Blog Tag: Federal Circuit
Federal Circuit Upholds Lower Court Decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.
By Rory Lootsma
(August 18, 2022) The Federal Circuit has affirmed that Eagle Pharmaceuticals, Inc. did not infringe Par Pharmaceutical, Inc. patents, easing Eagle’s path to market a generic competitor to Par’s Vasostrict®
product. Par had alleged that Eagle’s abbreviated new drug application (ANDA) infringed U.S. Patent Nos. 9,744,209 and 9,750,785, both titled “Vasopressin formulations for use in treatment of hypotension.” An example molecular structure is shown here:
Some of Par’s arguments had alleged that because the pH of Eagle’s products would be so close to Par’s claimed ranges for pH, inevitable drift in pH would occur over time, causing infringement. In affirming, Chief Judge Moore explained that the District Court had not committed clear error in finding otherwise. The infringement inquiry “begins and ends” with Eagle’s ANDA specification, so predicting future drift cannot show infringement.
Thus, the Federal Circuit upheld the District Court’s decision against Par Pharmaceutical and affirmed the finding of no infringement. The Federal Circuit’s decision is available here.
A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention if it has been for sale for over one year prior to the patent filing.
On July 6, 2022, in Junker v. Medical Components Inc., inventor Larry Junker filed a petition for certiorari asking the Supreme Court to review the Federal Circuit’s finding of invalidity of his design patent under the on-sale bar. Mr. Junker alleged that Medical Components, Inc. and Martech Medical Products, Inc. (collectively “MedComp”) infringed U.S. Design Patent No. D450,839 (the “D’839 patent”), entitled “Handle for Introducer Sheath.” An introducer sheath is a device used to place catheters. The D’839 patent covered the design of the introducer sheath’s handle with rounded “Mickey-Mouse-shaped ears” that made the device easier to grasp when inserting the catheter and when peeling apart and removing the sheath. Figure 1 from the D’389 patent is reproduced below:
Mr. Junker and MedComp filed cross-motions for summary judgment debating whether the D’839 patent was invalid under the “on-sale bar” of 35 U.S.C. § 102(b) (pre-AIA). Under 35 U.S.C. § 102(b) (pre-AIA), a patent claim is invalid if “the invention was . . . on sale in this country, more than one year prior to the date of the application for patent in the United States.” The parties disputed whether a 1999 letter regarding a price quotation, sent more than one year before the D’839 patent was filed, constituted a commercial offer for sale. The letter was sent by a third party manufacturer to Boston Scientific.
The district court concluded that the letter was not a commercial offer for sale and accordingly granted Mr. Junker’s motion for summary judgment of no invalidity. After a bench trial, the court awarded Mr. Junker $1.25 million in damages. On appeal, the U.S. Court of Appeals for the Federal Circuit disagreed, finding that the letter contained sufficient terms to constitute a commercial offer for sale rather than a mere quotation.
In his petition for certiorari, Mr. Junker urges the Supreme Court to review the Federal Circuit’s ruling, arguing that the Federal Circuit misapplied contract law because the 1999 letter was sent by a third party who had no right to sell the invention, and the letter expressly stated it was a quotation rather than a price list.
Mr. Junker’s petition for certiorari is available here.
Federal Circuit Reverses PTAB’s Invalidation of Patent Claims for an Artificial Heart Valve (Snyders vs St. Jude)
On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for repairing a damaged heart valve.” St. Jude Medical LLC (“St. Jude”) filed for an inter partes review (IPR) at the PTAB for U.S. Patent No. 6,821,297, entitled “Artificial Heart Valve, Implantation Instrument and Method Therefor,” owned by Snyders Heart Valve LLC (“Snyders”).
In invalidating the claims, the PTAB interpreted the patent claim limitation of a “frame sized and shaped for insertion between the upstream region and the downstream region.” The PTAB found that the limitation also covers a frame that fits in place after removal of a damaged heart valve. The cited prior art allegedly also disclosed a valve insert sized to fit the valve after the damaged native valve was removed. Therefore, the PTAB found that the prior art anticipated the claims.
The Federal Circuit held that the PTAB erred in determining that the “sized and shaped” limitation “does not require the frame be sized and shaped for insertion into a damaged heart valve,” but “only that the frame is sized and shaped for insertion in a position between the upstream region and the downstream region.” The Federal Circuit reasoned that the PTAB’s construction was incorrect because “it covers frames sized and shaped for installation with the native valve removed, rather than only with the native valve in place.” The Federal Circuit cited language in the patent specification allegedly stressing that the disclosed artificial heart valve can be inserted without removing the native valve, an alleged express improvement on the prior art.
The Federal Circuit’s decision is available here.
On April 12, 2017, the Federal Circuit affirmed the determination by the US Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (Board) that the claims of U.S. Patent No. 8,324,283 (“the ’283 patent”) were invalid as obvious.
US Patent No. 8,324,283
According to public databases, Novartis AG is the assignee of the ’283 patent, directed to pharmaceutical compositions for the treatment of multiple sclerosis. The ’283 patent, according to its abstract, relates to sphingosine-1 phosphate (S1P) receptor agonists and a sugar alcohol suitable for oral administration. According to its label, Gilenya acts by internalizing S1P receptors, which sequesters lymphocytes in the lymph node, to prevent relapse of multiple sclerosis. According to the Food and Drug Administration (FDA), Gilenya, approved in 2010, became the first oral disease-modifying drug approved by the Food and Drug Administration (FDA) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis. A Novartis website states that Gilenya had over $3 billion in sales in 2016.
According to the Federal Circuit Decision, Torrent Pharmaceuticals Limited filed inter partes review (IPR) proceedings of the ’283 patent in 2014. The Board determined that the claims of the ’283 patent were invalid as obvious in its Final Written Decision of September 24, 2015. Novartis appealed the decision to the Federal Circuit, and the Federal Circuit affirmed the Board’s decision.
Federal Circuit Decision
According to the Federal Circuit’s decision, Novartis argued on appeal that the Board “erred in its motivation to combine analysis because it failed to read the prior art as a whole and overlooked critical evidence of . . . known disadvantages” of a claimed active ingredient. However, the Federal Circuit affirmed the Board’s finding, concluding that “substantial evidence supports the Board’s finding that . . . a person of skill in the art would have been motivated to combine” the features of the cited art.
On February 14, 2017, U.S. District Judge Michael Mosman of the United States District Court, District of Oregon granted a Joint Stipulated Motion for Dismissal with Prejudice submitted by Plaintiffs Smith & Nephew, Inc. and John O. Hayhurst, M.D. (inventor) and Defendant Arthrex, Inc. subject to the terms of a Settlement and License Agreement. Information about the settlement terms is not publicly available.
This agreement ends a 12-year long dispute between Smith & Nephew and Arthrex over Smith & Nephew’s U.S. Patent No. 5,601,557, which is directed to a method and apparatus for anchoring cartilage within a joint.
In 2004, Smith & Nephew sued Arthrex and alleged that certain products of Arthrex’s SutureTak® and PushLock® suture anchor families infringed the ‘557 patent (case number 3-04-cv-00029). According to the United States Court of Appeals for the Federal Circuit’s opinion of March 18, 2015, the parties had gone through three jury trials and two previous appeals. The third jury trial in 2011 produced a verdict of willful infringement and damages awards. Arthrex moved for Judgment as a Matter of Law (JMOL) of noninfringement, which was granted by the district court without an opinion. The Federal Circuit reversed and remanded the JMOL and reinstated the verdict in its S&N II opinion in 2013.
We previously reported the district court’s entering of judgment in favor of Smith & Nephew on remand, awarding a total of $88 million in damages and granting a permanent injunction against Arthrex. The judgment was affirmed by the Federal Circuit in its March 18, 2015 opinion. In June 2015, Smith & Nephew reported receiving a $99 million patent infringement payment from Arthrex.
In 2008, Smith & Nephew also sued Arthrex and alleged that different products from the same SutureTak® and PushLock® families infringed the ‘557 patent (case number 3:08-cv-00714). Judge Mosman granted in-part Smith & Nephew’s motion for summary judgment of infringement and denied Arthrex’s motions for summary judgment as of non-infringement. He also granted Smith & Nephew’s motion for summary judgment as to reasonable royalty damages.
According to the court’s public record, a jury trial was set for February 13, 2017 for the remaining issues in the lawsuit filed in 2008. On February 10, 2017, Judge Mosman vacated the jury trial, followed by the parties’ Joint Stipulated Motion for Dismissal with Prejudice.
Smith & Nephew and Arthrex filed a similar Joint Stipulated Motion for Dismissal with Prejudice in the 3-04-cv-00029 case, and in another lawsuit in the Eastern District of Texas relating to Arthrex’s patents (case number 2:15-CV-1047). The motion was granted by the Eastern District of Texas court, but denied as moot in the 3-04-cv-00029 case, which was closed when the September 2013 judgment was entered.
(January 13, 2015) The United States Court of Appeals for the Federal Circuit affirmed a lower court’s finding that W.L. Gore & Associates, Inc. (“Gore”) willfully infringed U.S. Patent No. 6,436,135 (“the ’135 patent”) . The ’135 patent, entitled “Prosthetic Vascular Graft,” states that its invention relates to vascular prostheses fabricated from highly expanded polytetrafluoroethylene [ePTFE].” According to the opinion, ePTFE is sold by Gore under the brand name “Gore-Tex®.” Figure 3 from the ‘135 patent is illustrated below:
According to the opinion, the dispute over the ’135 patent began with the filing of the 1974 patent application from which the ’135 patent issued – twenty-eight years later. The opinion states that during the pendency of the patent application, there was a dispute over inventorship between, inter alia, Peter Cooper, a Gore employee who assigned his rights to Gore, and Dr. David Goldfarb, who assigned his rights to C. R. Bard, Inc. (“Bard”). The opinion also notes that the patent office awarded the patent to Dr. Goldfarb and the patent issued in August 2002.
The opinion indicates that in 2003, Bard Peripheral Vascular, Inc. (“BPV”) and Dr. Goldfarb filed a complaint against Gore for infringement of the ’135 patent, and a jury found the ’135 patent valid and that Gore willfully infringed. After a lengthy procedural history, including three prior Federal Circuit decisions, the Federal Circuit affirmed a finding of willful infringement.
(January 20, 2015) KFx Medical Corp.’s $35 million patent infringement award against Arthrex, Inc. was upheld by the Federal Circuit. KFx’s lawsuit alleged that Arthrex’s SutureBridge and SpeedBridge devices infringed U.S. Patent No.7,585,311, 8,109,969, and 8,100,942, each entitled “System and method for attaching soft tissue to bone.” Figure 1 from the ‘311 patent is reproduced below:
The Federal Circuit upheld the Southern District of California court’s dismissal of Arthrex’s motion for a new trial after a jury found that Arthrex had infringed the KFx patents, and awarded KFx $29 million in damages. The district court judge later awarded additional damages and pre-judgment interest. The Federal Circuit’s decision is available here, and a press release from KFx is available here.
Federal Circuit Vacates $176 Million Damages Award to Covidien relating to Ethicon Harmonic Ultrasonic Cutters
The United States Court of Appeals for the Federal Circuit vacated a $176 million district court damages award to Covidien, formerly known as Tyco Healthcare Group LP, in a patent infringement suit against Ethicon Endo-Surgery, Inc., a subsidiary of Johnson & Johnson. Covidien’s lawsuit alleged that Ethicon’s Harmonic ultrasound cutting devices infringed U.S. Patent Nos. 6,682,544; 6,063,050; and 6,468,286. According to the Federal Circuit, “the asserted patents generally disclose a surgical device… that employs ultrasonic energy to cut and coagulate tissue in surgery.” Figure 12 from U.S. Patent No. 6,063,050 is illustrated below:
The Federal Circuit held that the claims Covidien asserted against Ethicon were invalid as obvious. The opinion stated that “the district court improperly held that the Ethicon Prototype could not be considered prior art under 35 U.S.C. § 103, and erred in finding that the… claims would not have been obvious.”
Federal Circuit Finds Antares’ Patent Claims Invalid for Failure to Satisfy the “Original Patent” Requirement
(November 17, 2014) The United States Court of Appeals for the Federal Circuit affirmed a lower court’s denial of Antares Pharma, Inc.’s (“Antares”) motion for a preliminary injunction seeking to enjoin Medac Pharma, Inc. and Medac GMBH (collectively, “Medac”) from infringing U.S. Patent No. RE44,846 (a reissue patent of U.S. Patent No. 7,776,015). U.S. Patent No. RE44,846, entitled “Needle assisted jet injector,” states that it is “directed to a device for delivery of a medicament, and in particularly to a jet injector with a short needle to reduce the pressure at which the jet injector must eject the medicament for proper delivery.” Figure 1 from the patent is illustrated below:
The Federal Circuit held the reissue claims were invalid “for failure to comply with the ‘original patent’ requirement of 35 U.S.C. § 251.” According to the Court, to satisfy the “Original Patent” requirement, the original patent’s specification “must clearly and unequivocally disclose the newly claimed invention as a separate invention.” The opinion stated that Antares’ original patent (U.S. Patent No. 7,776,015) claimed jet injection devices and Antares broadened its claims to cover any “injection device” on reissue and that any hints, suggestions, or indications in the specification to other means of injection were not enough to save the reissue claims.
Federal Circuit Affirms Rejection of Claims Directed to a System for Detection of Blood Within a Body Lumen
On July 19, the Federal Circuit affirmed a decision of the Board of Patent Appeals and Interferences that the claims of U.S. Patent Application No. 10/097,096 were obvious over a combination of prior art references. The ‘096 application states that it relates to “a method and system for detection of colorimetric abnormalities in vivo, and specifically within the gastrointestinal (GI) tract.” Figure 3 of the ‘096 application is shown below:
The Federal Circuit held that the Board’s affirmance of the Examiner’s rejection of all claims as obvious was “supported by substantial evidence.” The Federal Circuit found that the claims at issue were a “predictable variation of the combination of [the prior art references].” The Federal Circuit also rejected the Applicant’s argument that the Board relied on new grounds in reaching its decision, stating: “[w]hile the Board’s explanation may go into more detail than the examiner’s, that does not amount to a new ground of rejection.”
On Monday, June 3, 2013, the Federal Circuit affirmed the judgments of non-infringement and invalidity in a lawsuit filed by the University of Minnesota against AGA Medical. The opinion was authored by Judge Dyk.
The University of Minnesota alleged that AGA infringed two patents, U.S. Pat. Nos. 6,077,291 and 6,077,281, directed to “devices and methods for occluding septal defects or shunts in the heart or the vascular system.” Following claim construction, the District Court of Minnesota granted summary judgment that the ‘291 patent was not infringed, and the ‘281 patent was anticipated. On appeal to the Federal Circuit, the University of Minnesota argued that the district court had incorrectly construed the claims of the ‘291 patent, and incorrectly found the ‘281 patent invalid.
The Federal Circuit affirmed, holding that the District Court properly construed the ‘291 patent’s claim language, correctly held that AGA’s device did not infringe the asserted claims of the ‘291 patent, and correctly held that the ‘281 patent was invalid in view of the prior art.
Boston Scientific has prevailed in the appeal of its lawsuit against Cordis Corporation. Boston Scientific alleged in the lawsuit that Cordis’ 2.25 mm Cypher Sirolimus DES coronary stent infringed U.S. Pat. No. 5,922,021, entitled “Intravascular Stent”. Figure 1A from the ‘021 Patent is shown below:
In a per curiam decision, the Federal Circuit affirmed, without further comment, the District Court’s March 2012 decision, which awarded Boston Scientific enhanced damages based on a finding of willful infringement of the ‘021 patent. The total award to Boston Scientific was approximately $42 million. A 32% royalty rate was assessed on sales of Cypher stents not included in the judgment.
The ‘021 patent was previously subject to ex parte re-examination, and a re-examination certificate issued on April 17, 2012. According to a Cordis press release, Cordis discontinued manufacturing Cypher and Cypher Select Plus Sirolimus-Eluting Coronary Stents at the end of 2011.
Edwards Lifesciences succeeded in its appeal at the Federal Circuit in the lawsuit Edwards Lifesciences v. CoreValve. Edwards’ lawsuit asserted that the Medtronic CoreValve ReValving system infringed U.S. Patent No. 5,411,552, entitled “Valve Prosthesis for Implantation in the Body and a Catheter for Implanting Such Valve Prosthesis”.
The Federal Circuit upheld the District Court’s decision in favor of Edwards Lifesciences and sent the case back to the District Court to reconsider its decision to deny an injunction. The Federal Circuit’s decision is available here.