Hatch-Waxman Litigation: The Fish & Richardson Differential. An Integrated Approach and Strategy

Transcription

1 Hatch-Waxman

2 Hatch-Waxman Litigation: The Fish & Richardson Differential Fish is one of the largest firms in the U.S., practicing exclusively in the areas of intellectual property, litigation, and regulatory law. We have the premier patent litigation practice in the world, handling more patent litigation than any other firm and 30% more than our nearest competitors. We have won many of the most significant patent cases of the last decade. The sheer volume of complex IP litigation that we handle is beyond compare. Accordingly, our record of successfully litigating Hatch-Waxman and other patent cases for leading pharmaceutical companies goes unmatched, and over the past three years, our appellate victories have had broad-ranging impact on the development of law. For more than a century, we have helped pharmaceutical and other life sciences companies through waves of change within their industries providing comprehensive advice and guidance regarding respective laws and governing regulations to proactively protect their assets. We consistently deploy legal strategies and techniques that leverage our dynamic advantage in the service of our pharmaceutical and life sciences clients that are facing challenges under Hatch-Waxman. An Integrated Approach and Strategy Throughout our history we have maintained a simple but deeply rooted objective: protecting our clients intellectual property to allow them to maximize their market share, maximize the value of their intellectual property capital, and obtain a fair return on their hard work, investment, and innovation. When representing innovator drug companies, we pursue multiple strategies to maximize returns on our clients investments during market exclusivity periods. Our interdisciplinary teams provide a potent combination of attorneys and technology specialists who provide intricate, thorough, and expert knowledge to proactively and skillfully deliver results for our Hatch-Waxman clients.

3 We do this by taking an interdisciplinary approach ensuring that all scientific issues are understood fully throughout the product development and protection process by extending our intricate, thorough, and expert knowledge of the pharmaceutical industry and accompanying experience in all aspects complementary to Hatch-Waxman. Our patent litigators work closely with our patent prosecutors and trademark and regulatory attorneys to provide solutions that maximize the return on our clients significant investments in research and development. In the Hatch-Waxman context, this means that from the earliest stages we bring together the best team within the ranks of our firm to strategize the best course of action that will achieve our clients objectives. This fully integrated approach everything from pre-suit investigations to PTO actions, Orange Book tactics, Title I strategies of the Hatch-Waxman Act, ANDA filings (especially certification requirements pursuant to Paragraph IV), and FDA affairs has proven invaluable to our clients in pharmaceutical litigation. We are pleased to have secured numerous victories for our pharma clients, both at trial and before the Federal Circuit. Our work on these cases has helped clarify and mold the law, including the Federal Circuit s In re Cyclobenzaprine decision, which reemphasized the importance of objective considerations in an obviousness analysis. Jonathan Singer, head of Fish & Richardson s Life Sciences litigation practice Hatch-Waxman is the door into the courthouse, but once in front of a judge or jury, you must still litigate the underlying science; it is there that the differences in patent litigation experience, in technical mastery become evident.

4 Maximizing Market Exclusivity Early-stage Orange Book strategy comes into play in ANDA litigation We represented a branded-drug company facing generic competition on a key product. Relying on our multi disciplinary expertise and technical knowledge of the underlying patent rights, we counseled the company on an aggressive posture with respect to Orange Book patent listing and subsequently advanced an equally novel theory of infringement in district court. During the litigation, we counseled the client on its withdrawal of the listed drug in favor of a new formulation that was protected by three-year Hatch-Waxman exclusivity. We then assisted the client in the subsequent citizen petition filed by the generic manufacturer on the withdrawal issues while the FDA awaited a ruling by the Federal Circuit on the novel issues raised in litigation before approving any ANDAs. Thus, with a combination of litigation acumen and regulatory strategies, we assisted our client in lawfully dealing with the challenge of generic competition, thereby allowing our client to maximize its market opportunities through the assertion of its underlying patent rights. Technical mastery fends off a citizen petition We represented a manufacturer endeavoring to bring a low-cost version of an old antibiotic to market. The manufacturer retained Fish to navigate the difficult regulatory approval process to defend any litigation that might arise. When the original drug manufacturer sought to extend its market exclusivity with a blocking maneuver before the FDA and a threat of related patent litigation, our multidisciplinary team devised a creative counterstrategy for the client. Relying on our deep understanding of the drug s complex chemistry (provided by our in-house PhDs), we devised a two-pronged approach: first, to avoid claims of infringement, we presented the FDA with a novel patent carve-out theory to alter the client s drug label; and second, to end-run a regulatory stalling tactic, Fish attorneys presented the FDA staff with what was essentially a mini-trial on issues, which ultimately resulted in swift approval of the client s product..com info@fr.com Copyright 2013 Fish & Richardson P.C. These materials may be considered advertising for legal services under the laws and rules of professional conduct of the jurisdictions in which we practice. The material contained in this brochure has been gathered by the lawyers at Fish & Richardson P.C. for informational purposes only and is not intended to be legal advice. Transmission is not intended to create and receipt does not establish an attorney-client relationship. Legal advice of any nature should be sought from legal counsel. For more information about Fish & Richardson P.C. and our practices, please visit

5 Hatch-Waxman Litigation Experience Our clients know they can rely on Fish as the world s most experienced group of patent litigators to handle their cases. Because of our unmatched volume of patent litigation experience and significant record of success, we have deep institutional knowledge and insight into translating the language of patents and FDA applications into a language people can understand. Our significant record of success, as partially demonstrated below, fortifies our ability to win and provide solutions that maximize the return on our clients significant investments. ALPHAGAN P In re Brimonidine Allergan, Inc. v. Exela Pharmsci Inc., et al. Allergan, Inc., et al. v. Apotex Corp, Allergan, Inc., et al. v. Bausch + Lomb Labs Represented Allergan in multiple ANDA and paper NDA litigations related to Allergan s Alphagan, Alphagan P 0.15%, and Alphagan P 0.1% glaucoma medications. Fish obtained a judgment of infringement, validity, and enforceability against defendants Apotex and Excela on all five patents-in-suit in multidistrict litigation tried in the District of Delaware. On appeal, Fish obtained an affirmance-in-part, successfully maintaining Alphagan P s market share. AMRIX Eurand Inc., et al. v. Mylan Pharmaceuticals Inc., et al. Eurand Inc., et al. v. Impax Laboratories Inc. Eurand Inc., et al. v. Anchen Pharmaceuticals Inc., et al. Eurand Inc., et al. v. Teva Pharmaceuticals USA Inc., et al. Represented plaintiffs Eurand, Cephalon, and Anesta in Hatch-Waxman litigation related to the extendedrelease muscle relaxant Amrix. At the district court Fish received an adverse ruling that the two patents-insuit were obvious but, despite that ruling, successfully obtained an injunction from the district court requiring defendant Mylan Pharmaceuticals, which had launched its generic product at-risk, to withdraw from the market. That injunction was ultimately affirmed by the Federal Circuit. On the merits, Fish obtained a reversal of the district court s obviousness finding at the Federal Circuit. Fish is currently representing plaintiffs in an action to determine the damages resulting from Mylan s at-risk launch in the district court. COMBIGAN Allergan, Inc. v. Sandoz Inc. Allergan, Inc. v. Hi-Tech Pharmacal Co. Inc. Allergan, Inc. v. Alcon Laboratories Inc., et al. Allergan, Inc. v. Apotex Inc., et al. Allergan, Inc. v. Watson Laboratories Inc., et al. Represented Allergan in Hatch-Waxman litigation in the Eastern District of Texas relating to its glaucoma drug Combigan. Fish obtained a judgment of infringement and validity against defendants Sandoz, Alcon, Apotex, and Watson. Fish handled and argued the appeal before the Federal Circuit and is awaiting final decision. Fish continues to represent Allergan in district court litigation over Combigan against defendants Sandoz, Alcon, Apotex, and Watson in the Eastern District of Texas, relating to additional patents covering the drug. FENTORA Cephalon Inc., et al. v. Watson Pharmaceuticals Inc., et al. Cephalon Inc., et al. v. Barr Pharmaceuticals, et al. Cephalon Inc., et al. v. Sandoz Inc. Cephalon Inc. et al. v. Mylan Pharmaceuticals Inc., et al. Cephalon Inc., et al v. Impax Laboratories, Inc. Represented plaintiffs Cephalon and Cima Labs in litigations relating to Fentora, rapid-onset fentanyl tablets used in the treatment of opioid-tolerant patients suffering from breakthrough cancer pain. Fish identified and asserted a non-orange Book patent in response

6 to generic first-filer Watson Laboratories attempted design-around of the Fentora Orange Book patents and obtained a judgment of infringement and validity at the district court that was subsequently affirmed by the Federal Circuit. Fish also successfully tired four Orange Book patents against Mylan Pharmaceuticals winning a judgement of infringement, invalidity, and an injunction against generic entry. This case is on appeal. Additionally, Fish successfully represented plaintiffs against subsequent generic filers Barr Laboratories, Sandoz, Inc., and Impax Labs, who settled on terms favorable to plaintiffs. Fish is currently representing plaintiffs in district court litigation against later generic filers Mylan Pharmaceuticals and Impax Laboratories. LATISSE Allergan, Inc. and Duke University v. Apotex Inc., et al. Allergan, Inc. and Duke University v. Sandoz Inc. Alergan, Inc. and Duke University v. Hi-Tech Pharmacal Co., Inc. Allergan, Inc. and Duke University v. Watson Laboratories, Inc., et al. Represented plaintiffs Allergan and Duke University in Hatch-Waxman litigation relating to Latisse, Allergan s first-in-class treatment for eyelash hypotrichosis. After an eight-day bench trial, the district court found both patents-in-suit valid and infringed by defendants Apotex, Sandoz, and Hi-Tech Pharmacal Co., Inc. As a result, the FDA cannot finally approve the defendants ANDAs before patent expiration in May The district court also entered judgment against the Watson defendants on the same terms. Fish is currently representing Allergan in the appeal of this matter..com info@fr.com LUMIGAN Allergan, Inc. v. Barr Laboratories Inc. Allergan, Inc. v. Sandoz Inc. Represented Allergan in Hatch-Waxman litigation relating to its glaucoma drug Lumigan. Fish obtained a judgment of infringement and validity against defendants Barr Laboratories and Sandoz Inc. in the District of Delaware. Fish handled and argued the appeal before the Federal Circuit, which affirmed the district court s finding. LUMIGAN.01 Allergan, Inc. v. Sandoz, Inc. Representing Allergan in infringement case to be tried in Texas involving the glaucoma drug Lumigan.01. RANEXA Roche Palo Alto LLC, et al. v. Lupin Pharmaceuticals Inc., et al. Representing Roche and Gilead in Hatch-Waxman action over RANEXA, treatment for chronic angina. SULAR Sciele Pharma Inc., et al. v. Mylan Pharmaceuticals Inc., et al. Represented plaintiffs in Hatch-Waxman action relating to Sciele s blood-pressure drug, SULAR. XELODA Hoffman-La Roche Inc. v. Roxane Laboratories Inc., et al. Hoffman-La Roche Inc. v. Mylan Inc., et al. Hoffman-La Roche Inc. v. Teva Pharmaceuticals USA Inc., et al. Represented Hoffman-La Roche in Hatch-Waxman litigation involving XELODA, the first oral chemotherapy drug approved in the U.S. for treatment of breast and colorectal cancer and Dukes C Stage III colon cancer. Successfully settled the matter in Copyright 2013 Fish & Richardson P.C. These materials may be considered advertising for legal services under the laws and rules of professional conduct of the jurisdictions in which we practice. The material contained in this brochure has been gathered by the lawyers at Fish & Richardson P.C. for informational purposes only and is not intended to be legal advice. Transmission is not intended to create and receipt does not establish an attorney-client relationship. Legal advice of any nature should be sought from legal counsel. For more information about Fish & Richardson P.C. and our practices, please visit