The U.S. Patent and Trademark Office (USPTO) recently unveiled a new pilot program designed to assist patent applicants and practitioners during patent prosecution. The Post-Prosecution Pilot program, otherwise known as P3, arises under the Enforced Patent Quality Initiative and incorporates components from two existing programs, the Pre-Appeal Brief Conference and the After Final Consideration Pilot 2.0 (AFCP 2.0).
Continue Reading P3: A New Post-Prosecution Pilot Program Designed to Assist Applicants and Prosecutors During the Patent Application Process

In a recent case involving Apotex’s proposed biosimilar product to Amgen’s Neulasta® (pegfilgrastim). Amgen sought a preliminary injunction to enforce the Biologic Price Competition and Innovation Act (BPCIA) provision that requires an applicant to give notice 180 days before marketing an FDA-licensed product. In Amgen v. Sandoz, a divided Federal Circuit held that “the 180-day period runs from post-licensure notice.” In that case, the biosimilar applicant defaulted on the statutory process for exchanging patent information and channeling patent litigation (“information exchange”) required by 42 U.S.C. § 262(l), by not providing the reference product sponsor with a copy of the biosimilar application, as required by 42 U.S.C. § 262(l)(2)(A).
Continue Reading Biosimilar Applicants Must Provide Notice of Commercial Marketing

On May 9, 2016, the U.S. Court of Appeals for the Federal Circuit upheld the U.S. Patent and Trademark Office (PTO) Patent Trial and Appeal Board (PTAB) inter partes review determination that claims 1-6 and 8 of U.S Patent Number 7,566,537 (the ‘537 patent) were not invalid for obviousness under 35 U.S.C. § 103.
Continue Reading Federal Circuit Affirms PTAB’s Nonobvious Ruling While Clarifying the Motivation to Combine and Reasonable Expectation of Success Requirements

Last week, the USPTO issued further guidelines for patent examiners, instructing that rejections of applications based on ineligibility require detailed explanations for the basis of the rejection. This new requirement is distinguished from the previous guidelines by requiring examiners to provide more substantive information in their claim rejections. Along with the guidelines the USPTO issued several examples, which can be useful for examiners and applicants alike. The examples illustrate various claim scenarios, appropriate eligibility analysis, and potential applicant responses.
Continue Reading USPTO’s Updated Guidelines for Rejections Based on Lack of Patent Eligible Subject Matter

In Genetic Technologies Limited v. Merial L.L.C., the Federal Circuit upheld a district court’s determination that many claims of a patent relating to methods of analyzing sequences of DNA are invalid under 35 U.S.C. § 101. According to the opinion, Dr. Simons, the named inventor of U.S. Patent No. 5,612,179, discovered that amplifying and analyzing non-coding, or “junk” DNA could be used to detect genetic disorders.
Continue Reading Federal Circuit Affirms District Court’s Motion To Dismiss Under Mayo

For the first time, the Federal Circuit addressed the requirement of “actual notice” of a published patent application in order for a patent holder to obtain damages before issuance of a patent. The case arose from the appeal of a district court’s grant of summary judgement that Adobe Systems was not liable for patent pre-issuance damages under 35 U.S.C. § 154(d), because it had no knowledge of the published U.S. Patent Application that matured into the asserted U.S. Patent No. 8,578,820.
Continue Reading Practice Tips for Biotech Regarding Provisional Patent Rights After Rosebud v. Adobe

The PTAB recently deemed as precedential two decisions that further clarify when a petitioner can have a second chance to challenge a patent before the Board. In order for a PTAB to be designated precedential, it must be nominated – anyone can nominate, including the public. Then the chief judge, the director, and a majority of the PTAB judges who vote on it must agree that opinion should be precedential. Because of the length of the process, decisions are usually retroactively designated as precedential.
Continue Reading Second Chances at the PTAB: Two Precedential Board Opinions

Another layer of complexity has been added to patent prosecution under the District Court of Michigan’s expanded interpretation of the obviousness type double patenting (“ODP”) doctrine. The district court held that a continuation application can, in certain circumstances, invalidate its earlier filed and earlier issued parent under ODP. If upheld, patent prosecutors must carefully consider the scope of the claims in a continuation application especially when the parent application/patent receives patent term adjustment (“PTA”) extending its expiration date.
Continue Reading Parent Patent Invalidated by Later Filed and Later Issued Continuation Application Under Obviousness Type Double Patenting

The Federal Circuit recently denied Dow Chemical’s request for rehearing and rehearing en banc of Dow Chem. Co. v. Nova Chems. Corp. decided on August 28, 2015. The panel decision found that when multiple methods of measurement for a claimed parameter exist, a patentee must designate which method is being used. For a review of the court’s decision in the Dow Chem case, see our previous article here
Continue Reading No Review for Dow Chemical