Post-filing examples, even if made by different method than prior art, may be relied upon to show inherency, particularly if patent owner fails to show that inherent feature is absent in prior art
WHDA Blogging Team | January 21, 2020
Hospira, Inc. v. Fresenius Kabi USA, LLC
January 9, 2020
Lourie, Dyk, Moore. Opinion by Lourie.
Summary
The CAFC upheld the obviousness of claims based on an inherency theory. In particular, the CAFC saw no fault in the conclusion that the combination of prior art possessed an inherent property even though the data demonstrating the inherent property was from post-filing examples made by a different method than the combination of cited art. This is because the patent owner failed to demonstrate any situation where the inherent property was not present.
Details
Background
Hospira is the owner of U.S. Patent No. 8,648,106. Fresenius filed an Abbreviated New Drug Application (ANDA) stipulating to infringement of claim 6 of the ‘106 patent, but arguing that this claim is invalid. Claim 6 (which depends on claim 1) recites as follows:
6. [A ready to use liquid pharmaceutical composition for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof disposed within a sealed glass container, wherein the liquid pharmaceutical composition when stored in the glass container for at least five months exhibits no more than about 2% decrease in the concentration of dexmedetomidine,]
[] wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 4 μg/mL.
Dexmedetomidine is a sedative that was originally patented in the 1980’s. In 1989, safety studies were performed using a 20 µg/mL dosage in humans, but were eventually abandoned due to adverse side effects.
In 1994, FDA approval was granted to market a 100 µg/mL dose of dexmedetomidine under the name “Precedex Concentrate.” Precedex Concentrate was provided in 2 mL sealed glass vials/ampoules with coated rubber stoppers. Precedex Concentrate was sold with instructions for diluting to a concentration of 4 µg/mL prior to use.
Additionally, in 2002, a 500 µg/mL “ready to use” formulation of dexmedetomidine was granted approval for veterinary use in Europe. This product was called Dexdomitor, and was stored in 10 mL glass vials sealed with a coated rubber stopper. Dexdomitor has a 2 year shelf life.
The ‘106 patent explained that the prior art dexmedetomidine was problematic due to the requirement for dilution, and disclosed a premixed, “ready to use” formulation, which can be administered without dilution. The ‘106 patent stated that the invention was based in part on the discovery that the premixed dexmedetomidine “remains stable and active after prolonged storage.” The specification included studies of dexmedetomidine potency over time under different storage conditions, such as the material of the container. Further, the specification disclosed a manufacturing method that provided nitrogen gas into the headspace of the bottle.
District Court
The district court concluded that claim 6 was obvious in view of (a) the combination of Precedex Concentrate (100 µg/mL requiring dilution) and the knowledge of a person skilled in the art, and (b) the combination of Precedex Concentrate (100 µg/mL requiring dilution) and Dexdomitor (500 µg/mL not requiring dilution). In particular, the district court focused on the “4 µg/mL preferred embodiment”: a glass container made of glass and a rubber-coated stopper with ready to use 4 µg/mL dexmedetomidine. The main issue related to the “about 2%” limitation.
The district
court concluded that the “about 2%” limitation was inherent in the prior art’s
“4 µg/mL preferred embodiment.” To reach this conclusion, the district court
relied on evidence of 20+ tested samples, all of which met the “about 2%”
limitation. The court also relied on
expert testimony that the concentration of dexmedetomidine does not impact its
stability. Further, the court relied on the fact that neither the label of
Precedex Concentrate nor the label of Dexdomitor mentions chemical
stabilizers. Importantly, the district
court found insufficient evidence that it would have been expected that a lower
concentration of dexmedetomidine would reduce stability, or that oxidation
would occur in the absence of a nitrogen gas environment. The district court concluded that dexmedetomidine
is a “rock stable molecule” and that claim 6 is therefore invalid as obvious in
view of the prior art.
CAFC
At the CAFC, the main issue raised was whether the inherency conclusion of the district court was improper because it relied on non-prior art embodiments, rather than the alleged obvious combination of prior art. In particular, the data relied upon by the district court was entirely from Hospira’s NDA for Precedex Premix and Fresenius’s ANDA product. Both of these are after the filing date of the application. Both were made using the nitrogen gas environment method as described in the specification. As such, Hospira argued that it cannot be said that the data demonstrate the inherency of a preferred embodiment which may or may not be made using this manufacturing process.
However, the CAFC agreed with Fresenius that it was not an error to point to post-filing data in support of an inherency conclusion. Although the later evidence is not prior art, it can nonetheless be used to demonstrate the properties of the prior art. The NDA and ANDA data merely served as evidence to show whether there was the decrease in concentration over time of the 4 µg/mL preferred embodiment.
Additionally, the CAFC noted that claim 6 is not a method claim or a product-by-process claim. Since claim 6 includes no limitations relating to a nitrogen gas environment in the glass container, such limitations should not be read into the claim. Thus, the district court properly ignored the process by which the samples were prepared when considering inherency.
The CAFC then highlighted that the record included evidence that concentration does not affect the stability of dexmedetomidine, and also criticized Hospira for failing to present any examples of the 4 µg/mL preferred embodiment which did not satisfy the “about 2%” limitation. Furthermore, Hospira failed to demonstrate that the reason why the 20+ examples satisfied the “about 2%” limitation was because of the nitrogen gas in the glass container, and likewise that samples made by a different method would fail to satisfy the “about 2%” limitation.
Additionally, Hospira argued that the district court applied the wrong standard to inherency by applying a “reasonable expectation of success” standard. Although the CAFC agreed that the district court conflated two issues, they found that the district court’s “unnecessary analysis” was a harmless error and does not impact the outcome of the case. In other words, if a property is inherently present, there is no further question of whether one has a reason expectation of success in obtaining this property.
Returning to the merits, the CAFC concluded that claim 6 is obvious. Since there are no other relevant limitations recited in claim 6, the mere recitation of the inherent “about 2% limitation” cannot render the claim nonobvious. Rather, the patent was merely based on a discovery that dexmedetomidine is stable after long-term storage, but does not require any additional manufacturing limitations or the like.
Takeaway
-Applicants and patent owners should be aware that post-filing data can demonstrate inherency of prior art in some situations.
-When facing an issue of inherency, the Applicant or patent owner should focus on providing evidence to demonstrate the lack of an allegedly inherent feature in some situations, rather than criticizing the experimental design of the data alleged to show inherency.
-Applicants and patent owners should take care that non-inherency arguments are commensurate in scope with the claims. Here, the patent owner should have presented evidence relating to differences between drug potency in a nitrogen gas environment (as in the data relied upon by the court) as compared to a normal air environment (as in the combination of prior art). Although the claims do not require any particular environment, such data could have shown that even if the nitrogen gas environment (not prior art) satisfied the “about 2% limitation,” the non-nitrogen gas environment (prior art) did not necessarily satisfy the “about 2% limitation.”
-Applicants should be sure to claim all disclosed important features. In this case, positively reciting the nitrogen gas environment and the container at a minimum level of detail may have been sufficient to save the claims from obviousness.
Disavowal – Construing an element in a patent claim to require what is not recited in the claim but is described in an embodiment of the specification
WHDA Blogging Team | January 14, 2020
Techtronic Industries Co. Ltd. v. International Trade Commission
December 12, 2019
Lourie, Dyk, and Wallach, Circuit Judges. Court opinion by Lourie.
Summary
The Federal Circuit reversed the Commission’s claim construction order reversing the ALJ’s construction of the term “wall console” in each of claims in the patent in suit, holding that the ALJ properly construed the term “wall console” as “wall-mounted control unit including a passive infrared detector” because each section of the specification evinces that the patent disavowed coverage of wall consoles lacking a passive infrared detector. Consequently, the Court reversed the Commission’s determination of infringement as well because the parties agreed that the appellants do not infringe the patent under the ALJ’s claim construction.
Details
I. background
1. The Patent in Suit – U.S. Patent 7,161,319 (the “‘319 patent”)
Intervenor Chamberlain Group Inc. (“Chamberlain”) owns the ‘319 patent, which discloses improved “movable barrier operators,” such as garage door openers. Claim 1, a representative claim, reads as follows:
1. An improved garage door opener comprising
a motor drive unit for opening and closing a garage door, said motor drive unit having a microcontroller
and a wall console, said wall console having a microcontroller,
said microcontroller of said motor drive unit being connected to the microcontroller of the wall console by means of a digital data bus.
2. Prior Proceedings
In July 2016, Chamberlain filed a complaint at the Commission, alleging that Techtronic Industries Co. Ltd. and others (collectively, “Appellants”) violated Section 337(a)(1)(B) of the Tariff Act of 1930 by the “importation into the United States, the sale for importation, and the sale within the United States after importation” of Ryobi Garage Door Opener models that infringe the ‘319 patent.
The only disputed term of the ‘319 patent was “wall console.” The ALJ concluded that Chamberlain had disavowed wall consoles lacking a passive infrared detector because the ‘319 patent sets forth its invention as a passive infrared detector superior to those of the prior art by virtue of its location in the wall console, rather than in the head unit, and that the only embodiment in the ‘319 patent places the passive infrared detector in the wall console as well.
The Commission reviewed the ALJ’s order and issued a decision reversing the ALJ’s construction of “wall console” and vacating his initial determination of non-infringement. The Commission presented following reasons for the reversal: (i) while “the [‘319] specification describes the ‘principal aspect of the present invention’ as providing an improved [passive infrared detector] for a garage door operator,” the specification discloses other aspects of the invention, and a patentee is not required to recite in each claim all features described as important in the written description; (ii) the claims of U.S. Patent 6,737,968, which issued from a parent application, expressly located the passive infrared detector in the wall console, “demonstrat[ing] the patentee’s intent to claim wall control units with and without [passive infrared detectors];” and (iii) the prosecution history of the ‘319 patent lacked “the clear prosecution history disclaimer.”
Under the Commission’s construction, the ALJ found that Appellants infringed the ‘319 patent. Accordingly, the Commission entered the Remedial Orders against the Appellants.
The appeal followed.
II. The Federal Circuit
The Federal Circuit unanimously sided with the Appellants, concluding that Chamberlain disavowed coverage of wall consoles without a passive infrared detector because “the specification, in each of its sections, discloses as the invention a garage door opener improved by moving the passive infrared detector from the head unit to the wall console.”
The court opinion authored by Judge Lourie started scrutiny of the ‘319 specification with the background section. The court opinion found that the background section discloses that the prior art taught the use of passive infrared detectors in the head unit of the garage door opener to control the garage’s lighting, but that locating the detector in the head unit was expensive, complicated, and unreliable (emphases added). The court opinion moved on to state, [t]he ‘319 patent therefore sets out to solve the need for “a passive infrared detector for controlling illumination from a garage door operator which could be quickly and easily retrofitted to existing garage door operators with a minimum of trouble and without voiding the warranty.”
The court opinion further stated, “[t]he remaining sections of the patent—even the abstract—disclose a straightforward solution: moving the detector to the wall console” (emphasis added).
The court opinion dismissed the Commission’s argument that “[n]owhere does the ‘319 patent state that it is impossible or even infeasible to locate a passive infrared detector at some other location” by pointing out, “the entire specification focuses on enabling placement of the passive infra-red detector in the wall console, which is both responsive to the prior art deficiency the ’319 patent identifies and repeatedly set forth as the objective of the invention.”
As for the “other aspects of the invention” partially relied on by the Commission, the court opinion stated, “[t]he suggestion that the patent recites another invention—related to programming the microcontroller—in no way undermines the conclusion that the infrared detector must be on the wall unit .” More specifically, in response to Chamberlain’s and the Commission’s argument that portions of the description, particularly col. 4 l. 60–col. 7 l. 26, concern an exemplary method of programming the microcontroller to interact with the head unit by means of certain digital signaling techniques, matters not strictly related to the detector, the court opinion stated, “the entire purpose of this part of the description is to enable placement of the detector in the wall console, and it never discusses programming the microcontroller or applying digital signaling techniques for any purpose other than transmitting lighting commands from the wall console.”
Finally, the court opinion rejected the contention of Chamberlain and the Commission that the ‘319 patent’s prosecution history is inconsistent with disavowal, by stating, “there is [n]o requirement that the prosecution history reiterate the specification’s disavowal.”
In view of the above, the Court concluded that the ‘319 patent disavows wall consoles lacking a passive infrared detector. Accordingly, the Court reversed the Commission’s claim construction order and the determination of infringement.
Takeaway
· Disavowal, whether explicit or implicit, may cause a claim term to be construed narrower than an ordinary meaning of the term.
· Disavowal may be found with reference to an entire portion of the specification including an abstract and background section.
The United States Patent and Trademark Office cannot recover salaries of its lawyers and paralegals in civil actions brought under 35 U.S.C. §145
WHDA Blogging Team | December 26, 2019
Peter v. Nantkwest, Inc.
December 11, 2019
Opinion by Justice Sotomayor (unanimous decision)
Summary
The “American Rule” is the principle that parties are responsible for their own attorney’s fees. While the Patent Act requires applicants who choose to pursue civil action under 35 U.S.C. §145 to pay the expenses of the proceedings, the Supreme Court found that the American Rule’s presumption applies to §145, and the “expenses” does not include salaries of its lawyers and paralegals.
Details
There are two possible ways in which a dissatisfied applicant may appeal the final decision of the Patent Trial and Appeal Board. One option is to appeal to the United States Court of Appeals for the Federal Circuit under 35 U.S.C. §141. In choosing this avenue, the applicant will not be able to offer new evidence that was not presented before the USPTO. The other option is to seek remedy in filing a civil action against the Director of the USPTO in federal district court under 35 U.S.C. §145. Unlike under 35 U.S.C. §141, the applicant may introduce new evidence, and the district court would make de novo determinations based on the new evidence and the administrative record before the USPTO. Because 35 U.S.C. §145 allows for an applicant to introduce new evidence, the litigation can be lengthy and expensive. For this reason, the Patent Act requires applicants who choose to file a civil action under 35 U.S.C. §145 to pay “[a]l the expenses of the proceedings.” 35 U.S.C. §145.
In this case, the USPTO denied NantKwest, Inc’s patent application, which was directed to a method for treating cancer. NantKwest Inc. then filed a complaint against the Director of the USPTO in the Eastern District of Virginia under 35 U.S.C. §145. The District Court granted summary judgment to the USPTO, which the Federal Circuit affirmed. The USPTO moved for reimbursement of expenses, including the pro rata salaries of the USPTO attorneys and paralegals who worked on the case. The Supreme Court noted in its opinion that this was “the first time in the 170-year history of §145” that the reimbursement of such salaries were requested as a part of expenses. The District Court denied the USPTO’s motion. NantKwest, Inc. v. Lee, 162 F. Supp. 3d 540 (E.D. Va. 2016). Then a divided Federal Circuit panel reversed. NantKwest, Inc. v. Matal, 860 F. 3d 1352 (2017). The en banc Federal Circuit voted sua sponte to rehear the case, and reversed the panel over a dissent, holding that the “American Rule” (the principle that parties are responsible for their own attorney’s fees) applied to §145, after examining the plain text, statutory history, the judicial and congressional understanding of similar language, and policy considerations. NantKwest, Inc. v. Iancu, 898 F. 3d 1177 (2018). The Supreme Court granted certiorari.
The Supreme Court first notes as the “basic point of reference” the principle of the “American Rule” which is that “[e]ach litigant pays his own attorney’s fees, win or lose, unless a statute or contract provides otherwise.” While the USPTO did not dispute this principle, it argued that the presumption applies only to prevailing-party statutes, and as §145 requires one party to pay all expenses, regardless of outcome, it is therefore not subject to the presumption. However, the Supreme Court stated that Sebelius v. Cloer, 569 U.S. 369 (2013) confirm that the presumption against fee shifting applies to all statutes, including statute like §145 that do not explicitly award attorney’s fees to “prevailing parties.”
The Supreme Court then analyzed whether Congress intended to depart from the American Rule presumption. The Supreme Court first looked at the plain text, reading the term alongside neighboring words in the statute, and concluded that the plain text does not overcome the American Rule’s presumption against fee shifting. The Supreme Court also looked at statutory usage, and found that “expenses” and “attorney’s fees” appear in tandem across various statutes shifting litigation costs, indicating “that Congress understands the two terms to be distinct and not inclusive of each other.” While some other statutes refer to attorney’s fees as a subset of expenses, the Supreme Court stated that they show only that attorney’s fees can be included in “expenses” when defined as such.
Based on the foregoing, the Supreme Court concluded that the USPTO cannot recover salaries of its lawyers and paralegals in civil actions brought under 35 U.S.C. §145.
Takeaway
The USPTO has recovered attorney costs under a similar trademark law, 15 U.S.C. 1071, in the 2015 Fourth Circuit decision of Shammas v. Focarino, 114 USPQ2d 1489 (4th Cir. 2015). While the Supreme Court does not mention the applicability of the interpretation of “expenses” under 35 U.S.C. §145 to the interpretation of “expenses” in 15 U.S.C. 1071(b)(3), we would expect the Supreme Court to interpret “expenses” the same way in both of these statutes.
Heightened “original patent” written description standard applies for reissue patents
WHDA Blogging Team | December 20, 2019
Forum US Inc., v. Flow Valve, LLC.
June 17, 2019
Before Reyna, Schall, and Hughes. Opinion by Reyna.
Summary
The CAFC affirmed a district court decision holding that Flow Valve’s Reissue Patent No. RE 45,878 (“the Reissue patent”) is invalid because of insufficiently supported broadening claims. The original patent “must clearly and unequivocally disclose the newly claimed invention as a separate invention,” otherwise the claims in the reissue patent do not comply with the original patent requirement of 35 USC 251.
Details
Flow Valve’s original Patent No. 8,215,213 (“the original patent), entitled “Workpiece Supporting Assembly” relates to machined pipe fittings typically used in the oil and gas industry. The written description and drawings disclose only embodiments with arbors.
Figs. 4 and 5 from the original patent with arbors circled in red:
Claim 1 of the original patent also expressly claimed the arbors (emphasis added):
A workpiece machining implement comprising:
a body member having an internal workpiece channel, the body member having a plurality of body openings communicating with the internal workpiece channel;
means supported by the body member for positioning a workpiece in the internal work piece in the internal workpiece channel so that extending workpiece portions of the workpiece extend from selected ones of the body openings;
a plurality of arbors supported by the body member, each arbor having an axis coincident with a datum axis of one of the extending workpiece portions; and
means for rotating the workpiece supporting assembly about the axis of a selected one of the arbors.
When Flow Valve filed the reissue patent application, the patentees broadened the claims by adding seven new claims, where the arbor limitations were replaced by a “pivotable” limitation. Claim 14 is representative of the reissue patent:
Claim 14 of the reissue patent:
A workpiece supporting assembly for securing an elbow during a machining process that is performed on the elbow by operation of a workpiece machining implement, the workpiece supporting assembly comprising:
a body having an internal surface defining a channel, the internal surface sized to receive a medial portion of the elbow when the elbow is operably disposed in the channel; and
a support that is selectively positionable to secure the elbow in the workpiece supporting assembly, the body pivotable to a first pivoted position, the body sized so that a first end of the elbow extends from the channel and beyond the body so the first end of the elbow is presentable to the workpiece machining implement for performing the machining process, the body pivotable to a second position and sized so that a second end of the elbow extends from the channel beyond the body so the second end of the elbow is presentable to the workpiece machining implement for performing the machining process.
Forum US, Inc. sued Flow Valve for a declaratory judgment of invalidity of the reissue patent, arguing that the added reissue claims were invalid because they did not comply with the original patent requirement under 35 USC 251.
In particular, Forum argued that the claims broadened the original patent claims by omitting the arbor limitations, which is a violation of the original patent requirement of Reissue patent because the original patent did not disclose an invention without arbors.
In response, Flows Valve supplied an expert declaration asserting that a person of ordinary skill in the art would have understood from the specification that not every embodiment requires “a plurality of arbors” and that the arbors are an optional feature.
The district court granted Forum’s summary judgement, holding that “no matter what a person of ordinary skill would recognize, the specification of the original patent must clearly and unequivocally disclose the newly claimed invention in order to satisfy the original patent rule.”
Flows Valve appealed but the CAFC affirmed the district court’s decision.
In affirming the district court’s decision, the CAFC relied on two cases U.S. Indus. Chems., Inc. v. Carbide & Carbon Chems. Corp., 315 U.S. 668 (1942), and Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354 (Fed. Cir 2014), to the effect that, for broadening reissue claims, “it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification”, instead, the original patent “must clearly and unequivocally disclose the newly claimed invention as a separate invention.”
Like the District Court, the Appeals Court discounted the expert declaration, commenting that “when a person of ordinary skill in the art would understand ‘does not aid the court in understanding what the’ patent actually say.”
Take away
- Heightened “original patent” written description standard applies for reissue patents.
- Expert testimony on the understanding of a person of skill in the art as evidence is insufficient.
- If it is likely in the foreseeable future to have the needs to broaden the claims, use a continuation application so that applicant does not have to meet the additional “clear and unequivocal disclosure as separate invention” requirement of a broadening reissue.
