A taste of IP news, American-style
Thanksgiving is a time to reflect on life's blessings, great and small. No matter where we live in the world, one thing we can all be grateful for is the system of Intellectual Property (IP) rights that protects businesses, innovators and creatives together with the fruits of their imagination.
This month's IP news is a cornucopia of updates from the home of roast turkey and pumpkin pie. We carve up stories on the IP-related activities of U.S. agencies, affecting how domestic and foreign applicants seek patents and trademarks and potentially how some patents have been misused in the pharmaceutical industry.
Grab a plate and dive in.
Sprucing up a traditional spread
According to the World Intellectual Property Organization (WIPO), last year saw 3.46 million patent applications globally, the most filings ever recorded. The World Intellectual Property Indicators 2023 report shows that 46.8% of these, or 1.6 million, were received by the National Intellectual Property Administration of the People's Republic of China (CNIPA). The second most popular filing destination was the United States Patent and Trademark Office (USPTO), at a distant but still impressive 17.2% – or 594,340 applications.
Though the USPTO's share of all patent filings represents a drop from 23% a decade ago, absolute numbers at the Office have experienced a general upward trend over the years, a slight dip during the COVID-19 pandemic notwithstanding. It is reasonable to assume that the USPTO would seek to modernize its online systems for filing and managing patent applications.
And this is precisely what it has done. On November 15, the USPTO fully replaced the aging Electronic Filing System (EFS-Web) and Private Patent Application Information Retrieval (Private PAIR) with the Patent Center. Offering enhanced security and performance, the new platform removes the need for two separate tools to upload documents (EFS-Web) and access pending applications (Private PAIR).
Reflecting on this "important milestone," Under Secretary of Commerce for Intellectual Property and Director of the USPTO, Kathi Vidal, noted the inevitable disruption to old habits, "We appreciate that change can be difficult for those accustomed to and with internal systems built around Private PAIR, but we are ready to make this leap with our customers into a new era of technology that will lead to better processing and more efficiencies." More obliquely, the USPTO's director acknowledged the potential for growing pains when she stated that the Office is looking forward to working with stakeholders on "IT improvements that meet their evolving needs."
Upon its launch in 2017, the Patent Center initially operated in parallel with the two older systems, taking feedback from users to develop its functionality and interface while cultivating familiarity among industry practitioners and repeat filers. Vaishali Udupa, the Commissioner for Patents, promises that this responsiveness will not change now that the Patent Center is front and center. To suggest additional features or other improvements, email firstname.lastname@example.org.
Fresh from the oven or a little undercooked?
Of course, patents are only half of the USPTO's titular purview, and its trademark division is implementing similar upgrades this month. On November 30, the venerable Trademark Electronic Search System (TESS) will be retired and replaced by the new and less affectionately named Trademark Search tool. Being built upon a Bibliographic Retrieval System that dates back to 1993, TESS's architecture was becoming a little long in the tooth, according to a blog post from David Gooder, Commissioners for Trademarks.
In contrast to the Patent Center's six-year phase-in period, Trademark Search only entered public beta in September 2023. Nevertheless, the cloud-based platform integrates a more robust search syntax, a simplified interface for casual users and an advanced framework for detailed queries. Together, it is hoped these features will result in a more enjoyable, more reliable search experience.
However, migrating the operations of an IP office that received 767,375 trademark applications in 2022 is not without its difficulty. Due to the fact that USPTO examiners will continue to use the legacy Trademark Reporting And Monitoring (TRAM) system internally until some time next year, there will be a small number of discrepancies between the status returned by Trademark Search and that from the Trademark Status and Document Retrieval (TSDR) system. Until TRAM joins TESS, EFS-Web and Private PAIR in the great abbreviated beyond, the USPTO recommends using the TSDR system to verify any trademark status.
David Gooder goes on to mention that, as with the Patent Center, the Office welcomes user feedback to help "prioritize and develop updates beginning in 2024 and continuing for the life of the search system." That being so, from public comments attached to his article, trademark attorneys are concerned about the urgency of the handover and its unseemly short notice period.
Striken from the guest list
Finally, another agency of the U.S. government, the Federal Trade Commission (FTC), has set its sights on the improper use of drug patents to stymie competition from generic manufacturers. According to a policy statement published on September 14, 2023, the FTC suspects branded drug manufacturers of behavior that "may disincentivize investments in developing a competing product and increase the risk of delayed generic and follow-on product entry, reducing patient access to more affordable prescription drugs and increasing costs to the healthcare system." And it all rests on something referred to as the "Orange Book."
Officially titled the "Approved Drug Products with Therapeutic Equivalence Evaluations," the Food and Drug Administration (FDA) catalog lists those drug compounds and methods of use that have been deemed safe and effective. The purpose of the Orange Book, as laid out by the Hatch-Waxman Act in 1984, is to accelerate regulatory approval for generic medications based on branded originals. Brand manufacturers may attach patents to their drugs listed in the Orange Book, alerting generic manufacturers of when any exclusive rights will expire. However, in order to be appropriately included in the catalog, a patent's claims must directly relate to a sanctioned drug.
If another manufacturer believes a listed patent "is invalid or will not be infringed by the manufacture, use, or sale" of the relevant drug, it can file a certification to the FDA to that effect. However, doing so often allows the patent holder to sue for infringement, which generally prompts an automatic 30-month stay of FDA approval for the generic. Thus, simply contesting a patent's listing in the Orange Book could delay a non-branded drug from entering the market for more than two years.
On November 7, the FTC challenged over 100 patents it believes are being wrongly used to delay generic alternatives and keep branded product prices artificially high. Notice letters were sent to AbbVie, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Glaxo Group, Glaxo-Smith Kline, Impax Laboratories, Kaléo, Mylan Specialty, Norton Limited and Teva. The patents at hand affect products ranging from asthma inhalers to epinephrine autoinjectors (EpiPens).
The FTC has reserved the right to escalate matters if it believes such action is necessary to serve the public interest. This could involve investigating the contacted companies for unfair methods of competition prohibited by Section 5 of the FTC Act or even bringing charges of illegal monopolization.
This is just the first step in what could be a long, disputatious process. Then again, heated quarrels during Thanksgiving are as much a tradition as the proverbial apple pie.
Explore the European Union's expansion of IP exclusivity for traditional industries and two recent out-of-court settlements.