Ethinyl estradiol & Drospirenone – Australia

On 16 March 2017, The Federal Court of Australia has handed down its first detailed damages decision in a long time in a patent infringement claim against a generic pharmaceutical company. In doing so, it sets a new benchmark for damages claims by innovator companies whose products have been illegally copied. In Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd [2017] FCA 250, Bayer was awarded damages of over $25m plus interest, assessed on Bayer’s pre-tax losses. 

Bayer holds a patent which protects an oral contraceptive which it markets as “Yasmin”. In 2012 Generic Health entered the market with a competing oral contraceptive product known as “Isabelle”. Subsequently, Bayer also marketed its own generic product under the name “Petibelle”. Justice Jagot had previously found that Bayer’s patent was infringed as a result of the sale of “Isabelle”. A factual twist in the case was that Bayer sought to amend some of the original claims of the patent after Isabelle entered the market. Patent infringement proceedings were already on foot. The proposed amendments were tailored to focus more directly on the features of the “Isabelle” product, specifically as to dose, dosage form and testing for solubility. These amendments were approved in late 2012 under section 105 of the Patents Act 1990.

Bayer elected to seek damages for patent infringement, rather than an account of profits. In support of its claim, it argued that every sale of Isabelle, and of its own generic Petibelle, was in reality a lost sale for Yasmin. 

Calcipotriol & Betamethasone dipropionate – Canada

On March 14, 2017, The Federal Court of Appeal (FCA) dismissed Teva's appeal on both counts (utility and insufficiency of disclosure) and upheld the prohibition order granted by Federal Court pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations.

Leo Pharma Inc. markets DOVOBET® (calcipotriol/betamethasone dipropionate ointment) in Canada for the treatment of psoriasis. Teva Canada Limited sought approval for a generic version of DOVOBET® and was opposed by Leo. Leo's application was successful, and Federal court issued an order prohibiting the Minister of Health from approving Teva's proposed generic until the expiry of Canadian Patent No. 2,370,565 (the 565 Patent). The 565 Patent is listed on the patent register against DOVOBET®. It relates to a combination formulation of: at least one vitamin D or vitamin D analogue (Component A); at least one corticosteroid (Component B); and a solvent (Component C).

With respect to Utility, Teva argued that the Federal Court erred by dismissing its inutility allegation without evidence from Leo regarding the factual basis and logic or reasoning used by the inventors to support their sound prediction of the invention's utility. The FCA rejected Teva's argument that, as a matter of law, subjective proof of the inventors' prediction must be made through evidence directly from the inventors, not an expert witness.

With respect to Insufficiency, Teva argued that the Federal Court erred in law because it did not find that the 565 Patent fails to correctly and fully disclose the invention as contemplated by the inventors. The FCA held that one must always consider the nature of the invention to determine what needs to be included in the disclosure. Furthermore, the FCA accepted that non-inventive trial-and-error experimentation is permissible when determining whether a skilled person would be able to work the invention.

Omeprazole - Canada

On March 13, 2017, Apotex filed for leave to appeal the Federal Court of Appeal's (FCA) decision addressing validity and infringement of AstraZeneca's Canadian Patent No. 1,292,693 with the Supreme Court of Canada.

The Federal Court on March 16, 2015, held AstraZeneca's patent valid and infringed by Apotex's manufacture, sale, and promotion of Apo-Omeprazole capsules. Apotex appealed to FCA.

On appeal, the FCA on January 12, 2017, upheld the Federal Court's findings on construction, validity and infringement, and affirmed that a patent need only describe a single method or process for making the claimed invention. The FCA also dismissed AstraZeneca's cross-appeal on punitive damages. 

Efavirenz & Emtricitabine & Tenofovir - UK

On Mar 21, 2017, in Teva UK Ltd. v. Merck Sharp & Dohme Corp., [2017] EWHC 539 (Pat)(U.K. High Court 2017(Arnold, J.), claimants Teva et al. successfully challenged the validity of the Patentee-Defendant’s Supplementary Protection Certificate for the anti-retroviral medication “Atripla”.

In these proceedings the Claimants challenge the validity of the Defendant’s (“MSD’s”) supplementary protection certificate SPC/GB08/022 (“the SPC”) for a product described in the SPC as “A combination of efavirenz, emtricitabine or a pharmaceutically acceptable salt or ester thereof, and tenofovir or a pharmaceutically acceptable prodrug, salt or ester thereof, particularly tenofovir disoproxil, especially tenofovir disoproxil fumarate” (“the Product”). The SPC covers a product which is marketed by Bristol-Myers Squibb Co (“BMS”) and Gilead Sciences Inc under the trade mark Atripla. Atripla is an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV).

The Claimants contend that the SPC does not comply with Article 3(a) because the Product is not protected by European Patent (UK) No. 0 582 455 (“the Patent”), which is relied upon by MSD as the basic patent for the SPC. It may be noted that MSD obtained the SPC by amending the Patent to insert claim 17 and relying upon claim 17 as protecting the Product, but MSD did not rely upon claim 17 at trial. Instead, MSD relied solely upon claim 16.

The Claimants contend that the SPC does not comply with Article 3(c) because MSD had previously obtained an SPC for efavirenz based on the Patent, namely SPC/GB00/35 (“the 035 SPC”), which expired on 19 November 2013. It is common ground that the Patent discloses and claims both a class of compounds which includes efavirenz and efavirenz itself specifically. Accordingly, the Claimants say that the Product has already been the subject of a certificate within the meaning of Article 3(c), which compensated MSD for the delay in exploiting the invention in the Patent as a result of the need to obtain a marketing authorisation for efavirenz.

Court finally with respect to  Article 3(a) concluded that the scope of protection of claim 16 of the Patent extends to a combination of efavirenz and tenofovir or to a combination of efavirenz and emtricitabine, but not to a combination of all three. For the purposes of considering the Claimants’ case under Article 3(c), Court shall assume, contrary to the conclusion reached above, that claim 16 covers the combination of efavirenz with one or more nucleoside analogues active against reverse transcriptase, and hence covers the Product. Thus Court concluded that the SPC is invalid because it does not comply with either Article 3(a) or Article 3(c) of the SPC Regulation.

Bimatoprost - USA

On Mar 17, 2017, The Federal Circuit on Friday affirmed a lower court's dismissal of Allergan's patent suit against Sandoz over planned generic versions of the eyelash growth stimulant Latisse (Bimatoprost), finding the suit barred because the issues were already litigated in a prior case.

The Federal Circuit affirmed in-part & denied in-part District Court’ judgment with respect to collateral estoppel issue & invalidation of all claims of US 8,926,953.

After the USPTO issued the ’953 patent, Allergan filed two complaints asserting claims 1–26 of the ’953 patent against Sandoz (First Amended Complaint). These complaints form the basis for this appeal. However, Allergan was given leave to file second amended complaints, which reduced the disputed claims to claims 8, 23, and 26 of the ’953 patent (“the Asserted Claims”) (Second Amended Complaint).

Sandoz filed a motion to dismiss the subject suit pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief could be granted based on collateral estoppel, J.A. 957–62, 1918–21, which the District Court granted, Allergan, Inc. v. Sandoz, Inc. (Allergan IV), Nos. 1:14-cv-1028, 1:14-cv-1034 (M.D.N.C. Aug. 31, 2015) (J.A. 1–13).  The District Court stated that “[t]he ’953 patent at issue in this case claims . . . substantially the same subject matter as invalid ’404 patent claim 14 and the relevant claims of the ’054, ’161, and ’988 patents.” The District Court also entered judgment for Sandoz, holding that “[t]he ’953 patent is hereby declared and adjudged invalid as obvious.

Allergan appealed. For collateral estoppel issue CAFC denied Allergan’s arguments as non-persuasive & with respect to invalidation, CAFC said that District Court Erred in Invalidating the Entire ’953 Patent and invalidated only asserted claims. 

Dextromethorphan hydrobromide & Guaifenesin - USA

On Mar 06, 2017, in Reckitt Benckiser LLC v. Aurobindo Pharma Ltd., the Delaware Court granted Defendants’ motion for summary judgment of non-infringement of the asserted claims of U.S. Patent No. 6,955,821 (“the ‘821 patent”) and U.S. Patent No. 7,838,032 (“the ‘032 patent”) with respect to Defendants’ proposed generic version of Mucinex® DM, an extended-release tablet that contains dextromethorphan hydrobromide and guaifenesin.

The claim limitations of the patents-in-suit require the claimed drug product to include both an immediate-release formulation and a sustained release formulation of the drug guaifenesin. Defendants moved for summary judgment on the basis that Plaintiff failed to present sufficient evidence that Defendants’ proposed product has two distinct formulations, as required by each asserted claim. 

Adalimumab - UK

On Mar 03, 2017, The High Court has granted declarations to FKB and SB to the effect that their products lacked novelty or an inventive step at a particular date - Fujifilm Kyowa Kirin Biologics Company Limited and Samsung Bioepsis UK Limited v AbbVie Biotechnology Limited [2017] EWHC 395 (Pat). 

The dispute concerns the antibody adalimumab, marketed by AbbVie under the trade mark Humira.  Humira is approved for the treatment of rheumatoid arthritis, psoriatic arthritis and psoriasis.  The dosage regimes for those indications include the administration of 40mg of adalimumab every other week as a single dose via subcutaneous injection.  AbbVie has obtained or applied for a number of patents and divisionals for adalimumab which claim the use of this dosage regime, and applied for a fifth divisional patent.   Fujifilm Kyowa Kirin Biologics (FKB) and Samsung Bioepsis and Biogen Idec (SB) issued separate proceedings in 2015 and 2016 to revoke two of AbbVie's dosage regime patents (EP UK 2,940,044 and EP UK 1,944, 322) in an attempt to clear the way for their proposed biosimilar product launches after the SPC on Humira expires in Oct 2018.  Those patents were subsequently withdrawn by AbbVie.

FKB and SB allege that AbbVie is implementing a well-established strategy of dragging out proceedings for as long as possible, causing maximum expense and inconvenience to its opponents, and then throwing in the towel by withdrawing its patents, just before they are scrutinised by the court, whilst covering the same subject matter with further divisionals. The Claimants sought declarations that their products were obvious and/or anticipated at the claimed priority dates of certain of AbbVie’s patents, namely 8 June 2001 and 18 July 2003.  The reason behind these declarations to is to prevent their biosimilar products being threatened by any future divisional patents.

Summary of conclusions:

i)  AbbVie has proved that, at the date of filing of the PCT Application on 5 June 2002, Abbott Bermuda was “successor in title" to the invention the subject of US 961. Therefore, the 656 patent was entitled to its claimed priority date of 8 June 2001.

ii) The administration of the Claimants’ proposed products in the treatment of RA by a dosage regimen of 40 mg once every two weeks by subcutaneous injection was obvious as of 8 June 2001 in the light of Kempeni 1999.

iii)  Further or alternatively, the administration of the Claimants’ proposed products in the treatment of RA by a dosage regimen of 40 mg once every two weeks by subcutaneous injection was obvious as of 8 June 2001 in the light of Kempeni 2000.

iv) The administration of the Claimants' proposed products at a dose 40mg sc every other week for the treatment of psoriasis and psoriatic arthritis was anticipated or obvious as of 18 July 2003.

Tadalafil – USA

On Feb 28, 2017, The Federal Circuit ruled that the Patent Trial and Appeal Board incorrectly invalidated Los Angeles Biomedical Research Institute’s patent on drug Cialis (Tadalafil) for treating a condition related to erectile dysfunction based on obviousness. The patent-in-suit is U.S. Patent Number 8,133,903.

In two separate opinions (anticipation & obviousness) Federal Circuit affirmed the validity of US’903 patent challenged by Eli Lilly. With respect to obviousness court held that because the Board’s obviousness determination was predicated on an erroneous claim construction of two of the limitations of claim 1, and because the Board did not make factual findings as to whether there was an apparent reason to combine the prior art references to treat penile fibrosis and whether a person of skill in the art would have had a reasonable expectation of success from such a combination, we remand this case to the Board.

With respect to anticipation court  affirmed PTAB decision & said that the reference “Whitaker” may suggest” long term daily treatment by noting the beneficial effects of daily treatment (better erectile response and decreased side effects) in light of Example 6, but that is not enough. To anticipate, a reference must do more than “suggest” the claimed subject matter. Thus, we hold that substantial evidence supports the Board’s finding that Whitaker does not disclose the claimed treatment regimen with sufficient clarity to satisfy the demanding standard for anticipation.