Philip Brooks' Patent Infringement Updates

Mylan Sued Over Marketing Plans

The following is excerpted from a January 9, 2012 article by Kris B. Mamula, Reporter for the Pittsburgh Business Times:

Takeda Pharmaceutical, Watson Pharmaceuticals and Andrx Labs have sued generic drugmaker Mylan Inc. for patent infringement in connection with its plans to market pioglitazone hydrochloride and extended release metformin hydrochloride tablets, Canonsburg-based Mylan announced Monday.

The two drugs are ingredients in Actoplus Met XR, which is prescribed to control blood glucose levels in adults with type 2 diabetes. Two common strengths of the drug had combined sales of approximately $21.4 million for the year ending Sept. 30, according to IMS Health, a Danbury Conn.-based trade group.

In a 10-count civil lawsuit filed Jan. 3, Takeda, Watson and Andrx allege Mylan's generic equivalent product infringes on patents that expire in 2016, 2021 and 2026.

Read the full article here.

Patent Settlement Agreements Remain a Focus in the U.S. Congress

Alan Klein, partner in the Trial Practice Group of Duane Morris LLP, wrote the above-titled article for this month's INNsight newsletter at GenericsWeb. The following is excerpted from the article:

Patent litigation settlement agreements between brand and generic drug manufacturers are receiving increased scrutiny in the United States Congress with the introduction of legislation with bipartisan support. The proposed Bills seek to curtail such agreements and get generic drugs to market faster and end what critics have complained are “pay for delay” deals benefiting both brand patent holders and generic drug company challengers. As noted below, however, there is a flip side to this controversy which the generic drug industry has highlighted in its public responses to this legislation. Opponents point to the risks of litigation and to the broader benefits accruing to consumers, health insurance companies and government third-party payors from such settlement agreements.

The Preserve Access to Affordable Generics Act, introduced last January in the current Congressional term, would establish a presumption that such patent suit settlement agreements are anticompetitive if the generic first filer receives anything of value or agrees to limit or forego research, development, manufacturing, marketing or sales of the generic drug for any period of time.

A second Bill introduced earlier this month, titled the Fair and Immediate Release of Generic Drugs Act (the “FAIR Generics Act”), would prevent brand drug companies from so-called “parked exclusivities” – providing generics which are not first-to-file with the right to market a generic equivalent of the brand drug during the first filer’s 180-day exclusivity period.

Read the full INNsight article here.

Wellbutrin Maker Settles Class Action for $49 Million

The following is excerpted from an October 31, 2011 article by Zack Needles of The Legal Intelligencer published by the Pittsburgh Post-Gazette:

British drug-maker GlaxoSmithKline has reached a $49 million settlement agreement with a class of direct purchasers who accused the company of bringing "sham" patent litigation against manufacturers of generic versions of its popular antidepressant, Wellbutrin SR, in an attempt to prolong its monopoly on the market.

The Wellbutrin antitrust litigation began in 2004 when the plaintiffs charged that GSK filed "baseless" patent suits in an attempt to hinder rival manufacturers from entering the market with a generic competitor to Wellbutrin SR and that, during that time period, purchasers paid more for the drug than they would have if the generic versions had been available, according to the motion.

Read the full article here.

Mylan's Dey Pharma Successfully Obtains Patent Reexamination Certificates for Two Perforomist® Patents

The following is excerpted from an October 20, 2011 Mylan press release available on its website:

Dey Pharma L.P., a subsidiary of Mylan Inc. (Nasdaq: MYL), today confirmed that the U.S. Patent and Trademark Office (PTO) has issued Reexamination Certificates for two patents related to Perforomist® (Formoterol Fumarate) Inhalation Solution 20 mcg/2mL vial thereby confirming the validity of these patents. Sepracor, now known as Sunovion Pharmaceuticals, requested the PTO to re-examine these patents, which now has been completed.

Mylan Chairman and CEO Robert J. Coury commented: "We are pleased that the successful re-examination of these patents is complete as this only further strengthens our confidence in the intellectual property protecting our Perforomist product as well as our combination product currently in development. We are very excited about continuing to build on our brand division, Dey, which is and will continue to be an important growth driver for Mylan."

In addition to the two re-examined and granted patents, Dey owns five other relevant patents, giving it a total of seven U.S. patents which it believes are infringed by Sunovion's Brovana® product. In addition, Dey believes that Teva's Formotorol Fumarate product, which is the subject of an Abbreviated New Drug Application (ANDA) pending before the FDA, infringes several of Dey's U.S. patents. Mylan intends to vigorously defend its intellectual property in the pending patent litigations against Sunovion and Teva. The terms of the patents protecting Perforomist extend into 2021. 

Read the full press release here.

In other Mylan news, on October 19, 2011 it announced it , "has entered into a settlement agreement with Warner Chilcott resolving litigation related to Femcon® Fe Chewable Tablets, known generically as Norethindrone and Ethinyl Estradiol Tablets USP (Chewable), 0.4 mg/0.035 mg and Ferrous Fumarate Tablets USP (Chewable), 75 mg (28-Day Regimen). This medication is an oral contraceptive. Pursuant to the settlement agreement, the pending litigation has been dismissed and Mylan may begin to market and sell a generic version of Femcon Fe upon receipt of final product approval from the U.S. Food and Drug Administration. Additional details of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission."

Pfizer Settles with Teva Over Generic Lipitor in UK

The following item appeared on October 11, 2011 at Device Space:

Pfizer Inc. announced today that the company has settled its patent-infringement case against Teva and several other parties in respect of Teva's generic form of Lipitor in the U.K. Under the terms of the settlement agreement Teva and the other settling parties agree not to sell Teva's atorvastatin product in the U.K. before patent expiry in May of 2012. Teva acknowledges that Pfizer's Lipitor patent is valid and infringed by Teva's product. Other terms of the settlement remain confidential.

Go here for links to related articles.

Narrowing Claim Amendment Blocks Application of the Doctrine of Equivalents, Again

The following is excerpted from a September 12, 2011 article by Heather Morehouse Ettinger, Ph.D. of McDermott Will & Emery posted at the National Law Forum:

Addressing whether an amendment narrowing the claim scope during the prosecution limited the patentee’s ability to capture a generic’s different, but potentially equivalent, product as infringing, the U.S. Court of Appeals for the Federal Circuit affirmed a decision on summary judgment, finding that prosecution history estoppel applied and barred the application of the doctrine of equivalents (DOE). Duramed Pharmaceuticals, Inc. (Teva Women’s Health) v. Paddock Laboratories, Inc., Case No. 10-1419 (Fed. Cir., July 21, 2011 (Lourie, J.).

The district court granted Duramed’s motion for summary judgment of non-infringement, finding that the narrowing of the claims to recite a particular moisture barrier coating in view of the prior art was substantially related to patentability and, therefore, under Festo, a presumption of prosecution history estoppel applied. The district court further found that Duramed had not overcome this presumption, and thus the DOE could not be applied, because the prior art illustrated that polyvinyl alcohol moisture barriers were foreseeable. Duramed appealed.

The Federal Circuit affirmed, agreeing with the district court that, under Festo, because Duramed narrowed the scope of the claims during prosecution, a presumption of prosecution history estoppel applied.

Read the full article here.

Court Rules in Allergan's Favor on Lumigan Patent

The following is from a September 9, 2011 Reuter's update with reporting by Tom Hals; additional reporting by Rans Pierson in New York; and editing by Derek Caney:

Delaware District Court judge Sue Robinson ruled on Thursday that the generic drugmakers failed to prove Allergan's patents protecting Lumigan were invalid and found the generic forms infringed those patents.

Barr Laboratories Inc, a unit of Teva, and Novartis (NOVN.VX) (NVS.N) unit Sandoz filed abbreviated new drug applications (ANDA) in 2009 to make a generic version of the drug. Allergan sued, claiming patent infringement.

Lumigan has annual global sales of about $650 million, making it one of Allergan's biggest prescription eye medicines.

Access the update here.

Generic Candesartan Launch Opportunity - Prodrug Patent Expiration in 2012

The following is excerpted from an August 23, 2011 GenericsWeb press release:

GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article based on its proprietary Pipeline Patent Intelligence that analyses opportunities in launching generic versions of Atacand® (Candesartan cilexetil). Marketed by AstraZeneca and Takeda, Candesartan cilexetil is indicated for the treatment of hypertension and heart failure, with sales of US $1.5bn in 2010. Candesartan cilexetil is currently available in oral tablet formulations and in oral tablet fixed dose formulations in combination with Hydrochlorothiazide (Atacand HCT®).

The article by GenericsWeb highlights the following observations in relation to generic Candesartan:

• Patent protection of the candesartan cilexetil prodrug molecule remains in force in Europe via Supplementary Protection Certificates and national patent extensions in other major territories until 2012-2013.
• Patent protection has expired in Canada and generics are available from Apotex, Sandoz and Teva, and generics have been identified in Australia despite the extended molecule patent remaining in force.
• In all major territories where Candesartan has been marketed, the data and marketing exclusivity have already expired thus are not a factor for generic competition.
• Patents protecting the combination product with Hydrochlorothiazide (HCTZ) are identified in Canada, Europe and the US; however the granted European equivalent has recently been revoked and the Canadian patent is undergoing litigation.
• In the US, tentative FDA approvals for generic Atacand have been granted and several Paragraph IV filings have been identified relating generic Atacand and Atacand HCT.
• Generic companies KRKA and Teva appear in the top five applicants for patents relating to Candesartan.
• Since the initial and on-going approvals of Atacand HCT, several generic companies have submitting patent filings relating to combination products and their various uses.

GenericsWeb notes that: “Currently a barrier to generic competition, the expiry of the prodrug molecule patents in 2012 in Europe and the US means that generic competition to Candesartan is likely to be very strong, evidenced by the fact that generic Candesartan appeared in Canada only days after the expiry of the Canadian molecule patent.”

Generic combinations of Candesartan cilexetil and HCTZ may be prevented until 2014; however this will depend on the outcome of litigation in Canada, which is currently on-going. Since the revocation of the equivalent European patent, the outcome of new pending European applications concerning the combination is of great importance when considering generic Atacand HCT, as these are unlikely to proceed unopposed by major generic manufacturers.”

You can read the entire article here.

Pfizer Wins Viagra Patent Case Against Teva

The following is excerpted from an August 15, 2011 article by Phil Milford published by Bloomberg:

Pfizer Inc. (PFE) won a patent- infringement case that prevents Teva Pharmaceutical Industries Ltd. (TEVA) from marketing a generic version of the impotence drug Viagra until 2019.

U.S. District Judge Rebecca Beach Smith in Norfolk, Virginia, ruled Aug. 12 against Petach Tikva, Israel-based Teva, which claimed the patent wasn’t valid and couldn’t be enforced.

“Teva has not shown by clear and convincing evidence that the patent is invalid,” Smith said in a 110-page opinion. In addition, “there is utterly no evidence” to support Teva’s claim that that Pfizer intentionally withheld documents from the U.S. Patent and Trademark Office, Smith wrote.

The ruling was “a surprise,” Bloomberg Industries analyst Asthika Goonewardene said in an interview.

“The patent was a method-of-use patent, and usually these don’t hold up that well in court for small molecular drugs,” Goonewardene said. “The court’s decision to uphold this patent means other filers wanting to enter in 2012 are not likely to do so then.”

Read the full article here.

Patent Wars Stifle Innovation

The following is excerpted from an August 4, 2011 post by Larry Kahaner at the McGowan Blog on Business Leadership and Ethics published by The William G. McGowan Charitable Fund:

The founders of the United States believed that patents were so vital to a growing capitalist nation that they included intellectual property protection in the Constitution. Without a doubt, patents have been a cornerstone of innovation for which the U.S. has led the world. In fact, I believe that innovation can lead the U.S. out of the current recession if it’s not hamstrung by what I have dubbed ‘patent perversion.’

We see it in the pharmaceutical industry, where innovative companies are held hostage by generic drug makers who threaten to make a clone and are paid extortion money not to do so. In this case, the patent laws are not protecting the company that has taken the R&D risk.

Now, the Justice Department is investigating whether some high tech companies including Apple, Microsoft and Research in Motion (maker of the Blackberry smartphone), are playing fast and loose with the intent of patent laws by scooping up a portfolio of 6,000 patents in order to cripple Google’s Android software. The consortium calls themselves “Rockstar Bidco.” Don’t ask.

As a nation whose strength has always relied on innovation, creativity and risk-taking, this practice of patent perversion keeps us running in place and not ahead of the pack.

Read the full post here.