Tag: patent

1
A Win is a Win!
2
IPR of pre-AIA patent not an unconstitutional taking
3
New parallel importation laws in Australia
4
Pushing the limits of Australia’s grace period
5
USPTO Issues Report on Public Views Regarding Subject Matter Eligibility
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
Markush Madness: Watson Avoids Infringement by Adding an Element to a Formulation

A Win is a Win!

B.E. Technology LLC v. Facebook, Inc., Appeal No. 18-2356 (Fed. Cir. Oct. 9, 2019) identifies what it means to win in a case.  More particularly, the Federal Circuit explained how to determine whether a party is “the prevailing party.”  B.E. Technology (“B.E.”) brought a patent infringement suit in district court against Facebook and the case was stayed pending inter partes review.  The Patent Trial and Appeal Board ultimately held the claims of the patent in question to be unpatentable, which was confirmed on appeal.

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IPR of pre-AIA patent not an unconstitutional taking

In a notable, albeit not surprising, U.S. Federal Circuit decision today, the panel in Celgene Corp. v. Peter confirmed that an inter partes review finding of unpatentability of a pre-AIA patent is not an unconstitutional taking. (slip op. 2018-1171 (July 30, 2019)).

Noting an opening in the recent Supreme Court decision in Oil States, the Federal Circuit deemed the circumstances exceptional as their basis for review of an issue not before the PTAB in the underlying proceeding. The panel reasoned that the proceeding being “curative” in nature, and the approximately forty year period of time in which PTAB proceedings have existed subjecting granted patents to potential cancellations for that duration weighted against any unconstitutionality.

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New parallel importation laws in Australia

Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Act 2018 receives Royal Assent on 24 August 2018

The proposed changes to parallel importation law that we blogged about in January 2018 and May 2018 have become law.

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Pushing the limits of Australia’s grace period

Australia’s “grace period” provisions allow a patent applicant to disclose or use their invention within 12 months before filing a complete patent application in Australia.  In an interesting interpretation of those provisions, the Australian Patent Office has found that the grace period applies to whole of contents citations published after a patent application has been filed.

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USPTO Issues Report on Public Views Regarding Subject Matter Eligibility

On July 25, 2017, the United States Patent and Trademark Office (USPTO) issued Patent Eligible Subject Matter: Report on Views and Recommendations From the Public (Report). The Report summarizes public comments on the state of subject matter eligibility law.  Comments came from varied sources including industry, private practice, academia, trade associations, inventors, and small business.

After beginning with an overview of eligibility law in the U.S. and abroad, the Report summarizes the comments supportive and critical of the Supreme Court’s Bilski, Mayo, Myriad, and Alice decisions regarding subject matter eligibility. It polls opinions from the two most-impacted technology sectors, and reviews recommendations on how to move forward.

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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

Markush Madness: Watson Avoids Infringement by Adding an Element to a Formulation

On February 1, 2017, in Shire Development, LLC v. Watson Pharmaceuticals, Inc., the U.S. Court of Appeals for the Federal Circuit held that Watson’s proposed generic version of Shire’s LIALDA® did not infringe claims 1 and 3 of Shire’s U.S. Patent No. 6,773,720 (the “’720 patent”).[1]  In reversing the district court, the Federal Circuit determined that Shire’s claim to an outer layer “consisting of” a list of specific elements closes the universe of elements for infringement purposes, and Watson’s addition of an ingredient (“magnesium stearate”) to the outer layer of its accused product created non-infringement because it was outside the claimed list of elements.[2]  The Federal Circuit’s opinion rests on a strict reading of the Markush groups within the ’720 patent and a rejection of the district court’s broad reading of the Federal Circuit’s opinion in Norian Corp. v. Stryker Corp.[3]

Background
A Markush-type claim (also known as a Markush group) allows a patent drafter to capture independent, related claim elements in a single limitation.  The claim is characterized by the form “selected from the group consisting of A, B and C.”[4]  The “consisting of” language closes the group from including other members, such as “D.”  “Consisting of” limits an element to only the named members of the group, and an element selected from outside that group will not be covered by the claim.  In contrast, patent drafters frequently use an alternative preamble “comprising” to keep the claims open to additional, unrecited elements.[5]

Here, Shire sued Watson for infringing claims 1 and 3 of the ’720 patent by filing an Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration seeking to market a generic version of Shire’s drug LIALDA®.  The ’720 patent is directed to a controlled-release oral composition of mesalamine (5-amino-salicylic acid) used to treat Crohn’s disease and ulcerative colitis.  The claimed composition includes the mesalamine active ingredient; an inner, lipophilic matrix that “resists dissolving in water”; an outer, hydrophilic matrix that “readily dissolves in” water; and other optional excipients.

To read the full alert, click here.

By: Kenneth C. Liao and Peter Giunta

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