St. Jude's Hospital Sues Novartis over Research Tool Patents

St_judes_childrens_hospitalLest anyone think that Myriad Genetics is the only patentee asserting rights in patents having claims to isolated DNA molecules or other biological molecules, St. Jude's Children's Research Hospital, Inc. has sued Novartis Pharmaceuticals Corp. in the Federal District Court, Western District of Tennessee for infringing U.S. Patent Nos. 5,529,925; 5,770,421; and 6,696,548 (see "Court Report," October 20, 2013).  The grounds for St. Jude's infringement allegations are activities by Novartis "to research, develop, and evaluate small molecule tyrosine kinase inhibitors, including, but not limited to, LDK378," some of that research having taken place in Memphis, TN within the Court's jurisdiction.  Those activities include, according to the complaint, making or using "ALK nucleic acids, proteins, polypeptides, and/or antibodies in a manner that infringes the '925, '421, and '548 patents."  Novartis has declined St. Jude's demands for an explanation of its activities, St. Jude alleges in its complaint that Novartis' refusal to substantively respond supports an inference that Novartis "is and has been infringing the '925, '421 and '548 patents with knowledge of the patents" (and hence is willful), that "Novartis will continue to infringe the '925, '421 and '548 patents unless or until" enjoined by the Court; and that "Novartis has caused and will continue to cause St. Jude irreparable injury and damage by infringing the '925, '421, and '548 patents.  St. Jude will suffer further irreparable injury, for which it has no adequate remedy at law, unless and until Novartis is enjoined from infringing the '925, '421, and '548 patents."

The claims of the asserted patents read as follows:

The '925 patent:

1. An isolated nucleic acid molecule having the nucleotide sequence of the human cDNA insert encoding anaplastic lymphoma kinase protein, ALK, contained in plasmid pRMS17-2, deposited at the American Type Culture Collection as ATCC designation 69497.

2. A vector construct comprising a vector into which has been inserted the isolated nucleic acid molecule of claim 1.

3. A cultured host cell transformed with the vector construct of claim 2.

4. The vector construct of claim 2, wherein said vector construct is plasmid pRMS17-2.

5. A host cell transformed with the vector construct of claim 4.

The '421 patent:

1. An isolated human anaplastic lymphoma kinase (ALK) polypeptide, wherein said isolated ALK polypeptide
    (a) has tyrosine kinase activity; and
    (b) renders an interleukin-3-dependent lymphoid cell line factor independent.

2. An isolated ALK polypeptide of claim 1, comprising a polypeptide having the amino acid sequence of SEQ ID NO:2.

3. An isolated ALK polypeptide of claim 1, comprising a polypeptide having the amino acid sequence of SEQ ID NO:4.

4. An isolated ALK polypeptide, comprising at least one structural domain of an ALK protein having the amino acid sequence of SEQ ID NO:2, wherein said structural domain is selected from the group consisting of an extracellular domain, a transmembrane domain, a catalytic domain, a signal peptide domain, an intracellular domain, a kinase domain, an immunoreactive domain and a fusion domain.

5. An isolated ALK polypeptide according to claim 4, wherein said structural domain comprises amino acids 27-1030 of SEQ ID NO:2 as said extracellular domain.

6. An isolated ALK polypeptide according to claim 4, wherein said structural domain comprises amino acids 1031-1058 of SEQ ID NO:2 as said transmembrane domain.

7. An isolated ALK polypeptide according to claim 4, wherein said structural domain comprises amino acids 1023-1376 of SEQ ID NO:2 as said catalytic domain.

8. An isolated ALK polypeptide according to claim 4, wherein said structural domain comprises amino acids 1-26 of SEQ ID NO:2 as said signal peptide domain.

9. An isolated ALK polypeptide according to claim 4, wherein said structural domain comprises amino acids 1059-1620 of SEQ ID NO:2 as said intracellular domain.

10. An isolated ALK polypeptide according to claim 4, wherein said structural domain comprises amino acids 605-1509 of SEQ ID NO:2 as said kinase domain.

11. An isolated ALK polypeptide according to claim 4, wherein said structural domain comprises amino acids 1359-1460 of SEQ ID NO:2 as said immunoreactive domain.

12. An isolated ALK polypeptide according to claim 4, wherein said structural domain comprises amino acids 979-1078 of SEQ ID NO:2 (corresponding to amino acids 1-100 of SEQ ID NO:7) as said fusion domain.

The '548 patent:

1. An isolated antibody that specifically binds a polypeptide consisting of the amino acid sequence of SEQ ID NO: 2.

2. The isolated antibody of claim 1, wherein said antibody further specifically binds a polypeptide consisting of the amino acid sequence of SEQ ID NO:4.

3. An isolated antibody tat specifically binds a polypeptide consisting of the amino acid sequence of SEQ ID NO: 7.

4. The isolated antibody of claim 1, wherein said ALK polypeptide is denatured.

5. The isolated antibody of claim 3, wherein said polypeptide is denatured.

6. An isolated antibody that specifically binds an isolated polypeptide, wherein said isolated polypeptide consists of at least one domain of an ALK polypeptide consisting of the amino acid sequence of SEQ ID NO:2, wherein said domain is selected from the group consisting of an extxacellular domain, a transmembrane domain, a catalytic domain, a signal peptide domain, an intracellular domain, a kinase domain, an immunoreactive domain and a fusion domain.

7. The isolated antibody of claim 6, wherein said isolated polypeptide is denatured.

8. The isolated antibody of claim 1, wherein said antibody specifically binds to a fragment and wherein said fragment consists of amino acids 27-1030 of SEQ ID NO:2.

9. The isolated antibody of claim 1, wherein said antibody specifically binds to a fragment and wherein said fragment comprises amino acids 1031-1058 of SEQ ID NQ:2.

10. The isolated antibody of claim 1, wherein said antibody specifically binds to a fragment and wherein said fragment comprises amino acids 1023-1376 of SEQ ID NO:2.

11. The isolated antibody of claim 1, wherein antibody specifically binds to a fragment and wherein said fragment comprises amino acids 1-26 of SEQ ID NO:2.

12. The isolated antibody of claim 1, wherein said antibody specifically binds to a fragment and wherein said fragment comprises amino acids 1059-1620 of SEQ ID NO:2.

13. The isolated antibody of claim 1, wherein said antibody specifically binds to a fragment and wherein said fragment comprises amino acids 605-1509 of SEQ ID NO:2.

14. The isolated antibody of claim 1, wherein said antibody specifically binds to a fragment and wherein said fragment comprises amino acids 1359-1460 of SEQ ID NO:2.

NovartisThis suit may provide the first opportunity to determine the extent to which a defendant can extend the Supreme Court's Myriad decision to encompass isolated, "naturally occurring" biological molecules other than nucleic acids, and in the process provide a gauge as to how fundamentally the Court has harmed the patent system, the economy, and the public health.  Alternatively, depending on Novartis' activities, the company may be able to employ another 9-0 Supreme Court decision, the Merck v. Integra opinion, where the Court disregarded Congressional intent as set forth expressly in the legislative history of the Hatch-Waxman Act to expand the scope of the statutory safe harbor (35 U.S.C. § 271(e)(1)) to encompass development of chemical lead compounds that rarely if ever are submitted to the FDA or other regulatory agency.  That case explicitly excluded a determination of whether so-called "research tools" (which could include embodiments of the St. Jude's claims) should fall within the scope of the safe harbor; this case could provide an avenue for the Court to continue its expansion of non-infringing behavior with regard to patents relating to drug development and other invention related to the medical arts.