Gibbons Law Alert

Gibbons Law Alert

Category: Patent

Recent Federal Circuit Decision Illustrates Challenges in Proving Obviousness

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Posted in Patent / USPTO

On January 11, 2018

This non-precedential decision is of interest not for any new exposition of patent law but merely as a convenient marker to demonstrate how far the pendulum has swung away from the recent loose standards allowing disparate references to be combined to support an obvious rejection of a patent claim. In the district court below, a bench trial on a Hatch-Waxman infringement suit brought against defendants Dr. Reddy’s and Teva by Genzyme and Sanofi resulted in a decision for the plaintiffs. The court held that the defendants had failed to prove that the sole claim in issue (claim 19) was invalid for obviousness and as infringement was not disputed the verdict of infringement was entered. The technology in the case related to a method for mobilizing and harvesting stem cells in a subject by first treating the subject with G-CSF and then with plerixafor thereby increasing the number of stem cells available for harvesting from the blood for use in treating leukemia by transplantation. The defendants had relied on a combination of references to effectuate an obviousness defense. In a first combination, a paper by Hendrix et al. was cited to show that plerixafor produced increased white blood cells (WBCs) in the circulation. The authors suggested that the action of this agent may cause “release of...

Rule 37’s “Meet and Confer” Requirement Gaining Steam in Discovery Disputes

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Posted in Patent

On November 14, 2017

Merz N. Am., Inc. v. Cytophyl, Inc. is the latest federal district court decision analyzing the meet and confer requirement of Federal Rule of Civil Procedure 37. As discovery issues continue to dominate the first 12 to 18 months of civil litigation (depending on the jurisdiction), litigators should review recent decisions, at least one of which denied a discovery motion for failure to adequately meet and confer. Under Rule 37(a)(1), a party moving to compel discovery must certify that it “has in good faith conferred or attempted to confer with the person or party failing to make . . . discovery in an effort to obtain it without court action.” Because neither the Rule nor the advisory notes accompanying it specify which methods of conferring are appropriate, individual courts have interpreted Rule 37’s meet and confer requirement through local rules and judicial decisions. For example, the Local Rules for the Eastern District of Texas require, “at a minimum, a personal conference, by telephone or in person, between an attorney for the movant and an attorney for the non-movant.” Further, while some courts have addressed the merits of a motion to compel despite a failure to adequately meet and confer, see, e.g., Buskirk v. Wiles, 2016 U.S. Dist. LEXIS 168081 at *7 (S.D. W. Va. Dec....

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...

Purported Inventor’s Damaging Deposition Testimony Not Sufficient to Warrant Attorneys’ Fees for Failed Inventorship Challenge

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Posted in Patent

On May 25, 2017

If you practiced at the pharma-academia interface during the past five decades, you have no doubt heard the mantra it’s about the science and not about the money when issues arose. It was almost always about the money. A case in point is provided by the recent CAFC decision in University of Utah v. Max Planck Gesellschaft. In that case, Max Planck successfully defended a group of ten patents directed to improved methodologies relating to RNA interference, identified as the Tuschl II patents, against a claim to revise inventorship in these patents to name a Utah scientist (Dr. Bass) as sole or joint inventor. The factual basis for the inventorship claim arose from an interaction between Drs. Bass and Tuschl regarding the original methodology in RNA interference set out in a scientific publication identified, as Tuschl I. Such interaction resulted in what was deemed a mini review by Dr. Bass in the scientific journal cell which described the technology and set forth several hypotheses of Dr. Bass including one proposing the ‘3’ overhangs as the enzyme feature that was possibly responsible for the observed activity obtained by the Tuschl technology. During depositions taken in the course of discovery, defendants’ counsel obtained several damaging admissions from Dr. Bass which clearly undermined the claim of the University...

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...

The Regulatory Accountability Act of 2017 May Require a Revisit of Recent Precedent

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Posted in Patent / USPTO

On March 22, 2017

The Regulatory Accountability Act of 2017 is currently pending before the Senate Committee on Homeland Security and Governmental Affairs, which was recently passed by the House of Representatives with a 238-183 vote. If enacted, this bill would repeal the Chevron deference standard (“Chevron standard”), among other reforms, which potentially will require the courts to reconsider and overturn past precedent regarding the patent statute. The Chevron standard frequently appears in litigations involving federal agencies. This standard is rooted in the U.S. Supreme Court case, Chevron U.S.A. Inc. v. Nat. Res. Def. Council, 467 U.S. 837, 104 S. Ct. 2778 (1984), where the Court held that it should defer to agency interpretations of a statute that is “silent or ambiguous with respect to the specific issue.” Under this bill, courts instead would have to review relevant questions of law in these cases de novo. This bill would affect agency guidance from all federal agencies including the U.S. Food and Drug Administration, Environmental Protection Agency, and the agency most relevant to patent practitioners, the United States Patent and Trademark Office (“USPTO”). Although it is difficult to determine the reach of the implications from this bill, if enacted, it is possible that patent practitioners could see the effects. For instance, the 2011 America Invents Act gave the USPTO the...

Chief Justice Roberts Recuses Himself From Life Tech Case

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Posted in Biotech / Patent / Pharmaceuticals / USPTO

On January 23, 2017

An interesting event has occurred at the Supreme Court in the Life Technologies Corp (Life Tech) v. Promega Corp. (Promega) case (136 S.Ct. 2505 (2016)). Chief Justice Roberts recused himself from the deliberations of the case on January 4, 2017. In order to understand why the events played out the way they did, a brief synopsis of the case is being provided.

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