Baxalta Inc., et al. v. Genentech, Inc., No. 2022-1461 (Fed. Cir. (D. Del.) Sept. 20, 2023). Opinion by Moore, joined by Clevenger and Chen.
Baxalta sued Genentech in district court, alleging that Genentech’s Hemlibra® (emicizumab) product infringes Baxalta’s patent directed to treating patients with Hemophilia A. Historically, Hemophilia A has been treated by administering an enzyme known as Factor VIII. Baxalta’s patent focused on treating Hemophilia A in patients who develop Factor VIII inhibitors. To that end, the patent’s representative claim recites “an isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.”
Genentech moved for summary judgment of invalidity for lack of enablement. The district court granted the motion, and Baxalta appealed.
Reviewing the grant of summary judgment de novo, the Federal Circuit observed that, “as the Supreme Court recently reaffirmed in Amgen Inc. v. Sanofi, ‘the specification must enable the full scope of the invention as defined by its claims,’ allowing for ‘a reasonable amount of experimentation.’” The Federal Circuit summarized that, in Amgen, the claims were not sufficiently enabled because “the full scope of the claims covered potentially millions of antibodies, but the specification only disclosed the amino acid sequences of twenty-six antibodies that performed the two claimed functions.” Also, the “roadmap” and substitution techniques disclosed in the patent specification in Amgen did not provide a fully enabling disclosure, but instead amounted to “little more than two research assignments.”
The Federal Circuit ruled that “the facts of this case are materially indistinguishable from those in Amgen.” In this case, the court explained, “there are millions of potential candidate antibodies, … but the written description discloses the amino acid sequences for only eleven antibodies with the two claimed functions.” And “just like the roadmap rejected by the Supreme Court in Amgen, the [Baxalta] patent’s roadmap simply directs skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the eleven antibodies they elected to disclose.”
The Federal Circuit ruled that “Amgen makes clear that such an instruction, without more, is not enough to enable the broad functional genus claims at issue here.” “Under Amgen, such random trial-and-error discovery, without more, constitutes unreasonable experimentation that falls outside the bounds required by § 112(a).” Thus, the Federal Circuit affirmed the district court’s judgment that the challenged claims of the Baxalta patent are not enabled.
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Elekta Ltd. v. ZAP Surgical Systems, Inc., No. 2021-1985 (Fed. Cir. (PTAB) Sept. 21, 2023). Opinion by Reyna, joined by Stoll and Stark.
Elekta owns a patent directed to a device for treating a patient with ionizing radiation for certain types of radiosurgery and radiation therapy. ZAP filed an IPR petition asserting obviousness based on various combinations of references, including a combination of “Grady” and “Ruchala.” The Patent Trial and Appeal Board agreed with ZAP, finding that the claims would have been obvious.
During the IPR, Elekta argued that a skilled artisan would not have been motivated to combine and would not have had a reasonable expectation of success in combining the X-ray imaging source in Grady with the linac therapeutic source in Ruchala. The Board disagreed because linacs were known in the art and could be accommodated in an imaging system. As part of its analysis, the Board found that during the prosecution of Elekta’s patent, prior art “directed to imaging devices were cited, and were not distinguished based on an argument that imaging devices were not relevant art.” Elekta appealed.
On appeal, Elekta raised three main arguments: (1) that substantial evidence does not support the Board’s finding of a motivation to combine, (2) that the Board made no findings on a reasonable expectation of success, and (3) that even if the Board had made such findings, they are not supported by substantial evidence.
Addressing each argument in turn, the Federal Circuit first held that substantial evidence supports the Board’s finding of a motivation to combine. The evidence included the prosecution history, the teachings of the asserted references, and the expert testimony of record. As for the prosecution history, the Federal Circuit agreed with the Board that “the patentee notably did not argue that the prior art references directed to imaging devices were not relevant art.” Next, Ruchala itself identified advantages of combining imaging with the delivery of radiation. Still further, Zap’s expert provided reasons why skilled artisans would have been motivated to make the combination. The Federal Circuit ruled that, “taken together, this evidence provides substantial support for the Board’s finding” of a motivation to combine.
Second, the Federal Circuit disagreed with Elekta’s view that the Board articulated no findings on reasonable expectation of success. The court held that, “unlike a motivation to combine determination, which requires explicit analysis, … a finding of reasonable expectation of success can be implicit ….” The Federal Circuit noted the possible tension between this concept and the APA requirement that the Board must “explain its decisions with sufficient precision, including the underlying factfindings and its rationale.” But the court explained that “there is no such tension where the Board makes an implicit finding on reasonable expectation of success by considering and addressing other, intertwined arguments, including, as we hold today, a motivation to combine.” Here, the Federal Circuit could “reasonably discern” the Board’s view, and the court determined that “the Board made no error in addressing the issues of motivation to combine and reasonable expectation of success in the same blended manner that Elekta chose to present those very issues.”
Finally, as to the merits of a reasonable expectation of success, the Federal Circuit ruled that substantial evidence supports the Board’s implicit finding. The court concluded that “in some cases, as here, the evidence establishing a motivation to combine may establish a finding of reasonable expectation of success.” The Federal Circuit thus affirmed the Board’s final written decision finding the challenged claims unpatentable as obvious.
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Baxalta sued Genentech in district court, alleging that Genentech’s Hemlibra® (emicizumab) product infringes Baxalta’s patent directed to treating patients with Hemophilia A. Historically, Hemophilia A has been treated by administering an enzyme known as Factor VIII. Baxalta’s patent focused on treating Hemophilia A in patients who develop Factor VIII inhibitors. To that end, the patent’s representative claim recites “an isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.”
Genentech moved for summary judgment of invalidity for lack of enablement. The district court granted the motion, and Baxalta appealed.
Reviewing the grant of summary judgment de novo, the Federal Circuit observed that, “as the Supreme Court recently reaffirmed in Amgen Inc. v. Sanofi, ‘the specification must enable the full scope of the invention as defined by its claims,’ allowing for ‘a reasonable amount of experimentation.’” The Federal Circuit summarized that, in Amgen, the claims were not sufficiently enabled because “the full scope of the claims covered potentially millions of antibodies, but the specification only disclosed the amino acid sequences of twenty-six antibodies that performed the two claimed functions.” Also, the “roadmap” and substitution techniques disclosed in the patent specification in Amgen did not provide a fully enabling disclosure, but instead amounted to “little more than two research assignments.”
The Federal Circuit ruled that “the facts of this case are materially indistinguishable from those in Amgen.” In this case, the court explained, “there are millions of potential candidate antibodies, … but the written description discloses the amino acid sequences for only eleven antibodies with the two claimed functions.” And “just like the roadmap rejected by the Supreme Court in Amgen, the [Baxalta] patent’s roadmap simply directs skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the eleven antibodies they elected to disclose.”
The Federal Circuit ruled that “Amgen makes clear that such an instruction, without more, is not enough to enable the broad functional genus claims at issue here.” “Under Amgen, such random trial-and-error discovery, without more, constitutes unreasonable experimentation that falls outside the bounds required by § 112(a).” Thus, the Federal Circuit affirmed the district court’s judgment that the challenged claims of the Baxalta patent are not enabled.
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Elekta Ltd. v. ZAP Surgical Systems, Inc., No. 2021-1985 (Fed. Cir. (PTAB) Sept. 21, 2023). Opinion by Reyna, joined by Stoll and Stark.
Elekta owns a patent directed to a device for treating a patient with ionizing radiation for certain types of radiosurgery and radiation therapy. ZAP filed an IPR petition asserting obviousness based on various combinations of references, including a combination of “Grady” and “Ruchala.” The Patent Trial and Appeal Board agreed with ZAP, finding that the claims would have been obvious.
During the IPR, Elekta argued that a skilled artisan would not have been motivated to combine and would not have had a reasonable expectation of success in combining the X-ray imaging source in Grady with the linac therapeutic source in Ruchala. The Board disagreed because linacs were known in the art and could be accommodated in an imaging system. As part of its analysis, the Board found that during the prosecution of Elekta’s patent, prior art “directed to imaging devices were cited, and were not distinguished based on an argument that imaging devices were not relevant art.” Elekta appealed.
On appeal, Elekta raised three main arguments: (1) that substantial evidence does not support the Board’s finding of a motivation to combine, (2) that the Board made no findings on a reasonable expectation of success, and (3) that even if the Board had made such findings, they are not supported by substantial evidence.
Addressing each argument in turn, the Federal Circuit first held that substantial evidence supports the Board’s finding of a motivation to combine. The evidence included the prosecution history, the teachings of the asserted references, and the expert testimony of record. As for the prosecution history, the Federal Circuit agreed with the Board that “the patentee notably did not argue that the prior art references directed to imaging devices were not relevant art.” Next, Ruchala itself identified advantages of combining imaging with the delivery of radiation. Still further, Zap’s expert provided reasons why skilled artisans would have been motivated to make the combination. The Federal Circuit ruled that, “taken together, this evidence provides substantial support for the Board’s finding” of a motivation to combine.
Second, the Federal Circuit disagreed with Elekta’s view that the Board articulated no findings on reasonable expectation of success. The court held that, “unlike a motivation to combine determination, which requires explicit analysis, … a finding of reasonable expectation of success can be implicit ….” The Federal Circuit noted the possible tension between this concept and the APA requirement that the Board must “explain its decisions with sufficient precision, including the underlying factfindings and its rationale.” But the court explained that “there is no such tension where the Board makes an implicit finding on reasonable expectation of success by considering and addressing other, intertwined arguments, including, as we hold today, a motivation to combine.” Here, the Federal Circuit could “reasonably discern” the Board’s view, and the court determined that “the Board made no error in addressing the issues of motivation to combine and reasonable expectation of success in the same blended manner that Elekta chose to present those very issues.”
Finally, as to the merits of a reasonable expectation of success, the Federal Circuit ruled that substantial evidence supports the Board’s implicit finding. The court concluded that “in some cases, as here, the evidence establishing a motivation to combine may establish a finding of reasonable expectation of success.” The Federal Circuit thus affirmed the Board’s final written decision finding the challenged claims unpatentable as obvious.
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