What role does inherency have in an obviousness analysis?
| February 22, 2020
Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd.
December 27, 2019
Before O’Malley, Reyna, and Chen (Opinion by Reyna).
Summary
The Federal Circuit affirmed the district court’s decision invalidating as obvious patents directed to method of using a hydrocodone-only formulation to treat pain in patients with hepatic impairment. Important to the obviousness determination was the concept of “inherency”. Specifically, the Federal Circuit agreed with the District Court that where the claimed method of would have been obvious from the prior art, claim limitations directed to the pharmacokinetic properties of the formulation would be inherent in the combination of the prior art.
Details
Hydrocodone is an opioid pain medication commonly prescribed to treat prolonged, severe pain. The bulk of metabolism of many opioids, including hydrocodone, occurs in the liver. People suffering from hepatic impairment (i.e., liver dysfunction) are at increased risk of opioid overdose, because their livers cannot clear the drugs from their bloodstreams as quickly and effectively as would be the case for people with healthy livers. As such, when prescribed to patients with impaired livers, dosages of opioids are often adjusted to prevent build-ups.
Persion Pharmaceuticals, LLC (“Persion”) commercializes a hydrocodone drug under the brand name Zohydro ER. The drug is an extended-released hydrocodone-only product—that is, it contains no other active ingredients. Clinical trials on Zohydro ER revealed, to its inventors’ surprise, that the concentration of hydrocodone in the bloodstream of subjects with mild and moderate hepatic impairment was not dramatically higher than in patients with unimpaired livers. The inventors of Zohydro ER filed U.S. patent applications that eventually issued as U.S. Patent Nos. 9,265,760 (“760 patent”) and 9,339,499 (“499 patent”).
The 760 and 499 patents were directed specifically to methods of treating pains in patients with mild or moderate hepatic impairment, and the claims emphasized the similar effects that the hydrocodone-only formulation had on patients with and without hepatic impairment.
The relevant claims of the two patents fell into two categories. The “non-adjustment” claims recited the lack of need to adjust the dosage for patients with mild or moderate hepatic impairment relative to patients without hepatic impairment. Meanwhile, the “pharmacokinetic” claims recited certain pharmacokinetic (PK) parameters that highlighted the similarity in the results of administering the claimed formulation to patients with and without hepatic impairment.
Claim 1 of the 760 patent is representative of the “non-adjustment” claims:
1. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising:
administering to the patient having mild or moderate hepatic impairment a starting dose of an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, and wherein the starting dose is not adjusted relative to a patient without hepatic impairment.
Claim 12 of the 760 patent is representative of the “pharmacokinetic” claims:
12. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising:
administering to the patient having mild or moderate hepatic impairment an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate,
wherein the dosage unit provides a release profile of hydrocodone that:
(1) does not increase average hydrocodone AUC0-inf in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%;
(2) does not increase average hydrocodone AUC0-inf in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 30%;
(3) does not increase average hydrocodone Cmax in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 9%; and
(4) does not increase average hydrocodone Cmax in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%.
When Alvogen Malta Operations, Ltd. (“Alvogen”) filed an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Zohydro ER, Persion sued Alvogen for infringing the 760 and 499 patents.
Naturally, Alvogen sought to invalidate those patents.
The prior art at issue were Devane (US2006/0240105), Jain (US2010/0010030), Vicodin label, and Lortab label.
Devane disclosed the same formulation as Zohydro ER, and disclosed an in vivo study in which the formulation was administered to treat post-operative pains in patients following their bunionectomy surgery. Devane did not disclose patients with mild or moderate hepatic impairment.
Jain disclosed a hepatic impairment PK study on Vicodin CR, a hydrocodone-acetaminophen combination formulation. Jain reported that the PK parameters (Cmax and AUC values) for hydrocodone in Vicodin CR were similar in normal and hepatically impaired subjects.
The Vicodin and Lortab labels disclosed the dosing instructions for those drugs. Vicodin contains hydrocodone and acetaminophen. Lortab contains hydrocodone and ibruprofen. The labels did not provide any precautions or dosing restrictions for individuals with mild or moderate hepatic impairment.
The district court found that the claims were obvious over the cited prior art.
As to the “non-adjustment” claims, the district court found that a person of ordinary skill in the art would have been motivated to administer Devane’s formulation to patients with mild or moderate hepatic impairment, because Jain taught that the hydrocodone exhibited similar PK parameters in normal and hepatically impaired patients, while the Vicodin and Lortab labels did not require different dosages for patients with mild or moderate hepatic impairment.
As to the “pharmacokinetic” claims, the district court found that the claimed PK values were “inherent in any obviousness combination that contains the Devane formulation”, because Devane disclosed what was essentially Zohydro ER, i.e., the claimed formulation, and the claimed values were “necessarily present” in Zohydro ER.
On appeal, the Federal Circuit honed in on Persion’s challenge of the district court’s “inherency” determination. Persion argued that Devane did not teach administering its formulation to hepatically impaired patients, so that “the natural result flowing from the operation as taught” in Devane could not be the claimed pharmacokinetic properties.
The Federal Circuit disagreed, distinguishing between the applications of “inherency” in the obviousness and anticipation contexts:
To the extent Persion contends that inherency can only satisfy a claim limitation when all other limitations are taught in a single reference, that position is contrary to our prior recognition that “inherency may supply a missing claim limitation in an obviousness analysis” where the limitation at issue is “the natural result of the combination of prior art elements.”
As the Federal Circuit noted, the longstanding rule is that “an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations.”
Notably, there was no dispute that if administered under the same conditions, Devane’s formulation, which was identical to Zohydro ER, would necessarily exhibit the claimed PK values.
Related was Persion’s argument that the person skilled in the art would not have combined the cited prior art as the district court had. In particular, Persion argued that the district court should not have relied on the combination formulations disclosed in Jain and the Vicodin and Lortab labels.
Here also, the Federal Circuit disagreed. The Federal Circuit focused primarily on Jain’s teachings that its hydrocodone-acetaminophen combination formulation produced similar PK results for normal and hepatically impaired patients. That is, if Jain disclosed that its combination formulation was safe for patients with hepatic impairment, then it would be reasonable to expect the acetaminophen-free, hydrocodone-only formulation to be even safer. Further, considering Jain’s reported similarity in PK results for both hepatically impaired and unimpaired patients, it would have been obvious to the person skilled in the art to forgo dose adjustments when administering the same hydrocodone formulation to patients with hepatic impairment.
Where a claim defines some property of the claimed invention, it is not uncommon to find Examiners relying on inherency for those properties to complete their obviousness analyses. Reliance may be especially prevalent in chemical arts, as it has long been established that a chemical composition and its properties are inseparable. The Persion decision seems to reinforce the idea of inherency as a powerful argument that allows a missing limitation to be supplied based on some hypothetical combination of the prior art. That said, I suspect that the reach of the Persion decision will limited, as the fact that Persion’s claimed hydrocodone formulation already existed may have made it easier for the Federal Circuit to accept the finding of inherency.
Takeaway
- If the claim is directed to a new use of a known compound, then the claim should be more specific than a single, generic step of “applying the compound”. Consider defining the specific population or subpopulation that is helped by the compound, the specific conditions under which the compound is applied, and/or combination of the compound with other ingredients.
- If one can help it, avoid reciting intended results, which continue to be a complicated strategy. Not only could such a recitation force the issue of inherency, it could also raise the question of whether the recitation is even entitled to patentable weight, which is often a difficult argument to win with Examiners.
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
| 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.
Prior Art Based on Inherency Does Not Extend to “Probably” Existing Subject Matter, but Is Limited to “Necessarily” Existing Subject Matter.
| March 21, 2019
Personal Web Technologies, LLC v. Apple, Inc.
March 12, 2019
Before Moore, Taranto and Chen. Opinion by Chen.
Summary
In September, 2013, Apple, Inc. (Apple) filed an inter parties review (IPR) proceeding before the U.S. Patent Trial and Appeal Board (PTAB) against Personal Web Technologies, LLC (Personal Web) asserting unpatentability of U.S. Patent No. 7,802,310. The PTAB held that the ‘310 patent was obvious. On appeal, the Federal Circuit overturned the Board’s holding of obviousness on the basis that the Board had relied upon purported “inherent” subject matter in a prior art document without sufficient evidence that the purportedly inherent subject matter “necessarily exists” based on the teachings of the reference.
Details
Procedural Background
In September, 2013, Apple, Inc. (Apple) filed an inter parties review (IPR) proceeding before the U.S. Patent Trial and Appeal Board (PTAB) asserting multiple grounds of unpatentability of U.S. Patent No. 7,802,310 owned by Personal Web Technologies, LLC (Personal-Web). The PTAB held that the ‘310 patent was obvious over U.S. Patent No. 5,649,196 (Woodhill) in view of 7,359,881 (Stefik). Personal-Web appealed the PTAB’s ultimate determination of obviousness.
Factual Background
The ‘310 patent is directed to “Controlling Access to Data in a Data Processing System.” In the prior art, problems arose due to conventional naming techniques in which data files are typically identified by a name and/or pathname or location. In particular, with convention systems, when a data item is transferred from a first device to a second device, if the same data item exists in the second device a duplicate copy will be created on the second device.
According to the invention of the ‘310 patent, a data file or element is given a unique name by creating a “unique identifier” that is added to the data item’s identification along with its user-defined name, location, etc. In particular, this unique identifier is created by applying a cryptograph hash function to the data item, but creates a unique identifier for the specific data item. Accordingly, if the data item is different (e.g., modified), it will have a different unique identifier. However, if the data item is the same (e.g., not modified), it will have the same unique identifier.
The key patent claim at issue – independent claim 24 – is set forth below for reference. And, a key element of this claim at issue in this litigation is highlighted below.
24. A computer-implemented method implemented at least in part by hardware comprising one or more processors, the method comprising:
(a) using a processor, receiving at a first computer from a second computer, a request regarding a particular data item, said request including at least a content-dependent name for the particular data item, the content-dependent name being based, at least in part, on at least a function of the data in the particular data item, wherein the data used by the function to determine the content-dependent name comprises at least some of the contents of the particular data item, wherein the function that was used comprises a message digest function or a hash function, and wherein two identical data items will have the same content-dependent name; and
(b) in response to said request:
(i) causing the content-dependent name of the particular data item to be compared to a plurality of values;
(ii) hardware in combination with software determining whether or not access to the particular data item is unauthorized based on whether the content-dependent name of the particular data item corresponds to at least one of said plurality of values, and
(iii) based on said determining in step (ii), not allowing the particular data item to be provided to or accessed by the second computer if it is determined that access to the particular data item is not authorized.
In holding that the claim was obvious over U.S. Patent No. 5,649,196 (Woodhill) in view of 7,359,881 (Stefik), the PTAB held that the Woodhill reference inherently taught the highlighted features above.
Discussion
The Federal Circuit reversed the Board’s decision on the basis that the Board’s inherency finding determination of the above-noted highlighted feature lacked substantial evidence.
- The Federal Circuit’s Discussion of the Law
The Federal Circuit explained that “[w]hile it is possible that Woodhill’s system utilizes an un-stated Binary Object Identifier lookup table to locate binary objects of a previous version of a file that is going to be restored …, mere possibility is not enough.” The Court further indicated that “[i]nherency . . . may not be established by probabilities or possibilities” and that “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.”
The Federal Circuit explained that for inherency “a party must ‘show that the natural result flowing from the [disclosure] as taught would result in [the claimed subject matter]” – i.e., in this case that the “natural result flowing from the operation as taught would result in the performance of the questioned function.”
The Federal Circuit held that because the claimed subject matter “does not necessarily exist in the” Woodhill reference, reliance on inherency for that feature in the obviousness analysis was improper.
2. The Federal Circuit’s Discussion of the Evidence
In concluding that the Board’s inherency finding determination was not based on substantial evidence, the Federal Circuit explained that the Woodhill reference did not inherently include “causing the content-dependent name of the particular data item to be compared to a plurality of values” for the following reasons.
The Woodhill reference teaches a distributed management system in which files are apportioned into binary objects. The system uses binary object identifiers to determine whether a binary object has changed from one version of a file to the next, and only those binary objects whose content has changed needs to be backed up, thereby reducing the amount of data being backed up. In Woodhill, the binary object identifier is based on the contents of the binary object, such that the binary object identifier changes when the contents is changed.
At the PTAB, the Board had agreed with Apple’s argument that in order to determine which data needs to be restored in Woodhill by an update request, the system “must be able to” reference local data files using the binary object identification information received and, thus, that Woodhill must maintain some sort of file system or other mapping that allows the binary object identification record to serve as a lookup for the requisite file data that is to be restored. Thus, the Board asserted that Woodhill must inherently teach the disputed feature.
However, the Federal Circuit explained that “an equally plausible” understanding of Woodhill is that the system uses conventional file names and locations to locate files and the binary object information to locate a given binary object within the file. The Federal Circuit further explained that the only disclosed use of the binary object identifier in Woodhill is to perform a one-to-one comparison with the binary object identifier in the backed-up version of the object, which occurs after the object has been identified.
Takeaways
- This case emphasizes that inherency requires the “necessary” existence of subject matter that is not expressly shown or described in a reference. Accordingly, this case may be helpful in contesting rejections where asserted subject matter is not emphatically necessarily present, but deemed to be probable or likely by the Patent Office.
- This case also demonstrates that one way to
argue against a finding of inherency is to set forth an “equally plausible”
alternative that is supported by the reference.
That is, by demonstrating that an “equally plausible” alternative
subject matter may exist, it can be argued that the Patent Office cannot
conclude that the asserted subject matter inherently exist.
Post-filing clarification of an ambiguous feature in a pre-filing reference is not sufficient to establish inherent properties of the feature in the earlier publication
| July 31, 2018
Endo Pharmaceuticals Solutions et al. v. Custopharm Inc.
July 16, 2018
Before Moore, Linn and Chen. Opinion by Chen.
Summary
Custopharm argued that Endo’s patents were invalid due to anticipation or obviousness of three features of a drug and its administration: the dosage, the content of the vehicle, and the administration schedule. The arguments regarding the dosage were rejected on the grounds that they relied on a lesser-used industry treatment guideline. The arguments regarding the vehicle were rejected on the grounds that they relied on an improper inherency position, and that it would not have been obvious to modify the vehicle in view of a reference teaching a similar vehicle in a different context. Finally, the arguments regarding the administration schedule were rejected on the grounds that they relied upon an unsupported claim construction position, as well as an improper combining of the teachings of two references.
CAFC relies on extrinsic evidence to define a claim term and to demonstrate inherency
| February 23, 2018
Monsanto Technology LLC v. E.I. Dupont de Nemours & Co.
January 5, 2018
Before Dyke, Reyna and Wallach. Opinion by Wallach.
Summary
In this case, the CAFC affirmed a PTAB decision which relied on two pieces of extrinsic evidence. First, a journal article referred to by the specification was used to define the bounds of “about 3% or less.” Second, a Declaration submitted in the course of inter partes reexamination was used to demonstrate that claimed features are inherent in an anticipating reference. The CAFC explained that both were appropriate, and the claims are invalid as being anticipated by the cited art.
Obviousness Found Even When the Burden to Prove Inherency Remains on Examiner
| October 18, 2017
SOUTHWIRE COMPANY v. CERRO WIRE LLC
September 8, 2017
Before Lourie, Moore and Hughes. Opinion by Lourie.
Summary
Southwire Co. (the patent owner) owns No. 7,557,301 (the ’301 patent). An inter parte reexamination is initiated by a third party requestor, Cerro wire LLC (the requester). All the claims of the ’301 patent are found obvious over prior art references under 35 U.S.C. § 103. It is decided in the reexamination that one of the combinations of cited references inherently discloses a claimed parameter at issue. CAFC affirms PTAB’s conclusion that the claims are unpatentable as obvious, while rejecting part of the reasoning that the claimed parameter is inherently disclosed in the cited references.
Japanese Summary
本件特許はケーブルのジャケットの材料に潤滑剤を含ませて製造することで、完成したケーブル表面のフリクションを減らし、ケーブルをビル内等に設置するのに必要な引っ張り力を減少させることができるケーブルの製造方法に関する。当事者系再審査請求において、特許クレームは先行技術文献から自明であると拒絶され、審判部もその結論を支持した。特許権者は、主要引用例（Summers）にクレームの数値限定（ケーブルを設置するために引っ張る力を少なくとも30％減少させる特性）が内在的に（inherently）開示されているから自明であるとした特許庁の認定を不服として、巡回区控訴裁判所（CAFC）に提訴した。
CAFCは、前記引用例はケーブル表面のフリクションや設置のための力を測定しておらず、開示されている製法が必然的に（necessarily）クレームの数値限定を達成できること示す事実・証拠がないため、クレームの数値限定が内在的に開示されているという特許庁の認定は間違いであると指摘し、内在的開示の存在を否定した。内在的な開示は認められないが、その一方で主要引用例には製造時に潤滑剤を混入してフリクションの小さいケーブルを製造し得るプロセス自体は教示されているので、先行技術を克服するためにはクレーム限定が予期せぬ結果であることを示さなければならないとし、本件では予期せぬ結果の証明がないことを理由に発明が自明であるとの結論を支持した。
特許クレームは先行技術の製法とほぼ同一に見えるが、特許権者が定義したパラメータ（ケーブルを設置するために必要な力の範囲）をクレームすることで特許になった製法である。このようなパラメータ特許でも、先行技術の製法で「必ず」同じ結果が得られることを特許庁が示さなければ内在的な開示を認定してはいけないことが示唆された。しかし、他方で、先行技術と製法が実質的に同じである点で自明性が仮定されるので、出願人はそのパラメータ限定が予期せぬ効果であること示す証明責任があることが示唆された。
Establishing a General Premise Does Not Satisfy the High Burden of Proving an Inherent Disclosure of a Claimed Feature under an Obviousness Rejection
| December 22, 2014
Par Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc.
December 3, 2014
Panel: O’Malley, Wallach, and Hughes. Opinion by O’Malley.
Summary
Patent 7,101,576 (hereinafter ‘576) is directed towards a method of using megestrol nanoparticles to increase the body mass in a human patient suffering from wasting.
The CAFC vacated a District Court judgment of invalidity of the ‘576 patent and remanded for further analysis. The CAFC held that the District Court committed an error since the District Court analysis of inherency ignored the specific claim limitations at issue.
