisi ???
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UYGULANMAYANLAR

• Patent süresi uzatma (Supplementary Protection
  Certificate SPC)
• Ruhsat alma tarihinden itibaren maksimum 15
  yil (ABDde ruhsat alma tarihinden itibaren 14
  yil)
• Patent basvuru tarihinden itibaren 25 yili
  asamaz
• Pediatrik süre uzatimi (6 ay) (Paediatric
  Investigation Plan PIP)

• Farmasötik formülasyonlar için faydali model
  verilmiyor

• Tescil edilmis patentler için TPE nezdinde
  hükümsüzlük veya patente tecavüz olmadigina dair
  inceleme talebi yapilamiyor

• TPEde eczaci kökenli patent uzmani bulunmuyor

• Türkiye ile AB arasinda paralel ticaret
  yapilamiyor

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(No Transcript)
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• E) Fikri Mülkiyet Haklari
• Veri münhasiriyeti 5
• Beseri Tibbi Ürünler Ruhsatlandirma
  Yönetmeliginde yer alan veri münhasiriyetine
  dair hükümlerin tam üyelik gerçeklesinceye kadar
  geçerliligini sürdürmesi saglanmalidir.

• Ek Koruma Sertifikasi
• Ek koruma sertifikasi uygulamasina tam üyelik
  gerçeklestikten sonra belirlenecek belirli bir
  süre içince geçilmelidir.
• 3. Ek koruma sertifikasi hiçbir gerekçe ile
  geriye dönük olarak uygulanmamalidir.

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E) Fikri Mülkiyet Haklari (iii) Paralel
Ticaret
..yeni patent kanununda patent ve faydali
modelde hakkin tüketilmesinin TC/AB gümrük alani
içinde bölgesel tüketilmesi ilkesi kabul
edilmelidir.
EK 8 FIKRI SINAI VE TICARI MÜLKIYETIN
KORUNMASI Madde 10 (2) Taraflar arasindaki ticari
iliskilerde, fikri, sinai ve ticari mülkiyet
haklarina, hakkin tüketilmesi ilkesinin
uygulanmasi, bu karar ile öngörülmemistir.
Tasari (17.4.2009 tarihli metin) Patentin
Sagladigi Haklarin Tüketilmesi Madde 20- (1)
Patent sahibi tarafindan veya onun izni ile
Türkiyede satisa sunulmus olan patentli
ürünlerle ilgili fiiller, patentin sagladigi
hakkin kapsami disinda kalir.
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E) Fikri Mülkiyet Haklari (iv) Zorunlu
Lisans
. Az gelismis ülkelere ve ilaç üretim
kapasitesi olmayan veya yeterli olmayan ülkelere
ihracat sarti ile patentli ilaç ve ilaç
hammaddelerine talep üzerine zorunlu lisans
verilir
Tasari (17.4.2009 tarihli metin) Kamu sagligi
sorunlari nedeniyle eczacilik ürünlerinin uygun
ülkelere ihracati durumunda zorunlu lisans
MADDE 74-(1) Eczacilik ürünlerini, bu alanda
üretim kapasitesi olmayan veya yetersiz olan
ülkelere kamu sagligi sorunlari nedeniyle ihraç
etmek isteyenler, Yönetmelige uygun olarak
zorunlu lisans verilmesini talep edebilir.
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CAUTION !

• For most Generic Drug Developments, Molecule
  Patent expiry dates are the
• Tip of the Iceberg
• (Leighton Howard (CEO of Genericweb)
• ICSE2005 , Madrid)

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• Molekül, tek endikasyon, doz rejimi patentleri
• Jenerik rekabet mümkün degildir
• Patentin etrafindan dolasmak mümkün olmaz
• ihtiyati tedbir zorunlu

• Tuzlar, Hidratlar, Polimorflar vb.
• Jenerik rekabet mümkün
• RD ile patentin etrafindan dolasilabilir

• Çesitli formülasyon, proses patentleri
• Jenerik rekabet mümkün
• Patentin etrafindan kolayca dolasilabilir

From Webinar of Leighton Howard
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COMPOUND PATENT, MOLECULE PATENT US 4659716
Claim 1- A compound of the formula
or a pharmaceutically acceptable
salt thereof, wherein X represents Cl or F.
Desloratadine
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TEK ENDIKASYON
INDICATIONS . .. is indicated for the management
of obesity, ..
Claim 1. A method of treating obesity in humans
..of Sibutramine in conjunction with a
pharmaceutically acceptable diluent or carrier.
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NOVEL DOSE REGIMEN

• Posology
• cSSTI without concurrent Staphylococcus aureus
  bacteraemia Cubicin 4 mg/kg is administered once
  every 24 hours for 7-14 days or until the
  infection is resolved..

TR 2001/ 00841 B (CUBIST)  METHODS FOR
ADMINISTRATION OF ANTIBIOTICS WO 2000/018419
EP1115417 B1 US6468967  
Claim 1. Use of a daptomycin for the
manufacture of a medicament for treating a
bacterial infection in a human patient in need
of, wherein a dose for said treating is 3 to 75
mg/kg of daptomycin, wherein said dose is
repeatedly administered in a dosage interval of
once every 24 hours to once weekly. Problem
prolonged treatment with 3 mg/kg daptomycin
every 12 hours was shown to cause occasional
adverse effects (Baltz, supra). Transient
muscular weakness and pain were observed in two
of five human patients
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NOVEL DOSE REGIMEN
TR2005/04747 T4 (EP1296689B1) METHOD OF
ADMINISTERING BISPHOSPHONATES Claim 1- Use of
zoledronic acid ..
for the treatment abnormally increased bone
turnover ..
the period between administration is at least
about 6 months.
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NOVEL DOSE
Endikasyon Menopoz sonrasi kadinda osteoporoz
tedavisi için haftada bir 70 mg tablet
TR 2000/ 00145 T2 (Rejected) (MERCK Co.) Kemik
erimesini durdurmak için bir yöntem
Kapsam Kemik rezorpsiyonunun inhibisyonu için
her 3 gün ila 16 günde bir 8.75 mg ila 140 mg
alendronik asid kullanimi
Bölünmüs Patent
TR 2008/ 05763 B (Granted) (MERCK Co.) Kemik
erimesini durdurmak için bir yöntem
Kapsam Osteoporoz tedavisi için her 7 günde bir
70 mg alendronik asid kullanimi
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• Tuzlar, Hidratlar, Polimorflar vb.
• Jenerik rekabet mümkün
• RD ile patentin etrafindan dolasilabilir
• Legal yol (patent invalidation)

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NOVEL SALT
TR 2004/ 01793 T4 (SERVIER EP 1354873 B1) Salt
of perindopril and pharmaceutical compositions
containing it (Expiry Date 17 February 2023)
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NOVEL HYDRATE, SOLVATE
TR 2004 / 02579 T4 (B INGELHEIM EP1326862
B1) CRYSTALLINE MONOHYDRATE OF TIOTROPIUM
BROMIDE, METHOD FOR PRODUCING THE SAME . US
6777423 WO0230928
SPIRIVA Each capsule contains 22.5 microgram
tiotropium bromide monohydrate equivalent to 18
microgram tiotropium.

• The absorption of moisture ..
• Uniform distribution of the medicament..
• Since breakdown . as a side effect of the
  grinding (or micronizing).
• Surprisingly, it has been found that the
  monohydrate of tiotropium bromide, which can be
  obtained in crystalline form ., meets the
  stringent requirements mentioned above and thus
  solves the problem on which the present invention
  is based.

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POLIMORFLAR
Ranitidin hidroklorür (Form 1)
..ranitidine hydrochloride can be prepared in a
new crystalline form ..designated Form 2 have
larger crystals than the hitherto known Form 1
and exhibits more favourable filtration and
drying characteristics. Furthermore, Form 2 is
less hygroscopic than Form 1, ..
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POLIMORFLAR
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• Çesitli formülasyon, proses patentleri
• Jenerik rekabet mümkün
• Patentin etrafindan kolayca dolasilabilir

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PROCESS PATENT

• Claim 6. tert-butyl (E)- (6-2- 4-
  (4-fluorophenyl)-6-isopropyl-2- methyl
  (methylsulfonyl) amino pyrimidin-5-yl vinyl
  (4R, 6S)-2,2-dimethyl 1,3 dioxan-4-yl) acetate
  BEM

Ca
2
BEM --gt
Rosuvastatin
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NOVEL INDICATION
TR 2008/ 06194 T4 (UCB FARCHIM EP1569650
B1) USE OF LEVOCETIRIZINE FOR THE TREATMENT OF
PERSISTENT ALLERGIC RHINITIS  
CLAIM 1. Use of levocetirizine for treating
persistent allergic rhinitis or for decreasing
the symptoms of persistent allergic rhinitis .
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NOVEL PATIENT GROUP
TR 2000/ 02837 B (ABBOTT / ORION)  USE OF
DEXMEDETOMIDINE FOR INTENSIVE CARE UNIT
SEDATION WO 1999/049854 US6716867 EP1069893 
Claim 1. Use of dexmedetomidine .. for use in
sedating a critically ill patient who is given
intensive care, wherein the patient remains
arousable and orientated

• group must be distinguishable with respect to
  physiological or pathological status,
• may not overlap with previously treated group,
• may not be selected arbitrarily

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Resmi Patent Bülteninde Yayinlanan ILAÇLARLA
ILGILI BAZI ULUSAL BASVURULAR (2011-2012)
www.farmapatent.com.tr
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NOVEL COMPOSITION / FORMULATION
TR 1997/ 01018 B (LILLY WO9629995) 
Tablet core Olanzapine as an active ingredient
intimately mixed with a bulking agent binder,
disintegrant, a dry binder
subcoating effectively prevents the undesired
discoloration
color coat
Invention
A new solid oral formulation was prepared that
used a HPMC subcoating and a white color coating.
.. The HPMC coating which is free of
polyethylene glycol is much preferred to ensure
that discoloration does not occur on the tablet
surface.
Claim 1. A solid oral formulation comprising
olanzapine .wherein such solid oral formulation
is coated with a polymer selected from the group
consisting of HPMC, HEC, MHEC, Na CMC, HPC, PVP,
.. with the proviso that the coating or polymer
be free from polyethylene glycol
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NOVEL COMPOSITION / FORMULATION
TR 2001 / 1310 B (Bayer) PHARMACEUTICAL
MOXIFLOXACIN PREPARATION WO 2000/27398, US
6610327,  EP1128831 B1
Surprisingly, the use of lactose in the range of
amounts according to the invention confers to the
tablet which is prepared from the pharmaceutical
preparation according to the invention an
excellent hardness and excellent release
properties.
1. Pharmaceutical preparation for oral
administration which comprises moxifloxacin or a
salt and/or hydrate thereof, at least one dry
binder, at least one disintegrant, and at least
one lubricant, characterized in that the
preparation comprises from 2.5 to 25 of lactose.
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NOVEL DOSAGE FORM / COMPOSITION
TR 1997/00190 B (Wyeth) EXTENDED RELEASE
FORMULATION CONTAINING VENLAFAXINE
Problem/Solution In the extrusion process, heat
buildup occurred which dried out the extrudate so
much that it was difficult to convert the
extruded cylinders into spheroids. Addition of
hydroxypropylmethylcellulose 2208 to the
venlafaxine hydrochloride microcrystalline
cellulose mix made production of spheroids
practical.

• An extended release formulation of venlafaxine
  hydrochloride comprising
• ..spheroids comprised of ..
• venlafaxine hydrochloride .
  microcrystalline cellulose, .hydroxypropyl-methyl
  cellulose,
• .. wherein the spheroids are coated with a film
  coating composition comprised of ethyl cellulose
  and hydroxypropylmethylcellulose.

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FarmaPatent Arastirma Danismanlik http//www.farma
patent.com.tr
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