Tagged: Hatch-Waxman

Southern District of Florida Dismisses Patent Infringement Claims for Generalized Allegations and Declaratory Judgment Claims for Lack of Sufficient Immediacy

In Scilex Pharmaceuticals Inc. v. Aveva Drug Delivery Systems, Inc., Apotex Corp., and Apotex Inc., the United States District Court for the Southern District of Florida recently granted defendant Apotex, Inc.’s (“Apotex”) motion to dismiss various counts of the complaint. The case is a Hatch-Waxman litigation involving patents covering plaintiff Scilex Pharmaceuticals Inc.’s (“Scilex”) topical lidocaine patch ZTlido® and an ANDA that was filed by defendant Aveva Drug Delivery Inc. (“Aveva”). Apotex’s motion was based on three different grounds: (1) Rule 12(b)(2) for lack of personal jurisdiction; (2) Rule 12(b)(6) for the patent infringement counts of the complaint because Apotex was not the party that submitted the ANDA; and (3) Rules 12(b)(6) and 12(b)(1) of the declaratory judgment claims because Apotex did not submit the ANDA and/or because there was no immediacy to the controversy on claims for future infringement. See Reckitt Benkiser Inc. v. Watson Labs., Inc.-Fla., No. 09-60609, 2009 WL 10667836, at *2 (S.D. Fla. Oct. 13, 2009) (“The mere filing of a Paragraph IV certification constitutes an act of patent infringement . . .”). With respect to the first two grounds, the district court granted Apotex’s motion, but granted Scilex leave to amend the complaint with respect to the patent infringement claims. Apotex argued that the claims in the case were based...

DNJ Court Denies Request for Early Summary Judgment Finding Motion Made Mid-Fact Discovery Premature

In Metacel Pharmaceuticals LLC v. Rubicon Research Private Limited, the United States District Court for the District of New Jersey recently denied the defendant’s request for leave to file a motion for summary judgment with respect to patent infringement. The plaintiff opposed the motion arguing that discovery was ongoing, and, in particular, the defendant had not yet produced certain samples necessary for the plaintiff to evaluate infringement. The plaintiff also argued there were also claim construction issues in the case that had not been resolved. The defendant’s motion was filed approximately two months before the parties’ opening claim construction briefs were due and, per the case’s scheduling order (ECF No. 25), fact discovery was to conclude 30 days after the court’s claim construction opinion. Agreeing with the plaintiff’s position, United States Magistrate Judge José R. Almonte found the defendant’s motion was “premature” and concluded that motions for summary judgment should be filed after claim construction. Gibbons will continue to monitor and report developments in Hatch-Waxman litigation in the District of New Jersey.

Northern District of California Relies on the Safe Harbor Defense of Section 271(e)(1) to Resolve Infringement Cases Early

Two recent decisions from the Northern District of California show courts’ willingness to dispose of cases early in litigation through the safe harbor defense. The safe harbor of Section 271(e)(1) allows competitors, before the expiration of a patent, to engage in otherwise infringing activities if the use is “reasonably related to” obtaining regulatory approval. These two decisions provide pre-litigation and litigation guidance for life science companies that manufacture regulated products such as drugs and medical devices. The Supreme Court has construed the safe harbor to apply to drugs as well as medical devices and other products subject to Food and Drug Administration (FDA) approval. Section 271(e)(1) of the Patent Act provides that: “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” In Carl Zeiss Meditec v. Topcon Medical Systems, the N.D. Cal. granted with prejudice a motion to dismiss the plaintiff’s patent infringement claim based on product testing as barred by the safe harbor of § 271(e)(1). Carl Zeiss alleged that software testing by Topcon...

28 Days to Amend Contentions Following Disclosure of Preliminary Claim Constructions

In an interesting decision applying California’s Local Patent Rules, Northern District of California District Court Judge William Alsup held that “after receiving the other side’s preliminary claim construction disclosure under Rule 4-2, a party in a patent litigation must move promptly to disclose any back-up contentions it may wish (or eventually wish) to make for its infringement or invalidity case, in the event the other side’s claim construction is thereafter adopted or else any such back-up contentions will be deemed waived. Promptly means within 28 days at the latest.” Fluidigm Corp., et al. v. IONpath, Inc. at 4. Judge Alsup’s decision was his answer to “the question of the extent to which our patent local rules require infringement and invalidity contentions to set forth not only a party’s primary theory but also its backup theory in case its opponent’s claim construction prevails.” Id. at 1. In answering that question, Judge Alsup provided a brief exposition on California’s Local Patent Rules. “Before our local patent rules, parties struggled to determine the opposing party’s theory of liability via discovery requests, such as contentions interrogatories.” Id. at 6. The adoption of local patent rules “replaced the bone-crushing burden of scrutinizing and investigating discovery responses with the parties’ infringement and invalidity contentions.” In alleviating that burden, local patent rules...

Paragraph IV to Paragraph III Conversion Does Not Deprive a District Court of Subject Matter Jurisdiction in Hatch-Waxman Cases

In a significant Hatch-Waxman decision, a Delaware District Court recently denied the defendants’ motion to dismiss under Federal Rule of Civil Procedure 12(b)(1), rejecting the argument that the conversion of the defendants’ Paragraph IV certifications to Paragraph III certifications deprived the court of subject matter jurisdiction, but granted the defendants’ motion for partial judgment on the pleadings under Federal Rule of Civil Procedure 12(c). In H. Lundbeck A/S v. Apotex Inc., the defendants converted their Paragraph IV certifications for certain patents at issue to Paragraph III certifications. Under 21 U.S.C. § 355(j)(2)(A)(viii), an ANDA filer must make any one of four (I-IV) certifications for each Orange Book listed patent. A Paragraph IV certification is an ANDA filer’s statement that it intends to market its bioequivalent pharmaceutical product before the expiration of a patent listed as covering that product because the ANDA filer believes such patent is either not infringed or invalid. A Paragraph III certification is an ANDA filer’s statement that it will not market its bioequivalent product until after the expiration of a patent listed as covering that product. The Court reasoned that in a Hatch-Waxman action, subject matter jurisdiction exists when a patent owner alleges that the filing of an ANDA infringes its patent under 35 U.S.C. § 271(e)(2) and conversion from a...

“Good Cause” Not Required for Contention Amendments in the District of Delaware

In Bio Delivery Sciences International Incorporated v. Alvogen PB Research & Development LLC, a Delaware District Court recently denied the plaintiffs’ motion to strike two prior art references from the defendants’ supplemental invalidity contentions, reasoning that the defendants were not obligated, as the plaintiffs argued, to demonstrate good cause for the amendment. The court noted that the case’s scheduling order did not contain a “good cause” requirement for amending contentions or a requirement that contentions be amended before the date on which the defendants served their amended contentions. The court reasoned that, while the amended contentions did need to comport with the requirements of Fed. R. Civ. P. 26, an analysis under the Pennypack factors did not require striking the references. In particular, the “possibility of curing the prejudice” and “likelihood of disruption of trial” factors militated strongly in the defendants’ favor because the plaintiffs did not need further discovery on the references and could address them easily in their expert reports, which would not have any impact on the trial date. Interestingly, had these defendants been litigating in the District of New Jersey they would have been obligated to demonstrate “good cause,” where Local Patent Rule 3.7 requires a showing of “good cause” for any party to amend “contentions, disclosures, or other documents required...

Plaintiffs’ Local Patent Rule 3.2(b) Document Production Sufficient to Support an “Invention Date” Predating a Disclosed “Priority Date”

Applying the plain language of the District of New Jersey’s Local Patent Rules, Chief Judge Wolfson recently ruled in Mitsubishi Tanabe Pharma Corp. v. Sandoz Inc., that the plaintiffs were not precluded from asserting an “invention date” derived from their Local Patent Rule 3.2(b) disclosures that differed from the “priority date” expressly disclosed in their Local Patent Rule 3.1(f) contention disclosures. Local Patent Rule 3.1(f) requires that infringement contentions disclose, “[f]or any patent that claims priority to an earlier application, the priority date to which asserted claim is allegedly entitled.” Local Patent Rule 3.2 governs the document production that must accompany Local Patent Rule 3.1 disclosures and Local Patent Rule 3.2(b) requires the production of “[a]ll documents evidencing the conception, reduction to practice, design, and development of each claimed invention, which were created on or before the date of application for the patent in suit or the priority date identified pursuant to L. Pat. R. 3.1(f), whichever is earlier.” An “invention date” and a “priority date” have distinct meanings in patent law. An “invention date” is the date when the inventor conceived the invention and reduced it to practice and the “priority date” is the filing date of the earliest patent application to which the patents-in-suit are entitled. The plaintiffs’ Local Patent Rule 3.1(f) infringement...

FDA Will Now Provide More Data on 180-Day Exclusivity in the Orange Book

In a recent alert, the FDA announced that effective June 18, 2019, the Agency will publish additional data in the Orange Book Paragraph IV Certifications list. To enhance the already published data, the Orange Book will now include (1) the number of potential first applicants; (2) the 180-day decision date; (3) the date of the “first applicant” approval; (4) the date of first commercial marketing by any first applicant; and (5) the expiration date of the last qualifying patent. According to the FDA, the updated data listing comports with the Agency’s commitment under the Drug Competition Action Plan where the FDA “committed to enhancing efficiency of the development and approval of ANDAs, with the ultimate goal of more approvals.” Historically, the Orange Book Paragraph IV Certifications list has contained relevant information related to 180-day eligibility for generic drug products. Until recently, the listings included the name of the drug product, dosage form, dosage strength(s), the reference listed drug, the New Drug Application Number and the date upon which the first substantially complete application containing a Paragraph IV certification was submitted to the Agency. The new data will provide greater clarity to Hatch-Waxman litigants in a variety of ways. More specifically, with respect to the number of first applicants, the data will provide the number of...

The Biologic Transparency Act (S. 659)

The Biologic Patent Transparency Act (S. 659) was introduced by Senators Susan M. Collins ((R) Maine) and Tim Kaine ((D) Virginia) to address an unintended burden when new biological products are presented to the FDA for approval. According to the sponsors, the Act “seeks to help increase patent transparency, promote biosimilar competition, bring needed biosimilar treatments to patients faster, and ultimately, lower drug prices for consumers.” Currently, there is no “official” listing of patents that relate to biological products comparable to what is available for small molecule drug products that are subject to patent and market exclusivity. Small molecule drug products patent listings are located in the commonly known “Orange Book.” Despite a lot of attention focused on biosimilar products and numerous litigations around the country, there is no official book for biologics that provides the transparency found with small molecule drugs. Instead, an “unofficial” book known as the “Purple Book” purports to identify the patents that cover a biological product. The Biologic Patent Transparency Act remedies this deficiency and requires manufacturers of approved biological products to list the patents covering their products with the FDA. In particular, the Act provides for the following: Codification and publication of the Purple Book to ensure that the public is aware of patents covering a biological product; Listing...