IP Law Bulletin

On November 1, 2014, the European Patent Office (EPO) will implement a revision to Rule 164 EPC that allows Patent Cooperation Treaty (PCT) applicants to have more than one invention searched when a unity of invention objection is present, regardless of whether the EPO was selected as the International Searching Authority (ISA) during the international phase. Under current practice, if the EPO is not the selected ISA, a supplemental European search report will address only the first invention mentioned in the claims, and any further inventions can only be pursued through divisional practice. Conversely, however, if the EPO is the selected ISA, applicants can request and pay for additional searches before selecting the invention to be pursued.

On August 4, 2014, the US Food and Drug Administration (FDA) released Draft Guidance on determining eligibility of a biological drug for regulatory exclusivity.

Under the Public Health Service Act (PHS Act), as amended in 2010, an abbreviated biosimilar application can be accepted by the FDA, but not until 4 years after the first licensure of the original reference product and, once accepted, such an application cannot be fully approved by the FDA for a period of 12 years from the reference’s first licensure. This reference product exclusivity is granted independently of any patent exclusivity, and therefore, by itself, provides a significant incentive to the sponsor of a Biologic License Application (BLA) who obtains the first licensure status. The date of first licensure is also critical to the timing of a follow-on biosimilar entry to the market.

The Leahy-Smith America Invents Act (AIA) introduced a number of important changes to U.S. patent law. Many of the provisions in the AIA do not apply to patent applications that have an effective filing date prior to March 16, 2013 (pre-AIA applications). For a number of reasons that have been well documented, it can be desirable to preserve an application’s status as a pre-AIA application.

In late June, the United States Supreme Court issued a long-awaited decision in Alice Corporation Pty. Ltd. v. CLS Bank International that may have broad-reaching implications on patenting software. At issue in the case was whether claims to a computer-implemented system and method for mitigating “settlement risk” in financial transactions are eligible for patenting under 35 U.S.C. § 101. In a unanimous decision, the Court held that the claims were directed to an abstract idea and, although implemented on a computer, were not patentable.

Following closely on the heels of the United States Supreme Court decision in Alice Corporation Pty. Ltd. v. CLS Bank International, 573 U.S. ___ (2014) (CLS Bank), the United States Patent and Trademark Office (USPTO) has issued guidelines for the examination of patent applications claiming abstract ideas, particularly, as those implemented on computers. The guidelines went into effect yesterday, but are preliminary: the USPTO indicates that it will issue additional guidance after further consideration of the Court's decision and public feedback. ¹

Today’s long-awaited decision by the United States Supreme Court in Alice Corporation Pty. Ltd. v. CLS Bank International, 573 U.S. ___ (2014) may have broad-reaching implications on patenting software. At issue in the case was whether claims to a computer-implemented system and method for mitigating “settlement risk” in financial transactions are eligible for patenting under 35 U.S.C. § 101. In a unanimous decision, the Court held that the claims were directed to an abstract idea and, although implemented on a computer, were not patentable.

Today the United States Supreme Court issued two opinions addressing patent law issues—Limelight Networks, Inc. v. Akamai Technologies, Inc. and Nautilus, Inc. v. Biosig Instruments, Inc. In both cases, the nation’s highest court unanimously reversed the Federal Circuit. In doing so, the Court simultaneously raised the bar for patentees with respect to patent infringement and lowered the bar for alleged infringers with respect to invalidity.

On May 15, 2014, the U.S. Patent and Trademark Office (USPTO) published rules to implement the patent term adjustment (PTA) provisions of the Leahy-Smith America Invents Act (AIA) and the AIA Technical Corrections Act, the latter of which was summarized in the January 2013 issue of the Nutter IP Bulletin. Under the new rules, the fourteen (14) month PTA period and the three (3) year PTA period are measured from the same date: the date on which an application was filed under 35 U.S.C. § 111(a) in an application under 35 U.S.C. § 111; or the date of commencement of the national stage under 35 U.S.C. § 371 in an international application. The rules also revised the provisions for notifying applicants of PTA determinations and the time period for requesting reconsideration (now by the date of issuance of the patent, and by seven months from the date of notification, respectively) and judicial review of the USPTO’s PTA determinations and decisions (now 180 days from the date of the USPTO’s decision on the patentee’s request for reconsideration). The new rules do not come as a surprise—rather, they adopt the interim rule published April 1, 2013, which are discussed in greater detail in an article from the May 2013 issue of the Nutter IP Bulletin.

On March 4, 2014, the U.S. Patent and Trademark Office (USPTO) published the long-awaited Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products. The Guidance implements new examination procedures to address the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics (holding that isolated natural DNA sequences are not patent eligible) and Mayo Collaborative Services v. Prometheus Laboratories (holding that application of a law of nature, using only known steps, is not patent eligible). Since those decisions issued in June 2013 and March 2012, respectively, the patent community has eagerly anticipated the USPTO guidelines.

Both the legislature and the judiciary are currently engaged in attempts to curb so-called “patent trolling” – the use of patents solely for litigation instead of innovation, development, and protection of marketed products. Rising concerns over this behavior led to the recent passage of H.R. 3309 (the “Innovation Act”) with overwhelming bipartisan support, only about a month after the bill was introduced to the House. The Innovation Act aims to encourage innovation by creating a number of alleged procedural safeguards against frivolous patent infringement claims, including heightening pleading requirements, limiting discovery, and shifting fees to the prevailing party. It also contains provisions for making post-grant review procedures before the Patent Trial and Appeal Board a more attractive alternative to challenging patents in court. The Innovation Act has generated its own set of concerns, however, particularly among small corporate or individual patent owners, who worry that the bill may unfairly limit the rights of all patent owners, and among certain members of the judiciary, who feel that the bill is an improper legislative encroachment on judicial authority.