Clontech Laboratories Inc v. Invitrogen Corp.
| Decision Date | 20 May 2003 |
| Docket Number | No. C.A.98-750-SLR.,C.A.98-750-SLR. |
| Citation | 263 F.Supp.2d 780 |
| Parties | CLONTECH LABORATORIES, INC., Plaintiff, v. INVITROGEN CORPORATION (formerly Life Technologies, Inc.) Defendant. |
| Court | U.S. District Court — District of Delaware |
Richard L. Horwitz, Potter, Anderson & Corroon, LLP, Wilmington, Delaware, Patton Boggs, LLP, McLean, Virginia (Marc R. Labgold, Kevin M. Bell, Laura A. Donnelly, of Counsel), Richard J. Oparil, Patton Boggs, LLP, Washington, DC, for plaintiff.
F.
Parsons, Jr., Karen Jacobs Louden, Morris, Nichols, Arsht & Tunnell, Wilmington, Delaware, Milbank, Tweed, Hadley & McCloy, Washington, DC (Robert J. Koch, James Pooley, of counsel), for defendant.
On December 22, 1998, plaintiff Clontech Laboratories, Inc. ("Clontech") filed suit against defendant Invitrogen Corporation (formerly Life Technologies, Inc. or "LTI") alleging false marking pursuant to 35 U.S.C. § 292. (D.I.I) Plaintiffs complaint was subsequently amended to include allegations of violation of the Sherman Act, 15 U.S.C. §§ 1, 2, and the Delaware Deceptive Trade Practices Act ("DTPA"), 6 Del. C. § 2531 et seq. (D.I.83, 137) The case was then temporarily stayed pending the outcome of related litigation in the United States District Court for the District of Maryland. (D.I.139) From October 7 to October 10, 2002, the court held a bench trial on the issues. The following are the court's findings of fact and conclusions of law pursuant to Fed.R.Civ.P. 52(a). This court has jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338.
1. Plaintiff Clontech is a California Corporation with its principal place of business in Palo Alto, California. (D.I.199) Clontech has developed and sold products for genomics as well as protein detection analysis and cellular biology. (D.I. 208 at 553) Clontech has also produced cDNA libraries using reverse transcriptase ("RT") and sold kits used to make cDNA. (D.I. 208 at 554)
2. In 1999, Clontech was acquired by Becton, Dickinson and Company, a medical devices and technology company. (D.I. 208 at 552-53) 3. Defendant Invitrogen, formerly Life Technologies, Inc. ("LTI"), is a Delaware Corporation with its principal place of business in Carlsbad, California. (D.I.199) Invitrogen also produces and sells products in the genomics and molecular biology field.
4. Reverse transcriptase. The technology at issue in this case relates to an enzyme known as reverse transcriptase or "RT." RT has been used as an important tool in molecular biology and recombinant DNA technology since the early 1980's. (D.I. 206 at 176-77) A principal use of RT is in the cloning of DNA molecules.
5. The RT enzyme consists of a polypeptide chain, i.e., a chain of amino acids. (D.I. 206 at 63-4, D.I. 207 at 365-66) The linear RT polypeptide corresponds to the linear DNA sequence which encodes the RT. (D.I. 206 at 67) In its natural form, however, the RT polypeptide is not linear but, instead, resembles a ball of string. (Id.)
6. RT in its native form or "wild-type" may be isolated from viruses such as the Moloney-Murine Leukemia Virus ("MMLV"). (D.I. 206 at 62) The wild-type RT has two primary activities: (1) DNA polymerase activity; and (2) RNase H activity. (D.I. 206 at 63-4)
7. DNA is a molecule comprised of two strands of nucleotide bases configured in a double helix formation. (PX 504; D.I. 206 at 63) In order to clone a DNA molecule to create a cDNA molecule, each strand of the DNA must be synthesized. (D.I. 206 at 64-5)
8. The DNA polymerase activity in RT enables the RT enzyme to utilize a mRNA molecule as a template to synthesize a complementary strand of DNA. (D.I. 206 at 64) This reaction, known as first-strand synthesis, results in a DNA/RNA hybrid molecule. (Id.)
9. In order to allow for the synthesis of the second strand of complementary DNA, the mRNA template must be removed. (D.I. 206 at 64-5, D.I. 207 at 328) The RNase H activity of the RT enzyme degrades the mRNA template in the DNA/RNA hybrid molecule which allows the DNA polymerase activity to synthesize a complementary second strand of DNA, called second-strand synthesis, resulting in a cDNA molecule. (Id.)
10. In the 1980s, scientists theorized that if one could eliminate the RNase H activity from RT, they might be able to synthesize cDNA more efficiently. (D.I. 206 at 177-78) However, before one could attempt to alter the RT's inherent activities or create mutants of the wild-type RT, it was necessary to obtain a cloned DNA sequence for the wild-type RT. (D.I. 206 at 65,178)
11. By at least 1984, research scientists successfully cloned the MMLV wild-type RT gene. (DX 12, 13, 14, 15; D.I. 206 at 179) Once the wild-type RT was successfully cloned, researchers then had to determine which amino acids in the RT gene were responsible for the RNase H activity. (D.I. 209 at 663-65) This area is known as the "active site." (Id.) By at least 1988, it was well-known in the scientific community where the specific RNase H region or active site of RT was. (DX 14; D.I. 209 at 667-68)
12. By at least 1987, scientists had created RT mutants with reduced RNase H activity. (D.I. 206 at 74, 179, D.I. 209 at 727)
13. Invitrogen's patents. On April 30, 1987, Dr. Michael Kotewicz and Dr. Gary Gerard submitted a Invention Disclosure Form ("IDF") to the management at LTI, Invitrogen's predecessor. (PX 10; D.I 206 at 72) The IDF was entitled "Reverse transcriptase lacking Ribonuclease H activity; RNase HRT." (PX 10) Drs. Kotewicz and Gerard described their invention as "an altered reverse transcriptase protein that has the polymerizing activity of the native enzyme, but is missing the RNase H activity." (PX 10, ¶ 2; D.I. 206 at 179) The inventors achieved this result by "deleting a portion of the RT gene." (Id.) This type of mutation is called a "deletion mutation." (PX 10, ¶ 9; D.I. 209 at 669)
14. Several days prior to filing a patent application on their invention, an article was published by Drs. Kotewicz, Gerard and others, disclosing the details of the invention thereby forfeiting the right to file for patent protection outside of the United States. (DX 16; D.I. 206 at 172-74) It was the usual practice at LTI to obtain both foreign and U.S. patent rights on its inventions. (D.I. 209 at 974-95)
15. On January 13, 1988, Drs. Kotewicz and Gerard filed a U.S. patent application on their RNase HRT invention. (PX 447; D.I. 206 at 92) During prosecution, the inventors distinguished their invention over the prior art disclosing enzymes with reduced RNase H activity by stating that none of the prior art exhibited, inter alia, "substantially no RNase H activity," as defined in the application. (PX 3 at 764-768; D.I. 206 at 95)
16. The application ultimately issued as U.S. Patent No. 5,244,797 ("the '797 patent") on September 14, 1993, entitled "Cloned Genes Encoding Reverse Transcriptase Lacking RNase H Activity." (PX 1; '797 patent)
17. The '797 patent is directed to "a gene which encodes reverse transcriptase having DNA polymerase activity and substantially no RNase H activity." (PX 1; '797 patent, col. 2, 11. 49-51) Claim 1 of the '797 patent claims:
A polypeptide having DNA polymerase activity and substantially no RNase H activity wherein said polypeptide may be used for the preparation of full length cDNA without significant degradation of the mRNA template during first strand synthesis wherein said polypeptide is encoded by a nucleotide sequence derived from an organism selected from the group consisting of a retrovirus, yeast, Neurospora, Drosophila, primates and rodents.
'797 patent, col. 19, 11. 17-25.
18. The '797 patent defines the term "substantially no RNase H activity" as "reverse transcriptase purified to near homogeneity and having an RNase H activity of less than 0.001 pmoles [3H](A)n solubilized per µg protein with a [3H](A)n•(dT)&n substrate in which the [3H](A)n has a specific radioactivity of 2,200 cpm/pmole." '797 patent, col. 9, 11. 14-19.
19. The RNase H activity must be measured at 20 minutes in a 50 |xl reaction volume. ('797 patent, col. 13, 11. 47-58; PX 121, 123)
20. Invitrogen also owns U.S. Patent No. 5,405,776 ("the '776 patent") entitled "Cloned Genes Encoding Reverse Transcriptase Lacking RNase H Activity." (PX 7; '776 patent) The '776 patent was a division of the '797 patent and is directed to "a gene which encodes reverse transcriptase having DNA polymerase activity and substantially no RNase H activity." ('776 patent, Abstract)
21. Invitrogen also owns U.S. Patent No. 5,668,005 ("the '005 patent") entitled "Cloned Genes Encoding Reverse Transcriptase Lacking RNase H Activity." (PX 5; '005 patent) The '005 patent was a continuation of the '776 patent and is directed to "a gene which encodes reverse transcriptase having DNA polymerase activity and substantially no RNase H activity." ('005 patent, Abstract) 22. Invitrogen also owns U.S. Patent No. 6,063,608 ("the '608 patent") entitled "Cloned Genes Encoding Reverse Transcriptase Lacking RNase H Activity." (PX 13; '608 patent) The '608 patent was a continuation of the '005 patent and is directed to "a gene which encodes reverse transcriptase having DNA polymerase acty." ('608 patent, Abstract)
23. Invitrogen produces and sells HRT products known as SuperScript ("SS") and SuperScript II (SSII"). (D.I.199) SS was introduced in 1989. (PX 460) The SS product is a truncated form of the MMLV RT enzyme created by deleting a portion of the MMLV RT enzyme responsible for RNase H activity. (D.I.199) That is, SS is a deletion mutation of the MMLV RT. (D.I. 206 at 66, 70, D.I.207 at 344)
24. SSII is a mutated form of the MMLV RT enzyme created by introducing three point mutations in the nucleotide sequence of the MMLV RT at points responsible for RNase H activity. (D.I. 206 at 70-1) That is, SSII is a...
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