Summary
This post examines the application of the non-obviousness standard to biotechnology inventions under US patent law. Through analysis of seminal Federal Circuit cases such as Hybritech v. Monoclonal, Amgen v. Chugai, In re Deuel, and In re Kubin, it highlights how courts have interpreted non-obviousness differently for biotech inventions compared to other fields. The discussion reveals that earlier, the reasonable expectation of success was considered lower in biotechnology, making the non-obviousness threshold less strict. However, divergent decisions in cases with similar facts indicate inconsistency in applying the standard. The post provides an objective, analytical review of how non-obviousness has evolved within the context of US biotechnology patents.
First Publication Date: 26th December 2010.
The Non-obviousness standards required for biotechnology inventions have been interpreted by courts to be different from the generally accepted principles. In Hybritech v. Monoclonal , a case involving a patent over “Immunometric Assays Using Monoclonal Antibodies”, the court held the patent non-obvious despite the existence of twenty prior art references because the prior art as a whole did not make the invention obvious at the time the invention was made. Though some references seemed to anticipate the invention, the Court pointed out that they were made after the date of conception of the invention, thus taking them out of the scope of prior art. The court in this case reiterated the importance of secondary indicia by determining the sandwich assays using monoclonal antibodies to be nonobviousn because of the commercial success, unexpected advantages and praise from experts of the diagnostic kits made by Hybritech.
In Amgen v. Chugai , a patent for DNA sequences encoding erythropoetin (Epo) was claimed to be invalid based on obviousness along with other claims. The Federal Circuit held the patent nonobvious by reasoning that it might have been feasible, perhaps obvious to try, to successfully probe a human gDNA library with a monkey cDNA probe but it does not indicate that the gene could have been identified and isolated with a reasonable likelihood of success. Neither the DNA nucleotide sequence of the human Epo gene nor its exact degree of homology with the monkey Epo gene was known at the time the claimed invention was made. According to the court, though the idea of using the monkey gene to probe for a homologous human gene might have been obvious to try, but the realization of that idea was not obvious. Finally, the court stated that hindsight is not a justifiable basis on which to find that ultimate achievement of a long sought and difficult scientific goal was obvious.In ‘In re Deuel ‘, a case involving an invention relating to isolated and purified DNA and cDNA molecules encoding heparin-binding growth factors, the Federal Circuit held the invention non obvious despite Bohlen and Maniatis references disclosing a group of protein growth factors and a general gene cloning method. The issue raised in this case was whether the combination of a prior art reference teaching a method of gene cloning, together with a reference disclosing a partial amino acid sequence of a protein, would render DNA and cDNA molecules encoding the protein prima facie obvious. The court held that the subject matter of the invention could not be conceived based on the teachings in the references because, until the claimed molecules were actually isolated and purified, it would have been highly unlikely for one of ordinary skill in the art to contemplate the claimed invention. The court further stated that ‘What cannot be conceived cannot be obvious.’In In re Kubin’s case, the invention dealt with an amino acid sequence of Natural Killer Cell Activation Inducing Ligand also referred to as NAIL which plays a major role in activation of the Natural Killer cells that are instrumental in fighting tumors and viruses. The patent office stated that the claimed amino acid sequence was obvious in light of combination of two prior art references namely Valiante’s patent bearing the U.S. Patent No. 5,688,690 which discloses a receptor protein called p38 receptor which the board found was essentially the same protein as NAIL and the Laboratory Manual on Cloning authored by Joseph Sambrook which provided information with regard to conventional techniques to isolate and sequence any gene. The federal circuit affirmed the Board’s decision stating that in light of the specific teachings of Sambrook and Valiante, artisans in this field had every motivation to seek and every reasonable expectation of success in achieving the sequence of the claimed invention. As per the Court, the claimed invention was reasonably expected in light of the prior art and was held to be obvious. Due to lack of maturity in the field, the non-obviousness requirement in USA was lower for biotechnology inventions when compared to other inventions. The reasonable expectation of success was considered to be lower and anything obvious to try was generally considered non-obviousns. However, the differing decisions in Deuel and Kubin cases, which have similar facts indicates that the non-obviousness standards are not applied on a case by case basis.
In Amgen v. Chugai , a patent for DNA sequences encoding erythropoetin (Epo) was claimed to be invalid based on obviousness along with other claims. The Federal Circuit held the patent nonobvious by reasoning that it might have been feasible, perhaps obvious to try, to successfully probe a human gDNA library with a monkey cDNA probe but it does not indicate that the gene could have been identified and isolated with a reasonable likelihood of success. Neither the DNA nucleotide sequence of the human Epo gene nor its exact degree of homology with the monkey Epo gene was known at the time the claimed invention was made. According to the court, though the idea of using the monkey gene to probe for a homologous human gene might have been obvious to try, but the realization of that idea was not obvious. Finally, the court stated that hindsight is not a justifiable basis on which to find that ultimate achievement of a long sought and difficult scientific goal was obvious.In ‘In re Deuel ‘, a case involving an invention relating to isolated and purified DNA and cDNA molecules encoding heparin-binding growth factors, the Federal Circuit held the invention non obvious despite Bohlen and Maniatis references disclosing a group of protein growth factors and a general gene cloning method. The issue raised in this case was whether the combination of a prior art reference teaching a method of gene cloning, together with a reference disclosing a partial amino acid sequence of a protein, would render DNA and cDNA molecules encoding the protein prima facie obvious. The court held that the subject matter of the invention could not be conceived based on the teachings in the references because, until the claimed molecules were actually isolated and purified, it would have been highly unlikely for one of ordinary skill in the art to contemplate the claimed invention. The court further stated that ‘What cannot be conceived cannot be obvious.’In In re Kubin’s case, the invention dealt with an amino acid sequence of Natural Killer Cell Activation Inducing Ligand also referred to as NAIL which plays a major role in activation of the Natural Killer cells that are instrumental in fighting tumors and viruses. The patent office stated that the claimed amino acid sequence was obvious in light of combination of two prior art references namely Valiante’s patent bearing the U.S. Patent No. 5,688,690 which discloses a receptor protein called p38 receptor which the board found was essentially the same protein as NAIL and the Laboratory Manual on Cloning authored by Joseph Sambrook which provided information with regard to conventional techniques to isolate and sequence any gene. The federal circuit affirmed the Board’s decision stating that in light of the specific teachings of Sambrook and Valiante, artisans in this field had every motivation to seek and every reasonable expectation of success in achieving the sequence of the claimed invention. As per the Court, the claimed invention was reasonably expected in light of the prior art and was held to be obvious. Due to lack of maturity in the field, the non-obviousness requirement in USA was lower for biotechnology inventions when compared to other inventions. The reasonable expectation of success was considered to be lower and anything obvious to try was generally considered non-obviousns. However, the differing decisions in Deuel and Kubin cases, which have similar facts indicates that the non-obviousness standards are not applied on a case by case basis.
References
Hybritech, Inc.,v..Monoclonal Antibodies, 802 F.2d 1367 (Fed. Cir. 1986).Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200 (Fed Cir. 1991)IN RE THOMAS F. DEUEL, YUE-SHENG LI, NED R. SIEGEL and PETER G. MILNER, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed Cir. 1995).In re Kubin, 561 F.3d 1351 (2009).
Hybritech, Inc.,v..Monoclonal Antibodies, 802 F.2d 1367 (Fed. Cir. 1986).Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200 (Fed Cir. 1991)IN RE THOMAS F. DEUEL, YUE-SHENG LI, NED R. SIEGEL and PETER G. MILNER, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed Cir. 1995).In re Kubin, 561 F.3d 1351 (2009).
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