IP Law Alert Blog

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...

Another District Court Addresses Viability of “Continuing Misappropriation” Under the Federal Defend Trade Secrets Act

Another District Court Addresses Viability of “Continuing Misappropriation” Under the Federal Defend Trade Secrets Act

The Federal Defend Trade Secrets Act (DTSA) provides a federal cause of action for misappropriation of a trade secret related to a product or service used in, or intended for use in, interstate or foreign commerce. See 18 U.S.C. § 1836(b). The DTSA applies to any trade secret misappropriation for which any act occurred “on or after the date of the enactment” of the DTSA. See P.L. 114-153 § 2(e). A Missouri district court recently held that the DTSA applies to trade secret misappropriation that continues after the DTSA enactment date (May 11, 2016)—even if the misappropriation began before the enactment date, see Roeslein & Assocs. v. Elgin, Civ. No. 17-1351(JMB), 2019 U.S. Dist. LEXIS 6981, at *36 (E.D. Mo. Jan. 15, 2019), adding to mounting precedent concluding the same. In Roeslein, developers of energy production facilities sued one individual (a former employee) and three corporate defendants for violation of the DTSA, among other claims. The corporate defendants moved to dismiss claims asserted against them under Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6), arguing that the plaintiffs’ DTSA claims were not cognizable because the plaintiffs failed to allege misappropriation on or after the DTSA’s enactment date. The court granted-in-part...

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...

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...

Need for Close Attention to Proposed Reasonable Royalty Evidence

Need for Close Attention to Proposed Reasonable Royalty Evidence

A recent court decision precluding a patent owner from relying on any of its proffered evidence to support a proposed reasonable royalty rate should be studied carefully by patent owners. See Acceleration Bay LLC. v. Activision Blizzard Inc., C.A. No. 16-00453-RGA, 2018 U.S. Dist. LEXIS 178362 (D. Del. Oct. 17, 2018). The case underscores how closely courts are evaluating evidence put forward to support a proposed reasonable royalty and the need to carefully vet such evidence (and decide who will present it) early in the case. In Activision, the defendant moved to preclude the plaintiff’s damages theories and supporting evidence. The court granted-in-part defendant’s motion. The plaintiff patentee had sought to support its proposed reasonable royalty rate of 15.5 percent with four pieces of evidence: (1) testimony of its Vice President of Licensing; (2) testimony of its CEO; (3) an industry report; and (4) an agreement between the defendant and a third party. The court precluded all four categories of evidence. First, the court precluded the testimony of the plaintiff’s licensing executive, stating that a reasonable royalty opinion is necessarily based on specialized knowledge, which the executive lacked. The court also found that the executive lacked personal knowledge of 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...

Federal Circuit Affirms PTAB Finding That CRISPR-Cas9 Inventions Are Patentably Distinct

Federal Circuit Affirms PTAB Finding That CRISPR-Cas9 Inventions Are Patentably Distinct

The Federal Circuit in Regents of the University of California v. The Broad Institute weighed in on the disputed inventorship of the breakthrough CRISPR-Cas9 technology, holding that the University of California (“UC”)’s invention of the mechanism in vitro did not render obvious Broad’s claims to the mechanism in eukaryotic cells. Gibbons previously reported on the technical background of CRISPR-Cas9. This post will focus on the inventorship issue and the implications of the Federal Circuit decision. In August 2012, UC researchers published an article showing that the CRISPR-Cas9 system, derived from prokaryotic cells like bacteria, could be used in vitro in a non-cellular experimental environment. Several research groups independently applied CRISPR-Cas9 in eukaryotic cells within months of UC’s disclosure. In February 2013, Broad researchers published an article describing the use of CRISPR-Cas9 in a human cell line. Both UC and Broad sought patent protection. UC, the senior party, claims the CRISPR-Cas system without referring to a particular cell type or environment. Broad, the junior party, claims the CRISPR-Cas system limited to use in eukaryotic cells, i.e., plant and animal cells. The Patent Trial and Appeal Board (PTAB) determined there was no interference-in-fact because, given the differences between eukaryotic and prokaryotic systems, a person...