Legal Docket: Mifepristone on its way to the Supreme Court

MARY REICHARD, HOST: It’s Monday, April 17th. Glad to have you along for today’s edition of The World and Everything in It. Good morning. I’m Mary Reichard.

NICK EICHER, HOST: And I’m Nick Eicher. It’s time for Legal Docket. News from the legal battle on the pro-life front came down on Friday.

Supreme Court Justice Samuel Alito placed a temporary hold on a lower court order that suspends FDA approval of the abortion pill. The most common one, known as mifepristone.

REICHARD: Right, that’s called an administrative stay. It doesn’t say anything about how thefull court will decide the issues. It only halts things for a few days to give the justices time to consider the case.

What happened is that last month, a district court judge in Texas revoked the FDA’s approval of the abortion drug. This after some medical and legal people argued that the FDA hadn’t properly approved the drug back in the year 2000 and then went on to expand access without considering safety precautions. For example, allowing the drugs to be dispensed by mail without a doctor’s involvement.

The Biden administration and the manufacturer that makes and distributes mail-order abortion pills appealed. The case first went to the US Circuit Court of Appeals for the 5th Circuit. The appeals court would’ve blocked abortion by mail order and required doctor involvement, but didn’t reverse FDA approval altogether.

So the Biden administration asked the Supreme Court for an emergency order to keep access to the drugs going while the lower courts work out the legal issues.

EICHER: This emergency order will resolve quickly, though, as all parties have until noon tomorrow to make their case, and the stay is only in effect until Wednesday.

That means we might expect the high court to decide sometime this week.

REICHARD: So we’ll be paying very close attention to this, because the case below presented significant evidence of the harms of this medication, beyond, of course, what it does to unborn children.

Alright, well, on to three other disputes heard by the Supreme Court in March.

A smorgasbord of legal issues: one deals with sentencing, the others with venue and patents.

First, the sentencing dispute in a case captioned Lora v United States. The facts involve a brutal turf war between drug dealers in the Bronx.

A man named Efrain Lora was convicted for his role in a drug–trafficking scheme that left a man shot dead. Lora didn’t pull the trigger, but he did serve as a scout around the victim’s home to alert the man who did pull the trigger. That’s aiding and abetting. Specifically, using a gun, in relation to a drug crime, that led to someone’s death. One, two, three.

EICHER: That’s one of his convictions. A second is for conspiracy to distribute cocaine, a third is for causing intentional killing to further the conspiracy.

The question is whether Lora’s sentences ought to run consecutively, one after another, or concurrently, all at the same time.

Lora argued for the latter, for his sentences to run concurrently. That would shave off five years behind bars. His lawyer Lawrence Rosenberg argued the lower courts were wrong to impose the lengthier time. And judges ought to decide which kind of sentence, given the unique circumstances of each case.

Listen to this exchange with Justice Brett Kavanaugh:

ROSENBERG: All we're saying is it preserves discretion. In an appropriate circumstance, a trial judge absolutely can still sentence consecutively.

KAVANAUGH: Right. I'm just getting to the point I -- I tend to doubt Congress really intended your result. You -- you -- so I take that heroic effort to explain why Congress might have wanted to get to this result. I think your better argument for me is that's just what it says.

ROSENBERG: Well, I -- I -- I would agree with this in this respect, Justice Kavanaugh. I do think the textual argument is the strongest argument here.

REICHARD: Usually, judges do have discretion to impose concurrent or consecutive sentences. But the law in question, the Armed Career-Criminal Act, isn’t clear under these facts, and the circuits are split. The law is a mess here and clarity is needed.

I do think drug dealer Lora has the upper hand here, because this Supreme Court bench tends to prefer plain language arguments over creative interpretations.

EICHER: This next case seeks to find out what courts should do if a person is tried in the wrong court. Should that person be acquitted, or can the government try the person again somewhere else for the same offense?

Legally, the term is venue. In criminal cases, venue is almost always where the crime occurred.

This case involves a software engineer and avid fisherman in Alabama named Timothy Smith. He hacked into a company in Florida that sells data on fishing spots across the Gulf Coast. A federal court in Florida convicted him of computer fraud, extortion, and theft of trade secrets.

For that, Smith received 18 months in prison. He appealed, and that’s the point where the wrong-venue problem surfaced.

REICHARD: Citing the wrong venue, the appeals court tossed his theft conviction. After all, Smith was in Alabama when he did the bad deeds.

And yet the appeals court upheld the extortion conviction. So Smith cites that inconsistency and argues he should have been acquitted altogether, of all counts, based on incorrect venue.

Some other federal circuits would have done that. Just not the one he’s dealing with.

On the other side, the federal government argues a venue error just means Smith gets another trial in the right venue. Because venue isn’t an element of his crime, and is distinct from guilt or innocence.

That didn’t seem to convince some justices. Listen to this exchange between lawyer for the government Sopan Joshi and Justice Sonia Sotomayor:

JUSTICE SOTOMAYOR: Why are we giving the government another chance at an apple it already took a bite at? And isn't that the center of our entire double jeopardy ruling? If the jury is going to determine whether you have sufficient evidence or not to prove either an element, a defense, a material, I don't know what, because our case law is very confusing as to what "venue" is, we seem all to -- to agree or people assume it's not an element of the crime, yet we submit it to the jury, and yet we do put the government to a burden of proof, and yet we don't want to call it an element. It's a little bit like that platypus, this mixed-up animal, isn't it?

SOPAN JOSHI: It -- it is a little mixed up.

EICHER: That mixed-up platypus of the law is why this dispute landed at the Supreme Court.

On to the final argument today, this one in a case captioned Amgen v Sanofi. A pharmaceutical company and a biotech company.

First, some very simplified science at the heart of the dispute here, because the companies are makers of antibodies.

An antibody is a protective protein your body’s immune system makes in response to the presence of a foreign substance, called an antigen. Antigens are things like bacteria, viruses, allergens or toxins that enter the body and make you sick. Antibodies are proteins your body makes to fight them off.

The company Amgen made an antibody that blocks a protein used to lower cholesterol levels, an alternative to what’s known as statin drugs. The company also laid out the atomic structure of that protein and then took that to claim broad patent protections. Then Amgen claimed that any antibody that could bind to that protein is covered by its patent, even antibodies that Amgen didn’t develop.

And Sanofi and Regeneron together patented another antibody with different properties to it.

Without getting too detailed, and maybe we’ve already crossed the line, each of these pharma companies create therapeutic uses for antibodies. Used to be, getting a patent on an antibody was almost routine. But that changed a few years ago. The patent office now only grants patent protection for the antigen targeted. Very specific.

REICHARD: Here, Amgen alleges that Sanofi infringed its patents, which Sanofi doesn’t dispute, except to say that Amgen’s patent isn’t valid.

So it couldn’t have done anything illegal, because as far as the law is concerned, infringing an invalid patent is meaningless.

You can hear the legal fragments of the dueling arguments in these two clips. Justice Elena Kagan asked about the scope of a patent claim. Here’s what Paul Clement, lawyer for the alleged infringer said:

PAUL CLEMENT: The truth has a way of leaking out. I mean, yeah, I mean I am saying that (laughter) because I think functional-genus claims are terrible. I think they retard the science.

And then from patent owner Amgen’s lawyer, Jeffrey Sindak:

JEFFREY SINDAK: When you say an invention, like the James Watt steam engine, you don't say which variant, which embodiment of the steam engine have you claimed. It's the steam engine, that principle, the invention which encompasses myriad types of inventions.

“Retard the science.” That's an argument for scientific progress. “Variants.” That's an argument for patent protection.

The purpose of patents is to encourage inventors to publish their ideas in exchange for short-term protection from copycats. Enough time to recoup their investment. Twenty years, to be exact.

But without that protection, it can, in Clement’s words, “retard the science.” Amgen’s paperwork only listed 26 antibodies and argues its patent should protect a lot more than that.

But Lamken for the other side argues Amgen takes this much too far, by taking Amgen’s patent disclosures required by the U.S. Patent and Trademark Office to take over an entire domain of invention.

Justice Clarence Thomas asked a basic question to the lawyer for the federal government on the side of Sanofi, the alleged infringer:

JUSTICE THOMAS: Mr. Lamken, several times you referred to invention of the antibodies, and I think I'm somewhat confused as to exactly what your invention is. So what is it exactly? Because I do -- we talk about enablement and we talk about someone being able to replicate it, but we're not talking about what has been invented with any particular precision.

LAMKEN: Right.

“Enablement” is a term used in patent law. It requires a patent to disclose sufficient detail that a person with the skill could replicate the invention. If the explanation requires a lot of experimenting to get it right, the patent should be rejected. That’s part of the deal: the government will enforce the patent, but first the inventor has to explain what the invention is. Then once the 20 years is up, others can improve upon it to everyone’s advantage.

An editorial in the Wall Street Journal put it this way: Nobody ought to be allowed to “monopolize facts of nature and keep others from developing their own antibodies.”

That’s what Paul Clement’s saying.

CLEMENT: They've overclaimed, they've underenabled, their patent is invalid. This Court has long applied the same principle in Morse, in Lamp, and in Holland Furniture. Samuel Morse invented the telegraph. He did not invent the fax machine. That is why this Court correctly rejected the final broad functional claim in his patent. Thomas Edison discovered the key to incandescent light, but we'd all be fumbling around in the dark if this Court had not invalidated the broad unenabled claims in Sawyer and Man's patent in the Lamp case. The stakes here are comparable.

It seems to me most justices will be reluctant to stifle innovation in biotech. Amgen admitted its claims would include literally millions of antibodies not yet identified.

JUSTICE GORSUCH: So, if we agree on the law, what’s left for this Court?

CLEMENT: Nothing, except maybe a DIG. (Laughter)

Not with a shovel. Remember, the acronym DIG stands for dismissed as improvidently granted, DIG. Lawyer for the federal government agreed with that as the correct way to resolve this case.

And that’s this week’s Legal Docket!

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