Introduction
Imagine you're a generic drug manufacturer, and you've spotted what looks like a billion-dollar opportunity. There's a blockbuster psychiatric medication called “paliperidone palmitate” that costs patients hundreds of dollars per month, and you think you can prove that the key patent protecting it is invalid. The drug itself is not new or even patented but the method of dosing the drug through a series of injections is claimed in a patent, U.S. Patent No. 9,439,906 (“the '906 patent”).
Here's your strategy. You'll file an application with the FDA to essentially make a copy of the brand-name drug in what's called an “Abbreviated New Drug Application” or “ANDA”—that's how generic approval works under the Hatch-Waxman Act. You know this will inevitably trigger a patent lawsuit, but you're not worried. In fact, you're counting on it.
You've done your homework on the prior art related to the patent, and you're confident that the patent's dosing regimen—150 milligrams injected by hypodermic needle on day one, 100 milligrams a week later, then monthly maintenance doses—is so obvious that it never should have been patented in the first place. The prior art shows that the brand-name company had previously and publicly tested both 150 mg doses and 100 mg doses. Putting them together in a decreasing sequence? That's just routine optimization that any skilled physician would have tried.
So when the '906 patent's owner, Janssen Pharmaceuticals, sues you for patent infringement, you don't even bother fighting about whether your generic drug infringes the patent's dosing regimen. Of course it does—that was the whole point of copying the dosing regimen in your ANDA. Instead, you focus on the real prize—proving that Janssen's patent is invalid and clearing the way for your product launch.
Welcome to Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 2025-1228 (Fed. Cir. July 8, 2025) (“Decision”)—a case that reveals how billion-dollar pharmaceutical patent battles can hinge on seemingly simple questions that turn out to be anything but simple.
But this isn't really a story about dosing a drug in stages. It's about when courts can empower patent challengers with the legal equivalent of an “obviousness shortcut button” that, when pressed, compels the patent owner to prove the patent's nonobviousness rather than the other way around. In a typical case, the patent challenger bears the burden of proving the alleged invention was obvious based on clear and convincing evidence. Here, Teva argued that it had no such burden in a case of “legal schizophrenia” under the patent law—where the court determines as a threshold matter that the patent is “presumptively obvious.”
The Medicine That Isn't Medicine (Until Later)
To understand why this case matters, we need to start with something that shows why pharmaceutical dosing is often way more complex than most people realize. Janssen wasn't actually injecting the active drug into patients. It was injecting what's called a “prodrug”—think of paliperidone palmitate as a time-release capsule that gets injected into your muscle. Once inside your body, it is slowly converted to “paliperidone,” the actual antipsychotic medication that treats schizophrenia. See Decision at 4 (“In the human body, paliperidone palmitate turns into paliperidone, a prior-art antipsychotic medication that was commercially available in tablet form for oral administration”).
It's like having a slow-dissolving sugar cube in your coffee, except the “sugar cube” is engineered to slowly release medicine at just the right rate over an entire month. This isn't just a convenience feature—it's solving a real medical problem and helping a lot of patients along the way.
See, patients with schizophrenia often struggle with medication compliance. The old oral version of paliperidone had to be taken daily, and when patients missed doses—which happened frequently—the consequences were devastating. As Janssen's patent explains, noncompliance “often result[ed] in worsening of symptoms, suboptimal treatment response, frequent relapses and rehospitalizations, and an inability to benefit from rehabilitative and psychosocial therapies.” Id. at 4 (quoting the '906 patent, col. 1, lines 50-57).
The monthly injection regimen solved this by eliminating the daily pill burden. But here's where things get scientifically interesting. Creating an effective dosing schedule for a prodrug that converts inside the body isn't as simple as just giving the same amount every month.
The Dosing Puzzle That Helped Patients & Sparked a Patent War
Janssen's breakthrough was figuring out a specific loading dose strategy. Instead of giving equal monthly doses like you might expect, Janssen developed a decreasing sequence. The first two doses, 150 mg-equivalent on day one and a 100 mg-equivalent a week later, get injected into the deltoid muscle (your shoulder), while 25-150 mg-equivalent maintenance doses can go into either the deltoid or gluteal muscle (your hip). See Decision at 4-5.
Let's think about why this matters. Your first injection creates a tiny “medicine factory” inside your body that starts producing paliperidone immediately but slowly. A week later, your second injection adds a smaller factory. Both factories are running simultaneously, and you need their total output to hit the therapeutic sweet spot without overdoing it. The subsequent maintenance doses continue that in vivo production of paliperidone in just the right amounts—like automatic payroll deposits that keep your bank account topped off while avoiding overdraft fees.
Echoing that drug delivery mechanism, Janssen named its pharmaceutical product “Invega Sustenna,” a medication that generated billions in revenue by dramatically improving treatment compliance for schizophrenia patients.
Enter the Generic Challenger
Let's return to December 2017. Teva filed its ANDA seeking FDA approval to manufacture and sell a generic version of Invega Sustenna. See Decision at 8. Under the Hatch-Waxman Act, the ANDA filing triggered a patent dispute filed by Janssen. Teva stipulated that its generic would infringe Janssen's patent—meaning Teva would use the same dosing regimen while arguing the patent was invalid because the claimed dosing schedule was “obvious.”
Here's where the legal strategy gets fascinating. Of course, Teva wasn't arguing that it invented something different. Instead, Teva was arguing that Janssen's invention was so obvious that it never should have been patentable in the first place. If Teva could prove that assertion, the patent would be invalidated, and the company would be free to launch its generic version of the drug.
Teva's obviousness argument seemed compelling at first glance. Teva built its case around three key pieces of prior art, all from Janssen's own work. First was the NCT00210548 protocol (“the '548 protocol”)—a clinical trial protocol that detailed Janssen's Phase III study testing the hypothesis that “a regimen of three equal-amount doses of paliperidone palmitate would be more effective than a placebo.” Decision at 9 (emphasis added). This protocol specifically called for administering “at least three equal doses of 50, 100, or 150 mg-eq. of paliperidone palmitate at specified time intervals.” Id.
Second, Teva pointed to Janssen's own U.S. Patent No. 6,555,544 (“the '544 patent”), which disclosed “‘a pharmaceutical composition suitable as a depot formulation for administration by intramuscular or subcutaneous injection, comprising'” a “‘therapeutically effective amount'” of paliperidone palmitate. Decision at 9 (quoting the '544 patent, col. 9, line 65, through col. 10, line 4).
Third was Janssen's International Publication No. WO 2006/114384 (“WO '384”), which described paliperidone palmitate formulations “‘filled aseptically into sterile syringes'” in dose volumes “‘between 0.25 ml and 1.50 ml depending on the dose needed'”—which “‘corresponds to 25 to 150 mg-eq. of paliperidone.'” Decision at 9 (quoting WO '384).
Teva's theory was straightforward. Janssen had already tested 150 mg doses (in the '548 protocol), already tested 100 mg doses (also in the '548 protocol), and already disclosed the broader dosing range of 25-150 mg (in WO '384). Combining these known doses into a decreasing sequence was just routine optimization that any skilled physician would have tried.
As Teva saw it, this was a classic case of selecting doses from overlapping dosing ranges disclosed in the prior art—exactly the kind of situation where courts typically apply a presumption of obviousness. See, e.g., In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”); Galderma Laboratories, L.P. v. Tolmar, Inc., 737 F.3d 731, 736-38 (Fed. Cir. 2013) (same).
Teva's “Obvious Ranges” Gambit
The presumption of obviousness is like the TSA PreCheck of patent challenges. Normally, when you challenge a patent for obviousness, you have to prove by “clear and convincing evidence” that a skilled artisan would have been motivated to combine prior art references and would have had a reasonable expectation of success in doing so. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1359-60 (Fed. Cir. 2007).
But in certain cases, involving “overlapping numerical ranges” in things such as drug dosing and metal alloy production, courts have developed a presumption that, like TSA PreCheck, shortcuts this analysis. The basic rule, established in cases like In re Peterson, is that “[a] prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” In re Peterson, 315 F.3d at1329.
When this presumption applies, the burden shifts to the patent owner to prove why the invention isn't obvious. To do that, the patentee must show “teaching away, unexpected results, or other pertinent evidence of nonobviousness.” E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006-07 (Fed. Cir. 2018).
Think of it like this. If an old cookbook mentioned baking at 325-375°F, and you patent a recipe calling for 350°F, a court might presume your temperature choice was obvious because 350°F falls within the previously disclosed range. You'd then have to prove why your specific temperature was actually a breakthrough, not just a predictable outcome of routine optimization.
Teva's strategy was basically the same. Instead of an old cookbook, Teva pointed to Janssen's prior art paliperidone documents to argue that this overlapping-range presumption should apply to Janssen's patented dosing regimen. Teva's argument was essentially: “Look, the prior art disclosed 150 mg doses and 100 mg doses within broader ranges. Janssen just picked numbers from those ranges and arranged them in sequence. That's obvious optimization, so the presumption should apply.”
If the court had agreed, Janssen would have faced an uphill battle to prove its dosing regimen represented a genuine breakthrough rather than routine tinkering with known dosing amounts.
Where the Court Drew the Line
But the Federal Circuit wasn't buying it. In a decision that clarifies important boundaries around the obviousness presumption, the court rejected Teva's argument and held that Janssen's patent claims were not invalid for obviousness.
The court's analysis turned on a crucial distinction that's perfect for understanding how the law of patent obviousness really works. Yes, the prior art contained the individual numbers that Janssen used (150 mg and 100 mg). But the court found that Janssen's invention wasn't just about selecting numbers from ranges.
As the court explained: “The treatment regimen at issue is a combination of dosages and times of injection—with decreasing loading doses—where the evidence reasonably characterizes the combination as an integrated unit of steps taken over time for achieving desired medicinal effects (on the brain) in a patient over time.” Decision at 19.
This is where the court's reasoning gets sophisticated. The judges recognized that not all optimization is created equal. Sometimes you're just fine-tuning something within well-understood parameters—like a GPS autopilot that takes you directly to your programmed destination via known routes. But other times, what looks like simple optimization actually requires genuine inventive leaps—like encountering unexpected road construction, discovering that a scenic bypass nobody knew about that actually gets you there faster and more safely, and realizing you've found a fundamentally better route.
The Federal Circuit found that Janssen's decreasing dose strategy fell into this second scenario. It wasn't just a matter of picking numbers from known ranges and expecting them to work together. Instead, it required recognizing that the standard approach—equal monthly doses—might not be optimal for a prodrug system and then figuring out how to choreograph two overlapping release cycles to achieve steady therapeutic levels.
Think about what this means in practical terms. Janssen didn't just look at prior art that mentioned 150 mg doses and prior art that mentioned 100 mg doses and say, “Let's try those numbers in sequence.” Instead, it made what the court called “the crucial choice . . . to start with a particular high first loading dose and then follow it with a second, lower loading dose.” Id.
This choice was fundamentally different from the typical overlapping-range scenario. The court noted that this “choice for the combination of loading doses is addressed to the relation between two dosage figures in a way that does not clearly fit within the presumption's focus on simply selecting a number or range overlapping a prior-art range of a variable.” Id. (emphasis in original).
This distinction proved crucial because the prior art actually pointed in the opposite direction. The previous disclosures taught equal dosing (the '548 protocol tested “three equal-amount doses”) or even increasing dosing strategies. See Decision at 27 (prior art taught adjusting dose upward). But Janssen went in the opposite direction—decreasing doses. That wasn't optimization within a known framework; it was choosing a fundamentally different approach to solving the prodrug timing puzzle. Instead of following the GPS, Janssen took the scenic route.
When the Obviousness Shortcut Button Doesn't Work: Teva's Uphill Battle
With the obviousness presumption off the table, Teva faced the much harder task of proving obviousness through traditional analysis. Under this framework, it had to show by “clear and convincing evidence” that a skilled artisan would have been motivated to combine the prior art references to arrive at Janssen's specific dosing regimen, and that the skilled artisan would have had a reasonable expectation of success in doing so. See Pfizer, 480 F.3d at 1361.
This is where Teva's case fell apart.
The Motivation Problem
First, Teva couldn't prove that a skilled physician in 2012 would have been motivated to develop a decreasing dose regimen. Remember, the prior art was pointing in different directions entirely. The '548 protocol tested equal doses. Other references actually taught practitioners to “begin with lower initial doses and to adjust the dose upward as needed”—an increasing regimen, not a decreasing one. Decision at 27.
Teva tried to salvage its motivation argument by pointing to other prior art references about loading dose strategies for different psychiatric medications. It cited studies by Ereshefsky from 1990 and 1993 that discussed loading doses for haloperidol, and a 2001 paper by Karagianis about olanzapine dosing. Id. at 23-24.
But after careful analysis of the evidence, the court found these references weren't persuasive. The Ereshefsky studies involved patients who were “already stabilized on oral haloperidol” before starting experimental regimens with long-acting injectables, so they “would not have taught a relevant artisan to use long-acting injectables to ‘load' patients.” Id. at 24-25. As for Karagianis, Teva's own expert testimony undermined its argument—while one Teva expert claimed Karagianis taught using high first loading doses for acutely ill patients, another Teva expert explained that skilled artisans “would not use long-acting injectables to treat an acutely agitated patient.” Id. at 25.
The Expectation-of-Success Problem
Even if a skilled artisan had been motivated to try decreasing loading doses, Teva couldn't prove they would have reasonably expected it to work. This is where the complexity of psychiatric medication dosing became crucial to the court's analysis.
The court found that skilled artisans “would be motivated to use a dosing regimen that is safe and effective,” but that multi-dose regimens like Janssen's “introduce additional complexities . . . beyond those of single-dose regimens and may lead to adverse effects.” Id. at 28-29. These complexities included “excess accumulation of the drug in a patient's body and fluctuation of drug levels between administrations.” Id. at 28-29.
Think about why this matters. A skilled physician in 2012, looking at the limited prior art on paliperidone palmitate dosing, would have seen that the only multi-dose study (the '548 protocol) “included no safety or efficacy results.” Id. at 29. Without clinical data showing that multi-dose regimens were safe and effective, why would they expect a decreasing dose sequence to work better than the simpler monthly dosing approach?
In short, the prior art was focused on simple monthly dosing of direct-acting drugs or equal-dose regimens. Janssen had to figure out how to choreograph two overlapping prodrug release cycles to achieve steady therapeutic levels while avoiding the peaks and valleys that could cause side effects or treatment failure.No wonder the court was skeptical of Teva's argument that this was “routine experimentation.”
This wasn't optimization—this was innovation.
How the Science Added Complexity to the Analysis
Now here's something fascinating that the Federal Circuit didn't explicitly discuss but explains a lot about why it rejected the “routine optimization” argument. Remember how paliperidone palmitate isn't actually the medicine—it's a prodrug that converts into the real paliperidone medicine inside your body?
This conversion factor makes the dosing strategy way more complex than Teva's “obvious ranges” argument suggested. When you're managing a prodrug system, you're not just deciding “how much medicine”—you're orchestrating a complex timing puzzle that the prior art simply didn't address.
The court's skepticism about “routine experimentation” makes perfect sense in this context. Converting from equal-dose regimens (what the prior art taught) to decreasing loading doses (what Janssen invented) required understanding how overlapping prodrug release cycles would interact—knowledge that wasn't routine in 2012.
This also explains why the court emphasized that Janssen's invention was an “integrated unit of steps taken over time.” Managing prodrug conversion timing isn't just optimization of individual doses—it's innovation in how multiple doses work together in a prodrug system.
Conclusion
The Janssen v. Teva decision reveals a fundamental truth about innovation—sometimes the most valuable breakthroughs hide behind deceptively simple facades. What appeared to be straightforward number-selection from prior art ranges turned out to be a sophisticated solution to the prodrug timing puzzle—one that required genuine insight into how overlapping release cycles could work together as an integrated therapeutic system. The Federal Circuit's refusal to apply the obviousness presumption wasn't just legal hairsplitting; it was recognition that real innovation often occurs in the spaces between established knowledge, where routine optimization ends and inventive discovery begins.
Looking ahead, this decision provides important guidance for an industry grappling with increasingly complex therapeutic regimens. As pharmaceutical companies develop more sophisticated drug delivery systems—from gene therapies with intricate dosing protocols to personalized medicine requiring patient-specific titration strategies—the line between obvious optimization and patentable innovation will only become more critical. The Federal Circuit's framework reminds us that when billions in R&D investment and patient access to life-changing treatments hang in the balance, obviousness analysis must dig deeper than surface-level similarities to understand whether claimed inventions represent genuine advances in the art of healing.
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