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GSK sued Teva in Delaware federal court in 2014 over its generic version of GSK’s heart drug Coreg. Teva argued that it followed U.S. Food and Drug Administration instructions to “carve out” from its label a patented method for using the drug to treat heart failure.

A jury found Teva still infringed the patent and awarded GSK $235 million in 2017. A judge then overturned the verdict, but the patent-focused U.S. Court of Appeals for the Federal Circuit reinstated it in 2020.

The Federal Circuit affirmed after a rehearing last year that Teva’s label, combined with its marketing materials, encouraged doctors to prescribe the generic in an infringing way. The appeals court rejected GSK’s bid for a full-court rehearing in February in a 7-3 decision.

Teva, in its Supreme Court petition, told the justices that the ruling would cause “havoc” and discourage the use of skinny labels, which it said are “extraordinarily common” and “save patients and the federal government billions.”

GSK responded in a court brief that the case “presents no threat to generic companies who operate properly under the law.”

The U.S. Supreme Court is yet to decide for its opinion on whether the court should hear Teva Pharmaceuticals USA Inc’s challenge to a $235 million award for GlaxoSmithKline LLC in a patent dispute over generic heart medication.

Delhi High Court Decision

Sun Pharma Laboratories Ltd vs Intas Pharmaceuticals Limited 

Facts

Sun Pharma (plaintiff) registered a mark “SETARET” on a “proposed to be used” basis in 1998, though it was never eventually used. In June 2022, it applied for a new trademark “SITARED” and started using it in June 2022 for Sitagliptin. Registration for this mark is still pending. The Intas (defendant) marks are SITARA-D/SITARE and they are not registered. The plaintiff claimed an injunction against the defendant’s marks “SITARA-D/SITARE” for allegedly infringing the Plaintiff’s registered mark ‘SETARET’, and passing off their goods marked SITARED.

The Order

The court did a two-fold assessment of the present case. Dealing with the issue pertaining to passing off first, it assessed the similarity between the unregistered marks SITARED (plaintiff’s) and SITARA-D (defendant’s)  and then moved to assess whether Plaintiff’s registration for ‘SETARET’ will entitle it to interim relief. 

On the issue of passing off, the court held that the competing marks (SITARED and SITARA-D) are dissimilar, contain non-proprietary terms and are launched almost simultaneously therefore, no prima facie case of passing off is made by the Plaintiff. On deference to registration for seeking an interim injunction, the court held that SETARET has never been used by Plaintiff, despite being registered some 24 years ago!! And thus, does not merit an interim relief only by the virtue of this registration. Finally, as a note of caution, the court also directed Defendant to seek prior approval from the court before launching its products bearing the ‘SITARE’ mark.

In 2018, Eagle filed its Abbreviated New Drug Application (ANDA) with the FDA seeking to market a generic version of Par’s vasopressin injection product (Vasostrict) used for emergency blood pressure treatment.  Par had listed two patents in the Orange Book as covering its product and so, as required, Eagle’s ANDA included a Paragraph IV certification that the two patents were either (1) invalid or (2) would not be infringed.  35 U.S.C. § 355(j)(2)(A)(vii)(IV).

In order to facilitate resolution of brand-generic patent conflict, the Patent Laws include a form of paper infringement–a legal fiction that simply filing an ANDA and Paragraph IV certification counts as a form of patent infringement.  This gives the branded drug maker (here PAR) the ability to immediately sue to keep the generic off the market (if the patent turns out to be enforceable).  But, these Hatch-Waxman lawsuits are considered a form of declaratory relief and no actual damages are available.  This setup also means that these cases are not “Suits at common law” and so the Seventh Amendment right to a jury trial does not apply.  Thus, ANDA patent lawsuits are ordinarily decided by bench trial–and typically by one of the Delaware district court judges.  In patent law, injunctive relief has been difficult to obtain, but under the Hatch-Waxman law, the FDA will automatically delay any market approval by 30 months if the brand-patentee sued.

Vasopressin is a naturally occurring mammalian hormone and been generally known for decades.  As its name suggests the chemical has always been known since its naming for its ability to constrict blood vessels — the same use that Par’s patents claim.  Par’s two patents here cover a particular vasopressin composition (9,750,785) and a method of treatment using the composition (9,744,209).

Both Par patents include a pH requirement: “wherein the unit dosage form has a pH of 3.7-3.9.” In its ANDA, Eagle was careful to specify that its product would have a slightly different pH range: 3.4–3.6.  Eagle then argued that this difference was enough to avoid infringement.

Despite its nominal specifications, Par presented evidence that (it claims) Eagle’s product pH would “drift up” while sitting on the shelf.  It coupled that evidence with the very slight difference between Eagle’s product and Par’s patent to make the argument that Eagle’s product “would inevitably drift into Par’s claimed range.” Slip Op.   The district court (Judge Connolly) held a three-day bench trial and ultimately issued a judgment of noninfringement.  In particular, Judge Connolly concluded that the evidence failed to prove any upward drift of pH, but rather simply “minor fluctuations” without “any discernable trend.” Id. On appeal, the Federal Circuit has affirmed–seeing no “clear error” in the district court’s factual findings.

As mentioned above that this form of ANDA-filing infringement is a legal fiction created by Congress to facilitate a more competitive marketplace.   One problem then is that there is no actual product to inspect.  We have the ANDA filing, but there are always substantial design choices before final release.   The prophetic inquiry thus looks to what is the “probable ANDA product” and asks whether that probable product would be infringing if actually made.

Still, the primary guide is the ANDA documents as the source of infringement in this highly regulated area. At times, a court can look to other relevant evidence, but only when the ANDA filing fails to “speak clearly and directly to the question of infringement.”  Rather, the court assumes that the ANDA filer will “act in full compliance with its representations to the FDA.”  

Here, the ANDA documents are clear that the product does not infringe. The pH range in Eagle’s ANDA document is different than that claimed by Par.  And, the ANDA filings also indicate that the pH range will remain stable throughout the shelf life of the product.  Thus, the ANDA documents indicate no drift into Par’s protected space.

AstraZeneca AB Vs. Intas, Alkem Pharma & Others

Date of decision: 20th July 2021

In the High Court Of Delhi At New Delhi

In a current landmark decision of the Delhi High Court, AstraZeneca AB and AstraZeneca Pharma India Limited (the Plaintiffs) have been denied the request for an interim injunction towards  Indian pharmaceutical companies, Intas Pharmaceuticals Limited (Intas) and Alkem Laboratories Limited (Alkem) and others (collectively, the Defendants), concerning the production of the compound-in-difficulty i.e., Dapagliflozin [“DAPA”], which became supposed to be infringing the Plaintiffs’  patents bearing Indian Patent numbers 205147 [“IN 147”] and 235625 [“IN 625”], the previous being the genus patent even as the latter being claimed to be the species patent. The patent time period for IN 147 expired on October 02, 2020, even as the patent time period for IN 625 is legitimate until May 15, 2023. The patents Squibb and have been subsequently assigned to the Plaintiffs via an undertaking deed in 2014.in query have been to start with being registered via way of means of Bristol Myers

Facts of the case

The matter primarily issues two patents of the Dapagliflozin drug used in diabetes.

a) Indian Patent No. 205147 discloses a Markush structure i.e., a patent covering a collection of compounds that disclosed the opportunity of personal diversifications and combinations which could run into numerous million [if not more] structurally various compounds.

b) Indian Patent No. 235625 discloses a specific compound of dapagliflozin.

Issues

Whether or not the compound-in-issue i.e. Dapagliflozin [“DAPA”] which, according to the plaintiffs, is included in IN 147 stands disclosed both, in law moreover as on facts? 

Whether the subject matter of the species patent held by AstraZeneca was disclosed in the genus patent held by the same person, thereby invalidating the species patent for lack of inventive step and being obvious to a person skilled in the art?

Judgment

At the stage of the preliminary injunction, it is not necessary for the Defendants to conclusively prove the invalidity of the patent; the establishment of a prima facie case is sufficient. The fact that the infringement suit was filed with regard to both patents is sufficient evidence at this stage that DAPA is under both patents. On a comparison of relevant extracts from both patents ‘147 and ‘625, there emerges no substantial technical advancement or economic significance that would make the synthesis of DAPA an “inventive step” under Section 2(1)(ja). The terminal disclaimer filed by the Plaintiffs in USPTO, even if not a complete bar, operates as estoppel by conduct. The non-compliance with Section 8 was wrong and it makes Patent ‘625 vulnerable to revocation. Therefore, the injunction prayed for by AstraZeneca was refused.

Observations

The court found that the fact that the plaintiffs have taken out an infringement motion each for IN ‘147 and IN ‘625 is a enough clue, at least at this juncture, that DAPA is alleged in each suit patents. It appears incongruous to the court that a patent holder can take out an infringement action for a patent and yet ever it isn’t disclosed.

In the prevailing case, the Indian genus patent i.e. IN ‘147 bears the priority dates 12.10.1999 and 05.04.2000 while the Indian species patent i.e. IN ‘625 bears 20.05.2002 as its precedence date. For the purposes of Section 64(1)(a) this element is enough.

Therefore, so long as the defendant can set up that the innovations up to now claimed in any claim of the entire specification [in this case IN ‘625] turned into a legitimate declaration of an in advance precedence date contained inside the entire specification of some other patent [i.e. IN ‘147], a ground for revocation is made out.

The court observed that there is no enhancement of the known efficacy, within the meaning of Section 3(d) of the Act, between the product subject matter of IN ‘147 and the product subject matter of IN ‘625.

With respect to one invention, there can be only one patent, As DAPA was already disclosed in IN ‘147, the same compound cannot enjoy double patent term protection.

The U.S. Court of Appeals for the Federal Circuit in connection with patent litigation involving DUEXIS® tablets (800 mg ibuprofen and 26.6 mg famotidine), a drug approved for treating the signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers. Each of the patents-in-suit was owned by Horizon Medicines LLC (“Horizon”) and related to pharmaceutical compositions that combine 800 mg ibuprofen and 26.6 mg famotidine in a tablet.

In the litigation, Horizon sought to prevent Alkem from marketing a generic equivalent to DUEXIS® tablets. After a three-day bench trial held in September 2020, the District Court for the District of Delaware (Judge Richard A. Andrews) held that the asserted claims of U.S. Patent No. 8,067,033 (the “‘033 patent”) were invalid for obviousness under 35 U.S.C. § 103, and not infringed either literally or under the doctrine of equivalents, and that the asserted claims of U.S. Patent No. 8,067,451 (the “‘451 patent”) were not infringed based on a favorable claim construction entered before trial.

Alkem launched its product while Horizon’s appeal was pending, and lawfirm successfully defeated Horizon’s motion for an injunction pending appeal in the District Court. The Federal Circuit affirmed the District Court’s finding that the asserted claims of the ‘033 are invalid for obviousness, the District Court’s construction of the ‘451 patent, and the District Court’s finding that the asserted claims of the ‘451 are not infringed.