Claim Construction Should Be Well-Grounded in Both Intrinsic and Extrinsic Evidence
Bo Xiao | January 15, 2024
ACTELION PHARMACEUTICALS LTD v. MYLAN PHARMACEUTICALS INC.
Decided: November 6, 2023
Before REYNA, STOLL, and STARK, Circuit Judges.
Summary
The Federal Circuit ruled that the patent claim term “a pH of 13 or higher” could not be interpreted solely based on the patent’s intrinsic evidence. The court remanded the case to the district court, instructing it to consider extrinsic evidence to determine the proper construction of this claim limitation.
Background
The case of Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc. involves a dispute over patent infringement related to epoprostenol, a drug used for treating hypertension. Actelion Pharmaceuticals, the patent holder, owns two patents of the drug: U.S. Patent Nos. 8318802 and 8598227. These patents disclose a pharmaceutical breakthrough in stabilizing epoprostenol using a high pH solution, which is otherwise unstable and difficult to handle in medical applications.
Mylan Pharmaceuticals, aiming to enter the market with a generic version of epoprostenol, filed an Abbreviated New Drug Application (ANDA). In this process, Mylan certified under Paragraph IV that the patents held by Actelion were either invalid or would not be infringed by Mylan’s manufacture, use, or sale of the generic drug. In response, Actelion asserted these patents against Mylan, claiming infringement.
The key issue in the dispute revolves around the interpretation of the phrase “a pH of 13 or higher” in the patent claims. This particular claim is crucial because the stability of epoprostenol is significantly impacted by the pH level of its solution. Actelion’s patents suggest that the epoprostenol bulk solutions should preferably have a pH adjusted to about 12.5 to 13.5 to achieve the desired stability. However, in the claims, Actelion’s patents only set the limitation as “a pH 13 or higher” as shown in claim 11 of the ’802 patent, a representative of the asserted claims:
11. A lyophilisate formed from a bulk solution comprising:
(a) epoprostenol or a salt thereof;
(b) arginine;
(c) sodium hydroxide; and
(d) water,
wherein the bulk solution has a pH of 13 or higher, and wherein said lyophilisate is capable of being reconstituted for intravenous administration with an intravenous fluid.
The dispute centered on the interpretation of the pH value specified in the patent claims. Actelion contended that the claim should encompass pH values that effectively round up to 13, including values like 12.5. Conversely, Mylan argued for a narrower interpretation, asserting that the claim should only cover pH values strictly at 13 or higher, thus excluding anything below this threshold, such as 12.5.
This interpretation was critical in determining whether Mylan’s generic version of epoprostenol would infringe upon Actelion’s patents. The district court initially adopted Actelion’s interpretation, which led to a stipulated judgment of infringement against Mylan.
Discussion
The Federal Circuit’s analysis began with a de novo review of the district court’s decision. The central question was whether the district court’s adoption of Actelion’s interpretation, which included pH values that could round up to 13 (such as 12.5), was appropriate. This broader interpretation affected the scope of the patent and the potential infringement by Mylan’s generic version of the drug. In scientific and technical contexts, the practice of rounding pH levels, such as rounding 12.5 to 13, depends on the specific requirements of the situation and the level of precision needed. pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution, and even small changes can represent significant differences in acidity or basicity.
Mylan Pharmaceuticals argued for a narrower interpretation of the term. They insisted that “a pH of 13” sets a definitive lower limit, suggesting that any pH value below 13, even those marginally lower like 12.995, would not fall within the scope of the patent. Mylan suggested that if a margin of error was considered necessary for a pH of 13, it should be minimal, encompassing a range only from 12.995 to 13.004. This interpretation was grounded in the belief that precision was implicit in the claim term, as the absence of approximation language like “about” in the claim suggested an exact value.
In contrast, Actelion Pharmaceuticals argued for a broader interpretation. They argued that the term should include values that round up to 13, thus potentially including values such as 12.5. Actelion’s argument was based on the principle that a numerical value in a patent claim includes rounding, dictated by the inventor’s selection of significant figures, unless the intrinsic record explicitly indicates a different intention. Actelion maintained that rounding was a common practice in scientific measurements and that the absence of specific approximation language did not necessarily dictate a precise value.
One of the key findings of the Federal Circuit was the inadequacy of intrinsic evidence to resolve the dispute conclusively. Intrinsic evidence, which includes the original patent claim language, specification, and prosecution history, is generally the primary resource for interpreting patent claims. However, in this case, these sources did not clearly define the precision of the pH value in question. The specification stated that, “the pH of the bulk solution is preferably adjusted to about 12.5-13.5, most preferably 13.” This language suggested that while the inventor recognized a preferred range (about 12.5-13.5), they specifically highlighted a most preferred value (13). The Federal Circuit also noted that the specification uses both “13” and “13.0” and various degrees of precision for pH values generally throughout the specification. Moreover, the prosecution history shows that the Examiner drew a distinction between the stability of a composition with a pH of 13 and that of 12. However, such distinction does not clarify the narrower issue of whether a pH of 13 could encompass values that round to 13, in particular 12.5.
The specifications and prosecution history left ambiguous whether the term referred exclusively to a pH of 13.0 or could include values that round up to 13. Recognizing this ambiguity, the Federal Circuit emphasized the need for extrinsic evidence to properly interpret the term. This approach is aligned with the Supreme Court’s guidance in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., which acknowledged the importance of considering such evidence in certain contexts of patent claim interpretation. The Federal Circuit decided to vacate the district court’s ruling and remand the case for further consideration of extrinsic evidence.
Takeaway
- Precise and specific wording in patent claims is crucial, especially in technical fields, as it defines the scope and protection of the invention.
- Although intrinsic evidence (claim language, specifications, and prosecution history) is primary in patent interpretation, it may not always be sufficient. In cases where intrinsic evidence is ambiguous or lacks clarity, extrinsic evidence such as expert testimonies, scientific literature, and other technical documents becomes crucial for a comprehensive understanding of the claim.
FUNCTIONAL CLAIMS REQUIRE MORE THAN JUST TRIAL-AND-ERROR INSTRUCTIONS FOR SATISFYING THE ENABLEMENT REQUIREMENT
Andrew Melick | January 5, 2024
Baxalta Inc. v. Genentech, Inc.
Decided: September 20, 2023
Moore, Clevenger and Chen. Opinion by Moore
Summary:
Baxalta sued Genentech alleging that Genentech’s Hemlibra product infringes US Patent No. 7,033,590 (the ‘590 patent). Genentech moved for summary judgment of invalidity of the claims for lack of enablement. The district court granted summary judgment of invalidity. Upon appeal to the CAFC, the CAFC affirmed invalidity for lack of enablement citing the recent Supreme Court case Amgen v. Sanofi.
Details:
Baxalta’s patent is to a treatment for Hemophilia A. Blood clots are formed by a series of enzymatic activations known as the coagulation cascade. In a step of the cascade, enzyme activated Factor VIII (Factor VIIIa) complexes with enzyme activated Factor IX (Factor IXa) to activate Factor X. Hemophilia A causes the activity of Factor VIII to be functionally absent which impedes the coagulation cascade and the body’s ability to form blood clots. Traditional treatment includes administering Factor VIII intravenously. But this treatment does not work for about 20-30% of patients.
The ‘590 patent provides an alternative treatment. The treatment includes antibodies that bind to Factor IX/IXa to increase the procoagulant activity of Factor IXa which allows Factor IXa to activate Factor X in the absence of Factor VIII/VIIIa. Claim 1 of the ‘590 patent is provided:
1. An isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.
The ‘590 patent describes that the inventors performed four hybridoma fusion experiments using a prior art method. And using routine techniques, the inventors screened the candidate antibodies from the four fusion experiments to determine whether the antibodies bind to Factor IX/IXa and increase procoagulant activity as claimed. Only 1.6% of the thousands of screened antibodies increased the procoagulant activity of Factor IXa. The ‘590 patent discloses the amino acid sequences of eleven antibodies that bind to Factor IX/IXa and increase the procoagulant activity of Factor IXa.
Citing Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), the CAFC stated that “the specification must enable the full scope of the invention as defined by its claims, allowing for a reasonable amount of experimentation. Citing additional cases, the CAFC stated “in other words, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.”
Baxalta argued that one of ordinary skill in the art can obtain the full scope of the claimed antibodies without undue experimentation because the patent describes the routine hybridoma-and-screening process. However, the CAFC stated that the facts of this case are indistinguishable from the Amgen case in which the patent at issue provided two methods for determining antibodies within the scope of the claims. In Amgen, the Supreme Court stated that the two disclosed methods were “little more than two research assignments,” and thus, the claims fail the enablement requirement.
The CAFC described the claims in this case as covering all antibodies that (1) bind to Factor IX/IXa; and (2) increase the procoagulant activity of Factor IXa, and that “there are millions of potential candidate antibodies.” The specification only discloses amino acid sequences for eleven antibodies within the scope of the claims. Regarding the method for obtaining the claimed antibodies, the specification describes the following steps:
(1) immunize mice with human Factor IX/IXa;
(2) form hybridomas from the antibody-secreting spleen cells of those mice;
(3) test those antibodies to determine whether they bind to Factor IX/IXa; and
(4) test those antibodies that bind to Factor IX/IXa to determine whether any increase procoagulant activity.
The CAFC stated that similar to Amgen, this process “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 Supreme Court in Amgen also stated that the methods for determining antibodies within the scope of the claims might be sufficient to enable the claims if the specification discloses “a quality common to every functional embodiment.” However, no such common quality was found in the ‘590 patent that would allow a skilled artisan to predict which antibodies will perform the claimed functions. Thus, the CAFC concluded that the disclosed instructions for obtaining claimed antibodies, without more, “is not enough to enable the broad functional genus claims at issue here.”
Baxalta further argued that its process disclosed in the ‘590 patent does not require trial-and-error because the process predictably and reliably generates new claimed antibodies every time it is performed. The CAFC stated that even if a skilled artisan will generate at least one claimed antibody each time they follow the disclosed process, “this does not take the process out of the realm of the trial-and-error approaches rejected in Amgen.” “Under Amgen, such random trial-and-error discovery, without more, constitutes unreasonable experimentation that falls outside the bounds required by § 112(a).”
Baxalta also argued that the district court’s enablement determination is inconsistent with In re Wands. The CAFC disagreed stating that the facts of this case are more analogous to the facts in Amgen, and the Amgen case did not disturb prior enablement case law including In re Wands and its factors.
Comments
When claiming a product functionally, make sure your specification includes something more than just trial-and-error instructions. The CAFC suggested in this case that the enablement requirement may be satisfied if the patent discloses a common structural or other feature delineating products that satisfy the claims from products that will not. The CAFC also suggested that a description about why the actual disclosed products perform the claimed functions or why other products do not perform the claimed function would be helpful for satisfying the enablement requirement.
Ramification of Silence in Prosecution History and Reminder on Formulating Effective Obviousness Arguments
Fumika Ogawa | November 17, 2023
ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.
Decided: September 21, 2023
Before Reyna, Stoll, and Stark. Opinion by Reyna.
Summary
The CAFC held that motivation to combine references is supported by substantial evidence including the patent prosecution history where relevancy of certain prior art, similar to an asserted reference in the IPR, was not contested by the applicant. The CAFC also rejected the patent owner’s arguments on lack of requisite findings on reasonable expectation of success, where such findings can be implied from express findings on motivation to combine as the two issues are interrelated to each other.
Details
Elekta’s U.S. Patent No. 7,295,648 (the “’648 patent”) pertains to ionizing radiation treatment. The technology is designed to deliver therapeutic radiation, such as one created by a linear accelerator or “linac,” to a target area of a patient such as brain tumors for treatment purposes. The ‘648 patent discloses that the linac, because of its great weight, requires a suitable structure to support the device while allowing a wide range of movement to focus the radiation precisely, leading to a challenge in implementing the linac-based system for treating highly sensitive, complex areas as with neurosurgery.
Representative claim 1 of the ‘648 patent recites:
A device for treating a patient with ionising radiation comprising:
a ring-shaped support, on which is provided a mount,
a radiation source attached to the mount;
the support being rotateable about an axis coincident with the centre of the ring;
the source being attached to the mount via a rotateable union having a an axis of rotation axis which is non-parallel to the support axis;
wherein the rotation axis of the mount passes through the support axis of the support and the radiation source is collimated so as to produce a beam which passes through the co-incidence of the rotation and support axes.
In the underlying inter partes review, the final written decision concluded, among other things, that claim 1 of the ’648 patent is obvious over a combination of Grady and Ruchala. In essence, Grady teaches an X-ray imaging device having a sophisticated rotatable support structure similar to that recited in the body of claim 1, whereas Ruchala teaches a linac-based radiation device for treating tumors, which may correspond to “treating a patient with ionising radiation” of claim 1.
On appeal, the CAFC addressed Elekta’s three main arguments regarding obviousness of claim 1: (1) “the Board’s findings on a motivation to combine are unsupported by substantial evidence”; (2) “the Board failed to make any findings, explicit or implicit, on a reasonable expectation of success”; and (3) “even had the Board made such findings, those findings are not supported by substantial evidence.” The CAFC reviewed the Board’s legal conclusions de novo and its factual findings for substantial evidence.
- Substantial evidence for the motivation to combine
Elekta argued that substantial evidence was lacking with the Board’s finding of a motivation to combine the references. In particular, Elekta asserted that no motivation would have existed for a skilled artisan to combine Grady and Ruchala, one disclosing “radiation imagery” and the other for “radiation therapy,” where incorporating Ruchala’s linac radiation into Grady’s imaging system would not improve its imagery function in any aspect, whilst the linac’s heavy weight would hamper precision and control, thereby “render[ing] the device essentially inoperable.”
The Board’s obviousness conclusion relies on, among other findings, its review of the prosecution of the ’648 patent, wherein “patents directed to imaging devices were cited, and were not distinguished based on an argument that imaging devices were not relevant art,” along with the pertinent field being framed in the IPR as one that “includes the engineering design of sturdy mechanical apparatus[es] capable of rotationally manipulating heavy devices in three dimensions oriented in a variety of approach angles with high geometrical accuracy, in the context of the radiation imaging and radiation therapy environment.”
The CAFC held that there was substantial evidence for the motivation to combine. Specifically, the CAFC noted that such evidence includes the prosecution history of the ’648 patent, in which Elekta “notably did not argue that prior art references directed to imaging devices were not relevant art.” The CAFC concluded that such failure to distinguish imaging radiation prior art during the patent prosecution, along with the asserted references and an expert testimony pointing to benefits of combining imagery and therapeutic radiation functions, substantially support the motivation to combine.
- Findings on the reasonable expectation of success
Elekta argued that the Board’s obviousness determination was devoid of any findings on reasonable expectation of success.
The CAFC disagreed, finding that a sufficient, implicit finding was made as to the reasonable expectation of success. The CAFC contrasted findings of reasonable expectation of success, which “can be implicit,” with those of motivation to combine, which must be “explicit.” Although an explicit finding would be usually required to support determinations made by the Board, the CAFC points to its precedent where the Board’s rejection of a patent owner’s motivation to combine argument based on teaching away constituted an implicit finding of a reasonable expectation of success, as the latter could be “reasonably discern[ed]” in the Board’s findings on “other, intertwined arguments.”
The CAFC noted that Elekta’s own arguments on the motivation to combine and the reasonable expectation of success presented before the Board were “blended”: Elekta essentially asserted that the suggested combination, lacking precision and control due to the device’s heavy weight, would fail to serve its intended purposes so as to negate motivation to combine, and consequently, would also negate reasonable expectation of success. As such, the CAFC held that by making express findings on the motivation to combine, the Board adequately made an implicit finding on Elekta’s argument on reasonable expectation of success.
- Substantial evidence for the reasonable expectation of success
Elekta argued that substantial evidence was lacking in the Board’s findings, if any, on reasonable expectation of success.
The CAFC succinctly rejected the argument. The CAFC noted that the evidence establishing a motivation to combine may—but not always—establish a finding of reasonable expectation of success. And that was the case with the present appeal, where “the arguments and evidence of reasonable expectation of success are the same for motivation to combine.”
Takeaways
This case presents an interesting situation pointing to one potential ramification of prosecution history made by silence: A failure to object to the scope of pertinent art during patent prosecution undercuts the patent owner’s argument in attacking the motivation to combine, where the asserted prior art is arguably from a disparate field. It is important to consider potential benefits and downsides of presenting or not presenting certain arguments during prosecution.
Another takeaway is the importance of formulating non-obviousness arguments on an issue-by-issue basis even if interrelated issues are involved; doing so would help keep the analysis of reasonable expectation of success from being comingled with the issues of motivation to combine.
Tags: motivation to combine > prosecution history > Reasonable Expectation of Success
IPR Amendments: Broader is Broader (even narrowly so).
Michael Caridi | September 15, 2023
Sisvel International S.A. v. Sierra Wireless, Inc, Telit Cinterion Deuschland GMBH
Decided: September 1, 2023
Before Prost, Reyna and Stark. Authored by Stark.
Summary: Sisvel appealed a PTAB IPR decision based on claim construction and denial of entry of a claim amendment for broadening the claim. The CAFC affirmed the Board on both counts, noting that broad disclosures in the specification will lead to a broad interpretation of the claims, and that claim amendments which encompass embodiments that would come within the scope of the amended claim but would not have infringed the original claim will be considered broadening.
Background:
In an IPR involving Sisvel’s patent claims 10, 11, 13, 17, and 24 of U.S. Patent No. 7,433,698 (the “’698 patent”) and claims 1, 2, 4, and 13-18 of U.S. Patent No. 8,364,196 (the “’196 patent”), the PTAB had found all claims unpatentable as anticipated and/or obvious in view of certain prior art.
The issues centered on the phraseology in the claims regarding the “connection rejection message” being used to direct a mobile communication means to attempt a new connection with certain parameter values such as a certain carrier frequency.
Claim 10, reproduced below, was the primary representative claim used by the CAFC:
10. A channel reselection method in a mobile communication means of a cellular telecommunication system, the method comprising the steps of:
receiving a connection rejection message;
observing at least one parameter of said connection rejection message; and
setting a value of at least one parameter for a new connection setup attempt based at least in part on information in at least one frequency parameter of said connection rejection message.
On appeal, Sisvel challenged the Board’s construction of the single claim term, “connection rejection message.”
Sisvel also challenged the Board’s denial of their motion to amend the claims on the basis that the amendment enlarged their scope.
Decision:
(a) Claim construction of “connection rejection message”
Sisvel appealed the Board’s construction of giving “connection rejection message” its plain and ordinary meaning of “a message that rejects a connection.” Sisvel’s purported a construction of “a message from a GSM or UMTS telecommunications network rejecting a connection request from a mobile station.” However, the PTAB found that such a construction would improperly limit the claims to embodiments using a Global System for Mobile Communication (“GSM”) or Universal Mobile Telecommunications System (“UMTS”) network.
Sisvel argued that UMTS and GSM “are the only specific networks identified by [the] ’698 and ’196 patents that actually send connection rejection messages” provided for in their specification.
The CAFC, in required fashion, reiterated the Phillips claim-construction standard – whereby “[t]he words of a claim are generally given their ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history,” citing Thorner v. Sony Comput. Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (citing Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc)) 669 F.3d at 1365.
After reviewing, the Court found that the intrinsic evidence provided no persuasive basis to limit the claims to any particular cellular networks. They noted that the specification, while only expressly disclosing embodiments in a UMTS or GSM network, in fact still included broad teachings directed to any network. The CAFC affirmed the Board, noting that a person of ordinary skill in the art would not read the broad claim language, accompanied by the broad specification statement to be limited to GSM and UMTS networks.
(b) IPR Amendment
The Court also considered Sisvel’s contention that the Board erred during the IPR by denying its motion to amend the claims of the ’698 patent. The Board had denied Sisvel’s motion, concluding that the amendments to original claim 10 would have impermissibly enlarged claim scope. Original claim 10 and substitute amended claim 36 read as follows:
The Court first noted that broadening claims are not allowable during an IPR in the same fashion as in a Reissue or Reexamination proceeding at the USPTO. They further delved into the law of what constitutes a broadening of a claim noting that a claim “is broader in scope than the original claim if it contains within its scope any conceivable apparatus or process which would not have infringed the original patent” citing Hockerson-Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 74 (Fed. Cir. 1999).
The Court further remarked that it is Sisvel’s burden, as the patent owner, to show that the proposed amendment complies with relevant regulatory and statutory requirements, citing to 37 C.F.R. § 42.121(d)(1) (“A patent owner bears the burden of persuasion to show, by a preponderance of the evidence, that the motion to amend complies with the [applicable] requirements . . . .”).
The PTAB’s denial had focused on the last (“setting a value”) limitation, comparing the original claim’s requirement that the value be set “based at least in part on information in at least one frequency parameter” of the connection rejection message, while in the substitute claims the value may be set merely by “using the frequency parameter” contained within the connection rejection message. The Board had concluded that “[i]n proposed substitute claim 36, the value that is set need not be based, in whole or in part, on information in the connection rejection message and, thus, claim 36 is broader in this respect than claim 10.” J.A. 73.
The Court agreed with the PTAB’s reasoning that, in the context of these claims, “using” is broader than “based on” and that whereas the original claim language required that the value in a new connection setup attempt be at least in some respect impacted by (i.e., “based” on) the frequency parameter, the substitute claim removes this requirement. They concluded that this removal of a claim requirement can broaden the resulting amended claim, because it is conceivable there could be embodiments that would come within the scope of substitute claim 36 but would not have infringed original claim 10, citing Pannu v. Storz Instruments, Inc., 258 F.3d 1366, 1371 (Fed. Cir. 2001) (“A reissue claim that does not include a limitation present in the original patent claims is broader in that respect.”).
Take aways:
- The Phillips standard is reiterated with the Court finding that even general disclosures within a specification (i.e. not supported by any embodiments) will provide sufficient intrinsic evidence that a skilled artisan will be considered to interpret the claim language to encompass the general disclosures.
- Drafting claim amendments in a post-grant proceeding at the USPTO must be done with extreme care. Any logically conceivable interpretation of the amendment whereby embodiments would come within the scope of substitute claim but would not have infringed the original claim will be considered broadening.
