Category: Life Sciences

1
Federal Circuit holds that reissue application of hemodialysis shunt patent impermissibly recaptured surrendered subject matter
2
Getting closer to put the UPC into force
3
Methods of genetic testing still patentable (Meat & Livestock Australia v Cargill decision)
4
Protecting Plant Innovations in the U.S., Australia and New Zealand
5
Federal Circuit Instructs the PTAB on Written Description in University Interference Proceeding
6
New Developments in Patent Eligibility of Diagnostic Methods
7
Sandoz v. Amgen – Biosimilars at the U.S. Supreme Court
8
Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument
9
Australian Patent and Plant Breeder’s Rights Year in Review
10
2016-2017 Technical Review of Gene Technology Regulations 2001

Federal Circuit holds that reissue application of hemodialysis shunt patent impermissibly recaptured surrendered subject matter

The Federal Circuit, in a nonprecedential decision, held that claims of a reissue application were properly rejected because they recaptured subject matter surrendered during the original prosecution of U.S. Patent No. 8,282,591 (“the ’591 patent”).[1]

The ’591 patent is directed to an arteriovenous shunt that connects a graft to an artery and passes returned blood through a “single lumen venous outflow catheter” into the right atrium of a patient’s heart.  This system reduces the risk of infection, clotting, and hyperplasia compared to systems that remove and return blood through a graft connected to a vein.[2]

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Getting closer to put the UPC into force

April 26, 2018 is a remarkable date: first it’s World IP Day celebrating IP around the world. Second, and this is unique, the British IP Minister Sam Gyimah MP announced that the UK ratified the Unified Patent Court Agreement (UPC Agreement). By doing so the UK agreed to be bound to both the UPC agreement and the UPC’s Protocol on Privileges and Immunities (PPI). The UPC will be a court common to the contracting member states within the EU having exclusive competence in respect of European Patents and European Patents with unitary effect.

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Methods of genetic testing still patentable (Meat & Livestock Australia v Cargill decision)

On Friday 9 February, the Federal Court handed down its highly anticipated decision in Meat & Livestock Australia Limited v Cargill, Inc [2018] FCA 51. The matter has attracted substantial media attention in Australia and generated debate about whether patents claiming methods which use genetic information should be allowed.

The principal claims of the application in suit involve method claims for identifying a trait of a bovine subject from a nucleic acid sample. In particular, the invention made use of single nucleotide polymorphisms (SNPs).

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

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

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

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

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

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.)

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Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument

All nine U.S. Supreme Court justices heard argument on Wednesday April 26th, in Sandoz Inc., v. Amgen Inc.  The Supreme Court is reviewing interpretations of the Biologics Price Competition and Innovation Act (BPCIA) made by the U.S. Court of Appeals for the Federal Circuit. Wednesday’s arguments focused on four main issues:

  1. whether the FDA could preliminarily grant licensure prior to the expiration of the 12 year statutory period;
  2. whether the notice of commercial marketing requires official licensure to be made;
  3. whether the “patent dance” was required by the BPCIA; and
  4. whether state law could be used to enforce compliance with the “patent dance” elements of the BPCIA.

Industry watchers hope that the Supreme Court will streamline the process for getting biosimilars to market by providing increased certainty.

To read the full alert, click here.

By: Theodore J. Angelis, Peter Giunta, Kenneth C. Liao, Margaux L. Nair and Jenna Bruce

Australian Patent and Plant Breeder’s Rights Year in Review

K&L Gates has prepared the first edition of Patent and Plant Breeder’s Rights Year in Review which examines the significant judgments, development and events effecting patents and plant breeder’s rights in Australia.

The Review looks at a number of cases over the year including the Australian High Court’s decision in D’Arcy v Myriad Genetics Inc in the biotech industry, whether an Australian affiliate of an international pharma company was an exclusive licensee and whether it had standing to sue, and the Productivity Commission’s “IP Arrangements” Inquiry Report plus other updates. Click here for the summary or click here for the ePublication.

By: Simone Mitchell, Veg Tran, Michael Christie, Alex Dunlop, Jillian Lim, Jamie Wolbers and Jessica Mandla

2016-2017 Technical Review of Gene Technology Regulations 2001

UPDATE: OGTR Releases Guidelines on Organisms Containing “Gene Drives”

The deadline for submissions on the discussion paper prepared by the Office of the Australian Gene Technology Regulator (OGTR) concerning its review of the Gene Technology Regulations closed on 16 December 2016, and submissions received by the Regulator have yet to be made publicly available.

However, the OGTR has now issued guidelines for Institutional Biosafety Committees (IBCs) and researchers on the regulatory requirements for organisms containing engineered ‘gene drives’ following the discussion paper consultation which revealed that some stakeholders were not aware organisms genetically modified to contain ‘gene drives’ are GMOs. The guidelines reflect the current requirements under the Gene Technology Act 2000 (Act) and will be amended to reflect any changes that are ultimately made.

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