patent – Page 3 – IP Law Watch

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

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.)

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

May 02 2017

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:

whether the FDA could preliminarily grant licensure prior to the expiration of the 12 year statutory period;
whether the notice of commercial marketing requires official licensure to be made;
whether the “patent dance” was required by the BPCIA; and
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

Apr 12 2017

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

Apr 05 2017

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

To Perform a Technical Function or Not: This is Rubik’s Question.

Dec 02 2016

After the CJEU decision in case C-30/15 P, fans of three-dimensional trade marks will be wondering if the opportunity to register them is as straightforward as it appears from the recent reform of the Regulation No. 207/2009.

For 10 years, Simba Toys and Seven Towns have been involved in the Rubik’s cube saga, which began in 1999, when the three-dimensional sign reproducing the popular Hungarian toy was registered as a Community trade mark.

The application for a declaration of invalidity filed in 2006 by Simba Toys was based mainly on the infringement of Article 7(1)(e)(ii) of Regulation No 40/94, which prevents a trade mark consisting exclusively of the shape of goods which is necessary to obtain a technical result to be registered.

The EUIPO Cancellation Division as well as the Board of Appeal and the General Court rejected the arguments of the German firm on the grounds that the essential characteristics of the sign at issue are a cube and a grid structure on each surface of the cube and that they do not perform any technical function.

Hence, the appellant’s argument was rejected because the rotating capability of the lattices did not result from the shape presented, but from the invisible internal mechanism which was not part of the graphical representation filed in the trade mark application.

As often happens, the above decisions have been overturned by the CJEU. In particular, the approach of the lower courts was found to be too narrow as they did not take into account the additional elements relating to the function of the actual goods in question.

Lastly, the court held that not taking into account the rotating capability of the cube would extend the trade mark protection to any other kind of puzzle with a similar shape. On the other hand, the technical function behind the cube falls within the scope of Article 7(1)(e)(ii), which precludes the granting of a permanent monopoly on technical solutions. Therefore, in this case it would be more appropriate to consider a patent protection as it has a limited life unlike trademarks.

In conclusion, while the Rubik brand will continue to ensure its exclusivity through other trademarks, copyright, passing off and unfair competition protection, this case made it clear that an effective access to the registration of unconventional trade marks remains as uncertain as the interpretation of Article 7(1)(e)(ii).

By: Serena Totino and Michał Ziółkowski

The Australian Patent Office Once Again Allows Claims Directed to Nucleic Acids

Nov 28 2016

In Commonwealth Scientific and Industrial Research Organisation v BASF Plant Sciences GmbH [2016] APO 83, the Australian Patent Office has once again confirmed that nucleic acids are patentable in Australia.[1]

The opposed application relates to methods of producing polyunsaturated fatty acids in the seeds of transgenic plants. The application included claims directed to a recombinant nucleic acid molecule comprising nucleic acid sequences coding for a polypeptide with Δ6-desaturase activity, a polypeptide with Δ5-desaturase activity, a polypeptide with Δ6-elongase activity and a polypeptide with Δ5-elongase activity, as well as one or more copies of a promoter and a terminator.

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