Drug product patent term expiration and the challenge begins

Mittal Bhawana*A, Kaur GurpreetB, Kumar VikasB

A- SD College, Barnala, Punjab, INDIA
B- Deptt. of Pharmceutical Sciences, Punjabi University, Patiala
Abstract:-Patent is used as a safe measure to prevent unlawful use/manufacturing of a product or process. While according
to GATT provisions there is 20 years exclusivity for product patent in case of pharma products but every pharma MNC uses
some “Defensive Strategies” to further extend their patent protection period. With molecules like rosiglitazone
(Avandia,GSK), ramipril (Altace, Monarch), lansoprazole (Prevacid, Aboott/Takeda) going off-patent in 2009, the big
phamra players are ready to use defensive strategies.
Preclinical Phase Successful Clinical Phase
completion
I II III IV Generic Drug
of approval
Preclinical •IND tested •Several •100 to 1000 •Post marketing
•Testing in animals File ANDA (Submit
•ADME of drug and metabolites phase on Human hundred subjects taken phase data showing
•Metabolites Toxicity •20 to 80 patients •Information •Continuous bioequivalence with
Healthy •Both safety used to create review process innovators product).
volunteers and efficacy package inserts
•Acess accessed
File IND Safety

Milestone in generic drug approval process

DESI review Paper NDA Hatch-Wxman act Para IV filling Under Hatch-Wxman act
(1962) or 505 b(2) (1984)
Para IV filling by prospective generic manufacturer.
•Safety and Efficacy •NDA can be •Title I includes provisions
required in NDA filed for the similar to ANDA process Patent is invalid or not infringed by generic application.
•FDA announced 2 year generic version and Paper NDA.
grace period for of drug based on •Title II include patent term NDA holder starts patent infringement Suit.
manufacturers to supply published restoration rules.
eveidence of efficacy of scientific YES NO
drug products marketed literature. (Automatic 30 months stay and 180 day (Generic applicant may
before 1962. exclusivity) enter)
Defensive strategies used by big pharma companies
Defensive strategy Evidence/Description Example
Authorised generics (Branded generics) Generic divisions established by big pharma; Pfizer.s Merck’s authorized generic version of Simvastatin
Greenstone; Novartis Sandoz etc or Big pharma do financial (ZOCOR), Dr. Reddy's Laboratories launched
settlements with generic manufacturers authorized generic version of GlaxoSmithKline's
Imitrex (sumatriptan succinate)

Pricing and aggressive marketing
branded drugs
Citizen’s petitions (Blocking petitions)
Settling lawsuits filed by generic
compnies challenging blockbuster
patents
Big Pharmacy/ pharmacy benefit managers (PBMs), all
branded drugs about to go off patent or already off-patented
Makers of branded drugs may question the safety of generic
version
Slows generic’s entry to market.
Legal fights create uncertainty amoung generic
manufacturers about rising the lauch of generics.
At end of patent expiration this will hinders
generics companies ability to compete
GSK’s questioned safety of Buproprion generics
(Wellbutrin XL)
Schering-Ploough paid Upsher-Smith to delay
bringing to market a generic version of potassium
chloride (K-Dur), a blood pressure medication