Gibbons Law Alert

Gibbons Law Alert

Tagged: Patent Infringement

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

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Posted in Biotech / Licensing / Patent

On June 21, 2019

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...

District Court Must Consider Whether the Patentee Must be Joined Before Dismissing the Case for Lack of Statutory Standing

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Posted in Licensing / Patent

On June 19, 2019

The question of who must join a patent infringement suit often raises interesting questions of rights, obligations, and control of the litigation. In the global marketplace with increased licensing arrangements, the extent of retaining rights can have a direct impact on the viability of a lawsuit and protecting intellectual property. Recently, the Federal Circuit in Lone Star Silicon Innovations v. Nanya Technology provided further clarification on what meets the standing requirement to bring a patent infringement case, and for dismissing a case for lack of standing. In this patent litigation, the asserted patents (twelve in all) were originally assigned to Advanced Micro Devices (AMD). AMD later executed an agreement purporting to transfer “all right, title and interest” in the patents to Lone Star. The transfer agreement, however, imposes several limitations on Lone Star. For example, Lone Star may only assert the patents against “Unlicensed Third Party Entit[ies]” specifically listed in the agreement. To add new entities, Lone Star and AMD both must agree. If Lone Star sues an unlisted entity, AMD has the right, without Lone Star’s approval, to sublicense the patents to the unlisted entity. Further, AMD can prevent Lone Star from assigning the patents, and AMD and its customers can continue to practice the patents. Finally, AMD shares in any revenue Lone Star...

Legislators Propose Framework To Reform Patent Eligibility Under Section 101

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Posted in Biotech / Patent / Pharmaceuticals

On May 2, 2019

On April 17, 2019, Senators Chris Coons and Thom Tillis, and Representatives Doug Collins, Hank Johnson, and Steve Stivers unveiled a framework to reform 35 U.S.C. §101. Section 101 of the Patent Act currently makes patentable “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Although the statute is relatively permissive, courts have limited patentable subject matter beyond the statutory mandate by creating judicial exceptions. Under these exceptions as articulated in Alice Corp. v. CLS Bank International, “[l]aws of nature, natural phenomena, and abstract ideas are not patentable.” The proposed framework seeks to address these exceptions to patent eligible subject matter through statute versus an ever-growing list of case law. Under the lawmakers’ proposed framework, reformed Section 101 would: Keep existing statutory categories of process, machine, manufacture, or composition of matter, or any useful improvement thereof. Eliminate, within the eligibility requirement, that any invention or discovery be both “new and useful.” Instead, simply require that the invention meet existing statutory utility requirements. Define, in a closed list, exclusive categories of statutory subject matter which alone should not be eligible for patent protection. The sole list of exclusions might include the following categories, for example: Fundamental scientific principles Products that exist solely and exclusively in nature Pure...

The Biologic Transparency Act (S. 659)

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Posted in Biotech / Patent / USPTO

On March 11, 2019

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...

Supreme Court Holds That Non-Public Sales are Invalidating Under Post-AIA Section 102

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Posted in Biotech / Patent / USPTO

On February 1, 2019

In a closely watched case directly addressing open questions after the enactment of the America Invents Act (AIA), a unanimous Supreme Court (Thomas, J.) held in Helsinn v. Teva that a sale to a third party, despite being confidential, nevertheless triggered the long-standing meaning of “on sale” under §102(a). Gibbons previously reported on this much anticipated decision. As background, Helsinn owns patents directed to reducing the likelihood of a serious side effect of chemotherapy treatment. Almost two years before applying for a patent, Helsinn and a third party entered into a license agreement and a supply and purchase agreement. The agreements were publicly announced, but required the third party “to keep confidential any proprietary information received under the agreements.” The Federal Circuit held that because the sale between Helsinn and the third party was publicly disclosed, the on-sale bar applied. Before enactment of the AIA, 35 U.S.C. §102(b) barred the patentability of an invention that was “patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent.” By enacting the AIA, Congress amended §102 to bar the patentability of an “invention [that] was patented, described in a printed publication, or...

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

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Posted in Patent / USPTO

On December 14, 2018

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 convene a Precedential Opinion Panel to review a decision in a case and determine whether...

Stem Cell Transplant-Related Patent Found Valid Under Alice

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Posted in Patent / Pharmaceuticals

On October 31, 2018

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 court then found that, “even if those claims were directed simply to the natural phenomenon...

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

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Posted in Biotech / Pharmaceuticals

On October 18, 2018

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 of a disease or condition.” Under Article 20.K.1, this provision need not be implemented until...

Patent Infringement Defendants’ Attempt to Transfer Venue Thwarted

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Posted in Patent / Pharmaceuticals

On September 5, 2018

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, 28 U.S.C. § 1400(b), the court turned to the defendants’ arguments for transfer. With respect...

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

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Posted in Patent

On August 22, 2018

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 physical place as a “building or part of a building set apart for any purpose.”...

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