IP Law Alert

IP Law Alert

Practical Perspectives on Intellectual Property Legal Developments

Tag Archives: Biotech / Biotechnology

Chief Justice Roberts Recuses Himself From Life Tech Case

Posted in Biotech, Patent, Pharmaceuticals, USPTO
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.… Continue Reading

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

Posted in Pharmaceuticals
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.… Continue Reading

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

Posted in Patent
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.… Continue Reading

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

Posted in Patent
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.… Continue Reading

PTAB Finds DNA Sequencing Patent Claims to be Invalid

Posted in Biotech, Patent
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.… Continue Reading

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

Posted in Patent
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.… Continue Reading

An End to the Seed War: Monsanto and DuPont Call Off Their Patent and Antitrust Lawsuits as a Decision in Bowman v. Monsanto is Pending

Posted in Licensing, Patent
On March 25, seed giants DuPont and Monsanto entered into technology licensing agreements that ended their ongoing patent and antitrust lawsuits. According to the terms of the agreement, DuPont will pay at least $1.75 billion in licensing and royalty fees to Monsanto from 2014 to 2023. These payments include fixed royalty payments from 2014 to 2017, totaling $802 million, and per-unit based royalty payments from 2019 to 2023, subject to annual minimums, totaling $950 million. DuPont and Monsanto also will dismiss their respective patent and antitrust lawsuits, including the August 2012 damage award of $1 billion against DuPont that have been pending since 2009. Further details on these agreements can be found in DuPont and Monsanto's joint March 26 press release and DuPont's March 26 Form 8-K.… Continue Reading

NJIPLA Pharmaceutical/Chemical Patent Practice Program

Posted in Patent
The 26th Annual New Jersey Intellectual Property Law Association (NJIPLA) Pharmaceutical/Chemical Patent Practice Update will feature the Honorable Faith S. Hochberg of the United States District Court for the District of New Jersey, who will provide a judge’s perspective on emerging issues under the AIA. The program will take place on December 5, 2012, from… Continue Reading

Biosimilars: Data Exclusivity and the “Patent Protection Gap”

Posted in Biotech, Patent, Pharmaceuticals
Several bills are currently pending in Congress establishing expedited marketing approval pathways for biosimilar drugs. The proposed pathways are analogous to the pathway for small molecule chemical drugs established by the passage of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. The Hatch-Waxman Act includes a data exclusivity provision whereby the FDA is prohibited from approving a competitor's drug application relying on the innovator's data for a statutory period of time. Recent debates concerning the biosimilar bills have focused on the data exclusivity period. These debates highlight the differences between biological drugs and small molecule chemical drugs and why a longer exclusivity period may be necessary to fill the "patent protection gap."… Continue Reading
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