One correct way of reciting a Markush group in the claim
WHDA Blogging Team | January 24, 2020
Amgen Inc. v. Amneal Pharmaceuticals LLC
January 7, 2020
Lourie (Opinion author), Newman, and Taranto
Summary
The Federal Circuit reversed the district court’s claim construction of the Markush groups as being closed to unrecited elements because the claim recites “comprising” as the transitional phrase and “at least one” in front of each of the Markush groups. Furthermore, the Federal Circuit affirmed the district court’s holding of noninfringement under the doctrine of equivalents by one of the Defendants’ products due to prosecution history estoppel.
Details
Amneal, Piramal, and Zydus each filed an Abbreviated New Drug Application (ANDA), seeking approval of a generic version of Sensipar®, a formulation of cinacalcet hydrochloride used to treat secondary hyperparathyroidism in adult patients with chronic kidney disease who are on dialysis and to treat hypercalcemia in patients with parathyroid cancer and primary and secondary hyperparathyroidism. Amgen holds the approved New Drug Application for Sensipar®, and sued them for infringing U.S. Patent No. 9,375,405 (the ‘405 patent).
The ‘405 patent is directed to a rapid dissolution formulation of cinacalcet. Claim 1 of the ‘405 patent is as follows:
A pharmaceutical composition comprising:
(a) from about 10% to about 40% by weight of cinacalcet HCl in an amount of from about 20 mg to about 100 mg;
(b) from about 45% to about 85% by weight of a diluent selected from the group consisting of microcrystalline cellulose, starch, dicalcium phosphate, lactose, sorbitol, mannitol, sucrose, methyl dextrins, and mixtures thereof,
(c) from about 1% to about 5% by weight of at least one binder selected from the group consisting of povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, and mixtures thereof; and
(d) from about 1% to 10% by weight of at least one disintegrant selected from the group consisting of crospovid[o]ne, sodium starch glycolate, croscarmellose sodium, and mixtures thereof,
wherein the percentage by weight is relative to the total weight of the composition, and wherein the composition is for the treatment of at least one of hyperparathyroidism, hyperphosphonia, hypercalcemia, and elevated calcium phosphorus product.
The ‘405 patent issued from U.S. Patent Application 12/942,646 (the ‘646 application). The original ‘646 application contained only one claim, which recited a “pharmaceutical composition comprising an effective dosage amount of a calcium receptor-active compound and at least one pharmaceutically acceptable excipient, wherein” the composition achieved a specific dissolution profile. Later, Amgen filed a Preliminary Amendment, which cancelled claim 1 and added new claims 2-24. The newly filed claim 2, which ultimately issued as claim 1, is as follows:
A pharmaceutical composition comprising:
(a) from about 10% to about 40% by weight of cinacalcet HCl;
(b) from about 45% to about 85% by weight of a diluent selected from the group consisting of microcrystalline cellulose, starch, dicalcium phosphate, lactose, sorbitol, mannitol, sucrose, methyl dextrins, and mixtures thereof,
(c) from about 1% to about 5% by weight of at least one binder; and
(d) from about 1% to 10% by weight of at least one disintegrant,
wherein the percentage by weight is relative to the total weight of the composition.
The Examiner rejected the new claims. Then, Amgen filed an amendment of the independent claim 2, reciting “from about 10% to about 40% by weight of cinacalcet HCl in an amount of from about 20 mg to about 100mg.” Then, Amgen conducted a phone interview with the Examiner. During the interview, the Examiner proposed an Examiner’s Amendment of the independent claim 2, and Amgen accepted the Examiner’s Amendment. Specifically, the Examiner’s Amendment revised the binder and the disintegrant limitations into their current, Markush group format. Then, the claims are allowed. After the Notice of Allowance was issued, Amgen filed a number of RCE Requests with new IDS submission. In one of the RCE Requests, with regard to the previous Examiner’s Amendments, Amgen remarked that “[t]hese amendments have not been made in response to a prior art rejection but rather to place the claims in proper format and to better define the claimed subject matter, including equivalents.” The Examiner issued a Notice of Allowance after each RCE Request.
In the district court proceeding, one key issue is the construction of the binder and disintegrant Markush groups. The district court held that the Markush groups for the binder and disintegrant elements are closed to unrecited binders and disintegrants, relying on Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350 (Fed. Cir. 2016). Furthermore, the district court held that Amneal does not infringe the ‘405 patent because Amneal uses Opadry Clear YS-1-7006 as the binder, a product that contains PEG 400 and PEG 8000 in addition to hydroxypropyl methylcellulose, which is a listed binder in claim 2. Furthermore, the district court held that Piramal does not infringe the ‘405 patent under the doctrine of equivalents because prosecution history estoppel barred Amgen’s argument that the cold-water soluble fraction of the preglatinized starch used by Piramal is equivalent to providone, a listed binder in claim 2.
On appeal, first, the Federal Circuit reversed the district court’s claim construction regarding the binder and disintegrant Markush groups. Specifically, contrary to the district court’s interpretation, because claim 1 uses “comprising” as the transitional phrase and “at least one” in front of each Markush group, the binder and disintegrant Markush groups do not preclude other binders and disintegrants in the claimed composition. Without more, such language is satisfied when an accused product contains a component that is from the Markush group and that meets the limitation’s other requirements such as concentration requirement for the component. Furthermore, the Federal Circuit held that Opadry used as a binder by Amneal contains HPMC, which is a listed binder in claim 1. Thus, irrespective of whether other components such as PEG are present, provided that Amneal’s formulation contains from about 1 to about 5% HPMC, the formulation literally infringes. Accordingly, the Federal Circuit vacates and remands those findings by the district court.
Next, the Federal Circuit held that Amgen’s doctrine of equivalents argument is barred by prosecution history estoppel. During the prosecution, Amgen accepted the Examiner’s Amendment that revised the claim’s disintegrant and binder limitations to be in Markush group format. Such an amendment narrows the scope of the claim, and Amgen failed to carry its burden to demonstrate that the Examiner’s Amendment was made for a reason unrelated to patentability. The Amgen’s statement in the later RCE Request was made over eight months after the Examiner’s Amendment was accepted, and accordingly does not provide any insight on the reasons for the Examiner’s Amendment. Furthermore, the tangential exception to prosecution history estoppel does not apply here because the use of pregelatinized starch as a binder is taught in the cited prior art. An amendment made to avoid prior art that contains the equivalent in question is not tangential.
Accordingly, the Federal Circuit vacated and remanded the district court’s judgment that Amneal does not infringe the ‘405 patent, and affirmed the district court’s judgment that Piramal does not infringe the ‘405 patent.
Take away
- The claims should recite “comprising” as the transitional phrase and “at least one” in front of the Markush groups to avoid being constructed to be closed to unrecited elements in the Markush groups.
- The original specification should contain a complete set of claims instead of one claim because later amendments may inevitably invoke prosecution history estoppel, which would bar most of the doctrine of equivalents arguments.
- The patent drafter should be mindful of an independent claim with an overly broad scope. Any later amendments during the patent prosecution may invoke prosecution history estoppel. Accordingly, the applicants have the risk of losing any protection afforded by patent infringement under the doctrine of equivalents.
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.
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