By Kevin E. Noonan --
Lest 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.
This 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.
This may also the case to challenge to the so-called "antibody exception" to the written description requirement.
Although I haven't analyzed the claimed sequence and I'm assuming that this was a previously unsequenced gene (prior to the filing of the application), claim 1 of the '925 patent would seem to fall snugly within the cDNA exception carved out by the Supreme Court in Myriad.
Absent some clear definition in the specification that provides some defined structure, claim 1 of the '421 patent is dead on arrival. Claims 2 and 3 seem more viable, although the challenge under 101 to "isolated" naturally occurring proteins is a real issue that the Supreme Court will surely need to address.
Claim 4 of the '421 patent also seems like a non-starter, given that some of the domains referred to are small and likely obvious in view of similiar domains (with similar functions) in many other previously described proteins.
I'm pretty sure that "public health" hasn't been harmed at all by the Myriad decision. But Myriad was harmed and they will certainly be harmed again. That's good for the patent system and everybody else (except Myriad and, I suppose, Myriad's cheerleaders).
Posted by: Bruce from ELO | October 25, 2013 at 11:47 AM
Dear Bruce:
Unless the Court's Myriad decision expands to encompass antibiotics, antibodies, anticancer drugs, etc.
We'll see who are the cheerleaders then.
Thanks for the comment.
Posted by: Kevin E. Noonan | October 25, 2013 at 02:19 PM