Tagged: Biotech / Biotechnology

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

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...

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

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...

Constitutionality of IPRs and PGPs

Constitutionality of IPRs and PGPs

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...

Federal Circuit Overturned as SCOTUS Creates a New Patent Venue Rule

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 §...

Chief Justice Roberts Recuses Himself From Life Tech Case 0

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 0

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.

The Patient Survives: Third Party Challenge to PTO Revival of Patent  Application Barred under the Administrative Procedures Act 0

The Patient Survives: Third Party Challenge to PTO Revival of Patent Application Barred under the Administrative Procedures Act

The Federal Circuit Court of Appeals recently held that a third party may not challenge a decision by the United States Patent and Trademark Office (“PTO”) to revive an application under the Patent Cooperation Treaty and enabling statutes (“PCT”) through the Administrative Procedures Act (“APA”). See Excela Pharma Sciences, LLC v. Lee, No. 13-1206 (Fed. Cir. Mar. 26, 2015). In combination with the Federal Circuit’s prior holding in Aristocrat Technologies Australia Pty Ltd. v. International Game Technology, 543 F.3d 657 (Fed. Cir. 2008), this holding puts such decisions beyond the reach of third parties, whether affirmatively attacked under the APA or defensively raised in a later infringement action.

Award of Preliminary Injunction to Declaratory Judgment Defendant in the District of Delaware Offers Cautionary Tale in Opposition Strategy 0

Award of Preliminary Injunction to Declaratory Judgment Defendant in the District of Delaware Offers Cautionary Tale in Opposition Strategy

District Court Judge Sue L. Robinson, U.S.D.J., of the United States District Court for the District of Delaware granted a rare preliminary injunction to the declaratory judgment defendant in a patent infringement action, highlighting the importance of presenting infringement arguments under both parties’ claim constructions and expert analysis that supports invalidity. CryoLife Inc. v. C.R. Bard Inc. et al., No. 14-559, Dkt. Entry No. 116, Mem. Order. The injunction bars sales of PerClot Topical, CryoLife’s blood-clotting powder product.

PTAB Finds DNA Sequencing Patent Claims to be Invalid 0

PTAB Finds DNA Sequencing Patent Claims to be Invalid

As we have previously reported, Inter Partes Review (IPR) was introduced on September 11, 2012, under provisions of the America Invents Act (AIA) as one of new several tools for challenging the validity of granted patents in the U.S. Patent & Trademark Office (USPTO). With an anticipated pendency of 18 to 24 months to final written decision upon filing of an IPR request, the USPTO’s Patent Trial and Appeal Board (PTAB) is presently proceeding to issue its first IPR decisions. Although a majority of IPR requests filed to date have been directed to patents in the electrical and computer arts, decisions are also being rendered for patents in other technology domains including the biological arts.

The End of an Era for Gene Patents?  Supreme Court Rules that Isolated DNA is Unpatentable 0

The End of an Era for Gene Patents? Supreme Court Rules that Isolated DNA is Unpatentable

Over thirty years ago, the USPTO awarded the first gene patent (US 4,447,538) and the Supreme Court held that biological inventions were subject to patent protection. Since then, tens of thousands of U.S. “gene” or DNA related patents have issued. However, there has been much uncertainty over the patentability of such inventions as of late.