Weekly Patent Litigation Round-Up

 

SPCs and orphan drugs-- is the double layer getting messy or is it just a matter of timing? A new ruling of the District Court in the Hague to shed some light?

The ruling of the District Court  in the Hague in the case C/09/595262 KG ZA 20-605 concerns the pharmaceutical Exjade (generic substance deferasirox), protected both by  a patent and subsequently a Supplementary Protection Certificate as well by an Orphan Drug Designation. Novartis sued Mylan for infringement of the  SPC (under the term of its Paediatric Extension) on Exjade; Mylan  countersued alleging  the invalidity of the Paediatric Extension. The specific ruling concerns preliminary relief proceedings...

https://ipkitten.blogspot.com/2020/10/spcs-and-orphan-drugs-is-double-layer.html

 

Menzis Zorgverzekeraar N.V. and AnderZorg N.V. v. AstraZeneca B.V. and AstraZeneca AB, District Court The Hague 14 October 2020, Case no. C/09/541261 / HA-ZA 17-1084

On the 14th of October 2020 the Dutch District Court of The Hague has issued a noteworthy and ground breaking interlocutory judgment in the case of health insurance company Menzis against the pharmaceutical company AstraZeneca. Menzis is set to be rewarded compensatory damages due to the unjust enrichment of AstraZeneca and their role in the lack of price competition for their medicine Seroquel XR...

http://eplaw.org/nl-menzis-et-al-v-astrazeneca-et-al/

 

Vaccine formulation patent invalid for obviousness and not infringed (Patents Court)

In Merck Sharp & Dohme Ltd v Wyeth LLC [2020] EWHC 2636 (Pat), the Patents Court has held that a patent for a formulation of vaccines which avoided aggregation caused by silicone in the container material was invalid for obviousness...

https://uk.practicallaw.thomsonreuters.com/w-027-9771?transitionType=Default&contextData=(sc.Default)&firstPage=true

 

Central government publishes The Patents (Amendment) Rules, 2020.

In exercise of the powers conferred by section 159 of the Patents Act, 1970, the Central Government has further revised the Patents Rules, 2003 and these rules would be called the Patents (Amendment) Rules, 2020. The Rules have been amended particularly with regard to the requirements relating to working statements/ form-27. Some important changes are as follows:-

https://patentsrewind.wordpress.com/2020/10/21/central-government-publishes-the-patents-amendment-rules-2020/

 

Only ‘Disclosed’ if ‘Identified’: IPAB Quashes Ceritinib Patent Revocation

An IPAB bench consisting of Chairman Manmohan Singh J. and the new technical member for Patents Dr. B.P. Singh has quashed the Controller of Patent’s decision that revoked Novartis’s patent on the anti-cancer drug Ceritinib. It held that while the compound was contained in a broader genus patent, it was not ‘disclosed’ therein, as it hadn’t been specifically identified. The 104-page order examines several issues regarding novelty and obviousness, the extent of coverage and disclosure, and timelines for filing of evidence..

https://spicyip.com/2020/10/only-disclosed-if-identified-ipab-quashes-ceritinib-patent-revocation.html

 

China adopts revised patent law with Hatch-Waxman-like incentives for innovative drugs

On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with regard to pharmaceuticals in the world’s fastest growing consumer market. As we reported here, the most significant change for life science companies is adoption of Hatch-Waxman-like incentives to encourage companies to develop and seek approval in China of new, innovative drug products, and to encourage generic companies to challenge reference product patents…

https://www.engage.hoganlovells.com/knowledgeservices/news/china-adopts-revised-patent-law-with-hatch-waxman-like-incentives-for-innovative-drugs

Pirfenidone - USA

Claim Construction (District of Delaware): Oct. 20, 2020

Civil Action No.: 19-cv-78 -RGA

Plaintiff: Genentech, Inc. et al.

Defendants: Aurobindo Pharma Limited, et al.

Court issued claim construction of a single term in US 7,566,729, US 7,635,707 and US 8,592,462. The Court heard oral argument on September 23, 2020. Plaintiffs Genentech and InterMune brought cases against Defendants, alleging Hatch-Waxman Act patent infringement. The cases have been consolidated. Defendants argued that the term “Grade 2 abnormality in one or more biomarkers of liver function” as recited in various asserted claims of the three patents should be construed as indefinite.

 

CONSTRUCTION OF TERM:

“Grade 2 abnormality in one or more biomarkers of liver function”

Plaintiffs’ proposed construction: A value obtained from a blood chemistry test of abnormal liver function that meets the grading criteria for a ‘Grade 2 adverse effect’ set forth in the Common Terminology Criteria for Adverse Events v3.0 (CTCAE) published Aug. 9, 2006 by the National Cancer Institute, as also presented in Table 1 of each of the ’729, ’707, and ’462 patents, and incorporated by reference therein.

Defendants’ proposed construction: The term is indefinite.

Court’s construction: The term is not indefinite. Plaintiffs’ proposed construction is adopted.

 

Plaintiffs argued that “one or more biomarkers of liver function” is defined in the specification as the five biomarkers alanine transaminase (ALT), aspartate transaminase (AST), bilirubin, alkaline phosphatase (ALP), and gamma-glutamyltransferase (GGT). Plaintiffs contended that the specification consistently identifies “Grade 2 abnormalities” with respect only to these five biomarkers, which are listed in Table 1. Defendants contended that a person of ordinary skill in the art (POSITA) would be unable to determine which liver function tests are in fact “biomarkers of liver function.” Defendants pointed to several instances in the specification where, they argued, “biomarkers of liver function” is not clearly defined. For example, defendants note an instance in the specification which states, “Examples of biomarkers of liver function include, but are not limited to” ALT, AST, bilirubin, ALP, and GGT. Defendants have also identified other tests that can be used to assess liver function, but which are not mentioned in the specification.

Court, however, agreed with Plaintiff and said that the disputed claim term can be construed with reasonable certainty. Court said that the specifications of all three patents use the term “biomarkers of liver function” to refer to the five tests—ALT, AST, bilirubin, ALP, and GGT—on a basis sufficient to inform a POSITA as to the scope of the term.  All three patents contain two tables which only list the toxicity criteria for the five tests, ALT, AST, bilirubin, ALP, and GGT. The patent claims require a “Grade 2 abnormality” and only the five tests—ALT, AST, bilirubin, ALP, and GGT—are defined in terms of the requisite elevation levels that would constitute such a “Grade 2 abnormality.” Consequently, a POSITA seeking to understand the term “Grade 2 abnormality in one or more biomarkers of liver function” would look to the specification and find that only the five tests—ALT, AST, bilirubin, ALP, and GGT—are defined in terms of a “Grade 2 abnormality.” As a result, a POSITA would be able to determine with “reasonable certainty” which tests constitute “biomarkers of liver function.”

Everolimus - USA

 

IPR decision: Oct. 05, 2020

AIA Review #	Filing Date	Institution Date	Petitioner	Patent	Respondent	Final Written Decision
IPR2016-01479	07/22/2016	02/15/2017	Par Pharmaceutical, Inc*.	9,006,224	Novartis AG	Challenged   claims patentable

*This proceeding as initially filed named Par Pharmaceutical, Inc. as the sole Petitioner. Argentum Pharmaceutical LLC was joined as a party to this proceeding via a Motion for Joinder in IPR2017-01063; West-Ward Pharmaceuticals International Limited was joined as a party via a Motion for Joinder in IPR2017-01078. Subsequently, Par and West-Ward separately requested termination of their participation in the proceeding pursuant to settlement. Argentum Pharmaceutical LLC is the sole remaining Petitioner.

US 9,006,224 (Novartis AG; Exp: 07/01/2028)

1. A method for treating pancreatic neuroendocrine tumors, comprising administering to a human subject in need thereof a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin as a monotherapy and wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy.

Carvedilol – USA

 

On Oct 02, 2020, Federal Circuit vacated district court’s grant of JMOL and reinstated the jury verdicts of infringement and damages.

Background of the case:

Glaxo owns US 5,760,069 patent which claims treatment with a combination of carvedilol and one or more of an angiotensin-converting enzyme (“ACE”) inhibitor, a diuretic, and digoxin. GSK on Nov. 25, 2003 filed reissue application for ’069 patent, which ultimately issued as US RE40,000 on Jan. 8, 2008. This patent expired on June 7, 2015. Glaxo own another patent, US 4,503,067 which claims carvedilol and related compounds. This patent expired on March 5, 2007. Both these patents were listed in Orange Book (OB) for drug, Coreg®. USFDA initially approved carvedilol in Sep 1995. In May 1997, the FDA approved carvedilol for the additional treatment of congestive heart failure. In March 2002, Teva filed ANDA with PIII certification to US’067 patent & P-IV certification to US’069 patent. Glaxo did not sue Teva based on any of OB listed patents. Teva received FDA “tentative approval” for its ANDA in 2004. Teva, on June 9, 2004, issued a press release to this effect mentioning among other things that its product is “AB rated” to Coreg®. On expiration of the ’067 patent in 2007, Teva launched its generic carvedilol tablet. Teva’s label dated “8/2007” mentioned 2 indications:

1. Left Ventricular Dysfunction following Myocardial Infarction(MILVD)… 

2. Hypertension…

Before this final approval, Teva carved out third indication ie. Congestive Heart Failure. Thus, in September 2007, when the FDA finally approved Teva’s ANDA as an AB-rated version of GSK’s Coreg®, Teva’s skinny label was only indicated for hypertension and post-MI LVD—neither of which was covered by any patent.

Both Teva and the FDA announced the approval of generic carvedilol with a press release. Teva also announced that it would immediately begin shipping its product but did not suggest that its product should be used to treat CHF. In 2011 the FDA required Teva to amend its carvedilol label to include CHF indication. Teva, thus, amended its label to include the indication for treatment of heart failure, as required by the FDA. On July 3, 2014, GSK filed suit for induced infringement of the RE’000 patent. Jury trial was initiated. Teva presented the defenses of patent invalidity and non-infringement. Teva argued that since it had omitted (“carved out”) CHF indication from its initial 2007 label till Apr. 2011 (Skinny period) Teva could not be found to induce prescribing physicians to infringe the ’000 patent. Teva also argued that it could not be found to induce prescribing physicians to infringe the ’000 patent between May 2011 (when it amended label to include CHF) to June 2015 when patent expired (full label period).

The jury found that Teva induced infringement of claims 1–3 during the period starting January 8, 2008 to April 30, 2011 (Skinny period); and that Teva induced infringement of claims 1–3 and 6–9 during the amended label period starting May 1, 2011 and ending June 7, 2015 (full label period). The jury assessed damages based on a combination of lost profits and royalty, and found that the infringement was willful. The district court granted Teva’s motion for JMOL (judgment as matter of law), stating that the verdict of induced infringement was not supported by substantial evidence because “GSK failed to prove by a preponderance of the evidence that ‘Teva’s alleged inducement. The district court explained that: “Without proof of causation, which is an essential element of GSK’s action, a finding of inducement cannot stand.” The court stated that “even in Sep. 2007, when generic companies (including Teva) began selling carvedilol, doctors relied on guidelines and research, as well as their own experience, in addition to GSK marketing.” Therefore, a reasonable fact-finder could only have found that these alternative, non-Teva factors were what caused the doctors to prescribe generic carvedilol for an infringing use & not Teva. GSK appealed.           

Federal Circuit analysis:

Glaxo argued that Teva’s marketing of carvedilol with knowledge and intent of its infringing use, and promotion of its generic product as the same as Coreg®, meet the legal requirements of active inducement of infringement.  Teva responds that the district court correctly ruled that Teva could not be liable for inducing infringement, because cardiologists already knew of carvedilol and its uses, and Teva did not directly “cause” them to infringe. Federal Circuit said that there was substantial evidence to support the jury’s verdict of inducement to infringe the ’000 patent. The jury received evidence that Teva’s promotional materials referred to Teva’s carvedilol tablets as “AB rated” equivalents of the Coreg® tablets. This means Teva’s product can be substituted for Coreg® & since, Coreg is approved for CHF indication, Teva’s label would induce physician to prescribe for CHF indication. GSK’s witness, Dr. McCullough, testified that doctors are “completely reliant” on information provided by the generic producers, and that doctors receive Teva’s product catalogs, visit its website, and read its product guides. Dr. McCullough told the jury that the press release of Teva “indicates that we should be able to prescribe generic carvedilol for heart failure”. Dr. McCullough testified that Teva’s Spring 2008 catalog lists Teva’s carvedilol tablets next to Coreg® tablets and uses the phrase “AB rating,” and that this would lead a doctor to believe that “they’re therapeutically interchangeable.”

There was ample record evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides, to support the jury verdict of inducement to infringe the designated claims for the period of the ’000 reissue patent. The district court, thus, applied an incorrect legal standard for granting JMOL to Teva. Federal Circuit, therefore, reversed the grant of JMOL & remanded for entry of judgment on the verdict.

Dissent form Chief Judge Prost:

Judge Prost said that this case is about whether Teva induced infringement of GSK’s reissue patent, RE40,000, by marketing its generic carvedilol of for unpatented uses through a “skinny label” & “full label” period.

With respect to skinny label, Judge Prost said that Congress provided for skinny labels for exactly these circumstances, such that the lone method covered in the ’000 patent would not foreclose access to more affordable carvedilol. Here, the Majority undermines Congress’s provision for skinny labels by substantially nullifying section viii. Teva in this acted exactly as Congress intended. Teva waited until GSK’s patent covering the carvedilol compound expired to launch its product covering two unpatented indications—hypertension and post-MI LVD. So, when GSK’s ’000 reissue patent later issued—reciting a narrow method of treating a third indication, CHF—Teva’s skinny label did not even suggest using its product according to the patented method. In marketing its generic carvedilol, Teva never stated that it was approved, or could be used, to treat CHF. Moreover, the parties agreed that when Teva launched, its skinny label did not instruct doctors to prescribe generic carvedilol to treat CHF. Also, GSK failed to present evidence showing that doctors relied on the label in making prescribing decisions. District court was right when it granted JMOL in favour of Teva a because “neither sufficient nor substantial evidence supports the jury’s finding of inducement.”

With respect to full label, Judge Prost said that at the FDA’s direction, Teva amended its label years later to include the patented method, but there was still no inducement via the full label. Nothing changed in the market, and doctors’ prescribing decisions were not affected. GSK failed to prove causation during the full label period. No evidence suggests that any affirmative act by Teva actually caused doctors to directly infringe the patented method. Specifically, no evidence suggests that doctors relied on Teva’s full label in making their prescribing decisions. The record also demonstrated that many generic carvedilol sales occurred without the doctors’ knowledge at all. In sum, to the extent the doctors prescribed generic carvedilol to treat patients according to the claimed method, no evidence shows that they did so because of any action taken by Teva. The district court’s JMOL of noninfringement during the full label period should therefore be affirmed.

Judge Post further said…”Teva did everything right—using a skinny label, taking care not to encourage infringing uses—and yet, given today’s result, it was ultimately more costly for Teva to sell an unpatented drug for unpatented uses than it would have been to stay out of the market altogether: Teva only sold $74 million worth of carvedilol during the allegedly infringing period (mostly for unpatented uses) but now owes $234 million in damages for sales made for a single indication. This irony reflects the fact that Teva’s product was dramatically less expensive—costing less than 4 cents per pill as compared with Coreg®’s price of at least $1.50 per pill. Teva should not be liable for inducement”.

Ceritinib – India

On Sep 29, 2020, Intellectual Property Appellate Board (IPAB) set aside the order of Learned Controller finding compound patent invalid.

Brief background of the case is like this. Appellant, Novartis filed patent application - IN 3951/DELNP/2009 on Jun. 16, 2009. This application claims compound, Ceritinib as tyrosine kinase receptor inhibitor. This application was granted as IN 276062 on Sep 28, 2016. Post grant opposition was filed by Natco Ltd. on Sep 26, 2017. Patentee & opponent then filed their respective written submissions.  Hearing was rescheduled few times & finally it was held on Apr. 09-10, 2019. During this period additional documents were also filed after the announcement of date of hearing. Parties filed post hearing submissions & on Aug. 16, 2019, the Learned Controller by its order revoked the patent under lack of novelty, inventive step, section 3(d) & lack of sufficiency.

Appellant filed appeal to IPAB on violation of principle of natural justice. IPAB came heavily on the reasoning of Learned Controller & found that Learned Controller did not follow the proper procedure of law. IPAB said that the Learned Controller disregarded the recommendation of the Opposition Board which found patent valid. Second, the Learned Controller considered the evidence filed by the Opponent in relation to patent term extension and orange book listing but has disregarded the rebuttal evidence filed by the Appellant. Third, the Learned Controller has failed to consider the arguments on novelty given by the Appellant and has also failed to rely upon the expert affidavit submitted along with it.

With respect to novelty, IPAB said that the entire finding of invalidity is based without any prior art cited which discloses or exemplifies Ceritinib, the compound subject matter of IN 276026. The Controller has engaged in prohibited act of “cherry picking” of the constituents, substituents, their arrangement, their positioning, their linkage and interplay from the subject patent IN 276026 and tried to locate them in the vast pool of possible substituents contained in markush claims of prior art citations. It is also settled practice that in order to demonstrate lack of novelty, the anticipatory disclosure must be entirely contained within a single document. However, if a cited document refers to a disclosure in another document in such a way as to indicate that, that disclosure is intended to be included in that of the cited document, then the two are read together as though they were a single document. Here, Learned Controller took help of two cited prior arts to attack “novelty’ of the subject patent by picking suitable equivalent substitutions, keeping inventive structure of the subject patent IN’026 in sight.

IPAB also said that the opposition was filed by M/s Natco Pharma Limited on 26/09/2017. At the time of filing of opposition, opponent paid fees as a natural person. So, filing the opposition by a legal entity and paying the prescribed fee of filing opposition with the fee which is applicable to natural person (INR 2400) is not justifiable. If the balance fee of (INR 9600) was paid on 08/11/2017 – a date much later than the last date of filing opposition, the opposition was not maintainable as per the provisions of the Patents Act and the Rules made there under. The post-grant opposition was not maintainable ab initio for lack of filing proper prescribed fee.

IPAB finally found that the impugned order is void of merit & thus set aside the order. 

Ibrutinib - India

 

On Sep 29, 2020, Intellectual Property Appellate Board (IPAB) set aside the order of Learned Controller finding compound patent invalid.

Brief background of the case is like this. Appellant, Pharmacyclics Inc. filed patent application - IN 1642/DELNP/2009 on Mar. 12, 2009. This application claims compound, Ibrutinib as Bruton Tyrosine Kinase inhibitor. This application was granted as IN 262968 on Oct 03, 2014. Post grant opposition was filed by Laurus labs on Sep. 24, 2015. Patentee & opponent then filed their respective written submissions.  Hearing was rescheduled few times & finally it was held on Nov 22, 2019. During this period additional  documents were also filed after the announcement of date of hearing. Parties filed post hearing submissions & on Mar 04, 2020, the Learned Controller by its order revoked the patent under lack of inventive step.

Appellant filed appeal to IPAB on many grounds under procedural & technical aspects. IPAB come heavily on these two aspects & found that Learned Controller did not follow the proper procedure of law. IPAB citing the judgment of High Court (W.P.(C) No. 12105/2019; decided on 20/11/2019) provided important pointers while dealing with the post grant opposition.

Let’s see the IPAB findings in summary:

Technical aspects (Inventive step)

1. The prior arts should be analogus to the claimed invention.

[The prior art relied upon by the opponent pertains to LCK inhibitors, whereas, the invention pertains to BTK inhibitors.]

2. Reasoning of substitution of one group by another group should be justified properly.

[Here, IPAB said that Learned Controller made not only legal error but also scientific errors when deciding the issue of inventive step which is neither based on the arguments of the Appellant/Respondent, written submissions or the evidence filed by their experts.]

3. There should be proper motivation to combine the references.

[IPAB said that Motivation to attach a Michael acceptor from prior art to hypothetical compound has not even referred in the impugned order.]

4. There should not be any hindsight analysis in inventive step inquiry.

[IPAB said that the substitutions are somehow trying to trace back to the invention by keeping the invention in forefront and it amounts to “hindsight analysis”.]

Procedural aspects:

1. Trend of filing additional evidences under Rule 60 after the hearing being fixed by the Controller or place documents having evidentiary value in guise of “publication” under Rule 62(4).

[IPAB said that these actions do not find proper basis in the Rules and need to be addressed so as to smoothen the process of post–grant oppositions and reduced the timelines being consumed unduly. It should be ensured that the provisions of Rules 60 and 62 should be followed strictly.]

2. Learned Controller should provide reasons for his findings.

[IPAB said that it is well within his powers as provided in the law to disagree with the opinion of the opposition Board, but while he disagreed on this ground should have annotated the reasons thereof properly.]

3. Inventive step is mixed question of law & facts.

[Here, Learned Controller ignored the legal aspects from the determination of the “inventive step” & focused only on factual aspects.]

4. There is no concept of “ordinary” person skilled in the art in the Indian Patent Act, 1970.

[IPAB said that the determination of “inventive step” as envisaged in the Patents Act under section 2(1)(ja) clearly stipulates “person skilled in the art” & not “ordinary” person skilled in the art. Therefore, inquiry should be made in view of the person skilled in the art when dealing with inventive step attack.]

IPAB, therefore, set aside the impugned order of the Learned Controller.