Gibbons Law Alert

Gibbons Law Alert

Tagged: Patent Infringement

While the PTO Director has Discretion to Institute an IPR, the Board Must Review All Petitioned Claims Upon Institution

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Posted in Patent / USPTO

On April 25, 2018

The U.S. Supreme Court in SAS Institute v. Iancu held that when the Patent Trial and Appeal Board (PTAB or “the Board”) institutes an inter partes review (IPR), it must decide the patentability of all claims challenged in the original petition. Here, in a case with wide-reaching implications, the questions centered on the United States Patent and Trademark Office (USPTO) Director’s discretion and subsequent control of an IPR. In the underlying case, SAS filed a petition for IPR alleging that all 16 claims of a particular patent were unpatentable. The Board instituted review on nine of the challenged claims and denied review on the rest, eventually finding eight of the instituted claims unpatentable in a final written decision. The Federal Circuit rejected SAS’s argument on appeal that 35 U. S. C. §318(a) required that the Board decide the patentability of all 16 claims challenged in the petition. The Supreme Court, in a 5-4 opinion authored by Justice Gorsuch, reversed the Federal Circuit, striking down partial IPR decisions. The Supreme Court held that the plain text of §318(a) conclusively answers the question presented. The section directs that “[i]f an inter partes review is instituted and not dismissed under this chapter, the [Board] shall issue a final written decision with respect to the patentability of any patent claim...

The USPTO Under Recently Appointed Director Andrei Iancu Will Promote Innovation and Increase Reliability in Issued Patents

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Posted in Patent / USPTO

On April 18, 2018

Speaking to the U.S. Chamber of Commerce on April 11, 2018, recently sworn-in USPTO Director Andrei Iancu gave an impassioned speech about his vision for the patent system. Director Iancu outlined challenges facing the USPTO and goals the agency aspires to achieve, focusing on two main objectives: (1) creating a new pro-innovation, pro-IP dialogue, and (2) increasing the reliability of the USPTO granting patents. Stakeholders should take note of the Director’s objectives and should anticipate policy changes that further strengthen the patent system. Creating a new pro-innovation, pro-IP dialogue One thing is clear from Director Iancu’s remarks: the USPTO under his leadership will strive to help the inventor and incentivize innovation. Consistent with this goal, the USPTO will “create a new narrative that defines the patent system by the brilliance of inventors, the excitement of invention, and the incredible benefits they bring to society.” “And it is these benefits,” Director Iancu continued, “that must drive our patent policies.” Much of the narrative of the patent system in recent memory has focused on curbing abuses of non-practicing entities sometimes referred to as “patent trolls.” And Director Iancu’s remarks suggest that the USPTO will actively try to change that narrative. Iancu explained that errors and abuse should be “identified and swiftly eliminated,” but on the whole, the...

What are “Acts of Infringement” and Where is “A Regular and Established Place of Business” for a Hatch-Waxman Defendant: The District of Delaware Weighs in on the Patent Venue Rule

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Posted in Patent / Pharmaceuticals

On September 20, 2017

We previously reported on the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Group Brands LLC, in which the Supreme Court created a new patent venue rule. The patent venue statute, 28 U.S.C. § 1400(b), provides that patent infringement suits “may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.” In TC Heartland, the Supreme Court held that “[a]s applied to domestic corporations, ‘reside[nce] in § 1400(b) refers only to the State of incorporation.” A Delaware District Court recently considered the provision of the patent venue statute not addressed by TC Heartland – where venue is proper if a “defendant has committed acts of infringement and has a regular and established place of business” in the context of a defendant’s motion to dismiss for improper venue. In Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals Inc., a patent infringement matter brought under the Hatch-Waxman statute and filed before the TC Heartland decision, the parties did not dispute that, in light of TC Heartland, the defendant, a West Virginia corporation, could not be said to “reside” in Delaware. Thus, venue would be proper in Delaware only if the defendant committed act of infringement in Delaware and had a...

Constitutionality of IPRs and PGPs

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Posted in Biotech / Patent / Pharmaceuticals / USPTO

On September 5, 2017

Recently, the Supreme Court granted certiorari in Oil States Energy Services v. Green’s Energy Group, Case 16-712 that may have implications on the constitutionality of America Invents Act (AIA) patent review proceedings such as Inter Partes Review (IPRs) and Post Grant Proceedings (PGPs). The case being reviewed involved a fracking patent granted to Oil States. Green’s Energy petitioned to have the Oil States patent reviewed in an IPR (6,179,053). The IPR resulted in the Oil States patent claims being held unpatentable. But, upon review at the Federal Circuit, Oil States challenged the decision and added that IPRs were not allowed under Article III and the Seventh Amendment of the Constitution. In particular, the Oil States argument advanced that the patents must be tried before a jury because invalidity of patent claims traditionally have been a jury issue before a court of competent jurisdiction. The Oil States argument then indicated that Congress could not delegate that right to an administrative agency. The Federal Circuit affirmed the USPTO’s IPR decision of invalidity, without the issuance of an opinion. Following that decision, Oil States petitioned for certiorari to the Supreme Court regarding three issues. The one issue was whether IPR was in violation of the Constitution’s Article III provision since there was no jury trial adjudication of the...

Natural Phenomenon Takes Back Seat to Analysis

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Posted in Patent / Pharmaceuticals

On August 1, 2017

In a recent decision of the CAFC entitled Millennium Pharmaceuticals, Inc. v. Sandoz Inc., et al, a consolidated appeal of cases 2015-2066, 2016-1008, 2016-1009, 2016-1010, 2016-1109, 2016-1110, 2016-1283, and 2016-1762, decided July 17, 2017, Judge Newman writing the opinion for a unanimous panel reversed a decision of the District Court for the District of Delaware holding the patent (US 6,713,446) on the cancer drug Velcade® invalid for obviousness. That drug had been used clinically to successfully treat multiple myeloma and mantle cell myeloma. The active moiety in Velcade® was the compound D-mannitol N-(2-Pyrazine)carbonyl-L-phenylalanine-L-leucine boronate. That compound arose as a result of a yearlong quest to solve the instability problem with solutions of the non-sugar containing bortezomib compound. When the inventor of the ‘446 patent (a scientist at the NCI and the University of Kansas) lyophilized bortezomib in the presence of mannitol he obtained the aforesaid boronate which had covalently incorporated the mannitol producing a new compound. This compound proved to be not only stabile on storage and in solution but also when administered to a subject functioned as a prodrug for bortezomib. No prior art was presented that taught or suggested a compound whose structure presented a basis for an obvious rejection using standard analysis of a pharmaceutical compound claim. In the District Court case,...

Federal Circuit Overturned as SCOTUS Creates a New Patent Venue Rule

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Posted in Patent

On May 26, 2017

In TC Heartland LLC v. Kraft Foods Group Brands LLC, the Supreme Court fundamentally changed the national patent litigation landscape when it considered “where proper venue lies for a patent infringement lawsuit brought against a domestic corporation” and held that “[a]s applied to domestic corporations, ‘reside[nce]’ in § 1400(b) refers only to the State of incorporation.” In so holding, the Supreme Court altered the established patent venue rule – that a corporation is deemed to reside anywhere in which it is subject to personal jurisdiction at the time the action is commenced – which was established by the Federal Circuit’s decision in VE Holding Corp. v. Johnson Gas Appliance Co., 917 F.2d 1574 (Fed. Cir. 1990). In VE Holding, the Federal Circuit held that the definition of venue in § 1391(c), the general venue statute, also applied to patent cases. The Supreme Court based the TC Heartland decision on its prior ruling in Fourco Glass Co. v. Transmirra Products Corp., 335 U.S. 222 (1957) in which, as it described in TC Heartland, it “definitively and unambiguously” held that “residence” in § 1400(b) “refers only to the State of incorporation” as well as its reasoning that “[t]he current version of § 1391 [as amended in 2011] does not contain any indication that Congress intended to alter...

Privilege Claims and the Common Interest Doctrine

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Posted in Patent

On March 24, 2017

In a recent decision, in the District of Massachusetts, Magistrate Judge M. Page Kelley addressed the validity of privilege claims regarding third party communications under the common interest doctrine. In this case, plaintiffs Crane Security Technologies, Inc. and Visual Physics, LLC, a wholly-owned subsidiary of Crane Technologies, Inc. (collectively, “Crane”) alleged that defendant Rolling Optics, AB (“RO”) infringed the Crane patents that “relate generally to optical systems that project synthetic images that ‘move’ and that include image icons formed as voids or recesses” therefore, “useful as [an] anti-counterfeiting feature[] on currency.” Crane is the exclusive licensee to the patents-in-suit from third party, Nanoventions (“NV”). The relationship between the parties began in 2002 when Crane entered into a confidentiality agreement with NV because Crane was interested in using NV’s optical system as a security device on currency. Over the course of the next several years, Crane and NV entered into numerous additional agreements, culminating in Crane’s “purchase[] [of] the intellectual property from NV in 2008.” During discovery, RO challenged approximately 600 entries on Crane’s privilege log regarding certain communications between Crane and third parties pertaining to the Crane’s transactions with NV, including: (1) communications between Crane and NV dated before the 2004 license agreement, while NV was prosecuting the patents-in-suit; (2) communications between Crane and NV...

New Jersey Follows Federal Circuit in Finding Jurisdiction Over Hatch-Waxman Defendants

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Posted in Patent / Pharmaceuticals

On May 2, 2016

We recently reported on the Federal Circuit’s holdings in Acorda Therapeutics, Inc. v. Mylan Pharm. Inc. and AstraZeneca AB v. Mylan Pharm., Inc., where it held that Mylan was subject to jurisdiction in Delaware because “Mylan’s ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs.” Earlier this month, the first decision from the District of New Jersey District applying the Federal Circuits ruling was rendered. In Helsinn Healthcare S.A., et al. v. Hospira, Inc., No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. April 5, 2016), Judge Mary L. Cooper held that sufficient minimum contacts is to find specific jurisdiction is established by the fact that Hospira filed an ANDA seeking to market a generic version of Helsinn’s Aloxi® product that if approved, the marketing of will take place in New Jersey.

Interesting Trends in Establishing Personal Jurisdiction in Hatch-Waxman/ANDA Litigations

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Posted in Patent / Pharmaceuticals

On April 5, 2016

Last week the Federal Circuit handed down one of its more anticipated decisions regarding jurisdiction in cases brought under 35 U.S.C. § 271(e)(2) (aka Hatch-Waxman or ANDA litigation). In its holding, the Federal Circuit stated that a “[defendant’s] ANDA filings and its distribution channels” are enough to “establish that [the defendant’s] plans to market its proposed [ANDA product in the forum state]” are enough to meet the minimum-contacts requirement to establish jurisdiction. It further held “there is no substantial argument that considerations of unfairness override the minimum-contacts basis for [the forum state’s] exercise of specific personal jurisdiction over” the defendants. This holding is much broader than the underlying district court rulings and limited the analysis to specific jurisdiction without addressing the underlying general jurisdictional questions.

Need to Construe “Plain and Ordinary Meaning”?

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Posted in Patent / Pharmaceuticals

On March 14, 2016

In 2005, the Federal Circuit established the framework for the construction of patent claim terms. In its landmark holding in Philips v. AWH Corp., the Federal Circuit stated that “words of a claim ‘are generally given their ordinary and customary meaning . . . [and] that the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art . . . .”

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