infringement : CAFC Alert

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

In a design patent infringement case, 35 U.S.C. §289 authorizes the award of total profit from the article of manufacture bearing the patented design

Kumiko Ide | May 27, 2015

Apple Inc. v. Samsung Electronics Co., Ltd. et al.

May 18, 2015

Before: Prost, O’Malley and Chen.  Opinion by Prost.

Summary

The CAFC affirmed the jury’s verdict on the design patent infringements and the validity of utility patent claims, and the damages awarded for these infringements appealed by Samsung.  However, CAFC reversed the jury’s findings that the asserted trade dresses are protectable.  Regarding the design patent infringement issue, Samsung proposed that functional aspects of the design patents should be “ignored” in their entirety in a design patent infringement analysis, the CAFC disagreed.  Moreover, the CAFC found that the district court did not err by allowing jury to award damages based on Samsung’s entire profits on its infringing smartphones.

サムスン社は、控訴審において、意匠特許の機能的部分は意匠特許侵害の分析において無視されるべきであると主張した。CAFCは、機能的部分の装飾的な特徴は意匠特許によりカバーされるため、意匠特許侵害の分析において機能的部分を無視すべきというサムスン社の主張には同意しなかった。また、サムスン社は、意匠特許侵害の損害賠償は、侵害商品の全体としての利益(entire profit)に基づいて計算されるべきでないと主張したものの、特許法第289条は、意匠特許侵害の損害賠償を侵害商品の全体としての利益(entire profit)に基づいて計算することを可能としているため、CAFCはこの主張にも同意しなかった。


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Be Mindful that the Potential Reach of Claimed Components under the Doctrine of Equivalents Can Be Affected by Amendments to Claimed Sub-Components.

Stephen Parker | October 9, 2014

EMD Millipore Corporation v. Allpure Technologies, Inc. (Precedential Opinion).

September 29, 2014

Panel:  Prost, O’Malley and Hughes.  Opinion by Prost.

Summary

EMD Millipore Corporation (Millipore) appeals the District of Massachusetts decision that the accused infringer, Allpure Technologies, Inc. (Allpure) does not infringe its U.S. Patent No. 6,032,543 entitled a Device for Introduction and/or Withdrawal of a Medium into/from a Container, either literally or under the doctrine of equivalents.   The Federal Circuit affirmed that there was no literal infringement because the claims required a removable transfer member having a two part seal connected after removal, while the Allpure device had two parts of a seal separated after disassembly.   In addition, the Federal Circuit held that Allpure did not infringe under the doctrine of equivalents due to prosecution history estoppel  based on narrowing amendments limiting the transfer member to such a two part seal, along with a lack of any argument that the reasons for such amendments was not a substantial one related to patentability.


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Divided Claim Construction Leads to Reversal of Jury Verdict Against Alleged Infringer

Cindy Chen | April 17, 2013

Saffran v. Johnson & Johnson

April 4, 2013

Panel: Lourie, Moore, and O’Malley.  Opinion by Lourie. Concurrence Opinions by Moore and O’Malley.

Summary

The Federal Circuit reversed a $482 million jury verdict against Cordis, a member of the Johnson & Johnson family. The reversal came as a result of the Federal Circuit’s significant narrowing of the district court’s construction of two key claim limitations. One claim term was narrowed because the Federal Circuit found that the patentee’s arguments made during prosecution of the asserted patent, for the purpose of distinguishing over cited prior art, amounted to prosecution disclaimer. Meanwhile, a structure identified in the specification by the patentee as the corresponding structure to a means-plus-function limitation was disregarded as such, because the specification failed to link the identified structure to the recited function with sufficient specificity.


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Vitiation exclusion: a judicial determination ensuring that doctrine of equivalents does not overtake statutory function of claims in defining scope of exclusive rights

Rob Raheja | January 2, 2013

Deere & Co. v. Bush Hog

December 4, 2012

Panel:  Rader, Newman and Plager. Opinion by Rader.

Summary

The United States District Court for the Southern District of Iowa, among other things, construed the claimed term “into engagement with” of ‘980 Patent to require direct contact and construed “being secured to” of ‘980 Patent as “fastened or attached.” Based on this construction, the district court granted Bush Hog & Co. LLC’s and Great Plains Inc.’s motions for summary judgment of noninfringement by holding that Deere did not raise a genuine issue of material fact as to literal infringement because the upper deck walls do not come into contact with the lower deck walls in any of the accused products. In addition, the district court held that Deere could not assert infringement under the doctrine of equivalents because doing so would vitiate the “into engagement with” limitation. Because in the context of the ‘980 Patent “into engagement with” encompasses indirect contact, the Federal Circuit vacated the district court’s construction of this term, reversed the grant of summary judgment, and remanded for further proceedings. Also, the Federal Circuit found that the district court invoked vitiation exclusion in error by refusing to apply the doctrine of equivalents because “a reasonable jury could find that a small spacer connecting the upper and lower deck walls represents an insubstantial difference from direct contact.” Therefore, the Federal Circuit also vacated the grant of summary judgment of no infringement under the doctrine of equivalents.


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Federal Circuit Judges Spar over Post-FDA-Approval Application of Hatch-Waxman Safe Harbor

Nicolas Seckel | September 4, 2012

Momenta Pharma v. Amphastar Pharma

August 3, 2012

Panel:  Rader, Dyk and Moore.  Opinion by Moore.

Summary:

Momenta sued Amphastar for infringement of Momenta’s drug testing method.  Amphastar argued that its use of Momenta’s patented method for testing Amphastar’s commercial batches is covered by the exception to infringement for activities related to FDA regulatory review under the “safe harbor” provision of section 271(e)(1). The District Court issued a preliminary injunction against Amphastar, holding that the “safe harbor” is limited to pre-FDA approval activities.  The Federal Circuit vacates the injunction.  Amphastar’s activities took place after FDA marketing approval of Amphastar’s product, but the plain language of the statutory “safe harbor” covers all uses of a patented invention that are “reasonably related” to submission of information under FDA regulatory review.  Since Amphastar’s manufacturing batch testing was mandated by FDA for commercialization, and not “routine” information gathered “voluntarily,” Amphastar’s use of Momenta’s patented method is exempted by the “safe harbor.”


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CAFC pointers on proving lack of “substantial non-infringing uses” in pleading contributory infringement

Le-Nhung McLeland | June 20, 2012

Toshiba Corporation v. Imation Corp.

Jun 11, 2012

Panel:  Dyk, Schall, and Moore.  Opinion by Moore.  Dissent by Dyk.

Summary:

(1)   Grant of summary judgment of non-infringement as to contributory infringement of ‘751 patent affirmed because plaintiff did not meet burden of proof that there was a lack of substantial non-infringing uses.

(2)   Grant of summary judgment of non-infringement as to induced infringement of ‘751 patent vacated because district court erred as a matter of law in holding that the existence of a substantial non-infringing use precludes a finding of induced infringement.

(3)   Grant of summary judgment of non-infringement of ‘966 patent vacated because it was based on erroneous claim construction.

(4)   No clear “take away” on claim construction from discourse between majority and dissent.


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