IP Law Watch – Page 35 – Legal issues, law and regulations concerning the world of IP

Protecting Plant Innovations in the U.S., Australia and New Zealand

Jul 19 2017

The development of new plant varieties can be a costly and time-consuming process. To incentivise breeding endeavours, governments around the world have developed legal mechanisms which effectively provide breeders with a period of market exclusivity in which to commercialise their new variety. The mechanisms vary from country to country, and this article briefly reviews those available in the United States, Australia and New Zealand.

To read the full alert, click here.

By: Michael Christie and Margaux Nair

Federal Circuit Instructs the PTAB on Written Description in University Interference Proceeding

Jul 13 2017

On June 27, 2017, the U.S. Federal Circuit vacated and remanded the Patent Trial and Appeal Board’s (Board) decisions in three interference proceedings between the Board of Trustees of Leland Stanford Junior University (Stanford) and the Chinese University of Hong Kong (CUHK) (Case No. 2015-2011).

Competing inventors at Stanford and CUHK developed methods for diagnosing aneuploidies—conditions characterized by an abnormal number of chromosomes (e.g., Down’s Syndrome and Turner’s Syndrome)—using maternal blood samples. Maternal blood contains very small amounts of fetal DNA, and maternal blood sampling is far less invasive than previous methods of sampling fetal DNA. Competing inventors developed techniques for detecting the fetal DNA in maternal blood.

A Stanford application was filed in 2007 with claims to analyzing certain “target sequences” of fetal DNA. A CUHK application, published in 2009, described a “random sequencing” method. This method uses a massively parallel sequencing (MPS) technique that does not require use of “target sequences.” After the CUHK application published, Stanford cancelled its original claims and replaced them with claims to sampling “randomly selected” DNA fragments using MPS. The 2007 Stanford application had disclosed that “the Illumina [DNA] sequencing platform” could be used to perform MPS.

Both Stanford and CUHK requested interferences before the Board to determine who invented the random sequencing method. CUHK claimed that, in 2011, Stanford saw CUHK’s claims to random MPS, and changed its application to claim that technique. CUHK moved to have Stanford’s claims held unpatentable for lack of written description support for random MPS. The Board found that Stanford’s specification disclosed “targeted” rather than “random” MPS, and would not have indicated to one of ordinary skill in the art that the inventor was in possession of the claimed random MPS method. It held Stanford’s claims unpatentable for lack of written description.

The Federal Circuit, inter alia, vacated the Board’s decision, stating that the Board erred in analyzing written description, and remanded the case. The Circuit first found the Board erred by relying on CUHK’s expert testimony and several publications discussing a DNA sequencing platform that differed from the Illumina platform. The Circuit further stated that the Board erred because “the Board’s task was to determine whether the [Stanford specification’s] written description discloses random MPS,” “not whether the description does not preclude targeted MPS.” Finally, the Circuit stated that the Board failed to compare specific sentences and phrases referencing the sequencing process of the Stanford specification to the Stanford claims, e.g., the specification phrase “using the attachment of randomly fragmented genomic DNA.”

On remand, the Circuit instructed the Board to examine whether a person of ordinary skill in the art would have understood that the Stanford specification disclosed random MPS sequencing, as opposed to whether the specification did not preclude targeted MPS sequencing. Specifically, it instructed the Board to determine whether a person of ordinary skill would have known, as of the Stanford priority date, that the reference to Illumina products meant random MPS sequencing as recited in the claims, by examining pre-filing date factual record evidence.

By: Peter Giunta and Jenna Bruce

New Developments in Patent Eligibility of Diagnostic Methods

Jul 11 2017

The U.S. Courts have repeatedly invalidated patents under 35 U.S.C. § 101 as lacking patentable subject matter in areas such as business methods and computer-based inventions. However, decisions addressing inventions in the life sciences are substantially less frequent. In Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017), the Federal Circuit provided some additional guidance for patent eligibility of life sciences inventions.

Three of the patents at issue were directed to methods of detecting myeloperoxidase (MPO) (diagnostic patents), and the fourth patent was directed to methods of treating patients with heart disease based on the MPO detection methods of the other patents. The district court granted the defendant’s motion to dismiss under Fed. R. Civ. P. 12(b)(6) for failure to state a claim because the diagnostic patents lacked patentable subject matter, and the Federal Circuit affirmed that decision.

According to the Federal Circuit, the diagnostic patents were directed to a law of nature: the correlation between MPO level and heart disease. Interestingly, the opinion notes that the correlation was known in the art prior to filing the patents, however, there was no way to directly detect the MPO or correlate the levels to a risk of heart disease. The Court found that the claims did not teach a new test or laboratory technique, nor did they alter the MPO levels. Rather, the levels existed in nature without human action. Thus, the Court concluded that the claims did “not result in an inventive concept that transforms the natural phenomena of MPO being associated with cardiovascular risk into a patentable invention.”

The Court left open the question of whether the method of treatment patent contained patent-eligible subject matter because the Court held that the pleadings for that patent were deficient (this patent was only alleged to be infringed through inducement or contributorily infringed).

Unlike other decisions on patentable subject matter in the life sciences area, the holding did not turn on whether the claims broadly preempted application of a law of nature. The Patent Owner argued that the claims should be patent eligible because they were narrow and did not preempt all uses of the alleged law of nature, but the Court stated that the preemption argument was fully addressed and made moot by its determination that the claims only disclosed patent-ineligible subject matter.

In view of this decision, care should be taken when drafting claims directed to diagnostic methods to be sure to clearly claim more than the diagnostic correlation.

By: Margaux Nair and Aaron Morrow

New Zealand joins the Global Patent Prosecution Highway

Jul 07 2017

On 6 July 2017, New Zealand joined the Global Patent Prosecution Highway (GPPH) pilot program, providing applicants for New Zealand patents with a means of expediting prosecution of their application.

The GPPH is an arrangement between the intellectual property offices of several jurisdictions including Australia, the United States, Japan, Canada and Korea. Under the GPPH, an applicant who receives a ruling that at least one claim has been allowed by a participating patent office may request that another participating patent office expedite examination of their application.

To be eligible for examination under the GPPH, the following requirements must be met:

the patent application to be examined under the GPPH must have the same earliest priority or filing date as the associated application which has already been examined by the participating patent office
the associated application must include one claim which has been deemed allowable by the participating patent office, and
the claims to be examined under the GPPH must sufficiently correspond with the allowed claims.

With regard to the third requirement above, applicants have the option of amending their claims so that they sufficiently correspond with those that have been allowed by another participating patent office. However, before making such amendments, applicants should consider the possibility of obtaining broader claims in certain jurisdictions. Patent laws vary between jurisdictions and a claim that was allowed in, say, the U.S., might be narrower that what could be obtained in New Zealand.

Prior to New Zealand’s entry into the GPPH, the options available to applicants seeking expedited examination were limited and burdensome. The GPPH now provides patent applicants with a simple way of accelerating prosecution of their patent application in several jurisdictions, potentially reducing the costs and time required to obtain a granted patent. However, allowance of a claim in one jurisdiction does not necessarily mean that a corresponding claim will be allowed in another jurisdiction.

By: Michael Christie

Sandoz v. Amgen – Biosimilars at the U.S. Supreme Court

Jul 06 2017

The U.S. Supreme Court unanimously decided Sandoz Inc., v. Amgen Inc., on Monday June 12, 2017, construing the Biologics Price Competition and Innovation Act (BPCIA). The Court held: (1) that the patent dance is not enforceable by injunction under Federal law, and (2) that a biosimilar applicant’s 180-day “notice of commercial marketing” can be provided before FDA approval. (See Sandoz Inc. v. Amgen Inc., Nos. 15-1039 and 15-1195, slip op. and our IP Alert Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument.)

One fee per class system introduced in Polish trademark law

Jun 23 2017

Changes have been introduced in the system of fees for the submission and protection of trademarks and industrial designs with the Polish Patent Office (PPO). An amendment of the Regulation of the Council of Ministers on fees relating to the protection of inventions, utility designs, industrial designs, trademarks, geographic designations and topographies of integrated circuits was published and entered into force at the end of 2016.

To read the full alert, click here.

By: Michał Ziółkowski

Lack of distinctiveness as an obstacle for EUTM registration

Jun 21 2017

The distinctiveness of a trademark is one of the conditions for obtaining a European Union trade mark (EUTM) registration. The concept of a trademark is defined through the prism of distinctiveness as its inherent characteristic, and also its basic function. This distinctiveness may be inherent (due to the unprecedented and extraordinary structure or content of the sign) or acquired (as a result of use of the sign on the market). Distinctiveness should be possessed by each representable and sensory perceptible sign capable of distinguishing goods or services that should perform the functions of a trademark in business or trade.

To read the full alert, click here.

By: Michał Ziółkowski

New regulation on the protection of EU trademarks

Jun 17 2017

On 16 June 2017, we saw the publication of the Regulation of the European Parliament and of the Council (EU) 2017/1001 of 14 June 2017, on the European Union trademark (OJEU L 154 of 16.06.2017), which is de facto the uniform text of Regulation No. 207/2009 as amended as a result of Regulation No. 2015/2424. The new regulation entered into force 20 days after being published in the Official Journal of the European Union and will apply starting 1 October 2017.

The publication of the new regulation is the result of a legal reform of trademarks in the EU. Because Regulation No. 207/2009 was amended significantly several times, for the sake of clarity and comprehensibility, the provisions have been unified.

The provisions of Regulation 2017/1001 are identical with those that were introduced by Amendment Regulation No. 2015/2424 and contain, among other items, a new definition of the term “trademark.”

Source: http://eur-lex.europa.eu

By: Michał Ziółkowski

Supreme Court to Consider Constitutionality of PTAB Proceedings

Jun 14 2017

On June 12, 2017, the U.S. Supreme Court granted Oil States Energy Services, LLC’s petition for a writ of certiorari to address the following question: “Whether inter partes review—an adversarial process used by the Patent and Trademark Office (PTO) to analyze the validity of existing patents—violates the Constitution by extinguishing private property rights through a non-Article III forum without a jury.” The Supreme Court declined to grant certiorari on Oil States’ remaining two questions presented, relating to amendment procedures and claim construction.

Oil States’ argument is that patents are private property rights that can only be revoked by an Article III court, not by an Article I agency. In particular, Oil States urges the Supreme Court to overturn the Federal Circuit’s decision in MCM Portfolio LLC v. Hewlett-Packard Co., which held that patents are public rights and that “Congress has the power to delegate disputes over public rights to non-Article III courts.”[1] The Federal Circuit has already upheld the constitutionality of the PTO’s ex parte reexamination process in Patlex Corp. v. Mossinghoff.[2] In doing so, consistent with MCM, the Federal Circuit affirmed the power of an Article I agency to adjudicate the validity of an issued patent in the first instance.[3]

The Supreme Court previously rejected three other petitions challenging the constitutionality of Patent Trial and Appeal Board (“PTAB”) proceedings. And, as recently as last month, the same issue was presented for en banc review to the Federal Circuit, which declined to review in a 10–2 vote.[4] Accordingly, this case will present the first opportunity for the Supreme Court to consider the constitutionality of the immensely popular post-grant proceedings put in place by the America Invents Act. The case also presents interesting issues regarding a patentee’s right to a jury trial under the Seventh Amendment.

Updates to this alert will be provided as they become available.

[1] 812 F.3d 1284, 1289 (Fed. Cir. 2015).

[2] 758 F.2d 594 (Fed. Cir. 1985).

[3] Id. at 604.

[4] Cascades Projection LLC v. Epson Am., Inc., No. 2017-1517, slip op. at 2 (Fed. Cir. May 10, 2017).

By: Jason Engel, Devon Beane and Erik Halverson

Coming Home? Part Two: Federal Circuit Denies Mandamus Petition Seeking Clarity on Waiver Issues Post-TC Heartland

Jun 13 2017

This legal alert is a follow-up to “Coming Home?: Federal Circuit Asked to Immediately Weigh in on Proper Venue Post-TC Heartland,” available here.

On the morning of June 9, 2017, the defendants in Cobalt Boats, LLC v. Sea Ray Boats, Inc., filed their Mandamus Petition seeking immediate review of the district court’s decision to deny their request to transfer venue. [1] The defendants also renewed their emergency motion to stay the proceedings pending Federal Circuit review. The Federal Circuit denied both requests late in the afternoon the same day. The Federal Circuit did not weigh in on any of the substantive issues regarding waiver of venue challenges, but rather determined that mandamus relief was not the appropriate recourse in this instance. [2]

As with the previous denial of the defendants’ emergency motion to stay, Judge Newman dissented from the opinion. Judge Newman again reiterated that “[t]here is little doubt that the Court’s decision in TC Heartland LLC v. Kraft Foods Grp. Brands LLC, No. 16-341, 2017 WL 2216934 (U.S. May 22, 2017), was a change in the law of venue . . .” [3] Judge Newman also opined that the case presented exceptional circumstances warranting mandamus review because “if the trial commences next Monday as scheduled, the landscape will have changed dramatically—without a stay, the event will be over, and an opportunity for this court to determine whether the district court’s decision was in compliance with the venue requirements revived by TC Heartland may have harsh consequences.” [4]

The district court in the underlying litigation is set to begin trial today.

Notes:
[1] No. 15-cv-21 (E.D. Va.).

[2] In re Sea Ray Boats, Inc., No. 17-124, Dkt. No. 15 at 2 (Fed. Cir. June 9, 2017).

[3] Id. at 5 (Newman, J., dissenting).

[4] Id.

By: Jason Engel and Devon Beane