December 13, 2011
Oyez, Oyez, Oyez! Last week the Court heard 2 patent-related cases on vastly different issues.
Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, No.10-844
The Caraco case was argued last Monday, December 5th (trascript available at 2011 WL 6020517). In this case the court must consider whether a generic manufacturer can bring a counterclaim against a pioneer manufacturer under the Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act of 1984).
In Caraco, “[T]he Court of Appeals for the Federal Circuit held that the Hatch-Waxman Act allowed a prospective manufacturer of a generic version of a drug to bring a counterclaim against a patentee, in a Paragraph IV patent infringement action triggered by the generic manufacturer’s abbreviated new drug application (ANDA), only if the drug patent did not claim any approved methods of using the listed drug, and thus, a counterclaim was not available on the ground that the drug patent did not claim all approved methods of using the drug.”
176 Intellectual Property Counselor 5
The question presented in Caraco’s petition for certiorari was:
“Whether this counterclaim provision applies where (1) there is “an approved method of using the drug” that “the patent does not claim,” and (2) the brand submits “patent information” to the FDA that misstates the patent’s scope, requiring “correct[ion].”” (You can find the Petition for Writ of Cert at this citation 2010 WL 5399206)
The counterclaim provision referred to above can be found at 21 U.S.C. § 355(j)(5)(C)(ii)(I)
Also remember, the patent in suit is available from the KeyCite History links:
COUNTER-CLAIM /P PATENT! /P DRUG & CARACO in Intellectual Property – Law Reviews, Texts & Bar Journals (IP-TP) database on Westlaw or in All Intellectual Property Secondary Sources in WestlawNext
Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150
The Prometheus case was argued last Wednesday, December 7th (transcript available at 2011 WL 6077582). In this case the patent covered a method of determining the proper dosage of thiopurine, a drug used to treat gastrointestinal and autoimmune diseases. The Supreme Court vacated and remanded the Federal Circuit’s prior decision (581 F.3d 1336) for further review in light of Bilski v. Kapppos, 130 S.Ct. 3218 (2010). On remand from the Supreme Court, the Federal Circuit held that this claimed method was patent eligible. 628 F.3d 1347.
In the Bilski case, the Supreme Court held that the court is not limited to the machine-or-transformation test as the only test for determining whether a process is patent eligible. This test provides that a claimed invention is not patentable it if is not tied to a machine and does not transform an article. The Supreme Court held that, while the machine-or-transformation test can be a useful tool for determining whether or not a process is patent eligible, this test is not the only means available for making this determination.
The Petition for Writ of Cert is available at this citation 2011 WL 992001
PROMETHEUS /P METHOD PROCESS /10 PATENT! in in Intellectual Property – Law Reviews, Texts & Bar Journals (IP-TP) database on Westlaw or in All Intellectual Property Secondary Sources in WestlawNext
Lastly, you might want to be alerted when these 2 cases are decided. We have yet to outline the steps for setting up a Westclip in this blog. So, here they are:
In Westlaw, click on the Alert Center link the upper right corner of the screen. In WestlawNext, from the homepage click the Tools tab and then click on the Alert Center link.
Follow these steps:
- Where it says WestClip follow the blue line to the right of the screen and click on Create.
- Name your clip in the “Name of clip” box
- Type in your Client ID (if you don’t have one just type in anything you wish, I use my initials).
- In the Database box type SCT
- In the Query box type TI(CARACO) or TI(PROMETHEUS) depending on which one you want this clip to grab.
- Now click the Edit link to the right of Delivery Settings
- Select the frequency with which you would like the WestClip to check for new cases
- Select E-mail for Destination and click the Properties button to input the correct email
- I recommend List of All Citations as your Result Format
- To the right of “No older than” make sure the number is 0 is in the Days box
- Uncheck the “Inform me of no results” box to avoid getting an email everyday telling you the opinion is not out yet.
- Click Save
- This will bring you back to the page where we named the clip, click Save again.
- Now you can see your clip listed under WestClip in your Alert Center.