Federal Circuit Court: Authority on Pharmaceutical Patent Cases

The Federal Circuit Court doesn’t just hear patent cases-it owns them. In the U.S., every single patent appeal, no matter where it starts, ends up in this one court. That includes the most complex, high-stakes cases in pharmaceuticals. When a drug company sues a generic maker over a patent, or when a generic company tries to knock out a patent before launching a cheaper version, it’s the Federal Circuit that makes the final call. This isn’t just another appeals court. It’s the only one that handles patent law nationwide, and that gives it enormous power over how medicines reach patients and how much they cost.

Why the Federal Circuit Controls Pharmaceutical Patents

The U.S. Court of Appeals for the Federal Circuit was created in 1982 to fix a broken system. Before then, patent cases were scattered across 12 regional circuit courts. One court might say a drug patent was valid; another might say the same patent was obvious. Companies couldn’t predict outcomes. The solution? Centralize all patent appeals in one court. That court became the Federal Circuit.

Today, it handles every patent appeal from every district court in the country. That includes cases under the Hatch-Waxman Act, the law that balances brand-name drug innovation with generic competition. When a generic drug maker files an Abbreviated New Drug Application (ANDA) with the FDA, it’s essentially saying: ‘We think this drug doesn’t infringe your patent.’ The brand-name company then sues. And that lawsuit? It goes to the Federal Circuit on appeal.

No other court has this authority. The Ninth Circuit hears copyright cases. The Second Circuit handles securities fraud. But only the Federal Circuit decides what makes a pharmaceutical patent valid, enforceable, or invalid. That’s why every major drug company, generic manufacturer, and patent lawyer watches its rulings closely.

ANDA Filings Create Nationwide Jurisdiction

In 2016, the Federal Circuit changed the game with its ruling in Mylan v. Mirati. Before that, brand-name companies could only sue generic makers in places where they had physical operations-like a factory or sales office. After the ruling, simply filing an ANDA with the FDA was enough to create personal jurisdiction anywhere in the U.S.

Why? Because the FDA application proves the generic company intends to sell its drug nationwide. The court said: ‘If you’re asking the FDA to approve your drug for sale across all 50 states, you can’t claim you’re not subject to lawsuits in Delaware just because you don’t have an office there.’

The result? A flood of lawsuits filed in Delaware. Between 2017 and 2023, 68% of all ANDA patent cases were filed there-up from just 42% in the previous decade. Why Delaware? Because its courts are experienced in patent law, and its procedures favor plaintiffs. For generic companies, this means they can be dragged into court in a state where they have no presence, just because they filed paperwork with the FDA.

That strategy has made litigation more expensive. The average cost of an ANDA patent case jumped from $5.2 million in 2016 to $8.7 million by 2023. And it’s not just about money-it’s about timing. The 30-month stay on generic approval is now almost always fully used, delaying cheaper drugs from reaching patients.

The Orange Book and Patent Listing Rules

The Orange Book-the FDA’s official list of approved drugs and their patents-is the linchpin of the entire Hatch-Waxman system. If a patent isn’t listed there, a generic company can’t be sued for infringement. But what if a brand-name company lists a patent that doesn’t actually cover the drug?

In December 2024, the Federal Circuit ruled in Teva v. Amneal that patents must ‘claim the drug’ to stay on the Orange Book. If a patent only covers a method of use, but the generic drug is approved for a different use, the patent can’t be listed. The court made it clear: listing a patent that doesn’t match the drug’s approved use is a violation of the law.

This decision forced companies to be much more precise. Before, some firms would list every possible patent-even ones with weak connections to the drug-to delay generics. Now, they must do a detailed ‘patent-drug claim mapping’ exercise. According to a 2024 survey, this has added about 17 business days to pre-listing legal reviews. It’s a small delay, but it’s one less tool for ‘evergreening’-the practice of extending monopoly protection through minor patent tweaks.

Obviousness in Dosing Regimens: A High Bar

One of the biggest battlegrounds in pharmaceutical patents is dosing. Can you patent a new way to take a drug-like ‘take one pill every 12 hours instead of every 8’? For years, companies tried to extend their monopolies with these kinds of patents.

Then came the April 2025 decision in ImmunoGen v. Sarepta. The court ruled that if the drug itself is already known, changing the dosage schedule alone usually isn’t enough to make a patent valid. The key question: Would a skilled scientist, looking at the prior art, expect the new dosing to work just as well?

‘Because both sides admitted that the use of IMGN853 to treat cancer was known in the prior art,’ wrote Judge Lourie, ‘the only question to resolve was whether the dosing limitation itself was obvious.’

This decision sent shockwaves through the industry. A 2024 Clarivate analysis showed that after this ruling, pharmaceutical companies cut their filings for secondary dosing patents by 37%. Instead, they’re investing more in entirely new drug compounds-where the patent protection is stronger and harder to challenge.

It’s not that dosing patents are impossible. But now, you need more than a new schedule. You need data showing the new dosing produces unexpected results-like fewer side effects, better patient compliance, or a dramatic improvement in efficacy. Generic companies have used this standard to win more cases. The Federal Circuit’s reversal rate for district court non-infringement rulings in pharmaceutical cases is now 38.7%, far higher than the 22.3% average across all patent cases.

Standing: Can You Challenge a Patent Before You Even Build the Drug?

Here’s a legal puzzle: Can a generic company challenge a patent before it’s even ready to launch? Or must it wait until it’s spent millions on clinical trials and manufacturing?

In May 2025, the Federal Circuit addressed this in Incyte v. Sun Pharma. The court said: To have standing, a company must show ‘concrete plans’ and ‘immediate development activities.’ That means Phase I clinical trial data, manufacturing agreements, or FDA pre-submission meetings. A vague statement like ‘We’re thinking about making this drug’ isn’t enough.

That’s a problem for many generic companies. Developing a drug takes years. Waiting until you’re deep in clinical trials means you’ve already spent millions-and the patent holder has already locked in pricing.

Even the court recognized the issue. Judge Hughes, in a concurrence, wrote: ‘A party seeking to develop a drug that may infringe an existing patent has a significant interest in trying to invalidate that patent before making the large financial and time investments such development efforts demand.’

His words are now fueling a proposed law-the Patent Quality Act of 2025-introduced by Senators Thom Tillis and Chris Coons. The bill would lower the standing bar for generic companies in pharmaceutical cases. If passed, it could make it easier and cheaper to challenge patents before the race to market even begins.

The Bigger Picture: Impact on Drug Prices and Access

The Federal Circuit’s decisions don’t just affect lawyers and patent offices. They affect your medicine cabinet.

With 82% of core compound patents being upheld, brand-name companies still have strong protection. But the court’s tightening of secondary patents-on dosing, formulations, and methods-has slowed the trend of evergreening. That’s good news for consumers. A 2024 Bernstein analysis predicts a 15-20% drop in evergreening strategies by 2027, which could mean more generics entering the market sooner.

At the same time, the court’s aggressive jurisdiction rules and strict standing requirements have raised the cost and complexity of challenging patents. Generic companies now need bigger legal teams, more data, and deeper pockets. That’s why some analysts say the system is becoming a two-tiered one: big players can fight, but smaller generics struggle to keep up.

And while the court’s clarity has helped some companies plan better, others say it’s created a legal minefield. A 2024 American Bar Association survey found that 57% of patent lawyers thought the Federal Circuit’s dosing obviousness standards were ‘too rigid.’

What’s clear is this: The Federal Circuit doesn’t just interpret patent law. It shapes the entire pharmaceutical market. Its rulings determine which drugs get approved, when they come to market, and how much they cost. For patients, that means more or fewer generic options. For companies, it means billions in revenue-or losses.

What Comes Next?

The Federal Circuit isn’t slowing down. In February 2025, it ruled that the Patent Trial and Appeal Board can still review the validity of expired patents-even if damages are no longer available. That keeps the door open for challengers to clear patent thickets even after a drug’s patent has expired.

It’s also extending its jurisdiction to biosimilars. In the Samsung Bioepis case, the court applied the same ANDA jurisdiction rules to biological drugs. That’s a big deal: biosimilar litigation has tripled since 2020, and the court’s rulings will define how quickly cheaper biologics enter the market.

One thing is certain: As long as the Federal Circuit holds exclusive authority over patent appeals, it will remain the most powerful court in American pharmaceutical law. Its decisions will continue to influence drug development, pricing, and access for years to come.