NEWS
When Trying to Save Money May Cost More
The USPTO offers significant fee discounts for small and micro entities. In particular, small entities include individuals, businesses with up to 500 employees, or non-profits.
Meanwhile, micro entities meet small entity requirements and have no more than four prior applications. Additionally, they must earn less than $241,830 per year. They also cannot assign or license inventions to entities exceeding that income limit.
As a result, small entities get a 60% reduction on most patent fees, while micro entities enjoy an 80% reduction.
However, these discounts sometimes lead applicants to claim small or micro status incorrectly. To address this, the USPTO now enforces penalties for false entity claims. Fines are at least three times the fees that should have been paid.
Furthermore, the Patent Office issues notices for payment deficiencies and sends orders to show cause why the fine shouldn’t apply.
Enablement and Prior Art: What Agilent v. Synthego Teaches Us About the Limits of Patent Protection
Enablement Depends on Context
In patent law, “enablement” is critical. However, the required detail varies depending on your goal—getting a patent or invalidating one.
This distinction became clear in Agilent Technologies v. Synthego. The principle is simple but powerful: To secure a patent claim, you must enable enough embodiments to cover its full scope. Yet, to invalidate a claim, you only need prior art enabling one embodiment. This rule isn’t new, but the case clarifies it sharply.
The Two Faces of Enablement
Under Section 112, inventors must enable the full scope of their claimed invention. This prevents overbroad patents that exceed the disclosure.
You cannot describe one version of an invention and claim all variations. Instead, you must teach the public how to make and use everything claimed.
The Supreme Court reinforced this in Amgen v. Sanofi. There, a broad antibody patent was invalidated because it disclosed only a few examples. The rest required undue trial and error, which the Court rejected.
By contrast, Agilent v. Synthego draws a sharp line. Anticipatory prior art—references that can invalidate a patent—does not need to enable every version. It only needs to enable one working embodiment.
A Research Proposal as Prior Art
Agilent’s patents covered chemically modified guide RNAs (gRNAs) that resist degradation in CRISPR gene editing.
Synthego challenged them using an abandoned Pioneer Hi-Bred application. This reference described broad theoretical possibilities for modifying gRNAs, but:
- It contained no proven examples.
- It proposed quadrillions of combinations.
- It was ultimately withdrawn after failing to work.
Agilent argued the reference was not enabling, likening it to Amgen’s vague disclosures. However, the court disagreed. The difference is simple: Amgen concerns patent applications, while Agilent addressed prior art. The disclosure bar is lower for invalidation.
Why This Matters
The court’s approach creates a clear firewall between two standards:
- Section 112 enablement: You must enable your full claimed scope for a valid patent.
- Prior art enablement: A reference must only enable a single working embodiment to defeat novelty.
This distinction significantly affects patent strategy and litigation.
The Power of Prophetic Prior Art
The Pioneer Hi-Bred application never worked and was abandoned. Most examples were prophetic and unproven. Yet the court ruled that if even one example is enabling, a patent can be invalidated. This shows prophetic prior art can be surprisingly powerful.
Key Takeaway
If you seek a patent, you face the high Amgen enablement standard. You must teach others to make and use your invention fully.
However, to invalidate another’s patent, even speculative, abandoned prior art can suffice—so long as it enables one embodiment.
Agilent v. Synthego teaches us this: In patent law, not all enablement is equal.
Jazz Loses the Tune: Courts Strike a Sour Note on System Patents
Federal Circuit Draws New Limits on Injunctions and Orange Book Listings
In a decision likely to affect the pharmaceutical industry, the Federal Circuit ruled in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC. The court clarified limits on injunctive relief and patent listings under the Hatch-Waxman Act.
Notably, the May 6, 2025 ruling made one point clear. Even when infringement is found, courts cannot block certain regulatory activities. That remains true if those activities fall within the Act’s “safe harbor” provision.
A Closer Look at the Dispute
Xyrem, GHB, and a Patented Distribution System
The case centered on Jazz’s narcolepsy drug, Xyrem. The drug contains GHB, a powerful sedative with known abuse risks.
To manage those risks, Jazz patented a single-pharmacy distribution system. That system tracks and controls how Xyrem is dispensed.
Meanwhile, Avadel sought FDA approval for FT218. Like Xyrem, it is GHB-based. However, FT218 uses a once-nightly dose and a different distribution approach.
The NDA Filing and Orange Book Challenge
When Avadel filed its New Drug Application, the FDA required a patent certification. That requirement stemmed from Jazz’s patent being listed in the Orange Book.
Jazz then sued Avadel for infringement. In response, Avadel challenged the Orange Book listing itself.
Specifically, Avadel argued the patent did not claim a drug. Nor did it claim a method of using one. Those, however, are the only patents eligible for listing.
The District Court Agrees with Avadel
The district court sided with Avadel. It found Jazz’s claims covered a “system,” not a drug or method of use.
That distinction proved decisive. Under Hatch-Waxman, only drug compositions and methods of use qualify for Orange Book listing.
As a result, the court ordered Jazz to delist its patent. Jazz then appealed.
The Federal Circuit Affirms the Delisting
Why System Claims Still Are Not Method Claims
On appeal, Jazz raised two main arguments. First, it claimed the patent covered a method of using Xyrem. Second, it argued FDA regulations supported broader listing categories.
The Federal Circuit rejected both points. In doing so, it emphasized several principles:
- Method claims must recite specific steps.
- A system that enables use is not itself a method.
- FDA regulations do not override patent-law fundamentals.
- Prescribing conditions do not convert systems into methods of use.
Accordingly, the court upheld the delisting order.
Clinical Trials Remain Protected by the Safe Harbor
Jazz also sought to stop Avadel’s clinical research activities. That effort failed.
The Federal Circuit was unequivocal. Even where infringement exists, courts cannot block protected research.
This includes clinical trials and open-label extensions. If those activities fall within the Hatch-Waxman safe harbor, they may continue.
That protection, the court noted, serves a clear purpose. It promotes innovation while speeding FDA approval.
Why This Ruling Matters
Taken together, the decision reinforces a key boundary. Commercial infringement is distinct from regulatory research.
It also tightens Orange Book eligibility standards. As a result, system patents face greater scrutiny.
For brand-name companies, the message is direct. If a patent does not claim a drug or method of use, it does not belong in the Orange Book.
For generics and 505(b)(2) applicants, however, the ruling offers reassurance. It preserves the streamlined path to market. That remains true even when system-based innovation is involved.
PatChat is now operational
We have added some AI functionality to our website in the form of a personalized Chat GPT-based AI agent.
You can access the chatbot at the lower righthand corner of the website.
The AI is trained on Bob’s books, and the FAQs from our website, so asking it questions will be like talking to Bob himself.
Have fun with it, but don’t bother asking non-IP related questions, it’s trained to stick to IP related topics.
IP Updates in Korea
Korea has added exporting an invention to the list of what constitutes “practicing an invention”. This means patent holders can claim damages from overseas sales more actively.
Korea has also introduced two limitations on patent term extensions. The first is that a patent term can’t be extended over 14 years from the date of receipt of marketing approval. The second is that only one patent becomes eligible for patent term extension per approval.
In trademark litigation, the Korean Supreme Court clarified standards for consumer surveys used as evidence of consumer recognition or perception.
USPTO discontinues the Accelerated Examination program
Given the long wait times for patent prosecution, the USPTO had offered several ways to speed the process up. One of those, Accelerated Examination, offered the option of having the attorney certify much of the examination work in advance. We used the accelerated examination process several times, and got quite good at it. In one instance we received notice of allowance in less than a month! Nevertheless, it seems many attorneys did a poor job of searching (intentionally or unintentionally), so the original premise of faster prosecution was faulty.
Track One, or Prioritized Examination, is still an option for speeding up the prosecution process.
Copyright Office Report on AI Training and Fair Use
Can AI Use Copyrighted Material Under Fair Use?
Can AI systems rely on the fair use doctrine when training on copyrighted works? That question sits at the center of ongoing copyright debates.
Fair use is a doctrine in U.S. copyright law. It allows limited use of copyrighted material without permission in certain situations. Courts apply a four-factor test to determine fair use. Those factors include the purpose of the use, the nature of the work, the amount used, and market impact. However, these factors are only guidelines. Importantly, no single factor guarantees fair use on its own.
Common Examples of Fair Use
Fair use often applies to criticism, commentary, and news reporting. It also commonly applies to teaching, scholarship, and research. For example, a reviewer may quote a copyrighted book without permission when critiquing that book. However, fair use is context-specific. Uses outside these categories may still qualify, while listed purposes may still fail.
AI Training Raises New Fair Use Questions
Generative AI systems train on massive datasets. Those datasets often include copyrighted material. As a result, a key question arises. Can AI training qualify as fair use and avoid infringement? This issue was the focus of a recent study. The study was issued by the U.S. Copyright Office (USCO).
Do AI models Infringe Training Data?
The USCO report concludes that AI training implicates several exclusive copyright rights. These include reproduction and derivative work rights. The report also examines a critical issue. Are a model’s weights themselves infringing copies?
Developers argue that models contain only numerical values. They claim these values are not copies of copyrighted works. Others disagree, pointing to AI outputs that closely resemble training data.
According to the USCO, similarity matters. When outputs are substantially similar, infringement concerns grow stronger. In those cases, the report finds a compelling argument. Copying model weights may implicate reproduction and derivative rights.
How the Fair Use Defense Applies to AI
The key issue when analyzing fair use has been whether the use is “transformative”. There is of course a spectrum. Where the output is based on a diverse dataset, it is more likely to be transformative. But where it is trained to generate outputs substantially similar to copyrighted works, then it is “at best, modestly transformative”.
Why the Human Learning Analogy Falls Short
The USCO rejected arguments that AI training is inherently transformative, because it is analogous to human learning. The report asserts that the analogy rests on a faulty premise. Fair use is not a defense for all acts if those acts are used for learning. An example was given that a student couldn’t rely on fair use to copy all of the books at a library. The analogy also breaks down technically. Humans retain imperfect, filtered impressions of works. AI systems do not. The structure of exclusive copyright rights is premised on certain human limitations.
What Comes Next for AI and Copyright
Currently, there are more than 40 cases currently pending related to the issue of AI using copyrighted materials. There won’t be a single answer whether unauthorized use is fair use. There is an ongoing discussion of some form of licensing scheme for AI training data. For now, the recommendation is to continue development without government intervention.