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On Wednesday, May 7, 2021, the United States officially endorsed waiving intellectual property protections for COVID-19 vaccines. While the United States has taken the opposite position in recent months, the administration asserts that its departure is guided, at least in part, by the goal “to get as many safe and effective vaccines to as many people as fast as possible.”[1] That goal, however, is unlikely to be affected by such a waiver in the short term due to uncertainty in World Trade Organization (“WTO”) politics, ongoing shortages on raw materials and equipment, and lag-time in retrofitting potential manufacturers.
Continue Reading Waiver Of Intellectual Property Protections For COVID-19 Vaccine Unlikely To Have Meaningful Impact In Short Term

A Federal Circuit panel on Tuesday vacated its earlier finding that Teva induced infringement of U.S. Patent No. RE40,000, GSK’s patent covering its drug, Coreg®, and set a new round of oral argument for February 23.  Back in October, the Court in a 2-1 decision found Teva liable for induced infringement, even though Teva’s original label did not include the indication covered by the ’000 Patent.  In its ruling, the Court took issue with Teva’s marketing materials stating that its generic product is an AB rated generic of Coreg tablets without specific reference to any indication.  Following the decision, generic drug manufacturers and other interest groups asked the Court to reconsider, arguing that the ruling would impede the availability of low-cost generic drugs to reach the market and would effectively nullify the purpose of the Section viii statement, which allows a generic company to “carve out” any reference to a patented indication from its product’s labeling.
Continue Reading Federal Circuit Agrees to Reconsider Ruling in GSK v. Teva Drug Patent Case

As the world grapples with its response to COVID-19, the availability and nature of intellectual property protection afforded for diagnostic tests, treatments, vaccines, and accompanying data is likely to have a significant impact on whether and how that information is shared—and therefore necessarily will implicate the response time for containing the virus and resolving the pandemic.  This article explores those available protections, and how they may enhance or impede innovation.  This article also discusses several alternative approaches that could be used during these extraordinary times to incentivize swift collaboration while still protecting the financial interests of the innovators.
Continue Reading IP Protection and the Open COVID Cure Chase

Patentees and inventors of cannabis compounds may be happy to learn a district court in Colorado recently held that, based on the record before it, U.S. Patent No. 9,730,911, entitled “Cannabis extracts and methods of preparing and using same,” is not directed to unpatentable natural phenomena. United Cannabis Corporation v. Pure Hemp Collective Inc., No. 1-18-cv-01922 (Apr. 17, 2019, Order) (William J. Martinez).
Continue Reading Yes, UCANN!

The Federal Circuit weighed in on patent subject matter eligibility again last week, finding certain amino-acid containing dietary supplements, and related methods of use, to be patent eligible. In Natural Alternatives Int’l v. Creative Compounds, LLC, the Federal Circuit vacated the decision of the district court in the Southern District of California, which held that several sets of claims issued to Natural Alternatives International (“Natural”) were not directed to patentable subject matter under 35 USC § 101. The district court found the claims not patent eligible following a motion on the pleadings. Although the claims at issue included methods of treatment, composition, and process claims, this entry looks at the court’s decision with respect to methods.  The decision could put some wind in the sails of developers of supplements and nutraceuticals.
Continue Reading Federal Circuit Weighs in on Patent Subject-Matter Eligibility of Dietary Supplements

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious. See 35 U.S.C. §§ 102 and 103. Thus, innovative step-improvements to, and new applications of, existing technology may be patentable. Moreover, these step-improvements may prove lucrative, particularly when the underlying technology has entered the public domain, e.g., due to the expiration of the original patents. This concept is illustrated time and time again in the pharmaceutical industry where companies therein typically pursue competitive advantages by attempting to extend the patentable life of key technologies. One recent story illustrating this point was amplified in recent news when the FDA cleared a new pill produced by Aprecia Pharmaceuticals—the first pill of its kind produced using patented 3D printing technology.
Continue Reading Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

The standard of review is frequently cited but often overlooked as being outcome-determinative in patent cases. A recent trio of decisions by the Federal Circuit illustrates the differences in outcome that result from the standard of review for issued patents, challenged for validity in the Federal Courts, versus that for patent applications examined for patentability by the U.S. Patent and Trademark Office. A renewed consideration of these differences may motivate a patent challenger to proceed proactively under one of the postgrant reexamination procedures within the U.S. Patent Office (i.e., post-grant review (PGR) and inter partes review (IPR)) rather than reactively in the context of an invalidity defense or declaratory judgment action.
Continue Reading Standards of Review: Implications for Patent Challengers

On Sept. 21, 2012, a three-judge panel of the Federal Circuit in In re Droge (2011-1600) held that the claims in U.S. patent application serial no. 10/082,772 (the ‘772 application”), directed to a method of recombining DNA in eukaryotic cells, were unpatentable for obviousness. The Federal Circuit affirmed the decision of the Board of Patent Appeals and Interferences, affirming the patent examiner’s rejection for obviousness despite an expert opinion from the applicant that the prior art failed to provide an expectation of success in the claimed combination.
Continue Reading Inventions In Unpredictable Fields — Not Always Unobvious

By Barry Wilson and Martin Bader

On July 9, 2012, a three judge panel of the Federal Circuit in CLS Bank International v. Alice Corporation (Appeal No. 2011-1301) ("CLS Bank"), decided a case of patent eligibility under 35 U.S.C. § 101. In a split decision, the panel reversed the district court’s finding that three Alice Corporation patents claiming a computerized trading platform for exchanging obligations are drawn to patent ineligible subject matter. In holding the claims valid, the court found that the claims at issue included computer implemented limitations that are integral to the invention and not token post-solution activity. The court stated that claims should not be found patent ineligible unless it is "manifestly evident," that the claims are directed to an abstract idea. CLS Bank is the first Federal Circuit decision on patent eligibility following the Supreme Courts’ unanimous reversal of that court in Mayo Medical Laboratories v. Prometheus Laboratories 566 U.S. ____ (2012) ("Prometheus"). The majority decision in CLS Bank, as characterized by the dissent, departs significantly from the § 101 analysis enunciated in Prometheus.
Continue Reading CLS Bank: The patent eligibility of computerized trading platforms for exchanging obligations