Our monthly newsletter reports on the patent law developments in biotech, biologics and pharmaceutical cases, legislation and federal agency actions. This month’s issue covers relevant news from June 2020.
Feel Like DOE is Having a Rebirth in Life Science Cases? You’re Not Alone
On June 15, 2020, the Supreme Court denied a petition for certiorari from the Federal Circuit’s 2019 Eli Lilly & Co. v. Hospira, Inc. opinion affirming infringement under the doctrine of equivalents (DOE). In doing so, the Supreme Court put to rest a more than decade-long dispute over attempts to market a generic version of Lilly’s Alimta®.
At issue in this latest iteration of Alimta ANDA litigation was Lilly’s U.S. Patent No. 7,772,209 (the ’209 patent) claiming an “improved method” for treating patients by administering pemetrexed disodium in combination with folic acid and vitamin B12. As originally filed, however, the asserted claims recited an “antifoliate,” not pemetrexed disodium (itself a species of antifolate). To overcome a prior art rejection during prosecution, Lilly narrowed that claim from administering an “antifoliate” to administering “pemetrexed disodium.” The generic applicants—Hospira and Dr. Reddy’s Laboratories (“DRL”)—developed an alternative salt: pemetrexed ditromethamine. Continue Reading
The PTAB Relies on the Adversarial Nature of AIA Proceedings
On July 6, 2020, in Hunting Titan, Inc. v. Dynaenergetics Europe GMBH, a Precedential Opinion Panel (POP) of the Patent Trial and Appeal Board (PTAB or Board) granted a patent owner’s motion to amend, after the Board denied the motion in an August 2019 Final Written Decision. This was only the fourth such decision since the POP’s creation.[1] The POP relied on the adversarial nature of PTAB proceedings and emphasized that the PTAB will only rarely raise a ground of unpatentability that a petitioner did not advance, and must provide parties adequate notice and opportunity to respond before it issues a decision. Continue Reading
Brompton Bicycle: European Court of Justice Unfolds Requirements for Copyright Protection of Functional Shapes
Protection of functional shapes is not just a matter of patent law. If patent protection does not exist or has already expired, the question arises whether shapes with a technical function may be eligible for protection by trade marks, designs, copyright or unfair competition law/passing-off.
In order to prevent monopolies on technical solutions prolonging the statutory term of protection of technical innovations under patent law, many jurisdictions provide for specific rules on the exclusion of functional features from being protected by other IP rights. Exploring the boundaries of these exclusions is an intriguing topic in our daily business.
US design patents may protect some functional features, as discussed in prior blogs here and here. As far as European law is concerned, the European Court of Justice (ECJ) just added another brick to the edifice with its judgment of 11 June 2020 for Brompton Bicycle.[1] Continue Reading
US Supreme Court Opens Doors to Generic.Com Trademarks
On June 30, 2020, the U.S. Supreme Court ruled that Booking.com was not a generic term and could be eligible for federal trademark registration.[1] This 8-1 ruling overturned the “sweeping rule” of the U.S. Patent and Trademark Office (“USPTO”) that the combination of a generic word and .com is generic and thus not eligible for trademark registration under US trademark law. The Court instead held, in an opinion penned by Justice Ginsberg: “A term styled ‘generic.com’ is a generic name for a class of goods or services only if the term has that meaning to consumers.” According to lower court determinations that the USPTO had not contested, consumers did not view Booking.com as a generic term for online hotel reservation services in general. Continue Reading
USPTO Announces Fast-Track Appeals Pilot Program
The United States Patent and Trademark Office (USPTO) has launched a new pilot program to fast-track ex parte appeals to the Patent and Trial Appeal Board (PTAB). While ex parte appeals to the PTAB are normally decided in the order in which they are docketed, this new Fast-Track Appeals Pilot Program will allow appellants to have their appeals advanced out of turn. Petitions for expedited appeals accompanied by the required fee of $400 are being accepted as of July 2, 2020. Continue Reading
Legal Insights Webinar – After Arthrex: The Implications of Arthrex and Its Progeny Going Forward
Join us on July 16, 2020 at 12pm EDT/9am PDT for a complimentary webinar – After Arthrex: The Implications of Arthrex and Its Progeny Going Forward.
Last fall, the Federal Circuit answered a challenge to the constitutionality of the appointment of administrative patent judges to the Patent Trial and Appeal Board. The court held that the America Invents Act, which provided for APJ appointments, violated the Constitution’s Appointments Clause.
Frank Bernstein and Bryan Jaketic will explore Arthrex and its multiple progeny, explain why we should care, and discuss real life implications and practice tips.
Additional information and registration is available here.
This program is pending 1.0 hour of CLE in AZ, CA, NJ, NY and OH.
COVID-19’s Impact on Section 337 Investigations at the U.S. International Trade Commission (Update)
Like many other Federal Agencies and U.S. District Courts, the U.S. International Trade Commission (“ITC”) has been open for business during the COVID-19 crisis, but on a limited basis. On June 22, 2020, the ITC announced plans for re-opening on a broader basis.
As the District of Columbia and the surrounding areas begin a phased re-opening, the ITC has developed a Three-Phase Plan to Re-Establish On-Site Business Operations at the ITC Building based upon Office of Management and Budget (OMB) and Office of Personnel Management (OPM) guidance adapted for federal agencies, as well as the Centers for Disease Control and Prevention (CDC), and other relevant agencies regarding COVID-19. The Three-Phase plan will be in effect until further notice. Continue Reading
New Ways of Notarization During the COVID Pandemic
If you regularly have documents notarized as part of your practice, you’re probably like me. Under normal circumstances, you probably have the privilege of walking down the hall or perhaps driving down the street to your local notary. As a result, you rarely consider the legal requirements for a proper notarization and how to get something notarized under exigent circumstances. Yet, these are not normal circumstances. In many places, that is not currently an option given COVID-19. Continue Reading
UK Drops Consumer Online ADR Requirement Due to Brexit
The UK officially left the European Union on 31 January 2020. We are now in a one-year transition period, during which the UK has basically maintained many pre-Brexit positions. That said, once the transition period expires, we anticipate a number of changes to UK consumer law. That is because much of existing UK consumer law is derived from EU legislation and case law, and there is a desire within the UK government to deviate from some of the less business-friendly aspects. The thrust of this is that there is a move towards less regulation.
One important change regards the current consumer law requirement for alternative dispute resolution (“ADR”). After the end of this year, with limited exceptions, businesses will no longer have to offer an online ADR option. Continue Reading
