The Claim Game

Patent Claim Analysis: Teva v. Sandoz

Today I am going to discuss patent claims involved in the case Supreme Court case Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.

Case Background: Teva sued Sandoz for patent infringement of Copaxone, a drug used to treat the neurological disorder Multiple Sclerosis. In defense, Sandoz claimed that Teva's patent claims were indefinite in that the term "molecular weight" had three possible meanings, and was not defined. The district court ruled that the claims regarding molecular weight were definite, and that Sandoz had infringed on Teva's patents. Sandoz appealed this decision and the appellate court found that Teva's molecular weight claims were indeed indefinite, and therefore the claims were invalid.

Patent at Issue: The patent at hand is U.S. Patent No. 5,800,808: Copolymer-1 Improvements in Compositions of Copolymers.

The claims of the the '808 patent follow as:

1. A method of manufacturing copolymer-1

comprising reacting protected copolymer-1 with hydrobromic acid
to form trifluoroacetyl copolymer-1
treating said trifluoroacetyl copolymer-1 with aqueous piperidine solution
to form copolymer-1,
and purifying said copolymer-1,
to result in copolymer-1
having a molecular weight of about 5 to 9 kilodaltons.

This patent describes a method of manufacturing copolymer-1 with a molecular weight of 5-9 kilodaltons. The reactions uses the starting materials of protected copolymer-1 and hydrobromic acid. This initial reaction forms trifluoroacetyle copolymer-1. Trifluoroacetyl copolymer-1 is treated with piperidine solution to form copolymer-1. The resulting copolymer-1 is purified and results in a molecular weight of 5-9 kilodaltons.

The Supreme Court ruled that though Sandoz had infringed Teva's patents, there is a lack of support regarding whether Teva's claims are definite.

Sources:

https://www.oyez.org/cases/2014/13-854

http://patentlyo.com/patent/2015/06/remand-deference-indefinite.html

http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/12-1567.Opinion.6-16-2015.1.PDF

Patent Claim Analysis: Nuclear Factors Associated with Transcriptional Regulation

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

of a gene whose transcription is regulated by NF-.kappa.KB
the method comprising reducing NF-.kappa.B activity
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

in a eukaryotic cell
of genes whose transcription is regulated by NF-.kappa.B
the method comprising reducing NF-.kappa.B activity
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

whose transcription is regulated by NF-.kappa.B in a eukaryotic cell
the method comprising reducing NF-.kappa.B activity
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,

wherein the viral gene is a cytomegalovirus (CMV),
human immunodeficiency virus (HIV)
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

of a cytokine gene
whose transcription is regulated by NF-.kappa.B
in a eukaryotic cell
comprising reducing NF-.kappa.B activity in the cell
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

comprising reducing NF-.kappa.B activity in cells
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

which external influences induce NF-.kappa.B-mediated intracellular signaling
the method comprising altering NF-.kappa.B activity in the cells
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

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

which are activated by extracellular influences which induce NF-.kappa.B-mediated intracellular signaling,
the method comprising reducing NF-.kappa.B activity in the cells
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

comprising reducing NF-.kappa.B activity in mammalian cells
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