The United States Supreme Court decided earlier this year that a 1957 opinion is still valid and still limits venue choices for patent infringement actions under 28 U.S.C. § 1400.  See TC Heartland LLC v. Kraft Foods Group Brands LLC, 581 U.S. ___ (2017) (citing Fourco Glass Co. v. Transmirra Products Corp., 353 U.S. 222, 226 (1957)).  In its extensively-covered TC Heartland decision issued in May, the Court held that “[a]s applied to domestic corporations, ‘reside[nce]’ in § 1400(b) refers only to the State of incorporation,” where the accused infringer has a “regular and established place of business” in the venue. While framed as merely confirmation of precedent from the 1950s, many practitioners and commentators viewed this decision as a dramatic change in the patent litigation landscape.

Since TC Heartland came down, lower courts have applied the new paradigm in differing ways.  As trends have developed in recent months, we thought it useful to provide a sampling of the various approaches to venue issues post-TC Heartland.  These issues include, for example, whether defendants who did not contest venue prior to the TC Heartland decision waived the defense of improper venue because the case was—or was not—an “intervening change” in the law, and how to assess whether a defendant has regular and established place of business in a particular venue.

Continue Reading Making the Sausage: Lower Courts Grapple With the Supreme Court’s TC Heartland Venue Decision

On August 25, 2017, the Patent Trial and Appeal Board issued a precedential opinion in Ex Parte McAward, reaffirming the Patent Office’s use of a lower pre-issuance threshold for indefiniteness distinct from the Supreme Court’s Nautilus standard.

A Tale of Two Standards

Under 35 U.S.C. § 112(b), the specification must conclude with “one or more claims particularly pointing out and distinctly claiming the subject matter” regarded as the invention. This definiteness requirement “secure[s] to the patentee all to which he is entitled” and “apprise[s] the public of what is still open to them.” Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996).

During examination, the Patent Office applies the broadest reasonable interpretation of a claim and thereafter determines indefiniteness using the In re Packard standard, in which a claim is indefinite when it contains words or phrases whose meaning is unclear. See In re Packard, 751 F.3d 1307, 1310 (Fed. Cir. 2014)(per curium).

Continue Reading Am I Being Clear Enough? – PTAB Reaffirms Lower Pre-Issuance Threshold for Indefiniteness in Ex Parte McAward

After an eight-year battle through the Federal Courts, the fight over attorneys’ fees in Octane Fitness v. ICON Health & Fitness has likely reached its end with the Federal Circuit upholding the hotly disputed $1.6 million award to Defendant Octane Fitness. This case previously made it up to the Supreme Court, which overturned the Federal Circuit’s prior standard for determining exceptional cases under 35 U.S.C. § 285. Following a remand to the District Court applying the new totality-of-the-circumstances test established by the Supreme Court, the parties again appealed to the Federal Circuit.

Continue Reading Octane Fitness Hits the Showers: Federal Circuit Affirms Attorneys’ Fees Award in Landmark Case

The Supreme Court’s decision five months ago in TC Heartland v. Kraft Food Group Brands was a sea change in the way courts interpret venue for patent infringement cases.  Since the Federal Circuit’s decision in VE Holding Corp. v. Johnson Gas Appliance Co., 917 F.2d 1574 (Fed. Cir. 1990), venue in patent infringement cases has been determined using 28 U.S.C. § 1391(c), which equates a corporate defendant’s residence with personal jurisdiction.  In TC Heartland, the Supreme Court effectively abrogated VE Holding by finding that a corporate defendant “resides” only in its State of incorporation for venue purposes.

Continue Reading District Courts Remain Split on TC Heartland and Waiver of Improper Venue Defense

In a move that could drastically change the patent law landscape, the United States Supreme Court recently granted certiorari in Oil States Energy Services LLC v. Greene’s Energy Group LLC, No. 16-712, to answer the question whether the inter partes review (IPR) process violates the U.S. Constitution by “extinguishing private property rights through a non-Article III forum without a jury.”

In 2001, Oil States Energy Services LLC (“Oil States”) was granted U.S. Patent No. 6,179,053 for a lockdown mechanism to ensure a mandrel is locked in an operative position during fracking.  Oil States sued Greene’s Energy Group LLC (“Greene’s Energy”) in the Eastern District of Texas in 2012 for infringing this patent, and in turn, Greene’s Energy petitioned the United States Patent and Trademark Office (USPTO) to institute an IPR on the patent.  This petition was granted. After the proceedings, the Patent Trial and Appeal Board (PTAB), the administrative body of the USPTO that handles IPRs, concluded the challenged patent claims were invalid.  Oil States appealed to the Federal Circuit, which affirmed the decision, and Oil States then petitioned the Supreme Court for certiorari.

Continue Reading Supreme Court to Decide the Constitutionality of Inter Partes Review

In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195 (U.S. June 12, 2017). The Court’s decision grants more flexibility to biosimilar companies and filers of abbreviated Biologics License Applications (“aBLAs”), holding that (1) a reference product sponsor is not entitled to injunctive relief under federal law for an applicant’s refusal to provide a copy of its aBLA and manufacturing information during the information exchange period contemplated by the BPCIA, and (2) an applicant may provide statutory 180-day pre-launch notice of commercial marketing before its proposed biosimilar product is licensed by FDA. An overview of the parties’ oral arguments before the Court on these issues can be found here.

Continue Reading Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling

DC_SupremeCourtIn keeping with recent erosion of patent rights, patent owners’ power to control the post-sale use and sale of their patented products was severely limited this week by the U.S. Supreme Court in the highly anticipated case regarding the patent exhaustion doctrine, Lexmark Int’l, Inc. v. Impression Prods., Inc., No. 15-1189.

As we reported earlier here and here, the Federal Circuit previously provided patent owners with some power to control their patented products—even after an authorized sale.  Specifically, the Federal Circuit held, in an en banc decision, that a patent owner’s patent rights are not exhausted if a patented product is sold with a clearly communicated restriction and that an authorized foreign sale of a product does not exhaust the patent owner’s U.S. patent rights to exclude associated with that product.

Continue Reading Supreme Court Overrules and Rewrites 25 Years of Federal Circuit Law on Patent Exhaustion

LifeSciences_TestOn May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S. Patent No. 8,273,707 (the “’707 patent”) by filing an abbreviated Biologic License Application (“aBLA”) for a biosimilar version of Amgen’s Neulasta (pegfilgrastim) product. Amgen asserted that the biosimilar manufacturing process disclosed in the Coherus aBLA will infringe the ’707 patent’s claimed protein purification process.

Continue Reading Amgen Sues Coherus Under BPCIA After Completing Patent Dance

Supreme-Court-seal II. jpgYesterday, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act (“BPCIA”) since this key law went into effect in 2010.  The BPCIA created a new, abbreviated pathway for highly similar biological products to enter the U.S. market by following in the footsteps of a reference biological product.  The Court’s decision, which should issue in June, will be closely watched by participants in the pharmaceutical, biotech, and health care sectors.

To read our full alert on the oral argument, please click here.

Continue Reading Amgen v. Sandoz: The Supreme Court’s First Tussle with the BPCIA

Supreme-Court-seal II. jpgIn a widely anticipated move with implications for patent litigation across the country, the Supreme Court ruled today that the equitable defense of laches is not available to limit damages in patent infringement cases subject to the six-year damages limitation of 35 U.S.C. § 286.

In S.C.A. Hygiene Prods. Aktiebolag v. First Quality Baby Prods., LLC, the Supreme Court extended to the patent context its reasoning in Petrella v. Metro-Goldwyn-Mayer, Inc. (2014) that laches cannot defeat a claim for copyright infringement damages brought within the rolling three-year limitations period prescribed by the Copyright Act.

Continue Reading Supreme Court Shuts the Door on Patent Laches