Claims for Patent: 8,455,194

Summary for Patent: 8,455,194

Title:	Diagnostic methods
Abstract:	This invention relates to a method of determining the susceptibility of an individual to statin-induced myopathy, comprising detecting the presence or absence of one or more polymorphisms in the SLCO1B1 gene in a biological sample from an individual, whereby the presence of one or more polymorphisms indicates that the individual has altered susceptibility to statin-induced myopathy.
Inventor(s):	Link; Emma (Oxford, GB), Parish; Sarah (Oxford, GB), Collins; Rory (Oxford, GB), Lathrop; Mark (Paris, FR)
Assignee:	Isis Innovation Limited (Oxford, GB)
Application Number:	13/408,672
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,455,194
Patent Claims:	1. A method, comprising: (a) assaying for the presence or absence of a C or T allele for single nucleotide polymorphism rs4149056 in the SLCO1B1 gene in a biological sample obtained from a patient in need of treatment with a statin; (b) correlating the identity of the allele of said polymorphism with risk of statin-induced myopathy; (c) establishing a statin type and dosage based on said patient's statin-induced myopathy risk; and (d) administering said statin type and dosage to said patient. 2. The method of claim 1, wherein said assaying step comprises amplifying at least part of the SLCO1B1 gene comprising said polymorphism, and identifying the nucleotide present in at least one allele of said polymorphism in the amplified gene. 3. The method of claim 2, wherein said assaying step comprises amplifying exon 6 of the SLCO1B1 gene comprising the SNP rs4149056. 4. The method of claim 1, wherein said biological sample is selected from the group consisting of individual cells, cell populations, bodily tissues, and bodily fluids. 5. The method of claim 1, wherein, for a patient with the TT genotype, said administered statin dosage is higher than the standard dosage, and for a patient with a CC or TC genotype, said statin dosage is the standard dosage. 6. The method of claim 1, wherein said statin is lovastatin, simvastatin, pravastatin, fluvastatin, atorvastatin, pitayastatin, or rosuvastatin. 7. The method of claim 6, wherein said statin is atorvastatin or simvastatin. 8. A method comprising: (a) assaying for the presence of a C or T allele for single nucleotide polymorphism rs4363657 in the SLCO1B1 gene in a biological sample obtained from a patient in need of treatment with a statin; (b) correlating the identity of the allele of said polymorphism with risk of statininduced myopathy; (c) establishing a statin type and dosage based on said patient's statin-induced myopathy risk; and (d) administering said statin type and dosage to said patient. 9. The method of claim 8, wherein said assaying step comprises amplifying at least part of the SLCO1B1 gene comprising said polymorphism, and identifying the nucleotide present in at least one allele of said polymorphism in the amplified gene. 10. The method of claim 9, wherein said assaying step comprises amplifying intron 11 of the SLCO1B1 gene comprising the SNP rs4363657. 11. The method of claim 8, wherein said biological sample is selected from the group consisting of individual cells, cell populations, bodily tissues, and bodily fluids. 12. The method of claim 8, wherein, for a patient with the IT genotype, said administered statin dosage is higher than the standard dosage, and for a patient with a CC or IC genotype, said statin dosage is the standard dosage. 13. The method of claim 8, wherein said statin is lovastatin, simvastatin, pravastatin, fluvastatin, atorvastatin, pitavastatin, or rosuvastatin. 14. The method of claim 13, wherein said statin is atorvastatin or simvastatin.

Details for Patent 8,455,194

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2028-02-29
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2028-02-29
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2028-02-29