Category: Patent

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

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,...

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

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

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...

CAFC Decision Issues Interpreting the Original Patent Requirement

CAFC Decision Issues Interpreting the Original Patent Requirement

As reported in a prior post, the Court of Appeals for the Federal Circuit (CAFC) recently had the opportunity to revisit the legal standard for invalidating reissue patent claims under the original patent requirement. In Forum US, Inc. v. Flow Valve, LLC, the CAFC affirmed a district court grant of partial summary judgment that certain reissue claims were invalid under the original patent requirement of 35 U.S.C. § 251. In the process, the Federal Circuit reaffirmed the legal standard set forth in a 2014 CAFC decision, Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354 (Fed. Cir. 2014). In Antares Pharma, the Federal Circuit held that to comply with the original patent requirement, an invention claimed in a reissue patent must either be for: (i) the same invention disclosed in the original patent or (ii) a newly claimed invention “clearly and unequivocally” disclosed as a separate invention in the original patent. See id. at 1362-1363. In Forum US, the plaintiff sought a declaratory judgment that claims 14-20 of U.S. Reissue Patent 45,878 were invalid. The original patent related to the machining of pipe joints used in the oil and gas industry. Each of the thirteen original patent claims required...

Legislators Propose Framework To Reform Patent Eligibility Under Section 101

Legislators Propose Framework To Reform Patent Eligibility Under Section 101

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...

Recent Decision Highlights Importance of Pleading Compliance with the Federal Patent Marking Statute

Recent Decision Highlights Importance of Pleading Compliance with the Federal Patent Marking Statute

A Delaware district court recently held that a patentee failed to state a claim for past patent infringement damages where the patentee failed to plead compliance with the patent marking statute in its complaint. See Express Mobile, Inc. v. Liquid Web, LLC, C.A. Nos. 18-01177-RGA, 18-01181-RGA, 2019 U.S. Dist. LEXIS 64362, at *5 (D. Del. Apr. 15, 2019). The decision highlights the importance of pleading compliance with the marking statute even where a product covered by the patent is not being offered for sale or sold in the United States. The federal patent marking statute (“Marking Statute”) provides a limitation on recoverable damages in patent litigation. See 35 U.S.C. § 287(a). It provides that “Patentees, and persons making, offering for sale, or selling within the United States any patented article for or under them, or importing any patented article into the United States, may give notice to the public that the same is patented, either by fixing thereon the word ‘patent’ or the abbreviation ‘pat.,’ together with the number of the patent.” The Marking Statute further provides that “[i]n the event of failure so to mark, no damages shall be recovered by the patentee in any action for infringement, except...

The Biologic Transparency Act (S. 659)

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...

PTAB Tackles Patentability Issues After New Guidelines

PTAB Tackles Patentability Issues After New Guidelines

Recently, the United States Patent and Trade Office (USPTO) enacted new guidelines to “clarify” the patentability standard and analyses. The USPTO stated that it had undertaken this clarification because many court decisions on the issue of patentability of method type patents in the computer arena had become very difficult for examiners to understand and apply in a predictive manner. As such, there were concerns that the examining corp was not reaching consistent examination and prosecution results. Following the enactment of the new guidelines, a Patent Trial and Appeal Board (PTAB) panel reviewed four patents relating to methods of electronically storing financial documents. The patents involved were US Patents 6,963,866, 7,552,118, 7,836,067 and 9,141,612 belonging to Mirror Imaging LLC (Mirror). Those patents were challenged by Fidelity Information Services LLC (Fidelity) because Fidelity asserted that only abstract ideas were involved, thereby being unpatentable subject matter under section 101. In fact, in a previous PTAB challenge on the same four patents, the PTAB actually opined that the Mirror patents were likely invalid. At the hearing, the questioning by the administrative patent judges centered around whether the abstract ideas are “integrated into a practical application.” Answers to the question of the practical application revolved...

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

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

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...

New CAFC Decision Interpreting the Original Patent Requirement of 35 U.S.C. § 251 May Be Imminent

New CAFC Decision Interpreting the Original Patent Requirement of 35 U.S.C. § 251 May Be Imminent

As intellectual property litigators who litigate reissue patents know, the Federal Circuit has not decided a case based on the original patent requirement of 35 U.S.C. § 251 since the 2014 Antares Pharma, Inc. v. Medac Pharma Inc. decision. 771 F.3d 1354 (Fed. Cir. 2014). In Antares Pharma, the court held that to comply with the original patent requirement, an invention claimed in a reissue patent must either be for: (i) the same invention disclosed in the original patent or (ii) a newly claimed invention “clearly and unequivocally” disclosed as a separate invention in the original patent. See id. at 1362. An appeal of a decision in Forum US, Inc. v. Flow Valve, LLC, Civ. No. 17-495-F (W.D. Ok.), Docket Entry 45, (CAFC Appeal No. 18-1765) invalidating certain claims pursuant to the original patent requirement is scheduled to be argued at the Federal Circuit on January 11, 2019 and may result in a new precedential decision applying the original patent requirement. In Forum US, the plaintiff sought a declaratory judgment that claims 14-20 of U.S. Reissue Patent 45,878 were invalid. The original patent related to the machining of pipe joints used in the oil and gas industry. Each of the 13...

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...