Rakoczy Molino Mazzochi Siwik L.L.P.

Intellectual Property Attorneys

Thank you for visiting the website of Rakoczy Molino Mazzochi Siwik LLP. We are a full-service litigation and intellectual property  law firm, having significant experience working with clients in the pharmaceutical, chemical, and biotechnology industries.

Please use this website to learn more about our firm and the intellectual property laws that affect our clients’ industries. If you have any questions or concerns, or would like to make an appointment to speak with one of our attorneys, please call us at (312) 527-2157 or fill out the form on the Contact Us page, and someone from the firm will be in touch with you shortly. We look forward to hearing from you.

New at Rakoczy Molino Mazzochi Siwik LLP

 

The U.S. Court Of Appeals For The Federal Circuit Affirms RMMS's Victory Involving Generic Ibandronate Products

On April 11, 2014, the U.S. Court of Appeals for the Federal Circuit affirmed summary judgment of invalidity of the asserted claims of U.S. Patent Nos. 7,718,634 ("the '634 patent") and 7,410,957 ("the '957 patent"). Plaintiffs brought suit in the U.S. District Court for the District of New Jersey seeking to prevent the firm's clients, Watson Laboratories, Inc., Actavis, Inc., Watson Pharma, Inc., and Cobalt Laboratories, Inc. ("Watson"), from launching a generic version of Boniva®. The District Court found the asserted claims of the '634 patent and '957 patent to be invalid due to obviousness under 35 U.S.C. § 103. The Federal Circuit affirmed that decision. Deanne Mazzochi, William Rakoczy, Paul Molino, Tara Raghavan, and Eric Hunt are counsel for Watson. Lead counsel Deanne Mazzochi argued the case before the Federal Circuit. This victory continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.

RMMS Secures Judgment Of Non-Infringement After A Trial Involving Generic Trizivir® (Abacavir Sulfate; Lamivudine; Zidovudine) Tablets

On December 17, 2013, the U.S. District Court for the District of Delaware issued a ruling finding that Lupin's generic Abacavir Sulfate; Lamivudine; Zidovudine Tablets do not infringe U.S. Patent No. 6,417,191 ("the '191 patent"). In the litigation, ViiV Healthcare UK Ltd. and ViiV Healthcare Co. sought to prevent Lupin's marketing of a generic equivalent to Trizivir® (Abacavir Sulfate; Lamivudine; Zidovudine). After a 4-day bench trial, the District Court concluded that Lupin's generic Abacavir Sulfate; Lamivudine; Zidovudine Tablets do not infringe the '191 patent.

This victory continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.

Deanne Mazzochi, Paul Molino, Rachel Pernic-Waldron, Roy Chamcharas, and Patrick Kilgore tried the case for Lupin.

RMMS Secures Judgment Of Patent Invalidity After A Trial Involving Gatifloxacin Ocular Formulation and Method:

On August 9, 2013, the U.S. District Court for the District of Delaware issued a ruling finding the asserted claims of U.S. Reexamination Patent No. 6,333,045 to be invalid. In the litigation, the patentees sought to prevent RMMS's client, Lupin, from marketing a generic equivalent to Zymar® (0.3 w/v% gatifloxacin) and Zymaxid® (0.5 w/v% gatifloxacin). After a bench trial, the District Court concluded that the asserted claims from the '045 patent were invalid as obvious. This victory continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.

Deanne Mazzochi, Paul Molino, William Rakoczy, Anuj Wadhwa, John Polivick, and Brian Murray tried the case for Lupin.

Federal Circuit Affirms Judgment Of Non-Infringement Involving Generic Mometasone Furoate Nasal Spray

On June 10, 2013, the U.S. Court of Appeals for the Federal Circuit affirmed the June 2012 ruling by the U.S. District Court for the District of New Jersey finding that Apotex Inc.'s generic mometasone furoate nasal spray product does not infringe U.S. Patent No. 6,127,353. In the litigation, Merck Sharp & Dohme Corp. (formerly known as Schering Corp.) sought to prevent Apotex's marketing of a generic equivalent to Nasonex® (mometasone furoate). After a 7-day bench trial, the District Court concluded that Apotex's generic mometasone furoate nasal spray product does not infringe the '353 patent.

Deanne Mazzochi argued for Apotex in the Federal Circuit. Deanne Mazzochi, Paul Molino, William Rakoczy, Andrew Alul, Roy Chamcharas, Matthew Anderson, and Yixin Tang tried the case in the district court for Apotex.

RMMS Secures Judgment Of Patent Invalidity And Non-Infringement After A Trial Involving Budesonide Inhalation Suspension

On April 1, 2013, the U.S. District Court for the District of New Jersey issued a ruling finding U.S. Patent No. 6,598,603 to be invalid and that Watson Laboratories, Inc. does not infringe U.S. Patent No. 7,524,834. In the litigation, AstraZeneca LP and AstraZeneca AB sought to prevent marketing of a generic equivalent to Pulmicort Respules® (budesonide suspension) by Watson (k/n/a Actavis). After a 7-week bench trial, and a 6-day Markman hearing, the District Court concluded that the '603 patent is invalid as obvious and anticipated by the prior art, and that Watson's generic product does not infringe the '834 patent.

This victory continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.

William Rakoczy, Amy Brody, Tara Raghavan, Heinz Salmen, Conly Wythers, and Natasha White tried the case for Watson/Actavis.

RMMS Defeats Motion for Preliminary Injunction Involving Generic Tiagabine Hydrochloride Products

On December 20, 2012, RMMS successfully defeated Plaintiff Cephalon, Inc.'s motion for preliminary injunction against the firm's clients, Sun Pharmaceutical Industries, Ltd. and Caraco Pharmaceutical Laboratories, Ltd. ("Sun"). After briefing and hearing argument and witness testimony on Plaintiff's motion to enjoin Sun from marketing its generic version of Gabitril®, the U.S. District Court for the District of New Jersey denied Plaintiff's motion, holding that Plaintiff had failed to demonstrate a likelihood of proving its allegations of patent infringement against Sun. Furthermore, the Court concluded that Sun had raised a substantial question regarding the validity of the patent-in-suit. Deanne Mazzochi, William Rakoczy, Paul Molino, Joseph Jaros, Anuj Wadhwa, and Yixin Tang are counsel for Sun. This victory continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.

The U.S. Court Of Appeals For The Federal Circuit Affirms RMMS's Successful Defeat Of A Motion for Preliminary Injunction Involving Generic Ibandronate Products

On March 14, 2012, RMMS successfully defeated Plaintiffs Hoffman-La Roche and Genentech Inc.'s motion for preliminary injunction against the firm's clients, Watson Pharmaceuticals, Inc. Watson Laboratories, Inc., Watson Pharma, Inc., Cobalt Pharmaceuticals, Inc. and Cobalt Laboratories, Inc. ("Watson"). After briefing and hearing argument and witness testimony on Plaintiffs' motion to enjoin Watson from launching its generic version of Boniva®, the U.S. District Court for the District of New Jersey denied Plaintiffs' motion, holding that Plaintiffs had failed to show that they were likely to succeed on the merits of their patent infringement claims at trial. On October 11, 2012, the Federal Circuit affirmed the District Court's decision. Deanne Mazzochi, William Rakoczy, Paul Molino, Tara Raghavan, and Eric Hunt are counsel for Watson. Ms. Mazzochi argued the case before the Federal Circuit. This victory continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.

RMMS LLP recognized as one of the top Hatch-Waxman litigation firms in the country by LMG Life Sciences

LMG Life Sciences recently recognized Rakoczy Molino Mazzochi Siwik LLP as a Recommended firm for General Patent Litigation and as Highly Recommended for Hatch-Waxman litigation.

LMG recognized RMMS LLP's expertise in the pharmaceutical, chemical, and biotechnology and other related fields distinguished the firm in this area. LMG noted the firm's partners have litigated numerous significant patent infringement cases including Neurontin, Paxil, and Pravachol. LMG also stated that RMMS LLP "is seen as a top-of-the-line IP litigation firm by peers within the industry. Rakoczy Molino is considered by its competitors as a dark horse candidate as the best Hatch-Waxman litigation firm in the country."

The founding partners were particularly noted for helping to create one of the more impressive Hatch-Waxman litigation firms in the country whose specialty is working with generic pharmaceutical companies.

RMMS Secures Judgment Of Non-Infringement After A Trial Involving Generic Mometasone Furoate Nasal Spray

On June 15, 2012, the U.S. District Court for the District of New Jersey issued a ruling finding that Apotex Inc.'s generic mometasone furoate nasal spray product does not infringe U.S. Patent No. 6,127,353. In the litigation, Schering Corporation sought to prevent Apotex's marketing of a generic equivalent to Nasonex® (mometasone furoate). After a 7-day bench trial, the District Court concluded that Apotex's generic mometasone furoate nasal spray product does not infringe the '353 patent.

This decision could have long-ranging impact in the pharmaceutical, chemical and biotechnology areas, and this victory continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.

Deanne Mazzochi, Paul Molino, William Rakoczy, Andrew Alul, Roy Chamcharas, Matthew Anderson, and Yixin Tang tried the case for Apotex.

RMMS Defeats Motion for Preliminary Injunction Involving Generic Ibandronate Products

On March 14, 2012, RMMS successfully defeated Plaintiffs Hoffman-La Roche and Genentech Inc.'s motion for preliminary injunction against the firm's clients, Watson Pharmaceuticals, Inc. Watson Laboratories, Inc., Watson Pharma, Inc., Cobalt Pharmaceuticals, Inc. and Cobalt Laboratories, Inc. ("Watson"). After briefing and hearing argument and witness testimony on Plaintiffs' motion to enjoin Watson from launching its generic version of Boniva®, the U.S. District Court for the District of New Jersey denied Plaintiffs' motion, holding that Plaintiffs had failed to show that they were likely to succeed on the merits of their patent infringement claims at trial. Deanne Mazzochi, William Rakoczy, Paul Molino, Tara Raghavan, and Eric Hunt are counsel for Watson. This victory continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.

RMMS Secures Summary Judgment of Non-Infringement Involving Generic Guaifenesin Extended-Release Tablets, 600 mg

On January 11, 2012, the U.S. District Court for the Western District of Michigan entered an order finding Perrigo R&D's generic extended-release guaifenesin tablet drug product does not infringe U.S. Patent No. 6,372,252. In the litigation, Adams Respiratory Therapeutics and Reckitt Benckiser, Inc. sought to prevent Perrigo R&D's marketing of a generic equivalent to Mucinex® (guaifenesin) 600 mg. Perrigo R&D was able to secure a non-infringement victory on summary judgment on all asserted claims. Christine Siwik, William Rakoczy, and Alice Riechers are lead counsel for Perrigo. This victory continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.

RMMS Defeats Motion for Preliminary Injunction Involving Generic Carbamazepine Extended-Release Capsules

On July 6, 2011, the U.S. District Court for the District of New Jersey denied a motion for a preliminary injunction that would have blocked full generic competition for carbamazepine extended-release capsules. Nostrum Pharmaceuticals sought a preliminary injunction prohibiting FDA from approving otherwise eligible abbreviated new drug applications (ANDAs) for carbamazepine extended-release capsules even after patent expiration. The denial permits the FDA to approve eligible ANDAs for carbamazepine extended-release capsules as Nostrum continues its case against FDA. Lara FitzSimmons, who argued for the firm's client, William Rakoczy, Christine Siwik, and Eric Hunt handled the case for the firm's client.

RMMS Secures Federal Circuit Ruling Affirming Trial Decision of Patent Invalidity Involving Generic Galantamine

On September 25, 2009, the U.S. Court of Appeals for the Federal Circuit issued a ruling affirming the U.S. District Court for the District of Delaware's finding that Janssen's '318 patent is invalid for lack of enablement. This decision clears the way for the firm's client to continue marketing its generic version of Janssen's Razadyne® (galantamine), which the client launched after the successful trial decision in September 2008, and represents a significant victory for the generic industry in general. William Rakoczy argued the case before the Federal Circuit. Also involved in the underlying litigation and appeal were Christine Siwik and Amy Brody.

RMMS Defeats Motion for Temporary Restraining Order Involving Generic Piperacillin/Tazobactam Injections

On September 24, 2009, the U.S. District Court for the District of Columbia denied a motion for temporary restraining order that would have prevented the firm's client, Apotex Corporation, from continuing to distribute the first generic piperacillin/tazobactam product. Plaintiff Wyeth Pharmaceuticals filed its motion against the U.S. Food and Drug Administration in order to prevent the marketing of FDA-approved generic version of Zosyn® (piperacillin/tazobactam). The denial permits the firm's client to continue distributing the first generic version of Zosyn®, as Wyeth continues its case against FDA.

RMMS Secures Federal Circuit En Banc Ruling Affirming Summary Judgment Of Noninfringement Involving Generic Cefdinir

On May 19, 2009, the U.S. Court of Appeals for the Federal Circuit issued a ruling affirming the U.S. District Court of the Eastern District of Virginia's finding that Lupin's generic cefdinir drug product does not infringe U.S. Patent No. 4,935,507. In the litigation, Astellas Pharma and Abbott Laboratories sought to prevent Lupin's marketing of a generic equivalent to Omnicef® (cefdinir). After RMMS secured an early advantageous claim construction ruling, Lupin was able to secure a noninfringement victory on summary judgment on all claims. On appeal, the Federal Circuit affirmed the claim construction and noninfringement ruling. In that opinion, the Federal Circuit addressed en banc an issue that had been vexing prior district courts for nearly two decades: the appropriate way to construe claims known as "product by process" claims. This decision is expected to have long-ranging impact in the pharmaceutical, chemical and biotechnology areas.

This victory enables Lupin to continue marketing its generic cefdinir product, and continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.

Deanne Mazzochi argued the case before the Federal Circuit. Also involved in the underlying litigation and appeal were Paul Molino, William Rakoczy, Amy Brody, Tara Raghavan, John McGuirk and Eric Hunt.

RMMS is proud to congratulate Christine J. Siwik, on being named one of 2008's "40 Illinois Attorneys Under Forty To Watch" by the Law Bulletin Publishing Company, publisher of the Chicago Daily Law Bulletin and Chicago Lawyer.

Ms. Siwik was recognized for her national reputation as a patent litigator, her commitment to clients, her knowledge and experience in the pharmaceutical industry, her work on federal patent and food and drug legislation, and her contributions to the community.

Ms. Siwik has been helping clients develop legal strategies and litigating generic pharmaceutical patent cases since 1995. She works closely with clients that have drug applications pending before the U.S. Food and Drug Administration, and assists clients in developing long-term legal and business strategies for developing, obtaining regulatory approval for, and launching pharmaceutical products.

RMMS Defeats Motion for Temporary Restraining Order and Preliminary Injunction Involving Generic Ramipril Capsules

On June 10, 2008, the U.S. District Court for the District of Maryland denied a motion for temporary restraining order and preliminary injunction against the firm's clients, Lupin Limited and Lupin Pharmaceuticals, Inc. Plaintiffs King Pharmaceuticals, Inc. and King Pharmaceuticals Research and Development, Inc. filed their motion in order to prevent Lupin from bringing its FDA-approved generic version of Altace® (ramipril) capsules to the market pending resolution of the underlying patent infringement litigation. After considering the briefing and hearing oral argument from the parties, the Court ruled from the bench, finding that Plaintiffs had not established a likelihood of success on the merits, and denied Plaintiffs' motion.

This victory enabled Lupin to immediately launch its products and be among the first generic companies to offer generic ramipril capsules, 1.25 mg, 2.5 mg, 5 mg and 10 mg. This ruling follows the firm's successful challenge to another patent asserted against Lupin by King, which first opened the ramipril market to generic competition in 2007.

RMMS Defeats Motion for Preliminary Injunction Involving Generic Clobetasol Propionate Foam Products

On March 19, 2008, RMMS successfully defeated Plaintiffs Connetics Corporation and Connetics Australia Pty. Ltd.'s motion for preliminary injunction against the firm's client, Perrigo Israel Pharmaceuticals Ltd. (formerly Agis Industries (1983) Ltd.). After briefing and hearing argument on Plaintiffs' motion to enjoin Perrigo from launching its FDA-approved generic version of Olux®, the U.S. District Court for the District of New Jersey denied Plaintiffs' motion from the bench. As a result of this ruling, Perrigo is now on the market with its generic clobetasol propionate foam product.

RMMS Defeats Motion for Preliminary Injunction for Generic Client in Patent Dispute

On April 25, 2006, the U.S. District Court for the District of Arizona issued a 15-page opinion denying a motion for a preliminary injunction against RMMS's client, Prasco, LLC. After briefing and a hearing before the Court, RMMS defeated Plaintiff Medicis Pharmaceutical Corporation's motion, which called for the removal of Prasco's product from the market. As a result, Prasco was able to keep its generic product on the market pending the outcome of the underlying patent litigation against Medicis.

Please see "Pressure Rises for FDA, Congress in Latest Drug Duel" by Christine Hines of the Legal Times.

RMMS Attorney Testifies Before Congress On Important Patent Reform Issues

In July 2005, Christine J. Siwik testified before U.S. Senate, Committee on the Judiciary, Subcommittee on Intellectual Property, at a hearing entitled "Perspective on Patents: Harmonization and Other Matters." Presently, both the U.S. Senate and House of Representatives are considering legislation that could significantly change the patent laws. Through her testimony, Ms. Siwik sought to protect the interests of the generic pharmaceutical industry. A copy of Ms. Siwik's written testimony can be found at http://judiciary.senate.gov/hearing.cfm?id=1582.

RMMS Wins Summary Judgment of Non-Infringement for Generic Client in Patent Dispute Involving Pfizer's Blockbuster Prescription Drug Neurontin®

On August 22, 2005, the U.S. District Court for the District of New Jersey issued two 30-page decisions granting summary judgment on non-infringement for RMMS's generic client, Apotex, on Pfizer's U.S. Patent No. 6,054,482 for Neurontin®, a prescription drug approved to treat seizure and postherpetic neuralgia. In the long-running patent dispute dating back to 1998, RMMS attorneys have successfully obtained judgments for Apotex on all 3 of Pfizer's Neurontin® patents.