Intellectual Property & Patent Litigation – Therapeutic Goods

Intellectual property and patent litigation demands a high level of expertise both from a legal, technical and strategic perspective with consideration of the client’s commercial objectives. Working with leading experts in the field, Stephens Lawyers & Consultants conducts litigation in areas of patent, trade mark, copyright and design infringement, the unauthorised use or disclosure of confidential information and trade secrets and disputes relating to the ownership of intellectual property.

Pharmaceutical patent litigation involving infringement and/or invalidity claims is complex. Strategic planning is required to achieve desired commercial outcomes. In the case of pharmaceutical companies in the generics drug market, the desired outcome is first to market following the originator drug, without infringing any patent. Whereas, the patentee aims to maximize its returns from the exploitation of the drugs and/or processes covered by the patent and maintain patent protection.

Stephens Lawyers & Consultants reported pharmaceutical patent cases include:

InterPharma Pty Ltd v. Hospira, Inc. [2019](No.5) FCA 960

Patents – alleged invalidity of pharmaceutical patent on grounds of lack of novelty, inventive step, clarity, manner of manufacture and fair basis. Whether proposed conduct threatened to infringe claims of pharmaceutical patent before expiry.

InterPharma Pty Ltd v. Hospira, Inc. [2018] (No.4) FCA 45

Patents – costs application of an interlocutory injunction application and application to discharge interlocutory application.

InterPharma Pty Ltd v. Hospira, Inc (No 3) [2017] FCA 1536

Patents – Application for interlocutory injunction in respect of alleged threatened infringement of pharmaceutical patent – alleged invalidity of patent on grounds of manner of manufacturer, lack of inventive step, novelty and fair basis.  Interlocutory relief granted.

Practice and Procedure – Interlocutory application to set aside interim injunctive orders on the basis of non-disclosure or misrepresentation

InterPharma Pty Ltd v Hospira, Inc [2017] FCA 1075

Patents- infringement of pharmaceutical patent. Practice and Procedure  (Application for interim injunction – relief granted)

InterPharma Pty Ltd v. Eli Lilly & Company and Anor [10 October 2008 FCA]

In these proceedings Eli Lilly claimed that InterPharma infringes:

(a) Eli Lilly Patent No. 565856 for an invention entitled ‘Difluoro nucleoside antivirals’, the term of which was extended for a five year period to 7 March 2009 (“Compound Patent”).

(b) Eli Lilly Patent No. 565856 for an invention entitled ‘Steroselective glycosylation process’ (“Process Patent”)

by applying for Pharmaceutical Benefits Scheme (“PBS”) listing and marketing of EBEGEMCIT, a pharmaceutical product containing the active ingredient gemcitabine hydrochloride. Eli Lilly sought an urgent interlocutory injunction requiring InterPharma to withdraw its PBS listing for EBEGEMCIT and to restrain InterPharma from importing, marketing, selling and otherwise exploiting EBEGEMCIT. Eli Lilly also sought to restrain InterPharma from applying for PBS listing, importing and marketing any product containing gemcitabine hydrochloride until the expiry of the Compound Patent and the Process Patent. InterPharma denied infringement and claimed invalidity of the Compound Patent and the Process Patent.

Jessup J refused to grant the interlocutory injunction in relation to the Compound Patent. The fact that the Compound Patent expires on 7 March 2009, calculations of any damages suffered by Eli Lilly was unlikely to present any real difficulties and the apparent strength on InterPharma’s case on invalidity were considerations relevant to the injunction not being granted.

In relation to the Process Patent, Jessup J granted a limited interlocutory injunction which restrained InterPharma from dealing with any gemcitabine hydrochloride product made by the process the subject of the evidence before the Court. The practical effect of the decision was that InterPharma was free to deal with any gemcitabine hydrochloride product made using other processes.

InterPharma Pty Ltd v. Commissioner of Patents and Anor [2008] FCA 1283

In these proceedings, InterPharma claimed that the decision of the Commissioner of Patents to grant an extension of term of Eli Lilly Patent 565856 entitled “Difluoro nucloeoside anti-virals” was not lawfully extended under section 70 of the Patents Act 1990. InterPharma further claimed that Eli Lilly, in making the application for extension of term of the patent, had represented to the Commissioner that the pharmaceutical substance on the Australian Register of Therapeutic Goods (“ARTG”), namely Gemzar (a drug for the treatment of cancer) on which it relied was disclosed in Claims 1 to 4 and 6 of the Patent, when this was not the case. The Patent only disclosed anti-viral compounds. InterPharma alleged that these representations to the Commissioner of Patents were made in trade and commerce and were false in contravention of Section 52 of the Trade Practices Act.

Elli Lilly issued an application under Section 31A of the Federal Court of Australia Act for summary judgment claiming that InterPharma had no reasonable prospects of success in relation to said claims.

Sundberg J. held that InterPharma had no reasonable prospect of success in its Section 52 claim because in his opinion the representations by Eli Lilly to the Commissioner of Patents were not made in trade or commerce. Sundberg J followed the decision of Glueck v Stang (2008) 76 IPR 75. In that case, the Court held that representations by Novopharm to the Australian Patent Office, in the course of applying for and obtaining a grant of patent to an invention, were not made in trade or commerce. Sundberg J dismissed InterPharma’s claim under Section 52.

In relation to InterPharma’s claim that the term of the Patent had not been lawfully extended, InterPharma claimed that it was an “aggrieved person” and therefore had standing to seek orders under Section 5 of Administrative Decisions (Judicial Review) Act 1977 (Cth) (ADJR Act), Section 39B the Judiciary Act and Section 192(1) of the Patents Act. Sundberg J rejected Eli Lilly’s claim that InterPharma’s standing had evaporated because InterPharma was not in a position to launch product sourced from EBEWE Pharma in Austria, because of an Austrian Court decision on 7 July 2008, which enjoined EBEWE Pharma from making and importing product. InterPharma claimed that it had other sources of supply. Although Sundberg J rejected Eli Lilly’s claims in relation to “lack of standing”, he held that InterPharma had no reasonable prospects of successfully prosecuting the claims because of delay, despite the fact that InterPharma was not incorporated when the Commissioner made its decision to extend the term of the Patent. InterPharma’s claims were dismissed.

Pharmacia Italia SPA & Pfizer (Perth) Pty Ltd v InterPharma Pty Ltd VID 1137/2005 – Federal Court – 31 October 2005.

This involved a hearing before Registrar Bardsley on 31 October 2005 where InterPharma sought an order that Pfizer (Perth) and Pharmacia Italia (“the applicants”) comply with InterPharma’s Notice to Produce to make available documents produced in the 1992 proceeding between Farmitalia Carlo Erba S.r.L and Delta West Pty Ltd (“Delta West proceeding”). The Delta West proceeding involved a challenge to the validity of the same patent the subject of the present proceeding brought by InterPharma. The documents cited in InterPharma’s Notice to Produce included affidavits and their exhibits, admissions and unsworn witness statements (“Delta West documents”).

The applicants contended that the Delta West documents attracted legal professional privilege, and this privilege had not been waived. Registrar Bardsley rejected this argument and ordered the applicants produce the Delta West documents under a confidentiality regime where access to the confidential documents was limited to InterPharma’s lawyers, counsel, independent expert witnesses and other persons the applicants consented to in writing.

Pharmacia Italia SPA v InterPharma Pty Ltd [2005] FCA 1675.

In these proceedings, Pharmacia Italia and Pfizer (Perth) (“the applicants”), alleged infringement by InterPharma of the Australian Patent No. 598197 entitled “Injectable ready-to-use solutions containing anti-tumour anthracycline glycoside” (“the patent”). The applicants alleged that InterPharma intended to import, sell and distribute ready-to-use solutions containing doxorubicin hydrochloride and epirubicin hydrochloride (“RTU solutions”) being anthracycline glycosides within the scope of the patent. InterPharma had obtained approval from the Therapeutic Goods Administration to market RTU solutions and a listing on the Schedule of Pharmaceutical Benefits (“PBS”).

InterPharma issued proceedings seeking to revoke the patent on various grounds claiming that the patent was invalid. The applicants then sought interlocutory relief to restrain InterPharma from importing, selling and distributing RTU solutions and to order that InterPharma procure the withdrawal of the PBS listing.

Justice Sundberg held that the applicants should be granted an interim injunction as they had established that there was a serious question to be tried on the alleged infringement of the patent; the applicants would suffer irreparable harm if the injunction was not granted and the balance of convenience favours the granting of the injunction. Justice Sundberg granted an interim injunction restraining InterPharma only from importing RTU solutions into Australia until the hearing and determination of the matter. The interim injunction restraining InterPharma from importing RTU solutions was discharged in June 2006.

Pharmacia Italia SPA & Pfizer (Perth) Pty Ltd v Mayne Pharma Pty Ltd, InterPharma Pty Ltd v the Commissioner of Patents and Pharmacia Italia SPA [2006] FCA 305.

Two separate proceedings brought by InterPharma and Mayne Pharma Pty Ltd were heard together before Justice Weinberg in the Federal Court in March 2006. InterPharma claimed that the decision by the Commissioner of Patents to grant an extension to Australian Patent No. 598197, “Injectable ready-to-use solutions containing an anti-tumour anthracycline glycoside”, (“the patent”) was not lawfully made under section 70(2)(a) of the Patents Act (Cth) 1990. The issue raised by Mayne Pharma concerned the rights a patentee has during the term of the patent extension. Justice Weinberg stated that both issues could be resolved by determining if claim 1 of the patent was correctly characterised as a “pharmaceutical substance per se” or if it involved elements of a process or method which take it outside the scope of that phrase. Justice Weinberg held that when claim 1 is read as a whole it claims a new and inventive substance not a method or process. Therefore, InterPharma’s challenge of the Commissioner of Patents’ decision to grant an extension to the patent was dismissed.