The Biologic Transparency Act (S. 659)

The Biologic Transparency Act (S. 659)

The Biologic Patent Transparency Act (S. 659) was introduced by Senators Susan M. Collins ((R) Maine) and Tim Kaine ((D) Virginia) to address an unintended burden when new biological products are presented to the FDA for approval. According to the sponsors, the Act “seeks to help increase patent transparency, promote biosimilar competition, bring needed biosimilar treatments to patients faster, and ultimately, lower drug prices for consumers.” Currently, there is no “official” listing of patents that relate to biological products comparable to what is available for small molecule drug products that are subject to patent and market exclusivity. Small molecule drug products patent listings are located in the commonly known “Orange Book.” Despite a lot of attention focused on biosimilar products and numerous litigations around the country, there is no official book for biologics that provides the transparency found with small molecule drugs. Instead, an “unofficial” book known as the “Purple Book” purports to identify the patents that cover a biological product. The Biologic Patent Transparency Act remedies this deficiency and requires manufacturers of approved biological products to list the patents covering their products with the FDA. In particular, the Act provides for the following: Codification and publication of the Purple...

PTAB Tackles Patentability Issues After New Guidelines

PTAB Tackles Patentability Issues After New Guidelines

Recently, the United States Patent and Trade Office (USPTO) enacted new guidelines to “clarify” the patentability standard and analyses. The USPTO stated that it had undertaken this clarification because many court decisions on the issue of patentability of method type patents in the computer arena had become very difficult for examiners to understand and apply in a predictive manner. As such, there were concerns that the examining corp was not reaching consistent examination and prosecution results. Following the enactment of the new guidelines, a Patent Trial and Appeal Board (PTAB) panel reviewed four patents relating to methods of electronically storing financial documents. The patents involved were US Patents 6,963,866, 7,552,118, 7,836,067 and 9,141,612 belonging to Mirror Imaging LLC (Mirror). Those patents were challenged by Fidelity Information Services LLC (Fidelity) because Fidelity asserted that only abstract ideas were involved, thereby being unpatentable subject matter under section 101. In fact, in a previous PTAB challenge on the same four patents, the PTAB actually opined that the Mirror patents were likely invalid. At the hearing, the questioning by the administrative patent judges centered around whether the abstract ideas are “integrated into a practical application.” Answers to the question of the practical application revolved...

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

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...

Stronger Patents Act Introduced in House of Representatives

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...

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...

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.

Brexit Raises Questions About the Future of the Unitary Patent and Unified Patent Court 0

Brexit Raises Questions About the Future of the Unitary Patent and Unified Patent Court

Recently, the UK voted to leave the EU. However, that has not happened yet for several reasons. The first reason is that the referendum actually needs to be voted on by Parliament, adopting the results of the referendum vote. A second reason is that withdrawal from the EU occurs when Article 50 of the Lisbon Treaty is enacted. Neither one of these two items has occurred. If Parliament agrees to follow the referendum outcome and votes to leave the EU, and if the UK gives notice under Article 50, then many trade agreements and treaties will need to be negotiated in a two-year period from date of notification.

Supreme Court Review Sought on Federal Circuit’s Standard for Appellate Review of Damages Awards 0

Supreme Court Review Sought on Federal Circuit’s Standard for Appellate Review of Damages Awards

Recently, the Commonwealth Scientific and Industrial Research Organization (CSIRO) filed a petition requesting the Supreme Court to review a Federal Circuit decision that vacated a $16 million award against Cisco Systems Inc. Supreme Court Docket No. 15-1440 CSIRO states that the case really revolves around a set of “rigid rules about damages awards in patent infringement cases.” The consequences of these rigid rules, according to CSIRO, is that trial judges in effect are stripped of their ability to determine damages.

Supreme Court to Review First AIA Trials Case 0

Supreme Court to Review First AIA Trials Case

Last month, the U.S. Supreme Court granted certiorari in Cuzzo Speed Techs., LLC v. Lee, in which it will review the first Inter Partes Review (IPR) decision from the Patent Trial and Appeal Board (PTAB) created under the America Invents Act. Last month, the U.S. Supreme Court granted certiorari in Cuzzo Speed Techs., LLC v. Lee, in which it will review the first Inter Partes Review (IPR) decision from the Patent Trial and Appeal Board (PTAB) created under the America Invents Act. The Court will specifically review: Whether the Federal Circuit erred in holding that, in an IPR proceeding, the PTAB may construe claims in an issued patent according to their “broadest reasonable interpretation” (“BRI”) rather than their “plain and ordinary meaning;” and Even if the Board exceeded its statutory authority in instituting an IPR proceeding, whether the Federal Circuit erred in holding that the PTAB’s decision to institute an IPR proceeding is judicially non-reviewable.

CRISPR Technology: A First-To-Invent Dispute in a Now First Inventor to File Patent Regime 0

CRISPR Technology: A First-To-Invent Dispute in a Now First Inventor to File Patent Regime

On March 16, 2013, with the enactment of certain provisions of the America Invents Act (AIA), the United States’ patent system moved from being a first to invent patent system (first-to-invent) to a first inventor to file patent system (first-to-file) and retired the use of interference proceedings to determine priority of invention. Prior to and after the initiation of first-to-file system, there has been much debate as to the virtues of both systems. One aspect of this debate was that inventors with less resources and universities benefited more from the first-to-invent patent system rather than the first-to-file where resources can impact the ability to file quickly. It was in this atmosphere and as forecasted, that there was a surge in pre-March 16 application by inventors who sought to have their application reviewed under the first-to-invent system.