Federal Circuit – Page 2

New Developments in Patent Eligibility of Diagnostic Methods

Jul 11 2017

The U.S. Courts have repeatedly invalidated patents under 35 U.S.C. § 101 as lacking patentable subject matter in areas such as business methods and computer-based inventions. However, decisions addressing inventions in the life sciences are substantially less frequent. In Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017), the Federal Circuit provided some additional guidance for patent eligibility of life sciences inventions.

Three of the patents at issue were directed to methods of detecting myeloperoxidase (MPO) (diagnostic patents), and the fourth patent was directed to methods of treating patients with heart disease based on the MPO detection methods of the other patents. The district court granted the defendant’s motion to dismiss under Fed. R. Civ. P. 12(b)(6) for failure to state a claim because the diagnostic patents lacked patentable subject matter, and the Federal Circuit affirmed that decision.

According to the Federal Circuit, the diagnostic patents were directed to a law of nature: the correlation between MPO level and heart disease. Interestingly, the opinion notes that the correlation was known in the art prior to filing the patents, however, there was no way to directly detect the MPO or correlate the levels to a risk of heart disease. The Court found that the claims did not teach a new test or laboratory technique, nor did they alter the MPO levels. Rather, the levels existed in nature without human action. Thus, the Court concluded that the claims did “not result in an inventive concept that transforms the natural phenomena of MPO being associated with cardiovascular risk into a patentable invention.”

The Court left open the question of whether the method of treatment patent contained patent-eligible subject matter because the Court held that the pleadings for that patent were deficient (this patent was only alleged to be infringed through inducement or contributorily infringed).

Unlike other decisions on patentable subject matter in the life sciences area, the holding did not turn on whether the claims broadly preempted application of a law of nature. The Patent Owner argued that the claims should be patent eligible because they were narrow and did not preempt all uses of the alleged law of nature, but the Court stated that the preemption argument was fully addressed and made moot by its determination that the claims only disclosed patent-ineligible subject matter.

In view of this decision, care should be taken when drafting claims directed to diagnostic methods to be sure to clearly claim more than the diagnostic correlation.

By: Margaux Nair and Aaron Morrow

Coming Home? Part Two: Federal Circuit Denies Mandamus Petition Seeking Clarity on Waiver Issues Post-TC Heartland

Jun 13 2017

This legal alert is a follow-up to “Coming Home?: Federal Circuit Asked to Immediately Weigh in on Proper Venue Post-TC Heartland,” available here.

On the morning of June 9, 2017, the defendants in Cobalt Boats, LLC v. Sea Ray Boats, Inc., filed their Mandamus Petition seeking immediate review of the district court’s decision to deny their request to transfer venue. [1] The defendants also renewed their emergency motion to stay the proceedings pending Federal Circuit review. The Federal Circuit denied both requests late in the afternoon the same day. The Federal Circuit did not weigh in on any of the substantive issues regarding waiver of venue challenges, but rather determined that mandamus relief was not the appropriate recourse in this instance. [2]

As with the previous denial of the defendants’ emergency motion to stay, Judge Newman dissented from the opinion. Judge Newman again reiterated that “[t]here is little doubt that the Court’s decision in TC Heartland LLC v. Kraft Foods Grp. Brands LLC, No. 16-341, 2017 WL 2216934 (U.S. May 22, 2017), was a change in the law of venue . . .” [3] Judge Newman also opined that the case presented exceptional circumstances warranting mandamus review because “if the trial commences next Monday as scheduled, the landscape will have changed dramatically—without a stay, the event will be over, and an opportunity for this court to determine whether the district court’s decision was in compliance with the venue requirements revived by TC Heartland may have harsh consequences.” [4]

The district court in the underlying litigation is set to begin trial today.

Notes:
[1] No. 15-cv-21 (E.D. Va.).

[2] In re Sea Ray Boats, Inc., No. 17-124, Dkt. No. 15 at 2 (Fed. Cir. June 9, 2017).

[3] Id. at 5 (Newman, J., dissenting).

[4] Id.

By: Jason Engel and Devon Beane

Coming Home?: Federal Circuit Asked To Immediately Weigh In On Proper Venue Post-TC Heartland

Jun 12 2017

In a case pending in the Eastern District of Virginia, set to start trial on June 12, 2017, the defendants filed a motion to transfer the case to the Eastern District of Tennessee following the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Group Brands LLC, No. 16-341, 2017 WL 2216934 (U.S. May 22, 2017). The district court ordered expedited briefing on the issue and ultimately determined that the defendants had waived their right to challenge venue. In particular, according to the district court, “TC Heartland does not qualify for the intervening law exception to waiver because it merely affirms the viability of Fourco [Glass Co. v. Transmirra Products Corp., 353 U.S. 222, 226 (1957)].” Cobalt Boats, LLC v. Sea Ray Boats, Inc., No. 15-cv-21, Opinion & Order at 6 (E.D. Va. June 7, 2017).

Because trial is just around the corner for these defendants, they filed an emergency motion to stay the district court case with the Federal Circuit to allow time to file a Petition for Writ of Mandamus (“Mandamus Petition”). On June 8, 2017, the Federal Circuit denied the motion without prejudice to refiling if defendants filed the Mandamus Petition. Interestingly, however, Judge Newman dissented from the denial, stating unequivocally that TC Heartland “was a change in the law of venue.” In re: Sea Ray Boats, Inc., No. 17-124, Dkt. No. 4 at 3 (Fed. Cir. June 8, 2017) (Newman, J., dissenting). Judge Newman explained that “[t]he processes of law are designed not for the convenience of judges, but as safeguards to litigants and warders of justice.” Id. at 4. Because the change in law “bring[s] the propriety of the current venue directly into question,” Judge Newman believed a stay of the underlying trial was appropriate. Id.

On the morning of June 9, 2017, the defendants filed their Mandamus Petition and renewed their emergency motion to stay the trial.

Updates to this alert will be provided as they become available.

By: Jason Engel and Devon Curtis Beane

Federal Circuit Holds That an Offer to Sell a Drug Product Was a Patent-Invalidating Offer for Sale under Pre-AIA § 102(b) Even Though the Offer Lacked “Safety and Liability Terms”

Jun 07 2016

On May 13, 2016, the Federal Circuit determined that Merck’s crystalline calcium salt of tetrahydrofolic acid (“MTHF”) had been the subject of a commercial offer for sale, and held Merck’s MTHF claim in U.S. Patent No. 6,441,168 is invalid under the on-sale bar provision of pre-AIA § 102(b). Specifically, the Federal Circuit held that Merck made an invalidating offer to sell MTHF when it sent a fax that included price, quantity, and delivery terms, and rejected the district court’s determination that additional, industry standard “safety and liability terms” were required for there to have been an “offer for sale.”

Please click here to view the alert.

by Trevor M. Gates, Theodore J. Angelis, Peter Giunta

What You Need to Know About the Recent Federal Circuit Rule Changes

May 02 2016

By: Devon C. Beane, Jason A. Engel, and Theodore J. Angelis

The U.S. Court of Appeals for the Federal Circuit recently implemented significant amendments to its Rules of Practice. The changes apply to all cases docked on or after April 1, 2016. In large part, the amendments were made to comport existing practices or requirements for electronic case filing with the Rules. Other changes, such as those relating to confidentiality, reflect a wholesale shift in Federal Circuit practice. This alert provides a brief overview of some of the more significant amendments. Please click here to read the full alert.

Amgen Prevails on Temporarily Excluding Zarxio® From Market

May 12 2015

After an unsuccessful attempt to obtain a preliminary injunction against Sandoz Inc.’s (“Sandoz”) Zarxio® in the District Court for the Northern District of California, Amgen Inc. (“Amgen”) has prevailed before the Federal Circuit in excluding the biosimilar from the market, at least temporarily. On May 5, 2015, the Federal Circuit granted Amgen’s motion for an injunction “preventing Sandoz [ ] from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO® biosimilar product until this Court resolves the appeal.” Amgen Inc. et al. v. Sandoz Inc. et al., Appeal No. 2015-1499, Dkt. 105 (Fed. Cir. March 27, 2015).

To read the full alert, click here.

Another Piece in the Software Patent Puzzle – The Federal Circuit’s First Take on Alice

Jul 28 2014

The Federal Circuit recently released its first interpretation of the Supreme Court’s late June decision in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, et al. (Alice) In Digitech Image Tech., LLC v. Electronics for Imaging, Inc., et al. (Digitech) the Federal Circuit added a few more wrinkles to the emerging law of software patent eligibility.

In Digitech, the Federal Circuit held that all of the asserted claims of U.S. Patent No. 6,128,415 were ineligible for patenting. The patent was directed to device profiles, which are data structures used to correct for hardware-specific distortions in digital image processing systems. Read More

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