Tapentadol - USA

On Apr 11, 2017, A New Jersey federal judge entered a final judgment and injunction barring Actavis Inc., Roxane Laboratories Inc. and Alkem Laboratories Ltd. from releasing generic versions of Depomed Inc.’s opioid painkiller Nucynta (tapentadol) until related patents expire.

This final judgment is related to the opinion issued by New Jersey district court on Jan 13, 2017. In this opinion District court found that Alkem infringed all the three asserted patents (US patent nos. RE39593 expiring on Aug 5, 2022; 7994364 expiring on Jun 27, 2025 & 8536130 expiring on Sep 22, 2028) whereas Actavis & Roxane infringed 2 patents (US’593 & US’364). Also defendants have failed to prove by clear & convincing standard that these 3 patents are invalid.

Fingolimod - USA

On Apr 12, 2017,  The Federal Circuit affirmed the Patent Trial and Appeal Board's decision invalidating a patent (US 8,324,283 expiring on Mar 29, 2026) covering Novartis' multiple sclerosis drug Gilenya (Fingolimod), in a win for generics makers Apotex, Mylan and Torrent pharma. The ‘283 patent covers a solid combination of a sphingosine-1 phosphate (S1P) receptor agonist (fingolimod) and a sugar alcohol (mannitol). The drug – sold under the trade name Gilenya – is used to treat multiple sclerosis

This was an appeal from the Final Written Decision of the United States Patent and Trademark Office, Patent Trial and Appeal Board (Board) in two consolidated inter partes review (IPR) proceedings of US’283 patent, owned by Novartis AG and Mistubishi Tanabe Pharma Corp. (collectively, Novartis). The Board instituted IPRs on all claims of the ’283 patent based on petitions filed by Torrent Pharmaceuticals Limited, Apotex, Inc. and Mylan Pharmaceuticals Inc. (collectively, Petitioners). After reviewing the claims, receiving extensive briefing, and hearing oral argument, the Board found all original claims of the ’283 patent and Novartis’ proposed substitute claims unpatentable as obvious.

On appeal, the court noted that the board considered the negative properties of using mannitol (teaching-away), but was not convinced, and sufficient evidence supported the Board’s decision.  The patentee also focused on the fact that the Board’s written decision did not expressly consider all of the patentee’s teaching-away arguments.  On appeal, the Federal Circuit rejected that argument – holding that “there is no requirement that the Board expressly discuss each and every negative and positive piece of evidence lurking in the record to evaluate a cursory argument.”

The court concluded that substantial evidence supports the Board’s finding that, despite mannitol’s potentially negative characteristics, it was nevertheless a valid consideration as an excipient for solid oral pharmaceuticals and a person of skill in the art would have been motivated to combine fingolimod and mannitol in the manner claimed by the ’283 patent. Indeed, the Board cites to multiple pieces of evidence establishing mannitol as one of a handful of excipients used in solid oral compositions and its primacy as a non-hygroscopic and compressible diluent which makes it particularly valuable in tableting. We, therefore, find no legal error in the Board’s treatment of the motivation to combine evidence nor do we find a lack of substantial evidence supporting its conclusion.

Lansoprazole - USA

On Apr 10, 2017, The Federal Circuit ruled that Sun Pharma did not infringe Takeda's blockbuster anti-ulcer drug Prevacid (Lansoprazole) with a planned generic version of the dissolving tablets & AFFIRMED the decision of New Jersey federal court.

Sun submitted to FDA ANDA No. 206013 for seeking approval to engage in the commercial manufacture, use and sale of lansoprazole delayed release orally disintegrating tablets, 15 and 30 mg, prior to the expiration of the patent-in-suit.

On Jul 06, 2016, New Jersey court Pursuant to the Stipulation and Order entered final Judgment of Non-infringement Based on Court's Claim Construction entered on June 9, 2016.

Without explaining its reasoning, a three-judge panel upheld the lower court’s decision of non-infringement.

Bivalirudin - USA

On Apr 06, 2017, The Federal Circuit ruled that Mylan Inc.’s planned generic version of the blood-thinner Angiomax does not infringe two patents owned by The Medicines Co., partly reversing a lower court’s decision.

The Medicines Company (“Medicines”) is the owner of U.S. Patent Nos. 7,582,727 (“the ’727 patent”) and 7,598,343 (“the ’343 patent”). In response to an Abbreviated New Drug Application (“ANDA”) submitted by Mylan, Inc. (“Mylan”), Medicines filed suit in the United States District Court for the Northern District of Illinois alleging that Mylan’s ANDA infringed claims 1–3, 7–10, and 17 of the ’727 patent, and claims 1–3 and 7–11 of the ’343 patent. Mylan counterclaimed seeking a declaration that the asserted claims were invalid. The district court held on summary judgment that the asserted claims of the ’343 patent were not infringed because Mylan did not satisfy the “efficient mixing” limitation of those claims. After conducting a bench trial, the court held that the asserted claims of the ’727 patent were infringed because those claims did not include an “efficient mixing” limitation.

The injectable product is made by dissolving bivalirudin into a solution, adjusting the pH with a solvent, and then by removing the solvent. The infringement issue revolved around how the bivalirudin was mixed. First, the Court of Appeals concluded that the Illinois District Court should have construed the claims of both patents to be the same – requiring “efficient mixing” to achieve the end product.

We hold that both the ’727 and ’343 patents include a “batches” limitation that requires batch consistency, which, according to the patents in suit, is achieved through efficient mixing. Efficient mixing is therefore required by the asserted claims of both patents. We further construe efficient mixing as defined by Example 5 of the patents’ specification. We therefore reverse the district court’s judgment of infringement with respect to the ’727 patent, and affirm its summary judgment of non-infringement with respect to the ’343 patent. We do not address the validity of the patents in suit.

Rivastigmine - USA

On Apr 04, 2017, Federal appeals court upheld a decision that invalidated Novartis AG's patents on the Exelon (Rivastigmine) skin patch for Alzheimer's disease, clearing the way for Noven Pharmaceuticals Inc. to launch a generic version of the drug.

The instant appeals concern inter partes reviews of U.S. Patent Nos. 6,316,023 (“the ’023 patent”) and 6,335,031 (“the ’031 patent”) (together, “the Patents-in Suit”). In two separate final written decisions, the U.S. Patent and Trademark Office’s (“USPTO”) Patent Trial and Appeal Board (“PTAB”) found that various claims of the Patents-in-Suit (“the Asserted Claims”) would have been obvious over the prior art. Novartis contest numerous aspects of the Final Written Decisions, including the PTAB’s conclusion that prior judicial opinions did not control its inquiry and the PTAB’s factual findings in support of its obviousness conclusion.

These very same patents were previously litigated and the claims were found to be nonobvious in federal district court. Novartis argued to the Federal Circuit that the arguments presented to the PTAB by Noven, as well as the prior art submitted to support those arguments, were the same as considered during litigation in federal court. The Federal Circuit disagreed, finding that the record in federal court was not identical to the record at the PTAB. But the Federal Circuit went further, saying that even if the records were identical Novartis’ argument would have to fail.

Chief Judge Prost wrote:

[E]ven if the record were the same, Novartis’s argument would fail as a matter of law. The PTAB determined that a “petitioner in an inter partes review proves unpatentability by a preponderance of the evidence (see 35 U.S.C. § 316(e)) rather than by clear and convincing evidence[] as required in district court litigation,” meaning that the PTAB properly may reach a different conclusion based on the same evidence. Noven II, 2015 WL 5782081, at *2 (italics omitted). That position comports with recent Supreme Court precedent…

CONCLUSION:

We affirm the PTAB’s conclusions that the Asserted Claims would have been unpatentable as obvious on the grounds discussed, we need not address the alternative grounds of unpatentability. (declining to address alternative grounds of unpatentability when the court upholds one such ground). Therefore, for the foregoing reasons, the Final Written Decisions of the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board are AFFIRMED. 

Dasatinib - Canada

On March 21, 2017, The Federal Court of Canada dismissed Bristol-Myers Squibb's prohibition application, finding that one of the patents (CA 2,366,932) had an overarching promise and lacked utility, and the other patent (CA 2,519,898) was "obvious to try."

BMS-Canada is a Canadian pharmaceutical manufacturer that distributes and sells, among other things, the pharmaceutical SPRYCEL® (Dasatinib) tablet. Both the ‘932 and the ‘898 Patents (together the “BMS Patents”) generally relate to the compound dasatinib, and have been listed on the Patent Register with respect to SPRYCEL®.

The Respondent, Apotex Inc. (the “Respondent”), is a generic pharmaceutical manufacturer. It filed an Abbreviated New Drug Submission (“ANDS”) with the Minister of Health (the “Minister”) seeking a Notice of Compliance (“NOC”) for APO-Dasatinib, using SPRYCEL® as the Canadian reference product. It served Notices of Allegation (“NOA”) regarding the ‘932 Patent and the ‘898 Patent (the ‘932 NOA and the ‘898 NOA, respectively), on May 26, 2015.

The Applicants commenced this prohibition application on July 2, 2015, seeking orders that the Minister be prohibited from issuing a NOC to Apotex for APO-Dasatinib until after the ‘932 and the‘898 Patents expire.

At the hearing the issues were narrowed to the following specific validity issues relating to three claims being asserted by the Applicants as being valid and infringed:

1.       Is claim 27 of the ‘932 Patent invalid because it lacked promised utility

2.       Is claim 1 or claim 3 of the ‘898 Patent invalid because it was obvious to try

Finally Justice Manson dismissed BMS's application, holding that Apotex's allegations of inutility (against the 932 Patent) and obviousness and double patenting (against the 898 Patent) were justified.

Zolmitriptan - USA

On Mar 29, 2017, District court of Delaware issued Trial opinion in Zomig (Zolmitriptan) case. 

Plaintiffs Impax Laboratories, AstraZeneca UK ("AZUK"), and AstraZeneca AB ("AZAB") brought suit against Defendants Lannett Holdings, Inc. and Lannett Company, Inc. for infringement of U.S. Patent Nos. 6, 750,237 and 7,220, 767 ("the Dearn patents"). The Dearn patents claim invention of a nasal formulation for zolmitriptan. Zolmitriptan is a member of the triptan class of drugs, which treat migraines. AstraZeneca Pharmaceuticals LP holds New Drug Application No. 21450 for zolmitriptan nasal spray. Zolmitriptan nasal spray, as well as other zolmitriptan products, are marketed as Zomig.

Plaintiffs brought this infringement suit after Defendants filed Abbreviated New Drug Application No. 206350. Defendants stipulated to infringement.I (D.I. 136). Defendants argue, however, that (1) Plaintiffs do not have standing to bring suit, (2) the Dearn patents are invalid as anticipated, and (3) the Dearn patents are invalid as obvious. The Court held a three day trial on September 6, 7, and 8, with closing arguments on the 9^th. 

CONCLUSION: Defendants have failed to prove the Dearn patents are invalid. If desired, Defendants should request an opportunity to cross-examine Ms. Allen within one week. If Defendants do not make that request, the parties should submit an agreed upon form of final judgment within two weeks.

Dimethyl Fumarate - USA

Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office (“USPTO”) decided in Patent Interference No. 106,023 regarding claims of Forward Pharma’s patent application 11/576,871 (the “’871 application”) that cover a method of treating multiple sclerosis (“MS”) with a 480 mg per day dose of DMF, the approved dose of Tecfidera®. In this decision, the PTAB ruled that the claims of the ’871 application are not patentable due to a lack of adequate written description.

For the second time in this month, Biogen has prevailed in a high-stakes legal dispute over patents on its blockbuster multiple sclerosis treatment Tecfidera.  The other case in which IPR filed by the Coalition for Affordable Drugs, a group led by hedge fund manager Kyle Bass, was dismissed on March 21, 2017.

In January, Biogen agreed to pay Forward Pharma $1.25 billion to license the Danish company’s intellectual property. The interference win now means that Biogen won’t owe royalties to Forward and will keep patent exclusivity on dimethyl fumarate through 2028. But Biogen may still owe Forward royalties in other jurisdictions such as Europe.

Dalfampridine - USA

On Mar 31, 2017, Delaware court issued Memorandum Opinion in Dalfampridine (AMPYRA) case.

Acorda Therapeutics, Inc. and Alkermes Pharma Ireland Limited ("Plaintiffs") allege that Apotex Corp., Apotex Inc., Mylan Pharmaceuticals Inc., Roxane Laboratories, Inc., and Teva Pharmaceuticals, USA, Inc. ("Defendants") infringe several United States Patents. Patent No. 5,540,938 (the '"938 patent" or the "Elan Patent") relates to the use of a sustained-release formulation of 4-AP, administered once or twice daily, to treat neurological diseases including multiple sclerosis ("MS"). Patent Nos. 8,007,826 (the '"826 patent"), 8,663,685 (the '"685 patent"), 8,354,437 (the "'437 patent"), and 8,440,703 (the '"703 patent") (collectively, the "Acorda Patents") relate to the use of 10 mg sustained-release formulations of 4-AP to treat walking impairments in individuals with MS.

The asserted claims of the Acorda Patents are directed to a method of improving walking in a human with multiple sclerosis by administering a 10 milligram dose of 4-AP twice per day, for either two weeks or twelve weeks. Certain claims also require that this dosage regimen produce particular pharmacokinetic results. Certain claims further mandate that there be no titration before or after administration of the 10 mg/twice-daily dose. Defendants argue that all of these claims are obvious because the prior art would have given a POSA a reasonable expectation of success in combining these limitations.

The Court concludes that Defendants have shown that the prior art taught the four disputed limitations: the use of 4-AP to improve walking; the use of a 10 mg/twice-daily dosage; the use of stable dosing; and the inherent pharmacokinetic limitations. The Court finds that a POSA would have been motivated to combine these limitations with a reasonable expectation of success. The Court also agrees with Defendants that the secondary indicia do not support a finding of non-obviousness with respect to any claim. As such, the asserted claims of the Acorda Patents are invalid.

CONCLUSION: 

Defendants have failed to prove by clear and convincing evidence that claims 3 and 8 of the Elan Patent are invalid due to obviousness. Defendants have proven by clear and convincing evidence that claims 1, 7, 38, and 39 of the '826 patent; claims 3 and 5 of the '685 patent; claims 1, 2, 5, 22, 32, 36, and 37 of the '437 patent; and claims 36, 38, and 45 of the '703 patent are invalid due to obviousness.

Everolimus - USA

On Mar 28, 2017, Delaware court issued trial opinion in Everolimus (ZORTRESS) case.

Plaintiffs Novartis brought the patent infringement actions against Breckenridge Pharmaceutical, Inc., Roxane Laboratories, Inc. and Par Pharmaceutical, Inc. in 2014.  Breckenridge, Roxane, and Par each filed an Abbreviated New Drug Application ("ANDA"), seeking to engage in the commercial manufacture, use, and sale of generic versions of Novartis's Zortress product. Plaintiffs allege that these ANDAs infringe U.S. Patent No. 5,665,772 ("the '772 patent"). Plaintiffs further allege that by filing these ANDAs, Roxane and Breckenridge induced infringement of U.S. Patent No. 6,239,124 ("the '124 patent") and Roxane and Par induced infringement of U.S. Patent No. 6,455,518 ("the '518 patent").

The Court held a bench trial on August 29-September 1, 2016. Defendants concede that their proposed products meet all limitations of the '772 patent.  Defendants argue that Plaintiffs have not proven by a preponderance of evidence that Defendants induced infringement of the '124 and '518 patents. Defendants further argue that the '772, '124, and '518 patents are invalid as obvious and for obviousness-type double patenting.

CONCLUSION: Defendants proved that the asserted claims of the '772 patent are invalid for obviousness type double patenting. Defendants failed to prove by clear and convincing evidence that the asserted claims of the '124 and '518 patents are invalid. Plaintiffs proved by a preponderance of the evidence that Defendants Roxane and Breckenridge induced infringement of claim 7 of the '124 patent and Defendants Roxane and Par induced infringement of claim 7 of the '518 patent.