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Item 1. Legal Proceedings

2021-03-31 compared with 2021-01-08 · 26 added, 61 removed, 27 unchanged (76% of the section changed)

7 unchanged sentences

(“Bard”) filed a suit in the United States District Court of Utah claiming certain of the Company's implantable port products infringe on three U.S.

patents held by Bard (the "Utah Action").

Bard’s complaint sought unspecified damages and other relief.

The Company filed petitions for reexamination in the US Patent and Trademark Office ("USPTO") seeking to invalidate all three patents asserted by Bard in the litigation.

The Company's petitions were granted and 40 of Bard's 41 patent claims were rejected and, following further proceedings, the Patent Office issued a Final Rejection of all 40 claims subject to reexamination.

Thereafter, Bard filed appeals to the USPTO Board of Appeals and Interferences for all three reexaminations which were decided as follows:

For US Patent No.

7,785,302, the rejections of six of the ten claims under reexamination were affirmed, but were reversed on four of the ten claims.

7,959,615 the rejections of eight of the ten claims under reexamination were affirmed but the rejections of the other two of the ten claims were reversed.

In the third, for U.S.

7,947,022 the rejections of all twenty claims under reexamination were affirmed.

Thereafter, Bard sought Rehearing in all three appeals and the Company sought Rehearing in the ‘302 and ‘615 appeals.

The USPTO denied all three Rehearing Requests, but modified its characterization of one prior art reference for the ‘302 and ‘022 decisions.

Bard filed appeals to the Federal Circuit Court of Appeals in all three reexams and the Company Cross-Appealed for the ‘302 and the ‘615 reexams.

MedComp also filed an Amicus Brief in support of the Company on November 22, 2017.

Meanwhile, on July 12, 2017 Bard assigned the asserted patents to Bard Peripheral Vascular, Inc.

(“BPV”) which was added as co-Appellant before the Federal Circuit and as a co-Plaintiff in the Utah action.

An oral hearing was held on September 5, 2018 and the Court rendered its decision on September 28, 2018, affirming that claims 1-5 and 10 of the ‘615 patent were invalid, but that claims 6-7 of the 615 patent and claims 1-4 of the 302 patent were valid over the prior art references considered in the Reexamination proceedings.

The Federal Circuit also reversed the PTAB’s claim construction ruling and remanded for consideration of obviousness for the remaining claims under the new claim construction ruling and for further findings with respect to whether one of the asserted references qualified as a printed publication.

On January 28, 2019, on remand, the USPTO reversed the rejections of the ‘302 claims 1-10, ‘022 claims 1-20 and ‘615 claims 8-9.

The USPTO has since issued Inter Partes Reexamination Certificates for the ‘302 Patent for the ‘022 patent and for the ‘615 patent.

The Company thereafter filed a Motion to Unstay the Utah Case and that motion was granted.

On November 4, 2019 the Court held a joint Status Conference among the Company’s Utah Action and two other cases filed by Bard on the same patents against MedComp and Smiths.

The Court set a schedule for defendant's Motions to Dismiss or Transfer.

The Company filed its motion on November 25, 2019;

and Bard filed a responsive brief and a motion for venue discovery on December 9, 2019.

The Company filed a responsive brief on December 16, 2019 and Bard filed a reply on December 23, 2019.

On February 27, 2020, the Court referred all non-dispositive motions to the presiding Magistrate and on March 3, 2020 the Court granted Bard’s Motion for Venue Discovery and denied the Company’s transfer motion without prejudice to re-filing after completion of the venue discovery, but no later than June 30, 2020.

Following venue discovery, AngioDynamics re-filed its Motion to Dismiss or Transfer on June 30, 2020.

Bard filed an opposition brief on July 28, 2020, and the Company filed a subsequent reply.

The Court granted AngioDynamics’s Motion to Transfer on November 16, 2020.

The case is currently pending in the District of Delaware and a scheduling conference has been set for January 21, 2021.The Company believes these claims are without merit and intends to defend them vigorously.

patents held by Bard (US Patent Nos.

7,785,302, 7,959,615 (“615”) and 7,947,022).

The case was stayed pending reexamination in the US Patent and Trademark Office ("USPTO").

Following the reexamination proceedings, and the parties’ related appeals to the Federal Circuit which resulted in further proceedings at the USPTO, certain claims of the 615 patent were held invalid, while the remaining claims of the 615 patent and the other two patents were upheld over the prior art references considered in the reexamination proceedings.

Thereafter, on November 16, 2020, the court granted the Company’s motion to transfer the case from the District of Utah to the United States District Court for the District of Delaware (“District of Delaware”).

The parties filed a proposed scheduling order on March 12, 2021.

The Company believes these claims are without merit and intends to defend them vigorously.

The Company has not recorded an expense related to the outcome of this litigation because it is not yet possible to determine if a potential loss is probable nor reasonably estimable.

On March 10, 2015, Bard and BPV filed suit in the United States District Court for the District of Delaware (the “Delaware Action") claiming certain of the Company's implantable port products infringe on three other U.S.

patents held by Bard, which are different from those asserted in the Utah action.

Bard's complaint seeks unspecified damages and other relief.

On June 1, 2015, the Company filed two motions in response to Bard’s Complaint - one sought transfer to the District of Utah where the Utah Action is currently pending, and the other sought dismissal of the entire complaint on grounds that none of the claims in the asserted patents is directed to patent eligible subject matter under Section 101 of the Patent Statute and in light of recent authority from the U.

Supreme Court.

On January 12, 2016, the Court issued a decision denying both motions.

A Markman hearing was held on March 10, 2017 and the Court issued its Claim Construction Order on May 19, 2017.

On May 19, 2017, Bard served its Final Infringement Contentions and on June 2, 2017, the Company served its Final Invalidity Contentions.

On October 20, 2017, the scheduling order for the case was amended to, among other things, set a trial date commencing July 23, 2018.

The parties completed Expert Discovery in January 2018 and completed briefing on their respective case dispositive motions on April 27, 2018.

On June 26, 2018, the Court denied all case dispositive motions, ruling that issues of material fact remained in dispute.

On July 9, 2018, the Court continued the trial until March 2019.

On January 9, 2019 the Court held a further claim construction hearing to resolve two outstanding claim construction issues prior to trial.

A Report and Recommendation (by Magistrate-Judge Fallon) was issued on February 11, 2019 and entered by the Court on February 28, 2019.

Jury selection was held on Friday March 1, 2019 and trial began on March 4, 2019.

On day four of the jury trial, at the close of C.R.

Bard’s case, the Court granted the Company's oral motion for judgment as a matter of law under rule 50(a) as well as its motions for summary judgement on the grounds that the asserted patents are invalid, ineligible, not infringed and not willfully infringed.

On April 5, 2019, Bard filed a precautionary Notice of Appeal to the Federal Circuit.

On April 26, 2019, the District Court issued a Memorandum and Order confirming the grant of judgment in the Company’s favor of patent ineligibility, non-infringement, patent invalidity and no willful infringement.

Meanwhile, on May 10, 2019, the Company filed a Motion for Attorney fees and non-taxable expenses under 35 USC Sec.

On May 21, 2019, the Court issued a Memorandum and Order which, inter alia, stayed proceedings on the Company’s fee Motion and the Company’s equitable claims pending appeal;

and entered Final Judgment on May 21, 2019 as well.

Bard filed a second Notice of Appeal on May 23, 2019.

Both appeals have since been consolidated and Bard’s opening brief was filed on September 27, 2019;

the Company's answering brief was filed on January 15, 2020;

and Bard’s reply brief was filed on March 4, 2020.

A hearing was held on June 1, 2020, and the court issued its decision on November 10, 2020.

The Federal Circuit reversed the judgment in part with respect to Section 101, and vacated and remanded the trial court’s invalidity and non-infringement judgments.

The Company filed a combined Petition for rehearing and rehearing en banc on December 10, 2020 which remains pending.

On March 10, 2015, Bard and Bard Peripheral Vascular filed suit in the District of Delaware claiming certain of the Company's implantable port products infringe on three U.S.

patents held by Bard (US Patent Nos.

8,475,417, 8,545,460, 8,805,478).

The case proceeded through trial which began on March 4, 2019.

On day four of the jury trial, at the close of Bard’s case, the Court granted the Company's oral motion for judgment as a matter of law as well as its motions for summary judgment on the grounds that the asserted patents are invalid, ineligible, not infringed and not willfully infringed.

On May 10, 2019, the Company filed a motion for attorney fees and non-taxable expenses under 35 USC Sec.

285, which remains stayed in the case.

Bard appealed the judgment to the Federal Circuit and on November 10, 2020, the Federal Circuit reversed the judgment in part with respect to Section 101, and vacated and remanded the trial court’s invalidity and non-infringement judgments.

The Company filed a combined Petition for rehearing and rehearing en banc on December 10, 2020, which was denied on January 15, 2021.

The Federal Circuit issued its mandate on January 22, 2021.

On March 15, 2021, the District of Delaware entered an order requiring the parties to submit status reports and denied as moot the Company’s motion for attorney’s fees and expenses.

The matter remains pending.

The Company maintains its belief that Bard’s claims are without merit.

The Company has not recorded an expense related to the outcome of this litigation because it is not yet possible to determine if a potential loss is probable nor reasonably estimable.

On March 8, 2021, Bard filed suit in the District of Delaware asserting certain of the Company’s port products (including certain related infusion sets) infringe U.S.

8,025,639, 9,603,992 and 9,603,993.

The Company has not yet answered, and the matter remains pending.

The Company maintains its belief that Bard’s claims are without merit.

The Company has not recorded an expense related to the outcome of this litigation because it is not yet possible to determine if a potential loss is probable nor reasonably estimable.

AngioDynamics, Inc.

11 unchanged sentences

AngioDynamics, Inc.

In this action, Merz alleged breach of contract against AngioDynamics based on a March 1, 2016 Distribution Agreement.

In this action, Merz alleged breach

of contract against AngioDynamics based on a March 1, 2016 Distribution Agreement.

On June 28, 2019, AngioDynamics reached a settlement with Merz.

2 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Legal Proceedings