Tagged: Patent Infringement

Recently Created USPTO Precedential Opinion Panel to Decide Joinder Issues in First Review

Recently Created USPTO Precedential Opinion Panel to Decide Joinder Issues in First Review

In September, the United States Patent and Trademark Office (USPTO) revised its Standard Operating Procedures 2, addressing among other things, the new Precedential Opinion Panel and the processes the panel will follow during any review. The newly created panel recently accepted its first case where it will consider issues of party and subject matter joinder as part of a larger review of patentability of patents directed to fracking technology. Proppant Express Investments v. Oren Technologies, IPR2018-00914, Paper 24 (PTAB Dec. 3, 2018). This blog post will provide an overview of the Precedential Opinion Panel and the issues it will address in its first review. USPTO Standard Operating Procedures 2, “sets forth the composition of the Precedential Opinion Panel, describes the mechanisms for invoking Precedential Opinion Panel review of a Board decision recently issued in a pending case, and explains the Precedential Opinion Panel review process.” The panel will typically consist of the USPTO Director, the USPTO Commissioner for Patents, and the Chief Judge of the Patent Trial and Appeal Board (PTAB). The resulting decisions will be precedential and have binding authority. Under USPTO procedures, there are three ways to obtain a rehearing from the Precedential Opinion Panel: “The Director may...

Stem Cell Transplant-Related Patent Found Valid Under Alice

Stem Cell Transplant-Related Patent Found Valid Under Alice

In Genzyme Corp. v. Zydus Pharmaceuticals (USA) Inc., a Delaware district court recently found two patents directed to methods of mobilizing progenitor/stem cells from bone marrow to the peripheral blood stream for use in stem cell transplantation valid under 35 U.S.C. § 101 as being directed to patent-eligible subject matter. The district court utilized the framework articulated in Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014), on which we have previously reported here, here, and here, to determine whether the patent claims covered patent-eligible subject matter or were patent-ineligible “[l]aws of nature, natural phenomena, [or] abstract ideas[.]” Under the Alice framework, the court first determines if the patent claims at issue are directed to a patent-ineligible concept, and, if so, then considers whether the claims contain an “inventive concept” which “transform[s] the nature of the claim into a patent-eligible application.” The district court found that the claims at issue were not directed to any patent-ineligible concept under step one of Alice because they were directed to the patent-eligible concept of “using plerixafor, itself a compound that does not naturally exist, to amplify a natural phenomenon – stem cell mobilization – in an unnatural way.” The...

U.S.-Mexico-Canada Trade Agreement to Promote Innovation in Biotechnology

U.S.-Mexico-Canada Trade Agreement to Promote Innovation in Biotechnology

On September 30, 2018, the United States, Mexico, and Canada reached an agreement in principle to replace the North American Free Trade Agreement (NAFTA). The pending United States-Mexico-Canada Agreement (USMCA) includes provisions governing the protection and enforcement of intellectual property rights. This blog post will cover the IP provisions of the USMCA, particularly as applied to pharmaceuticals and biologics. It’s important to note that the provisions of the USMCA prescribe a minimum requirement, some of which is already met or surpassed by the individual countries’ respective patent regimes. 1. Data protection for biologics Under Article 20.F.14, each country must provide, with respect “to the first marketing approval” of a product that “is or contains a biologic,” protection of undisclosed test or other data concerning the safety and efficacy of the product for “a period of at least ten years from the date of first marketing approval of that product.” This ten-year data exclusivity applies “at a minimum” to “a product that is produced using biotechnology processes and that is, or, alternatively, contains, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, for use in human beings for the prevention, treatment, or cure...

Patent Infringement Defendants’ Attempt to Transfer Venue Thwarted

Patent Infringement Defendants’ Attempt to Transfer Venue Thwarted

In federal cases, venue transfer is permitted pursuant to 28 U.S.C. § 1404(a), “[f]or the convenience of parties and witnesses, in the interest of justice . . . to any other district or division where it might have been brought or to any district or division to which all parties have consented.” The defendants in a patent infringement case venued in the District of New Jersey recently failed in their attempt to transfer venue of their cases to the District of Delaware pursuant to § 1404(a). The cases involve the alleged infringement of a patent that covers Suboxone sublingual film for the treatment of opioid dependence. The defendants argued that venue transfer was appropriate based on their consent to venue in Delaware, the discretionary factors outlined in Jumara v. State Farm Insurance, 55 F.3d 873 (3d Cir. 1995), and the first-filed rule. None of these arguments proved successful, as the magistrate judge issued reports and recommendations denying the motions of defendants Dr. Reddy’s, Teva, and Alvogen Pine Brook. And, the district judge affirmed and adopted the magistrate judge’s opinions. After first concluding that venue for the cases was proper in the District of New Jersey pursuant to the patent venue statue,...

What is “A Regular and Established Place of Business”?: A Case Compendium

What is “A Regular and Established Place of Business”?: A Case Compendium

Since the TC Heartland decision in which the Supreme Court ruled that the “residence” prong in the patent venue statute, 28 U.S.C. § 1400(b), refers only to the state of incorporation and not the definition conferred in the general venue statute, § 1391, parties and courts have focused attention on interpreting the alternative basis for venue under the statute: “where the defendant has committed acts of infringement and has a regular and established place of business.” TC Heartland v. Kraft Foods Group Brands, 137 S. Ct. 1514, 1516 (2017). Of particular interest is how courts have ruled on what constitutes “a regular and established place of business.” In September 2017, the Federal Circuit clarified that a “regular and established place of business” must meet three general requirements: “(1) there must be a physical place in the district; (2) it must be a regular and established place of business; and (3) it must be the place of the defendant.” In re Cray, 871 F.3d 1355, 1360 (Fed. Cir. 2017). First, there must be a “physical place,” i.e., a “physical, geographical location in the district from which the business of the defendant is carried out.” Id. at 1362. The Court defined a...

Surveying the CRISPR-Cas9 Patent Landscape in the United States

Surveying the CRISPR-Cas9 Patent Landscape in the United States

This post will discuss the patent landscape of the groundbreaking CRISPR-Cas9 systems in the United States, including pending legal disputes. A CRISPR-Cas9 system is a combination of protein and ribonucleic acid (“RNA”) that can alter the genetic sequence of an organism. CRISPR-Cas systems occur naturally in bacteria and help the bacteria target and cut identified virus deoxyribonucleic acid (“DNA”). The CRISPR-Cas9 system is being developed as a powerful tool to modify specific DNA in the genomes of more complicated organisms, including plant and animal cells. For the purpose of this overview, the mechanism of CRISPR-Cas9 is explained in the Patent Trial and Appeal Board (PTAB)’s Broad Institute v. The Regents of the University of California interference decision. As the decision explains, the CRISPR-Cas9 system comprises three effective parts: a guide-RNA sequence, an activator-RNA sequence, and a protein called Cas9. CRISPR-Cas9 alters a target DNA molecule by first binding the guide-RNA sequence to a specific sequence in the DNA of interest. The activator-RNA sequence then interacts with the Cas9 protein, and the Cas9 protein cuts the target DNA at a specific site. By linking a DNA-cutting protein (Cas9) to a specific site on the target DNA, the CRISPR-Cas9 system achieves specific targeted...

Post-Alice Plaintiffs Beware: The Northern District of California Awards Attorneys’ Fees in Exceptional Case

Post-Alice Plaintiffs Beware: The Northern District of California Awards Attorneys’ Fees in Exceptional Case

Abstract ideas are not patentable pursuant to 35 U.S.C. § 101. And, in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) the Supreme Court set forth a framework to determine whether a patent is directed to an unpatentable abstract idea. Following Alice, defendants frequently move to dismiss patent infringement actions based on Section 101. That is exactly what recently happened in Cellspin Soft, Inc., v. Fitbit, Inc. in the Northern District of California. In that case, the 14 defendants filed a joint motion to dismiss pursuant to Section 101, arguing that the patents were directed to the “abstract concept” of acquiring, transferring, and publishing data and that the claims recited only “generic computer technology” to carry out the abstract idea, and thus lacked a requisite “transformative step” which would render the abstract idea patentable. The District Court agreed and entered judgment in the defendants’ favor. Following their successful motion to dismiss, the defendants moved, again successfully, for attorneys’ fees under 35 U.S.C. § 285. In patent infringement actions, courts have discretion, pursuant to Section 285, to award attorneys’ fees in an “exceptional case.” And, the district court found that the Cellspin case was just that. In...

Supreme Court Expands the Scope of Damages to Include Foreign Sales

Supreme Court Expands the Scope of Damages to Include Foreign Sales

The Supreme Court in WesternGeco LLC v. ION Geophysical Corp. opened a new door to recover for patent damages in its holding that a patent owner can recover damages for patent infringement under 35 U.S.C. §271(f)(2) and §284 of lost foreign profits. The Patent Act outlines several ways an alleged infringer may be liable for patent infringement, including §271(f) which “expands the definition of infringement to include supplying from the United States a patented invention’s components.” 35 U.S.C. §284 authorizes “damages adequate to compensate for the infringement, but in no event less than a reasonable royalty for the use made of the invention by the infringer.” In this case, WesternGeco developed technology for surveying the ocean floor for oil and gas companies. ION Geophysical Corp. sold a competing system where the components were manufactured in the United States and shipped abroad. The Southern District of Texas found that ION Geophysical Corporation infringed WesternGeco’s patents, and that WesternGeco lost specific contracts due to ION’s infringement. The district court awarded $93.4 million in lost profits and $12.5 million in royalties. On appeal, the Court of Appeals for the Federal Circuit reversed the award of lost-profit damages following its precedent in Power Integrations, Inc....

Senator Hatch Proposes Legislation Forcing Challengers to Choose Between Filing a Hatch-Waxman Action or Filing an IPR

Senator Hatch Proposes Legislation Forcing Challengers to Choose Between Filing a Hatch-Waxman Action or Filing an IPR

On June 13, Senator Orrin Hatch, co-author of the Hatch-Waxman Act, proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (“IPR”) process for pharmaceuticals. The senator published a press release summarizing and explaining the proposed legislation. The amendment, titled the Hatch-Waxman Integrity Act of 2018, intends to “restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development” by “prevent[ing] alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design.” The proposed legislation would amend Sections 505(b)(2) and 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 355(b)(2) and 355(j)(2)(A) respectively) to require the applicant to certify to the FDA that “neither the applicant nor any party in privity with the applicant, has filed, or will file, a petition to institute inter partes review” in order to be eligible for abbreviated regulatory approval under the Hatch-Waxman Act. The applicant would further need to certify that it “is not relying in whole or in part on any decision issued by the Patent Trial and Appeal Board in an [IPR]” in making the certification that the relevant listed patent is invalid or will not be infringed. According to Senator...

A Domestic Corporation Can Reside in Only One District in the State of Its Incorporation for Patent Venue

A Domestic Corporation Can Reside in Only One District in the State of Its Incorporation for Patent Venue

The Federal Circuit in In Re BigCommerce recently held in a mandamus opinion that a domestic corporation incorporated in a state having multiple judicial districts “resides” for the purposes of 28 U.S.C. § 1400(b) only in a single judicial district within that state. In so holding, the Federal Circuit resolved a district court split with competing interpretations from the Eastern District of Texas and the Central District of California. The court’s opinion provides further guidance to practitioners and clarifies jurisprudence post TC Heartland. The patent venue statute provides that patent infringement suits may be brought (1) “in the judicial district where the defendant resides,” or (2) “where the defendant has committed acts of infringement and has a regular and established place of business.” 28 U.S.C. §1400(b) (emphasis added). The Central District of California in Realtime Data LLC v Nexenta System held that a domestic corporation “resides” in the state of its incorporation “only in the judicial district in which it maintains in principal place of business.” No 2:17-cv-07690, Dkt. 28 (C.D. Cal. Jan. 23, 2018). The Eastern District of Texas in Diem v. BigCommerce came to a different conclusion, holding that “a domestic corporation resides in the state of its incorporation and if that...