obviousness : CAFC Alert

Bayer left hard up when CAFC reversed district courts final judgment with some stiff words for the lower court.

Adele Critchley | November 9, 2017

Bayer Pharma AG, Bayer Intellectural Property GMBH, Bayer Heathcare Pharaceuticals, inc., v. Watson Laboratories Inc., Activis Pharma, Inc.

November 1, 2017

Before Lourie, Moore and O’Malley.  Opinion by Moore

Summary:

The CAFC held that the district court clearly erred in finding that a skilled artisan would not have been motivated to arrive at claims 9 and 11 of the patent-in-suit.

The patent at issue is directed to a formulation of vardenafil and at least two sugar alcohols in the form of an uncoated oral disintegrating table (ODT). It was agreed by both parties that the claim covered an immediate-release formulation. Bayer markets a commercial embodiment of the patent under the name Staxyn, and its utility is erectile dysfunction.


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Beware of an Interpretation of a Reference that is Based Upon a Hypothetical Embodiment

Bernadette McGann | October 27, 2017

Merck Sharp & Dohme B.V. v. Warner Chlilcott Company, LLC

October 19, 2017

Before Dyk, Linn, and Hughes. Opinion by Hughes.

Summary:

The CAFC reversed the finding by the District Court of Delaware that U.S. Patent
No. 5,989,581 was invalid as being obvious in view of International Patent Application
WO 97/02015 (hereinafter PCT ‘015).  In reviewing the findings by the District Court, the CAFC highlighted the breadth of the disclosure of PCT ‘015, the teaching away by PCT ‘015 of a one compartment ring system and noted that the finding was based upon impermissible hindsight.

Details:

Merck appeals the District Court of Delaware’s determination that claims 4 and 11 of U.S. Patent No. 5,989,581 (hereinafter ‘581) are invalid as obvious in view of International Patent Application WO 97/02015 (hereinafter PCT ‘015).  The commercial embodiment of ‘581 is the NuvaRing®, which is a ring shaped drug-delivery device.  Warner argues that ‘581 is invalid but concedes that its generic product would infringe ‘581 if the claims were valid.  Id. at 2.

The ‘581 patent achieves a stable release of both progestin, etonogestrel (ETO), and estrogen, ethinyl estradiol (EE), in a single compartment ring system.  The ‘581 patent overcomes the problems in the prior art by providing a ring made of a polymer that is supersaturated with ETO.  Claims 4 and 11 of ‘581 require a single compartment ring system comprising both progestin and estrogen.

1.  A drug delivery system comprising at least one compartment which comprises

a thermoplastic polymer core . . . said core comprising a mixture of a steroidal progestogenic compound and a steroidal estrogenic compound in a ratio by weight that allows a direct release of both said progestogenic compound and said estrogenic compound in physiologically required amounts,

said progestogenic compound being initially dissolved in said polymer core material in a degree of supersaturation of 1 to about 6 times of the amount by weight necessary for obtaining saturation concentration of said progestogenic compound in said polymer core material at 25° C,

said estrogenic compound being dissolved in said polymer core material in a concentration lower than that of said progestogenic compound . . . .

4.  A drug delivery system according to claim 1, wherein the amount of progestogenic compound dissolved in the thermoplastic core material is 2 to 5 times the amount necessary for obtaining saturation concentration.

5.  A drug delivery system in a substantially ring-shaped form and suitable for vaginal administration comprising at least one compartment which comprises

a thermoplastic polymer core . . . said core comprising a mixture of a progestogenic steroidal compound and an estrogenic steroidal compound in a ratio by weight of 10 parts of the progestogenic compound to 1.5–5 parts of the estrogenic compound. . . .

11.  A drug delivery system according to claim 5, wherein the core material comprises 0.55 to 0.8% by weight of etonogestrel and 0.12 to 0.18% by weight of ethinyl estradiol.

Warner argued that claims 4 and 11 of ‘581 are anticipated by or rendered obvious by PCT ‘015, which discloses a ring shaped drug delivery device releasing progestin, etonogestrel (ETO), and estrogen, ethinyl estradiol (EE).  However, the device of PCT ‘015 is a two compartment ring system.  PCT ‘015 explicitly criticizes one compartment ring systems, stating that such systems “show suboptimum release patterns for the difference substances…”  Id. at 5.

The District Court found that the ‘581 patent is obvious in view of PCT ‘015.  The judgment of the District Court was based upon the finding that PCT ‘015 discloses:

  • A two-compartment ring;
  • The second compartment is loaded with both ETO and EE;
  • The concentration of ETO is higher than EE ; and
  • The second compartment comprises 97% of the ring.

The District Court held that it would have been obvious to a skilled artisan at the time of invention “to modify the two-compartment ring so that pharmaceutically required amounts of both ETO and EE are delivered from one compartment.”  Id. at 7.

Law regarding Obviousness

  • “[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
  • Even if all elements of the claim were known, we still must resolve whether a person of ordinary skill in the art would have found it obvious to combine these elements or modify them in a way that meets the claim.
  • It is improper to combine references “like separate pieces of a simple jigsaw puzzle” without “explain[ing] what reason or motivation one of ordinary skill in the art at the time of the invention would have had to place these pieces together.” InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1349 (Fed. Cir. 2014).

Id. at 6.

The CAFC noted that “PCT ‘015 does not actually disclose a ring with a second compartment that comprises 97% of the ring, and includes a higher concentration of ETO than EE in the second compartment.”  Id. at 7.  Rather,  PCT ‘015  discloses a “broad range of values for the relative size of each compartment as well as concentrations of each compound.”  Id. at 7.  The CAFC highlighted the breadth of the disclosure of PCT ‘015 by illustrating that “the second compartment can occupy anywhere from 3% to 97% of the ring. Elsewhere, PCT ’015 explains that ‘the second compartment is loaded with 0.05-3% w/w” of ETO and “0.05-5% w/w’ of EE.”  Id. at 7.

To arrive at the hypothetical ring that the district court relied on for obviousness, the person of ordinary skill must make the second compartment 97% of the total ring, which is outside of the usual or preferred range disclosed in
PCT ’015. And the person of ordinary skill must also pick a concentration of ETO from the high end of the disclosed range, but conversely select a concentration of EE from the low end of the range. Nothing in PCT ’015 suggests picking these values out of the innumerable possible combinations of ETO concentrations, EE concentrations, and compartment length ratios. Instead, the only way to arrive at the hypothetical ring is by using the ’581 patent as a roadmap to piece together various elements of PCT ’015. That represents an improper reliance on hindsight.

(emphasis added) Id. at 7 and 8.  Further, it was noted that the PCT ‘015 was critical of an one compartment ring system, which the CAFC stated establishes that the District Court’s judgment was based upon impermissible hindsight.  A “person of ordinary skill in the art would pursue ‘identified, predictable solutions,’ not designs that were seemingly inoperable.”  Id. at 8.

Claim 11 recites a one compartment ring system having specific concentrations of each ETO and EE.  Warner had argued that “it would have been obvious to calculate the relative concentrations for each compound based on those release rates.”  Id. at 9.  The CAFC held that this argument is unpersuasive because the disclosure of dosage rate in PCT ‘015 is based upon a two compartment ring system.  Warner’s argument and the District Court judgment would require a skilled artisan to calculate the relative concentrations for a two compartment ring, and apply those concentrations to a single compartment, despite PCT ‘015 stating that a single compartment system is difficult to control while a two compartment system achieves consistent release rates.  Id. at 9.

The CAFC reverses the District Court’s judgment of invalidity and remanded the case.

Take away:

  • One should review an obviousness rejection to determine if it is based upon a hypothetical embodiment of the cited reference.
  • One should review the breadth of the disclosure of a cited reference. The breadth of the disclosure of a cited reference may provide arguments of non-obviousness.

Full Opinion

Obviousness Found Even When the Burden to Prove Inherency Remains on Examiner

Yoshiya Nakamura | 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。



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Tell Me Why: A conclusion of obviousness based on routine optimization must be supported by articulated reasoning

Cindy Chen and John M. Wang | October 16, 2017

In re Stepan Company

August 25, 2017

Before Lourie, Moore, and O’Malley. Opinion by Moore. Dissent by Lourie.

Summary

The Federal Circuit vacated a Patent Trial and Appeal Board panel’s finding of obviousness based on routine optimization, for failing to articulate some rational underpinning as to “why” routine optimization would have made the claimed invention obvious.


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When the acts of one are attributable to the other.

Adele Critchley | February 16, 2017

Eli Lilly and Company, v. Teva Parenteral Medicines, Inc., APP Pharmaceuticals LLC., Pliva Hrvatska D.O.O., Teva Pharmaceuticals USA, Inc., Barr Laborites, Inc.

January 12, 2017

Before Prost, Newman and Dyk.  Opinion by Prost.

Summary:

The case centered on Eli Lilly’s patent directed to methods of administering a chemotherapy drug after pretreatment with two common vitamins. The drug was marketed under the brand name ALIMTA®. The Defendants had submitted ANDAs seeking approval of a generic version of ALIMTA®. The CAFC upheld the district counts findings, in favor of Eli Lilly’s patent, in full. The issues addressed were induced infringement, and invalidity issues of indefiniteness, obviousness and obvious-type double patenting.

Details:

Eli Lilly is the owner of U.S. Patent No., 7,772,209 (patent ‘209), directed to methods of administering the chemotherapy drug “pemetrexed’ after pretreatment with two common vitamins (folic acid and vitamin B12). The purpose of the dual vitamin pretreatments is to reduce the toxicity of the pemetrexed to the patients. The drug was marketed under the brand name ALIMTA®.

The Defendants notified Eli Lilly that they had submitted ANDAs seeking approval of a generic version of ALIMTA®. After the ‘209 patent issued, Defendants sent Eli Lilly notices that they had filed Paragraph IV certifications under 21 U.S.C. §355(j)(2)(A)(vii)(IV), declaring that the patent was invalid, unenforceable or would not be infringed. Eli Lilly subsequently brought a consolidated action against the Defendants for infringement, alleging that the generic drug would be administered with folic acid and vitamin B12 pretreatments.

Eli Lilly asserted a number of claims at trial, all of which required patient pretreatment by ‘administering’ or ‘administration of’ folic acid, and a number of dependent claims which defined dosage restrictions.

The parties agreed for the purpose of appeal that no single actor performs all steps, rather they are divided between patient and physician.  Specifically, physicians administered vitamin B12 and pemetrexed, while the patient folic acid.

Initially, in June 2013, Defendants conditionally conceded induced infringement under the then-current law set forth in Akamai II (Akamai II held that “induced infringement can be found even if there is no single party who would be liable for direct infringement”). At the time, Akamai was subject of a petition to the Supreme Court for a writ of certiorari. The parties’ stipulation included a provision reserving Defendants right to litigate infringement if the Supreme Court reversed or vacated Akamai II.  While an appeal on invalidity was pending (district court had held the claims were not invalid), the Supreme Court reversed Akamai II, holding the liability for inducement cannot be found without direct infringement. In view of this, the parties in this case filed a joint motion to remand the matter to the district court for the limited propose of litigating infringement. CAFC granted the motion. The district court held a second bench trial and concluded that Defendants would induce infringement of the ‘209 patent. The court had applied the intervening Akamai V decision, which had broadened the circumstances in which others’ acts may be attributed to a single actor to support direct infringement liability.

Defendants timely appealed. The CAFC upheld the district courts findings, addressing each issue in turn.

(I) “Whoever actively induces infringement of a patent shall be liable as an infringer.” Importantly, liability for induced infringement “must be predicated on direct infringement.” (Akamai III). The patentee must also show that the alleged infringer “knew or should have known his actions would induce actual infringements.” A patentee seeking relief under §271(e)(2) bears the burden of prove.

The district court relied in part on the Defendants’ proposed product labeling as evidence of infringement. The labeling consisted of two documents: the Physician Prescribing Information and the Patient Information. Amongst other things, the information provides the following:

Instruct patients to initiate folic acid 400 [m]g to 1000 [m]g orally once daily beginning 7 days before the first dose of [pemetrexed]…

Instruct patients on the need for folic acid and vitamin B12 supplementation to reduce treatment-related hematologic and gastrointestinal toxicity…

To lower your chances of side effects of [pemetrexed], you must also take folic acid and vitamin B12 prior to and during your treatment with [pemetrexed].

It is very important to take folic acid and vitamin B12 during your treatment with [pemetrexed] to lower your chances of harmful side effects.  You must start taking 400-1000 micrograms of folic acid every day for at least 5 days out of the 7 days before your first dose of [pemetrexed].

The CAFC held that where, as here, no single actor performs all the steps of the method claim, direct infringement only occurs if “the acts of one are attributable to the other such that a single entity is responsible for the infringement.” Akamai V. In Akamai V, the CAFC held that directing or controlling other’s performance includes circumstances in which an actor (1) conditions participation in an activity or receipt of a benefit upon another’s performance of one or more steps of a patented method, and (2) establishes the manner or timing of that performance. The district court applied this two-point prong test to the subject case.

With respect to the first prong – the CAFC agreed with the district court’s findings. Specifically, the labeling information repeatedly instructs the patients to take folic acid and provides information about the dosage range and schedule. The labeling information explains that the folic acid is a “requirement for premedication” in order to “reduce the treatment-related hematologic and gastrointestinal toxicity” of pemetrexed. Eli Lilly’s expert testified that it is “the physician’s responsibility to initiate the supplementation of folic acid.” The patient information also informs patients that a physician may withhold pemetrexed treatment based on blood tests. Eli Lilly’s expert testified that a physician would withhold treatment if the patient had not taken their required dosage of folic acid to avoid toxicity.

The Defendants argued that the product labeling was mere guidance and insufficient to show conditioning. The Defendants also argued there is no evidence that physicians go further to “verify compliance” with their instructions. The CAFC replied that conditioning does not necessarily require double checking.

Next, the Defendants argued that an actor can only condition the performance of a step by imposing a legal obligation to do so. The CAFC rejected this argument, stating that infringement is not limited solely to contractual arrangements, and the like.

With respect to the second prong – the CAFC agreed with the district court’s findings. Specifically, the Physician Prescribing Information instructs physicians to tell patients to take folic acid at specific dosages and at a specific schedule. Moreover, the testimony of a Dr. Chabner was highlighted in part affirming that “it is the doctor” who “decided how much” the patient takes.

Defendants argued that patients are able to seek additional outside assistance regarding folic acid administration, but the CAFC held this was immaterial.

Thus, the two-point prong test of Akamai V was met. However, the mere existence of direct infringement by physicians is not sufficient to find liability for induced infringement. Eli Lilly carried this burden.

The district court held that the administration of folic acid before pemetrexed administration was ‘not merely a suggestion or recommendation, but a critical step,’ in light of the Defendants proposed labeling.

Defendants argued that Eli Lilly has not offered any evidence of what physicians do in general but only speculation about how they may act. They argued that physicians must go beyond labeling. The CAFC found this argument unavailing. For the purpose of inducement “it is irrelevant that some users may ignore the warnings in the proposed label,” if the label “encourage(s), recommend(s) or promote(s) infringement.” The product labeling included repeat instructions and warning regarding the importance of folic acid.

(II) Indefiniteness of “vitamin B12” – the Defendants argued in view of Nautilius that vitamin B12 is indefinite as the term is used in two different ways in the intrinsic record (vitamin B12 and Cyanocobalamin).

The district count accepted the testimony of Eli Lilly’s expert that one of ordinary skill in the art would understand in the context of the patent claims vitamin B12 to mean Cyanocobalamin. The CAFC saw no error in the districts court findings, holding that vitamin B12 has a plain meaning to one of skill in this particular art.

In addition, it was noted that claim 1 required administering a “methylmalonic acid lowering agent…” and claim 2 “vitamin B12.” Therefore, if vitamin B12 was to refer to a whole class of compounds it would be the same scope as claim 1. However, the doctrine of claim differentiation presumes that dependent claims are of narrower scope, and so reading the claims as to require ‘vitamin B12’ of claim 2 to be a specific compound within the scope of “methylmalonic acid lowering agent” avoids this problem.

The Defendants argued that if vitamin B12 means Cyanocobalamin, the given Markush group in claim 1 of the “methylmalonic acid lowering agent,” lists the same compound twice. The CAFC held that the mere fact that a compound may be embraced by more than one member of a Markush group recited in the claim does not necessarily render the scope unclear. The CAFC held the redundancy is support by the prosecution history (the Examiner had stated they were the same, in response the patentee removed Cyanocobalamin, but later put the term back into the claim).

(III) Obviousness – the CAFC agreed with the district counts finding that a skilled artisan would have concluded that vitamin B12 deficiency was not the problem in pemetrexed toxicity.

In brief, the Defendant had relied upon an Abstract published from an Eli Lilly scientist that showed homocysteine levels served as an indicator of either a folic acid or vitamin B12 deficiency and that such levels were elevated with increased pemetrexed toxicities. However, the levels of another marker methylmalonic acid (MMA), which more specifically is an indicator of just vitamin B12 deficiency, showed no correlation. The CAFC indicated this was sufficient for the claims not to be rendered obvious.

(V) Obviousness-type double patenting – the Defendants argued that the claims are not valid over an Eli Lilly’s earlier patent (US 5,271,974 – ‘974). The district court disagreed, and the CAFC upheld.

In brief, the ‘974 patent more broadly claimed a much greater amount of folic acid with an antifolate agent administrated to a mammal.  The claims of the subject patent are much more specific with regards to the amount of folic acid and the administration of a specific antifolate agent to a patient. The CAFC held this was sufficient for the claims to be patentably distinct.

Comments:

Method claims drafted to encompass actions of a single entity are still preferable, in order to reduce burden of proving infringement. However, where no single entity performs all the steps, direct infringement can be found if the steps of the method claim are performed under the control or direction by a single entity.

Naturally, patent specification drafters should always endeavor to be careful in their use of claim terminology.  Even so, where claim terms are have a specific meaning in their relevant arts, the courts tend to not apply those terms contrary to their common understanding, unless the applicant clearly intended to redefine the term.

Full Opinion

More than one point of attack of Prima Facie cases of Obviousness can be presented

Bernadette McGann | May 16, 2016

Pride Mobility Products Corp. v. Permobil, Inc.

April 5, 2016

Before Reyna, Chen, and Taranta.  Opinion by Taranta.

Summary:

Pride argued before the Board, in an inter partes review, and the CAFC that a skilled artisan would not be motivated to combine the cited art, as alleged, because it would compromise the performance of the resulting wheelchair.  The argument by Pride focused only on a lack of motivation to combine the cited art and did not address the potential issue that if the rejection is sustained, there is a prima facie case of obviousness.  The Board found, and the CAFC affirmed, that the disputed claims were obvious.


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Timeliness and relevance are not sufficient conditions for automatically granting a motion to submit supplemental information after IPR institution

John M. Wang | January 29, 2016

Redline Detection, LLC. v. Star Envirotech, Inc.

December 31, 2015

Before Wallach, Lourie, and Hughes.  Opinion by Wallach.

Summary

The Federal Circuit held that, with regard to the motion to submit supplemental information after the IPR is instituted, the two criteria in section 37 CFR 42.123(a), timeliness and relevance, are not sufficient conditions for automatically granting a motion to submit supplemental information.


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CAFC emphasizes “would have motivation” in obviousness determinations from Inter Partes Reviews

Michael Caridi | November 11, 2015

Belden, Inc. v. Berk-Tek, LLC

November 5, 2015

CAFC Panel and opinion author: Before Newman, Dyk and Taranto. Opinion by Taranto

Summary:

In an appeal from an Inter Partes Review, the CAFC rejected all claims of the ‘503 patent as being obvious over the prior art, emphasizing that the test for obviousness focuses on whether the skilled artisan would have a motivation to modify or combine the prior art disclosures to reach the claimed invention. The Court further upheld the authority of the Board to allow for consideration of a late filed Declaration by the Petitioner.


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Patentee Likely (Con)vexed After The Court of Appeals Fails To See Through The Same Lens as them…

Adele Critchley | September 17, 2015

Dome Patent L.P., vs. Michelle K. Lee, Director, U.S. PTO.

September 3, 2015

Before: Reyna, Schall and Hughes. Opinion by Hughes.

Summary:
The CAFC affirmed the decision of the District Court of the District of Columbia in U.S. Patent No. 4,306,042 (the ‘042 Patent) in which the District Court held that claim 1 would have been obvious to one of ordinary skill in the art since a single reference that teaches away will not prevent a finding of obviousness, if motivation can be found elsewhere.
The CAFC held that the district court did not err by only requiring the Patent Office to show that claim 1 of the ‘042 patent is obvious by a preponderance of evidence, since in re-examination there is no presumption of validity.


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Federal Circuit Finds Claimed Invention Obvious, Reversing Trial Judge & Jury

Scott Daniels | August 27, 2015

ABT Systems v. Emerson Electric

August 19, 2015

Before: Prost, Clevenger & Schall, opinion by Schall

Summary:

A jury found the ‘017 patent (U.S. Patent No. 5,547,017) to be valid and infringed, and awarded reasonable royalty to the patentee as damages. The trial judge subsequently denied the accused infringer’s motion for JMOL that the patent was invalid as obvious. On appeal, the Federal Circuit concluded that the claimed invention was obvious and that the trial judge should have granted the JMOL motion. The Federal Circuit therefore remanded the case to the trial judge with instructions to enter judgment in favor of the accused infringer.


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