Category:Patents

1
Australian Patent and Plant Breeder’s Rights Year in Review
2
Italy ratifies UPC Agreement and Introduces Provisions Against Indirect Counterfeiting
3
Supreme Court Signals Shift in Approach to Damages in Design Patent Infringement Cases
4
The Australian Patent Office Once Again Allows Claims Directed to Nucleic Acids
5
Proposed Australian-New Zealand Single-Desk Patent System Abandoned
6
Nucleic Acids Remain Patentable in Australia
7
Federal Circuit Confirms Cuozzo Does Not Disturb § 314(d) Bar on Appellate Review of PTAB Reconsideration of IPR Institutions
8
Practical Implications from the Federal Circuit’s Rare en Banc Reversal in Apple v. Samsung
9
Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®
10
Remicade® Update: Double Patenting Redoubles in Post-Gilead Biosimilar Case

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

Italy ratifies UPC Agreement and Introduces Provisions Against Indirect Counterfeiting

In December 2016 the Italian government ratified the Unified Patent Court Agreement (UPCA). By this ratification, Italian patent law now has a new rule on the prevention of indirect use of an invention (“indirect counterfeiting”), which is unprecedented in Italy.

The text of the new law amends the Italian Industrial Property Code by reference to Article 26 of the UPCA, by stating:

“A patent confers on its proprietor the right to prevent any third party not having the proprietor’s consent, from supplying or offering to supply, within the territory of the state in which that patent has effect, any person other than a party entitled to exploit the patented invention, with means, relating to an essential element of that invention, for putting it into effect therein, when the third party knows, or should have known by ordinary diligence, that those means are suitable and intended for putting that invention into effect.

The above paragraph does not apply when the means are common commercial products, except where the third party induces the person supplied to perform any of the acts prohibited under the qualification of direct use of the invention.”

This law – which was added to the pre-existing Article 66 of the Italian Industrial Property Code – makes reference to a list of persons and acts excluded from being able to exploit an invention. Such a list is contained in Article 68 of the Italian Industrial Property Code, which currently remains unmodified.

The implementation of this rule on “indirect counterfeiting” represents a step forward in legal protection for patents in Italy.

By: Alessandra Feller and Alessia Castelli

Supreme Court Signals Shift in Approach to Damages in Design Patent Infringement Cases

In its first design patent case in over a century, the Supreme Court on Tuesday, December 6, 2016, reversed a damages award Apple Inc. (“Apple”) had won over Samsung Electronics Co., Ltd. (“Samsung”) in their protracted patent battle.  The design patents at issue were directed to certain elements of Apple’s iPhone.  The Court focused its attention on the meaning of the term “article of manufacture,” suggesting that the Federal Circuit’s definition, which encompassed the entire phone, might be too broad.  Instead, the Court determined that “article of manufacture” could be limited to a particular component of a product, regardless of whether that component is severable (or sold separately) from the product as a whole.  Declining to decide how much money Apple was entitled to under this new interpretation, the Court remanded the case to the Federal Circuit for further proceedings.

Please click here to view the full alert.

By: Jason A. Engel, Gina A. Jenero, Jacob C. Vannette

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

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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Proposed Australian-New Zealand Single-Desk Patent System Abandoned

The proposed single application (SAP) and examination (SEP) processes for Australia and New Zealand have recently been abandoned, more than five years after they were first introduced. The SAP and SEP would have allowed applicants wishing to obtain patents in both countries to file a common application that would be examined by a single examiner at either IP Australia or IPONZ. Once accepted under each country’s law, two separate patents would be granted. Patent examiners would have had to learn to apply the laws of the other country.

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Nucleic Acids Remain Patentable in Australia

A recent Patent Office decision in Arrowhead Research Corporation [2016] APO 701 (“Arrowhead”) has confirmed that nucleic acids can still be patented in Australia.

Following the High Court of Australia’s ruling in D’Arcy v Myriad Genetics Inc [2015] HCA 352 (“Myriad”), the Australian Patent Office has been broadly objecting to claims that encompass isolated nucleic acids.  This practice has frustrated applicants and their attorneys who consider many of the objections to be reactionary, and not consistent with the facts and principles set out in Myriad. In a very recent decision, the Patent Office has confirmed that nucleic acids remain patentable subject matter in Australia by allowing claims directed to interfering RNA compositions.

In Myriad, the High Court clearly stated that it would not be concerning itself with “gene patents” generally, but with the disputed claims specifically (at [37]). Those claims defined isolated nucleic acids per se that were useful in the detection of breast cancer. While acknowledging that the claims defined a product created by human action, the High Court considered that the “substance” of the claims was information, which could not be the subject of a valid claim.

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Federal Circuit Confirms Cuozzo Does Not Disturb § 314(d) Bar on Appellate Review of PTAB Reconsideration of IPR Institutions

The Federal Circuit’s recent decision in Medtronic, Inc. v. Robert Bosch Healthcare Systems, Inc., addressed the effect of the Supreme Court’s decision in Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016), on the issue of whether termination of instituted inter partes review (“IPR”) proceedings based on a failure to meet the statutory filing requirements for a petition (namely, to identify all real parties-in-interest) would be barred from review by 35 U.S.C. § 314(d). The Court found that Cuozzo did not disturb Federal Circuit precedent as to the § 314(d) bar on review for reconsiderations of institution decisions.

Please click here to view the full alert.

By: Rebecca M. Cavin, James (Kwangho) Jang, Jason A. Engel                     

Practical Implications from the Federal Circuit’s Rare en Banc Reversal in Apple v. Samsung

In a precedential opinion issued en banc on Friday, October 7, 2016, the Federal Circuit overturned a panel decision, affirming and reinstating the district court’s judgment and the jury’s verdict. The majority opinion scrutinized and at times scolded the panel for taking on a role well outside of its appellate function and erroneously relying on extrinsic evidence to modify an agreed to and unappealed claim construction and hold claims invalid for obviousness. The majority characterized the appellate court’s function as “limited” and “requiring appropriate deference be applied to the review of fact findings.”

Please click here to view the full alert.

By: Jason A. Engel, Rebecca M. Cavin, Gina A. Jenero

Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®

The United States biosimilars market is beginning to grow, with two recent approvals for biosimilars: Erelzi® and Amjevita®.

On August 30, 2016, the Food & Drug Administration (“FDA”) approved Sandoz’s application for a biosimilar of Enbrel®.  The product is called Erelzi and is the first biosimilar of etanercept to be approved by the FDA.  Like Enbrel, Erelzi is administered by injection and is approved to treat moderate to severe rheumatoid arthritis and moderate to severe plaque psoriasis, among other conditions.  Erelzi is approved as a biosimilar, not interchangeable, product. It is identified as etanercept-szzs.

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Remicade® Update: Double Patenting Redoubles in Post-Gilead Biosimilar Case

On August 17, 2016, in Janssen Biotech, Inc. v. Celltrion Healthcare Co., District of Massachusetts Judge Mark Wolf faced a double patenting fact pattern that had not been adjudicated in a district court case since the Federal Circuit decided Gilead Sciences Inc. v. Natco Pharma Ltd. [1]  Judge Wolf held U.S. Patent No. 6,284,471 (the “’471 patent”) invalid for obviousness-type double patenting over U.S. Patent No. 6,790,444 (the “’444 patent”) because the ’471 patent expired later due to the changes to patent terms under the Uruguay Round Agreements Act (“URAA”), even though both patents claim priority to the same application and the ’471 patent issued years before the ’444 patent. [2]

Please click here to view the full alert.

By: Margaux L. Nair, Trevor M. Gates, Peter Giunta, Theodore J. Angelis

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