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Fish & Richardson Litigation Blog

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Infringement Analysis Under §271(e) Focuses On The Product That Is Likely To Be Sold Following ANDA Approval, Not

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Ferring B.V. v. Watson Labs, Inc. et al.,__ F.3d __ (Fed. Cir, Aug. 22, 2014) (LOURIE, Dyk, Reyna) (D. Nev. Jones) (2 of 5 stars)

Fed Cir affirmed non-obviousness but reversed infringement finding, and vacated the injunction and order preventing FDA approval of a generic product until patent expiration.  This is a companion appeal to Ferring, B.V. v. Apotex, Inc., involving the same patents but a different ANDA defendant.  Continue Reading »

If ANDA is Silent on Infringement, then Infringement is Assessed Based on the Product Likely to Be Sold; Courts Have Discretion to Consider Post-Trial ANDA Amendments

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Ferring B.V. v. Apotex, Inc. et al.,__ F.3d __ (Fed. Cir, Aug. 22, 2014) (Lourie, DYK, Reyna) (D. Nev.: Jones) (3 of 5 stars)

Fed Cir affirmed dismissal of Ferring’s Hatch-Waxman infringement claim as moot after Apotex’s amendment to its ANDA rendered it non-infringing.

The patents covered an extended-release drug and required that less than “about 70%” of the active ingredient dissolve after 45 minutes.  Apotex filed an ANDA in 2010 that did not specify the dissolution rate but amended it in 2014 to require at least 75% dissolution at 45 minutes.  The district court found that, although the 2010 ANDA infringed because its silence on the dissolution rate meant Apotex “could” sell an infringing product, the 2014 amended ANDA no longer infringed and thus dismissed the claim as moot.  Continue Reading »

Double-Patenting May Apply Whenever Two Patents Have Different Expiration Dates; Later-Expiring Patent to a Species Was Invalid Where Earlier-Expiring Patent Disclosed Small Genus and the Utility Claimed in the Later Patent

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AbbVie Inc. v. The Mathilda & Terence Kennedy Inst. of Rheumatology Trust, ___ F.3d ___ (Fed. Cir. Aug. 21, 2014) (DYK, Wallach, Chen) (S.D.N.Y.: Crotty) (2 of 5 stars)

Fed Cir affirms invalidity based on obviousness-type double patenting.  Kennedy obtained two related patents covering treatment methods for rheumatoid arthritis by co-administering two drugs. The later patent claimed a species of the genus covered by the first, earlier-expiring patent.  Continue Reading »

District Court Properly Clarified Claim Construction Post-Verdict to Require Method Steps Be Performed In a Particular Order to Avoid Rendering One Step Superfluous

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mFormation Techs., Inc. v. Research in Motion Ltd., ___ F.3d ___ (Fed. Cir. Aug. 22, 2014) (PROST, Schall, Hughes) (N.D. Cal.: Chen and Ware) (2 of 5 stars)

Fed Cir affirms JMOL of non-infringement. The patent covers a method remotely managing an electronic device that required “establishing a connection between the wireless device and the server” and “transmitting” information “from the server to the wireless device.” The district court, in granting JMOL, clarified that the “establishing” step had to be complete before transmission began, while the accused products did not. Continue Reading »

Federal Circuit Affirms Inequitable Conduct Finding in Apotex v. UCB

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The Federal Circuit’s recent decision in Apotex, Inc. v. UCB, Inc., — F.3d —-, 2014 WL 3973498 (Aug. 15, 2014), confirms that the doctrine of inequitable conduct is not yet dead. The Federal Circuit significantly tightened the standard for proving a patent is unenforceable for inequitable conduct in Therasense, Inc. v. Becton, Dickinson, & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc). The doctrine had traditionally required proof of (1) a “material” misrepresentation or omission to the Patent Office, and (2) that the person responsible for the misrepresentation or omission did it with the intent to deceive. The significant change in Therasense was ratcheting up the standard for materiality, holding that conduct was material only if the examiner would not have issued the patent “but for” the conduct. Therasense allowed for only one exception to this high standard—“affirmative egregious misconduct,” such as “the filing of an unmistakably false affidavit,” is also material regardless of whether it would have changed the examiner’s behavior. Continue Reading »

IPR’s and the Hatch-Waxman 30-Month Stay of FDA Approval

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H-W-vials-with-needle-image-for-brochure-xlargeWhen a patentee (the “brand”) files suit under the applicable provision of the Hatch-Waxman Act (“the Act”), 35 U.S.C. § 271(e)(2)(A), against a generic company (the “generic”) that has submitted an ANDA with a paragraph IV certification, the FDA cannot approve the ANDA for 30 months from the date of the patentee’s receipt of the so-called notice letter. 21 U.S.C. § 355(j)(5)(B)(iii). The court can lengthen or shorten the stay due to the lack of cooperation by the generic or the brand, respectively, or a preliminary injunction against the generic. Id. Thus, the length of the stay is subject to equitable considerations. Continue Reading »

When Sleeping Dogs Aren’t Allowed to Lie

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As we close year two of patent reform, we should be mindful that we only have six more years to use Covered Business Method review under the America Invents Act. Why should we care that only six years of CBM review remain? It offers defendants accused of infringing a qualifying patent one of the most powerful tools available to beat back an accuser who won’t let sleeping dogs lie. Continue Reading »

Hatch-Waxman Actions: Who Do You (Can You) Sue?

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After receipt of a so-called Paragraph IV Notice from a generic company, a patentee – the brand company has 45 days in which to file suit to secure a 30-month stay of FDA approval of the generic’s ANDA. Not much time! But who does the brand sue? The applicable statute, 35 U.S.C. § 271(e)(2)(A), envisions suit against the ANDA “submitter.” Yet this is complicated where multiple organizations are involved in the “submission.” Can suit be instituted against those that merely “aid and abet,” i.e., induce, the ANDA filing? These considerations are significant because relief under § 271(e)(4) (A)-(C) is available only against named defendants. Moreover, discovery burdens and expenses are greatly reduced where generic targets are joined as defendants, especially where discovery is sought from foreign entities. Thus, it behooves the brand to join all potential parties.

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Notice Of Invalidity Position Insufficient To Preserve Right To Post-Trial JMOL

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Medisim Ltd. v. Bestmed, LLC __F.3d__ (Fed. Cir. July 14, 2014) (PROST, Taranto, Chen) (S.D.N.Y., Scheindlin) (3 of 5 stars)

Fed Cir vacates JMOL of anticipation, and affirms JMOL of unjust enrichment and conditional grant of new trial on anticipation.

JMOL on anticipation:  BestMed forfeited its right to move for JMOL on anticipation under Fed. R. Civ. P. Rule 50(b) because it did not preserve its rights by moving under Rule 50(a) before the case was submitted to the jury.  BestMed’s evidence of its Rule 50(a) motion showed that BestMed thought the issue of anticipation was for the jury rather than for the court on JMOL.  BestMed also did not expressly move or cross-move for its own JMOL of anticipation.  Moreover, the district court’s statement that BestMed had preserved the record and renewed its motion related to unjust enrichment and not anticipation. Continue Reading »