Patent Claim Analysis: Nuclear Factors Associated with Transcriptional Regulation

Patent Claim Analysis: Nuclear Factors Associated with Transcriptional Regulation

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Today I am going to discuss the key patent claims involved in Ariad Pharmaceuticals et al. v. Eli Lilly and Company. 

Case Background: In this case, Ariad Pharma accused Eli Lilly of infringing on a patent regarding to Eli Lilly's osteoporosis medication and sepsis treatment. Though the lower court ruled in favor of Ariad, the appellate court reversed this decision, finding that the patent claims at hand were invalid due to lack of written description. 


Patent at issue: The patent at issue is US6410516 B1: Nuclear Factors Associated with Transcriptional Regulation. In this patent, the inventors claim the method of NF-kB, a transcription factor, that activates gene expression in the body's immune responses to infection. 

The first 10 Patent claims follow: 

1. A method for inhibiting expression in a eukaryotic cell
  1.  of a gene whose transcription is regulated by NF-.kappa.KB
  2. the method comprising reducing NF-.kappa.B activity 
  3. in the cell such that expression of said gene is inhibited. 

A method inhibiting gene expression of genes regulated by NF-.kappa.B.

2. A method for selectively inhibiting expression

  1. in a eukaryotic cell
  2. of genes whose transcription is regulated by NF-.kappa.B
  3.  the method comprising reducing NF-.kappa.B activity
  4. in the cell such that expression of said genes is inhibited

A method selectively inhibiting gene expression of genes regulated by NF-.kappa.B.

3. A method for reducing the level of expression of a viral gene

  1. whose transcription is regulated by NF-.kappa.B in a eukaryotic cell
  2. the method comprising reducing NF-.kappa.B activity
  3.  in the cell such that expression of said viral gene is reduced. 

A method reducing viral gene expression of viral genes regulated by NF-.kappa.B.

4. The method of claim 3, 

  1. wherein the viral gene is a cytomegalovirus (CMV), 
  2. human immunodeficiency virus (HIV) 
  3. or simian virus 40 (SV40) gene. 

A method reducing viral gene expression of a CMV, HIV, SV40 genes regulated by NF-.kappa.B.

5. A method for reducing the level of expression

  1. of a cytokine gene 
  2. whose transcription is regulated by NF-.kappa.B 
  3. in a eukaryotic cell 
  4. comprising reducing NF-.kappa.B activity in the cell 
  5. such that expression of said cytokine gene is reduced. 

A method reducing gene expression of a cytokine gene regulated by NF-.kappa.B.

6. A method for diminishing induced NF-.kappa.B-mediated intracellular signaling 

  1. comprising reducing NF-.kappa.B activity in cells 
  2. such that NF-.kappa.B-mediated intracellular signaling is diminished. 

A method for diminishing induced NF-.kappa.B-mediated intracellular signaling.

7. A method for modifying effects of external influences on a eukaryotic cell

  1. which external influences induce NF-.kappa.B-mediated intracellular signaling
  2.  the method comprising altering NF-.kappa.B activity in the cells 
  3. such that NF-.kappa.B-mediated effects of external influences are modified. 

A method for modifying the impact of extracellular influences that induce NF-.kappa.B-mediated intracellular signaling.

8. The method of claim 7

  1. wherein NF-.kappa.B activity in the cell is reduced. 

A method for modifying the impact of extracellular influences that induce NF-.kappa.B-mediated intracellular signaling such that NF-.kappa.B activity is reduced.

9. A method for reducing, in eukaryotic cells, the level of expression of genes 

  1. which are activated by extracellular influences which induce NF-.kappa.B-mediated intracellular signaling,
  2.  the method comprising reducing NF-.kappa.B activity in the cells 
  3. such that expression of said genes is reduced. 

A method for reducing gene expression of genes activated by extracellular influences that induce  NF-.kappa.B-mediated intracellular signaling.

10. A method for reducing the effects of bacterial infection on mammalian cells 

  1. comprising reducing NF-.kappa.B activity in mammalian cells 
  2. so as to reduce bacterial lipopolysaccharide-induced gene expression in the mammalian cells. 


A method for reducing the effects of bacterial infection on mammalian cells that reduces NF-.kappa.B activity in said cells. 

Taken together, these claims, along with the rest of the patent describe methods of modifying genes involved in NF-.kappa.B activity to inhibit, reduce, or modify in a particularized way,  NF-.kappa.B activity. Though the claims are very particular about the cells in which or the genes involved with  NF-.kappa.B activity, the claims fail to elaborate on the methods of reducing/inhibiting/modifying. The failure to write a written description describing these methods led the appellate court to declare the claims as invalid, finding Eli Lilly to not have infringed on Ariad's patents. 

 Sources:
http://www.casebriefs.com/blog/law/intellectual-property-law/intellectual-property-keyed-to-merges/patent-law-intellectual-property-keyed-to-merges/ariad-pharmaceuticals-inc-v-eli-lilly-co/
http://patft.uspto.gov/netacgi/nph-Parser?Sect2=PTO1&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-bool.html&r=1&f=G&l=50&d=PALL&RefSrch=yes&Query=PN/6410516
http://www.washingtonpost.com/wp-dyn/content/article/2006/05/04/AR2006050401787.html

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