Pharmaceuticals

December 8, 2011

Indiana District Court’s Verdict for Alcon Laboratories in Patent Infringement Suit Over Eye Medication Now Pending on Appeal

Indianapolis, IN – A patent infringement judgment from the Southern District of Indiana will be reviewed by the Federal Circuit Court of Appeals. In May, Chief Judge Richard L. Young of the Southern District of Indiana issued a verdict and judgment in favor of plaintiffs Alcon Research Ltd., Alcon Laboratories, Inc., both of Fort Worth, Texas and Hakko Kirin Co., Ltd. (f/k/a Kyowa Hakko Kogyo Co., Ltd.) of Tokyo, Japan, after a bench trial on the plaintiff’s patent infringement claims against Apotex, Inc., of Ontario, Canada and Apotex Corp. Weston, Florida. Alcon filed a complaint alleging Apotex infringed patent no.5,641,805, TOPICAL OPHTHALMIC FORMULATIONS FOR TREATING ALLERGIC EYE DISEASES, which has been issued by the US Patent Office.

Chief Judge Young presided over a bench trial April 26, 2010 to May 7, 2010, and final arguments were presented to the court on August 3, 2010. The Court found that plaintiffs had “proven, by a preponderance of the evidence, that the Defendants’ generic equivalent of Plaintiffs’ patented allergy topical ocular medication, Patanol®;, infringed claims 1-8 of the ‘805 patent[,]” and that the defendant failed to show, by preponderance of evidence, that the patent claims were invalid. The court also found that the defendants failed to prove, by preponderance of evidence, that the ‘805 patent is unenforceable due to inequitable conduct.

Apotex has appealed the case to the Federal Circuit Court of Appeals (docket number 2011-1455). Apotex’s brief was filed on October 3, 2011, and Alcon’s brief is due on December 23, 2011.

Practice Tip: One of the defenses raised by Apotex was to claim the patent was unenforceable due to inequitable conduct. Apotex claimed that one of the inventors of the ‘805 failed to disclose results of certain tests and other data in the patent application. Apotex claimed the inventor as well as the attorney who filed the patent application violated their duty of candor to the PTO, which is imposes pursuant federal regulations 37 C.F.R. § 1.56(c). Alcon, however, presented evidence that the tests in question were believed to be inconclusive and that the inventor simply forgot about another test. Under the totality of circumstances, the court found that a finding of deceptive intent was not warranted. The court, therefore, declined to find that the patent should not be enforceable under the theory of inequitable conduct.

In addition, the court held that Apotex could not raise an additional theory of invalidity – invalidity for lack of a written description – until after the trial. The court found that the late disclosure had prejudiced the plaintiff and therefore refused to consider the new theory.
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November 7, 2011

Eli Lilly & Co. Loses Appeal in British Supreme Court Over Patent Dispute Over Gene Sequence

By Overhauser Law Offices, LLC

London, U.K. – The Supreme Court of the United Kingdom has ruled against Indianapolis-based Eli Lilly & Company in a patent dispute. Lilly had challenged the validity of the patent of Human Genome Sciences, Inc., of Rockville, Maryland that covers the gene sequence of a protein called Neutrokine-α. Lilly had challenged the patent based on the fact that there is no known use of the protein. Thus, Lilly argued, the gene sequence was not patentable due to a lack of industrial application.

According to the Indianapolis Business Journal, Lilly continues to maintain the patent is invalid. The IBJ quoted a Lilly statement as stating “Human Genome Sciences seek to foreclose a whole area of research in a way that is not only harmful to the industry, but would ultimately and unjustifiably hinder the future development of new medicines.”

Practice Tip: The Court’s decision was based upon the European Patent Convention and United Kingdom patent doctrine requiring a patentable invention be susceptible to industrial application, which is similar to the U.S. patent doctrine of utility. The Court’s decision here holds that the U.S. doctrine of utility creates a higher bar to patentability that the E.U. and U.K. doctrine. The opinion explicitly rejected U.S. cases on the doctrine, including Brenner v Manson, 383 U.S. 519 (1966) and in re Fisher, 421 F.3d 1365 (2005).

October 28, 2011

Southern District Court Grants Partial Summary Judgment for Eli Lilly and Company in Dispute With Parkinson’s Disease Drug Licensee Over Products Liability Lawsuit

By Overhauser Law Offices, LLC

Indianapolis. IN – Judge Tanya Walton Pratt of the Southern District of Indiana has granted a Partial Summary Judgment for Eli Lilly and Company of Indianapolis, Indiana in a dispute with licensee Valeant Pharmaceuticals International of Irvine, California involving the costs associated with product liability lawsuits over Lilly’s Parkinson’s disease drug.

Lilly began selling a product called Permax, which is used to treat Parkinson’s disease, in 1989. In March 2002, Lilly entered an exclusive licensing agreement with Amarin Corporation allowing Amarin to market, use and sell Permax in the United States, including the licensed use of Permax trademarks. The parties’ license agreement prohibited either party from assigning rights or obligations under the contract to any third party absent written consent of the other party. In 2004, Valeant purchased the assets of Amarin, including the rights under the Permax license. Lilly provided written consent to this assignment in a letter agreement that also addressed costs and indemnification relating to defending a pending products liability lawsuit involving Permax. The present lawsuit was filed when a dispute arose between Lilly and Valeant over the costs and indemnification relating to the products liability lawsuit. After settlement of one of the products liability cases, Valeant refused to indemnify Lilly. Lilly sought a declaratory judgment requiring Valeant to pay certain litigation and settlement costs relating to the products liability suit.

In the court’s decision, Judge Pratt found that the parties’ contract was clear and unambiguous in providing a schedule for sharing costs associated with the product liability suit. Thus Valeant must pay Lilly pursuant the schedule in the contract.

Practice Tip: This case illustrates that license agreements, which grant the licensee limited rights to use the intellectual property, owned by the licensor, can come with additional responsibilities and obligations. It is important to have an intellectual property attorney draft and review license agreements to ensure that the parties understand what is included.
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August 12, 2011

Lilly Wins Patent Infringement Suit Regarding Chemotherapy Drug

By Overhauser Law Offices, LLC

Wilmington, DE – Indianapolis-based Eli Lilly & Company has won patent infringement protection of the drug Lilly’s drug ALIMTA drug, which is a chemotherapy drug used to treat mesothelioma and other lung cancers. Lilly co-owns the patent with Princeton University. The lawsuit arose from an Abbreviated New Drug Application filed with the Food and Drug Administration that had been filed by Teva Parenteral Medicines of Israel, alleging APP Pharmaceuticals LLC of Schaumburg, Illinois, and Barr Laboratories of Montvale, New Jersey. Their ANDA sought approval to sell generic versions of ALIMTA prior to the expiration of the patent.

As soon as the ADNA was filed, Lilly’s patent attorneys filed a patent infringement lawsuit in the District Court of Delaware. The defendants had claimed that the ALIMTA patent, patent no. 5,344,932, N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-glutamic acid derivatives, which has been issued by the US Patent Office, was invalid “under the doctrine of obviousness-type double patenting because the claimed invention is an obvious modification of inventions claimed in commonly-owned U.S. Patent Nos. 5,028,608 (“the ‘608 patent”) and 5,248,775 (“the ‘775 patent) in light of the relevant prior art.” The court held a five day bench trial in November 2010.

The Chief Judge Gregory Sleet wrote for the court in upholding the validity of the patent. “The court concludes that the examples found in the ‘775 patent specification do not support a finding of invalidity for obviousness-type double patenting because this case does not present a situation in which separate patents are sought for a claim to a compound and a claim to using that compound for the disclosed utility of the original compound.”

According to WISHTV.COM, Alimta was Lilly’s third best selling drug and had sales of $1.64 billion in first three quarters of 2010. The Alimta patent has been the subject of much litigation. On July 15, 2011, Lilly filed a patent infringement lawsuit regarding the same patent and against APP Pharmaceuticals, also a defendant in this case. Indiana Intellectual Law News blogged on the case here.

August 1, 2011

Lilly Wins Appeal Protecting Attention-Deficit Disorder Drug Patent

By Overhauser Law Offices, LLC

Washington, D.C. – Indianapolis-based Eli Lilly & Co. won a lawsuit against seven other pharmaceutical companies that sought FDA approval to sell competing drugs that would have utilized Lilly’s patented drug formula. The seven defendants, Actavis Elizabeth LLC, Sun Pharmaceuticals, Sandoz Inc., Mylan Pharmaceuticals, Apotex Inc., Aurobindo Pharma Ltd., and Teva Pharmaceuticals, had filed an Abbreviated New Drug Application (ANDA) seeking to utilize Lilly’s patented formula and claiming invalidity of Lilly’s patent, No. 5,658,590, Treatment of attention-deficit/hyperactivity disorder, which has been issued by the US Patent Office. The patented drug is marketed under the name Strattera and is used to treat Attention-Deficit Disorder.

Upon the filing of the ADNA, Lilly’s patent attorneys immediately filed this patent infringement lawsuit in the United States District Court of New Jersey. The district court sustained the ‘590 patent against the defendants’ challenges on the grounds of inequitable conduct, anticipation, obviousness, and non-enablement. However, the court held the claims invalid for lack of utility, which the court called “enablement/utility.” The Federal Circuit Court went further in protecting Lilly’s patent and upheld the patent in its entirety. The ruling ensures that Lilly’s patent will be fully enforceable through its expiration in 2017.

According to the Indianapolis Business Journal, the drug generated $577 million in sales for Lilly last year.

The case is Eli Lilly & Co. v. Actavis Elizabeth LLC et al, Case No. 2010-1500 in the Court of Appeals for the Federal Circuit, decided July 29, 2011. The opinion notes it is “nonprecedential.”
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July 15, 2011

Eli Lilly Company Sues APP Pharmaceuticals LLC for Patent Infringement of Chemotherapy Drug

By Overhauser Law Offices, LLC

Indianapolis, IN – Patent lawyers for Eli Lilly Company of Indianapolis, Indiana filed a patent infringement judgment suit in the Southern District of Indiana alleging APP Pharmaceuticals LLC of Schaumburg, Illinois infringed patent no.7,772,209 , Antifolate combination therapies, which has been issued by the US Patent Office.

The complaint states that APP has filed an abbreviated new drug application with the Food and Drug Administration seeking to sell a generic version of the drug ALIMTA, which is patented by Lilly, prior to the expiration of the patent. Lilly alleges that APP will begin to market and sell the generic drug. ALIMTA is a chemotherapy drug used to treat mesothelioma and other lung cancers. Lilly’s patent attorneys contend that the marketing and sale of APP’s generic version will infringe Lilly’s patent. The complaint alleges two counts of patent infringement and seeks a judgment of infringement, injunction, costs and attorney’s fees.

Practice Tip: This case has been filed before APP actually marketed or sold any of the infringing product. Rather, Lilly appears to have become concerned about infringement due to the new abbreviated new drug application and notice that APP provided to Lilly. It is common for a patent infringement lawsuit, seeking an injunction and declaratory judgment, to be filed after a new abbreviated new drug application is filed with the Food and Drug Administration. The Patent Act, 35 U.S.C. § 283, allows a court with jurisdiction to grant an injunction “to prevent the violation of any right secured by patent, on such terms as the court deems reasonable.”

June 9, 2011

Alcon Research Sues Watson Laboratories Inc for Patent Infringement of Allergy Eye Drops

By Overhauser Law Offices, LLC

Indianapolis, IN – Patent lawyers for Alcon Research Ltd of Fort Worth, Texas, Alcon Pharmaceuticals LTD of Switzerland, and Kyowa Haddo Kirin Co. of Japan filed a patent infringement in alleging Watson Laboratories Inc and Watson Pharma, Inc. of Parsippany, New Jersey, and Watson Laboratories, of Corona, California, infringed the following patent prior to the expiration:

Patent No. 5,641,805, Topical ophthalmic formulations for treating allergic eye diseases, Patent No. 6,995,186, Olopatadine formulations for topical administration and Patent No. 7,402,609, Olopatadine formulations for topical administration, which have been issued by the US Patent Office.

The Complaint alleges that Watson has filed an Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration “seeking approval to manufacture and sell a generic version of PATADAY™ ophthalmic solution,” a drug product that is covered by several patents owned by Alcon. The Complaint states that Watson sent a letter to Alcon on April 27, 2011 notifying Alcon of Watson’s ANDA and intent to manufacture and sells products covered by the ADNA. According to Alcon, Watson’s April 27 letter and ANDA stated that Alcon’s patents are invalid, unenforceable and/or will not be infringed. Alcon has made three claims of patent infringement and three claims for a declaratory judgment of infringement. Alcon’s patent attorneys are seeking an injunction, declaratory judgment, attorney’s fees and costs. Alcon has alleged that the basis for jurisdiction of the Southern District of Indiana is that Watson markets and sells drug products nationwide and in Indiana.

Practice Tip: Alcon’s patent attorneys filed this case before apparently before Watson actually sold any allegedly infringing products. Hence, they are seeking an injunction to prevent any potentially infringing sales as well as a declaration judgment of infringement, rather than monetary damages. These remedies, if granted, could prevent monetary damages that could occur if infringing products are sold. The Patent Act, 35 U.S.C. § 283, allows a court with jurisdiction to grant an injunction “to prevent the violation of any right secured by patent, on such terms as the court deems reasonable.”