Tagged: Life Sciences

NJ District Courts Continue to Enforce the Disclosure Requirements Regarding Contentions Pursuant to New Jersey’s Local Patent Rules

We previously reported in February 2014 and June 2014 that New Jersey District Court Judges will enforce the District of New Jersey’s Local Patent Rules’ contention disclosure requirements and bar parties from making arguments that were not properly disclosed in their contentions. Consistent with those rulings, in a recent opinion, in Impax Labs., Inc. v. Actavis Labs FL, Inc., Judge Chesler barred one of Actavis’s infringement arguments made during summary judgment as untimely because the argument was not sufficiently disclosed in its infringement contentions. In its opposition brief, Impax argued that Actavis raised new non-infringement arguments based on the pharmacokinetic profiles of its proposed generic product. Actavis claimed that its generic product did not meet claim limitations involving a “maximum concentration” limitation or a “40% fluctuation” limitation for two subsets of asserted claims. Upon review of Actavis’s contentions, the court found that Actavis did sufficiently disclose its non-infringement argument in regard to the “maximum concentration” limitation, but that it did not sufficiently disclose its non-infringement argument regarding the “40% fluctuation” limitation. The court found that Actavis’s non-infringement contentions regarding the “40% fluctuation” limitation stated that “there is no evidence that its products ‘result in a levodopa plasma concentration’ meeting the 40% fluctuation limitation.” Yet, in its summary judgment motion, Actavis expanded that argument by providing a...

Rule Change Alert! The Bayh-Dole Act Has New Time and Reporting Requirements

On April 30, 2018, The National Institute of Standards and Technology (NIST) issued rule changes regarding the Bayh-Dole Act. The Bayh-Dole Act was enacted in 1980 as the Patent and Trademark Law Amendments Act (Pub. L. No. 96-517), amended in 1984 by the Trademark Clarification Act of 1984 (Title V of Pub. L. No. 98-620), and again in 2000 by the Technology Transfer Commercialization Act of 1999 (Pub. L. No. 106-404). The Bayh-Dole Act created a uniform policy that allows small businesses and nonprofit organizations the option to retain title to inventions made under government contracts, grants, or cooperative agreements that are for the performance of experimental, developmental, or research work. The implementing regulations are found at 37 C.F.R. Part 401 and Federal Acquisition Regulation (FAR) Subpart 27.3. The April 30, 2018 revisions to the Bayh-Dole Act are categorized as follows: No time limit for government to request title. Since implementation, the government had 60 days within which it could request title to any inventions. The new rule removes the 60 day notice period. Quicker timeframe to prosecute patent applications. Previously, contractors and grant recipients had to notify the agency who granted them money of their intent to prosecute a patent application and maintain it and enter into reexamination or opposition proceedings not less than...

Stronger Patents Act Introduced in House of Representatives

On April 3, 2018, Representatives Steve Stivers and Bill Foster introduced H.R. 5340, entitled Support Technology and Research for Our Nation’s Growth and Economic Resilience (STRONGER) Patents Act implementation. This legislation parallels legislation introduced by Senators Chris Coons and Tom Cotton last year. This bill was introduced because its sponsors believe that the U.S. has driven innovation away with issues that particularly relate to the America Invents Act (AIA). The bill has the following portions in Section 102: Section A – Requires the Patent Trial and Appeal Board (PTAB) to use the same standard as District Courts when deciding what inventions the patent covers – claim construction. Currently, the PTAB uses the broadest reasonable interpretation standard and does not consider all of the evidence of a valid patent claim. Section B – Requires the PTAB to use the same burden of proof – clear and convincing evidence – that is used by District Courts. Right now, the PTAB uses the preponderance of the evidence standard. Section C – Ensures that a petitioner has a business or financial reason to bring the case before the PTAB. This is in direct response to the stockholder suits that have been brought in the PTAB against certain companies. Section D – Authorizes the United States Patent and Trademark Office...

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

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

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...

Federal Circuit Overturned as SCOTUS Creates a New Patent Venue Rule

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...

Chief Justice Roberts Recuses Himself From Life Tech Case

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.

Offering Compassionate Care While Alleviating Ethical Concerns: How Some Pharmaceutical Companies Are Meeting Both Demands

In recent years, families and friends of terminally ill patients have launched highly visible social media campaigns to secure access to potentially life-saving medicine, before those experimental drugs are approved. Pharmaceutical companies that are developing these investigational medicines often face difficult ethical and business relations dilemmas: there are limited exceptions for non-approved drug dissemination and the costs and consequences attendant on the exceptions can make either choice unpalatable. Companies and caregivers alike have struggled with how to fairly provide access to experimental drugs without negatively impacting long term drug development or approval.

Case Update: CryoLife Appeals Preliminary Injunction to Declaratory Judgment Defendant in Patent Case

CryoLife, Inc. has appealed the preliminary injunction recently issued against it in the United States District Court for the District of Delaware barring sales of its PerClot Topical blood-clotting powder product. CryoLife Inc. v. C.R. Bard Inc. et al., Dkt. Entry No. 121, Notice of Appeal. CryoLife has asked United States Court of Appeals for the Federal Circuit to review the district court’s grant of a preliminary injunction based on CryoLife’s failure to present (1) an alternative non-infringement argument based on Medafor, Inc.’s proposed claim construction and (2) expert analysis to support its invalidity contentions. As security, Medafor has agreed to pay CryoLife $100,000 if the injunction is overturned.

Heightened Pleading in Patent Complaints to Frustrate Trolls – Exception for Hatch-Waxman/ANDA Cases

All branches of government have worked to decrease frivolous litigation by non-practicing entities (“NPEs”), or patent trolls, in order to both encourage developing technology and allow businesses to utilize that technology without a looming threat of disruptive and costly litigation. In the course of our coverage of these efforts, we have seen state and federal legislative bodies, as well as the United States Patent and Trademark Office (“USPTO”), the executive branch, and the courts, suggesting potential solutions. Congress is currently weighing a revamped version of House Judiciary Committee Chairman Bob Goodlatte’s Innovation Act bill, which seeks to reform patent litigation by focusing on pleading standards.