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The Remicade Biosimilar Patent Dispute

While Sandoz has grabbed the biosimilar headlines for being the first company to have a product approved under the Biologics Price Competition and Innovation Act (its product Zarxio™ (filgrastim-sndz) is a biosimilar of...more

STRONG Patents Act Would Fix Micro Entity Gap

Senator Coons (D-Del) has introduced patent reform legislation that is similar to but different from the Goodlatte Innovation Act pending in the House. One section of S. 632 that does not have a parallel in H.R. 9 relates to...more

Federal Circuit Upholds Patent Term Adjustment Deduction for IDS Filed After Restriction Requirement

In Gilead Sciences, Inc. v. Lee, the Federal Circuit upheld the USPTO’s interpretation of the Patent Term Adjustment (PTA) statute as permitting the USPTO to charge “Applicant Delay” when an Information Disclosure Statement...more

Court Cites Objects of Invention in Claim Construction

Pacing Technologies, LLC v. Garmin International, Inc. is one of those Federal Circuit decisions that may send patent practitioners running to their files to double-check the phrasing used in their patent applications. Not...more

USPTO Seeks Input on Patent Quality

As announced in a February 5, 2015 Federal Register Notice, the USPTO is launching an enhanced quality initiative that includes a request for public comment on certain proposals and a two-day “Quality Summit” to be held March...more

Concerns About the Goodlatte Innovation Act

On February 5, 2015, House Judiciary Committee Chairman Bob Goodlatte (R-Va.) introduced the Innovation Act, which is touted as “address[ing] the ever increasing problem of abusive patent litigation.” The bill was introduced...more

Federal Circuit Affirms Use of Broadest Reasonable Interpretation of Claims in IPR Proceedings

In affirming the decision of the USPTO’s Patent Trial and Appeal Board (PTAB) in In re Cuozzo Speed Technologies, LLC, the Federal Circuit upheld the PTAB’s use of the “broadest reasonable interpretation” of the claims in...more

USPTO Seeks Input on Patent Privilege Issues

The USPTO is seeking public comment on patent privilege issues, regarding the legal protections afforded to communications between patent practitioners and clients in the U.S. and foreign countries. The USPTO is hosting a...more

Why Did the Supreme Court GVR the Shire Lialda Case?

On January 26, 2015, the Supreme Court granted certiorari, vacated, and remanded Shire Development LLC v. Watson Pharmaceuticals, Inc., to the Federal Circuit “for further consideration in light of Teva Pharmaceuticals USA,...more

Validity of Sequenom Patent Still to Be Decided

Although Sequenom has settled its dispute over U.S. Patent 6,258,540 with some parties, its case against Ariosa Diagnostics, Inc. remains active. Thus, we all should be waiting with bated breath to see whether the Federal...more

Supreme Court Calls for Some Deference in Claim Construction Standard of Review

On January 20, 2015, the Supreme Court issued its decision in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., finding that the Federal Rules of Civil Procedure call for some deference in the claim construction standard of...more

Can Any DNA Claims Still Be Patented?

In a decision issued December 17, 2014, in In Re BRCA1- And BRCA2-Based Hereditary Cancer Test Patent Litigation (Myriad II), the Federal Circuit invalidated Myriad’s primer claims and detection method claims under 35 USC §...more

Five Things You Need to Know About the USPTO Interim Guidelines on 101

The USPTO issued interim guidelines on 101 (“Interim Guidance”) on December 15, 2014. We summarized the Interim Guidance in this post, and now highlight five things practitioners and stakeholders need to know as they consider...more

USPTO Issues Final Patent Term Adjustment Rules Under Novartis

The USPTO has published final Patent Term Adjustment (PTA) rules addressing the treatment of Requests for Continued Examination (RCEs) under the Federal Circuit decision in Novartis v. Lee. The final rules create a new type...more

Federal Circuit Finds "Classic" Reissue Error

In Fleming v. Escort Inc., the Federal Circuit noted that the error on which Fleming’s reissue patents were based was a “classic” type of error justifying reissue: the inventor’s failure to appreciate the full scope of his...more

Three Patent Issues to Watch in 2015

Well, 2014 was a busy year in patent law, and it wasn’t all good news for patent holders. The Supreme Court made 35 USC § 101 a significant hurdle to patenting inventions across a broad swath of technologies, gave more teeth...more

Federal Circuit Invalidates Myriad Primer and Method Claims as Lacking Subject Matter Eligibility

In a case styled as In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (also known as Myriad v. Ambry), the Federal Circuit held four of Myriad’s “primer” claims and two of Myriad’s detection method claims...more

USPTO Finally Issues New Guidance On Patent Subject Matter Eligibility

The USPTO has issued new “Interim Guidance” for determining whether claims are eligible for patenting under 35 USC § 101. Although the new guidance technically applies to all technologies and all types of claims, Applicants...more

USPTO Issues Long-Awaited Revised Guidance on Patent Eligibility

The USPTO has issued new “interim” guidance for determining whether claims are eligible for patenting under 35 USC 35 U.S.C. § 101. Assuming the guidance document is published in the December 16, 2014 Federal Register, it...more

Sequenom Deal May Avoid Federal Circuit Decision

Less than a month after their case was argued at the Federal Circuit, Illumina Inc. and Sequenom Inc. have announced a deal to settle their patent infringement litigation. While I haven’t seen an order dismissing the case,...more

Federal Circuit Says Secret Prior Art Is Prior Art for All Purposes

In Tyco Healthcare Group LP v. Ethicon Endo-Surgery, Inc., the Federal Circuit agreed with the district court that Ethicon’s prototype constituted prior art under 35 USC § 102(g) based on its earlier date of conception, but...more

Federal Circuit Finds No Biosimilars Application Means No Case or Controversy for Sandoz

In Sandoz Inc. v. Amgen Inc., the Federal Circuit upheld the district court decision dismissing Sandoz’s declaratory judgment action for lack of jurisdiction. Although this may be the first Federal Circuit decision relating...more

Federal Circuit Notes High Burden of Invoking Inherency for Obviousness

In Par Pharmaceutical Inc. v. Twi Pharmaceuticals, Inc., the Federal Circuit vacated and remanded the district court decision holding the Par claims at issue obvious. The district court decision rested in part on the doctrine...more

The USPTO Is Off-Key With International Patent Law Harmonization

As a leader in science, technology and innovation, the United States long has played a central role in global intellectual property matters. As the world’s largest economy, the United States has played a central role in trade...more

Third Time Is the Charm for WildTangent Challenge of Patent Eligibility of Ultramercial Patent

In its third opinion reviewing the same district court decision, the Federal Circuit this time affirmed the district court’s grant of WildTangent’s motion to dismiss Ultramercial’s patent infringement complaint because the...more

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