Posts Tagged ‘supreme court’

Danie Roy

I don’t know how on earth I missed hearing about this until now, but it appears that the Supreme Court just heard the case of Caraco Pharmaceutical Laboratories v. Novo Nordisk.  Right now, Caraco is fighting for the right for generics to sue brand name companies if the brand names claim protection that is too broad.

Background:
Novo Nordisk had a patent on its drug for treating Type 2 Diabetes, Prandin (repaglinide), which has since expired. There are 3 approved uses for Prandin, 2 of which were part of the expired patent. Novo Nordisk holds another patent for a third use of the drug with another diabetes medication, which, of course, is still protected until the second patent expires. This should mean that generic drugmakers, such as Caraco, should be able to get FDA approval for the other two uses, right?

Apparently not:
Novo Nordisk submitted an extremely general description of the drug to the FDA, which covered all three uses. We’re back to that wonderful distinction between the USPTO and the FDA: approval of one is separate from approval of the other, but you definitely need both. But, what Novo Nordisk appears to be trying to do is obtain protection well beyond the expiration of the patent.

Can Novo Nordisk do that?
Well, that’s what the Supreme Court is going to be deciding on. The U.S. government and the generic companies are begging the Supreme Court to issue Novo Nordisk a stern “NO” and hand Caraco the right to sue. My knee jerk reaction is siding with the generics, too. The point of patents is that they are supposed to be enabling. That is, the information in a patent becomes property of the public once protection runs out. Intellectual property should be protected, yes, but there is a point at which that protection runs out.

The Court seemed to be disposed toward Caraco from what I read, but  a decision is not expected until the summer. Expect an update when I hear something!

Scott Nyman

 

A new patent litigation case is about to be heard by the Supreme Court that may have a greater impact on the patent landscape than the recently passed America Invents Act. On December 7, 2011, the Supreme Court will hear the case of Mayo Collaborative Services v. Prometheus Labs., Inc, Supreme Court No. 10-1150.

According to filings with the Supreme Court:

This case concerns whether a patentee can monopolize basic, natural biological relationships. The Court has twice granted certiorari on the question presented, without yet resolving the issue.  Last year, it granted certiorari, vacated, and remanded in this case to allow the Federal Circuit to reconsider this question in light of Bilski v. Kappos, 130 S. Ct. 3218 (2010).  And seven years ago it granted certiorari but dismissed the writ as improvidently granted in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124, 135 (2006), because petitioner there had not adequately preserved the question.

The question presented is:

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.”

The Mayo Clinic is arguing that the patent-at-issue basically involves the administration of a chemical substance to a patient and observing the patients metabolite level as his or her body is affected by the chemical. But, there is a catch. Prometheus does not claim the chemical administered to the patient, or the test used to measure the metabolite levels. Apparently, the patent is just for making a correlation between the chemical and the metabolite level to determine that it may indicate something. As a disclaimer, I have not thoroughly reviewed the patent to confirm its actual scope.

Patent trolls, or “non-practicing entities” in the terms of the Supreme Court, typically rely on these broad and potentially unenforceable patents to harass judgments out of their opponents. These trolls are aware that defending a claim of patent infringement often requires a large investment of time and capital, which often rewards the trolls with a quick nuisance settlement from the defendant.

The Mayo Clinic, along with a laundry list of others that have been on the defendant side of an infringement allegationf for a broad method claim, is hoping that SCOTUS will put an end to using these broad method patents as the basis of trolling litigation. If the bar for enforcing such sweeping subject matter for patents is restricted, so may be the use (or abuse, depending of your views) of these patents by non-practicing entities.

With this, I’ll leave you with a few excerpts from the recent (and hardly clarifying) discussion in Bilski v. Kappos, 130 s. Ct 3218 (2010), our best current view on the state of patent law.

The Court’s precedents provide three specific exceptions to § 101′s broad patent-eligibility principles: “laws of nature, physical phenomena, and abstract ideas.” Chakrabarty, supra, at 309100 S.Ct. 2204. While these exceptions are not required by the statutory text, they are consistent with the notion that a patentable process must be “new and useful.” And, in any case, these exceptions have defined the reach of the statute as a matter of statutory stare decisis going back 150 years. See Le Roy v. Tatham, 14 How. 156, 174-175, 14 L.Ed. 367 (1853). The concepts covered by these exceptions are “part of the storehouse of knowledge of all men . . . free to all men and reserved exclusively to none.” Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 68 S.Ct. 440, 92 L.Ed. 588 (1948).

The machine-or-transformation test may well provide a sufficient basis for evaluating processes similar to those in the Industrial Age—for example, inventions grounded in a physical or other tangible form. But there are reasons to doubt whether the test should be the sole criterion for determining the patentability of inventions in the Information Age. As numerous amicus briefs argue, the machine-or-transformation test would create uncertainty as to the patentability of software, advanced diagnostic medicine techniques, and inventions based on linear programming, data compression, and the manipulation of digital signals. (Citations omitted.)

It is important to emphasize that the Court today is not commenting on the patentability of any particular invention, let alone holding that any of the above-mentioned technologies from the Information Age should or should not receive patent protection. This Age puts the possibility of innovation in the hands of more people and raises new difficulties for the patent law. With ever more people trying to innovate and thus seeking patent protections for their inventions, the patent law faces a great challenge in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles. Nothing in this opinion should be read to take a position on where that balance ought to be struck.

Perhaps with this new opinion, the high court will give us a little more insight for determining that balance.

 

Read more:

Democrat and Chronicle

Patent Baristas

TacticalIP – Pharmaceutically Speaking Series

 

 

Danie Roy

A while back I wrote on using sites like Kickstarter to fund inventions. I weighed the pros and cons of depending on the kindness of strangers to fund an invention, and how such actions would affect an inventor’s ability to file for a patent. Today, I get to focus on Kickstarter once again, but with a completely different question: does Kickstarter infringe on a recently issued patent?

Brian Camelio (yes, that Brian Camelio) was recently issued U.S. Patent Number 7,885,887. As the founder of ArtistShare, a similar crowdfunding venture that began almost a decade before Kickstarter, Camelio obviously wanted his idea protected. And, as I’ve said before, it is, at its core, crowdfunding can be a very good idea (if handled properly!).

While Kickstarter doesn’t have a specific focus, ArtistShare looks to protect the rights of musicians. Unless you’ve been living under a music and news-free rock you’re aware that music piracy is a huge issue. ArtistShare looks to completely circumvent using the RIAA’s broken system by ensuring that artists get paid before the work is even produced, which allows the artist to produce even more work, resulting in a significantly healthier artist/fan relationship.

So does Kickstarter infringe? Well, as far as music ventures are concerned, yes. The patent is pretty explicit about that system, which matches Kickstarter’s pretty closely. Which is probably why Kickstarter is trying to get the patent invalidated.

Kickstarter is claiming the patent is directed to a business method. On their faces, Kickstarter and ArtistShare use the same business method, but, is the patent for a business method? Well… it really depends on how you look at it.

The first set of claims in the patent are directed to a computer program product. I could get into the controversy of the software patents, but I’d rather let the Supreme Court get to it eventually. As for the other sets, well, they’re all quite closely tied to servers and programs.

There’s really no way to predict how this will go down. There could be a court battle, there could be an “undisclosed settlement,” there could be an invalidation, maybe pigs will fly. No matter what happens, though, it will be interesting. Expect updates, because this is just too interesting to NOT cover.

Danie Roy

Some of you may remember when I wrote on patenting all the immunization schedules ever. Turns out that the really ridiculous patents just didn’t end there. Apparently, there is actually a patent that is broad enough to claim even thinking about the patented treatment. If you need a minute to reread that and let it sink in, go ahead. I needed a few minutes myself.

Prometheus Lab v Mayo is going all the way to the Supreme Court. Apparently, the method patent at hand involves administering the drug thiopurine, checking a patient’s blood for how much got absorbed into the body, and adjusting the dose accordingly. Someone please tell me how this didn’t get a 103 rejection and a look of disapproval.

I made this face when I read about this patent.

For those slightly less acquainted with medical issues, a lot of medications, especially those used in the treatment of autoimmune disorders (like thiopurine is), need to be closely monitored. The amount of the drug actually absorbed by and used in the body is critical for proper treatment. The problem is, everyone’s body is different, so different doses are necessary for different people.

Take a look at cyclosporine, for example. That drug has been around since the early 80′s and blood levels and adjustments are made in much the same manner. Take any other immunosuppressant, new or old, and it’s the same deal. One should conclude that it would be OBVIOUS to to use this method for any given immunosuppressant, or even a slightly unpredictable drug, for that matter.

What is killing me is that the Supreme Court is going to be deciding the issue of whether or not this is a valid method patent, and looking to Bilski. Am I missing something? The issue here shouldn’t be whether this passes the machine-or-transformation test (or any other test that can be reasonably used), but whether this should have issued as a patent in the first place. Lives actually do hang in the balance here, so I can understand Mayo’s frustration.

I can only hope the Supreme Court makes the right decision.

Danie Roy

My fascination with the pharmaceutical IP world usually leads me to wonderful news: generics, stem cell breakthroughs, and bionic eyes, for example. Very rarely, it leads me straight into the realm of disappointment. Today, however, I find myself in the land of complete and utter disbelief.

It’s not the good kind of disbelief, either. I found out that, apparently, Classen Immunotherapies owns patents on immunization schedules. That would be all fine and dandy if the patents didn’t cover ALL THE IMMUNIZATION SCHEDULES. Patently-O did a great overview of  that patent in litigation, and the questions it raises regarding process claims with regard to 35 USC §101. I want to talk about why it is obscenely broad, obvious, and just how outrageous it is that two of the three patents still stand after litigation.

The patents in question, 6,638,739, 6,420,139, and 5,723,283 are effectively claiming the process of testing immunization schedules and choosing the ones least likely to cause health problems in the future. I am not kidding. I’m almost surprised this didn’t get an obviousness rejection somehow involving Louis Pasteur. I then remembered that Mr. Pasteur only invented immunizations, not bothering to come up with schedules.

In any case, the CAFC decided that the questions of patentability lay in whether or not the process was patentable. The process fails the machine or transformation test horribly, and BARELY even has any physical steps. Even the CAFC characterized the steps as largely mental. But two of the patents still stand. Why? According to Judge Rader, the CAFC isn’t going to impose limits to §101 that aren’t there. I’m guessing that this case might make it to the Supreme Court, if sought. Why? Because not only are these patents borderline ridiculous, but a line will eventually be drawn somewhere for §101.

I’m actually slightly more surprised that nobody tried to pull the trigger on the “encompassing a human being” rule. MPEP § 2105 states that “If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. § 101 must be made indicating that the claimed invention is directed to nonstatutory subject matter.” We don’t have a solid court ruling on that yet, and the Classen patents are useless unless the method is used as claimed on “mammalian subjects,” which Classen itself identifies as “infants.”

Expect updates as this unbelievable mess unfolds. My head is still hurting over someone actually patenting all the immunization schedules.


SUNDAY, FEBRUARY 05, 2012

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