Medical

March 1, 2016

Indiana Patent Litigation: Lilly Sues India Manufacturer of Generic Drugs for Infringement

Indianapolis, Indiana – An Indiana patent attorney for Plaintiff Eli Lilly & Company (“Lilly”) of Indianapolis, Indiana filed a lawsuit in the Southern District of Indiana alleging that Biocon Limited of Bangalore, India will infringe its patented chemotherapy drug, which Lilly offers under the brand name ALIMTA.

At issue in this patent litigation is U.S. Patent No. 7,772,209 (the “‘209 patent”). In February, Biocon notified Lilly that it had submitted an Abbreviated New Drug Application (“ANDA”) to the FDA. Lilly believes that the product that is the subject of the ANDA will be marketed as a generic version of ALIMTA and that such conduct will infringe the ‘209 patent.

This federal patent infringement lawsuit, filed by an Indiana lawyer on behalf of Lilly, lists a single count: Infringement of U.S. Patent No. 7,772,209.

Lilly states that it will suffer irreparable injury unless Defendant is “enjoined from infringing the ‘209 patent, actively inducing infringement of the ‘209 patent, and contributing to the infringement by others of the ‘209 patent.” It seeks a declaratory judgment, equitable relief, damages, costs and attorneys’ fees.

February 9, 2016

Indiana Patent Litigation: Eli Lilly Asks Indiana Federal Court to Adjudicate Dispute Regarding Patented Pharmaceutical

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Indiana patent attorneys for Plaintiff Eli Lilly and Company of Indianapolis, Indiana (“Lilly”) filed an intellectual property lawsuit in the Southern District of Indiana asserting infringement of U.S. Patent No. 7,772,209 (“the ‘209 patent”), which was filed with the U.S. Patent and Trademark Office.

This patent infringement lawsuit asserts unlawful behavior by two Defendants. Specifically, the complaint states that Dr. Reddy’s Laboratories, Inc. of Princeton, New Jersey is acting on behalf of Dr. Reddy’s Laboratories, Ltd. of Hyderabad, India in seeking approval to manufacture and sell a generic version of Lilly’s ALIMTA®, a chemotherapy agent used for the treatment of various types of cancer. Lilly further contends that the two Defendants are agents and/or alter-egos of one another.

Lilly states that unless Defendants are “enjoined from infringing the ‘209 patent, actively inducing infringement of the ‘209 patent, and contributing to the infringement by others of the ‘209 patent, Lilly will suffer irreparable injury.”

This lawsuit, filed by Indiana patent lawyers for Lilly, lists a single count: Infringement of U.S. Patent No. 7,772,209. Lilly seeks a declaratory judgment, equitable relief, damages, costs and attorneys’ fees.

January 28, 2016

Indiana Patent Law: Court Rules on Eighteen Disputed Terms in Patent Infringement Litigation

By Overhauser Law Offices, LLC

Indianapolis Indiana – Following a Markman hearing, Judge Sarah Evans Barker considered 18 disputed terms in five patents owned by Plaintiff Bonutti Research, Inc. of Effingham, Illinois and licensed exclusively to Plaintiff Joint Active Systems, Inc., also of Effingham, Illinois. Fourteen of the terms were construed. The court held that the remaining four needed no further construction.

The patents-in-suit are: U.S. Patent No. 5,848,979, U.S. Patent No. 7,955,286, U.S. Patent No. 7,404,804, U.S. Patent No. 7,112,179 and U.S. Patent No. 8,784,343, which had been issued by the U.S. Patent and Trademark Office. It is alleged that Defendant Lantz Medical, Inc. of Indianapolis, Indiana infringed those patents.

The following terms were construed by the court:

• “drive means” (construed in two different contexts)
• “a main gear which is connected with said first cuff means and is rotatable with said first cuff means relative to said base”
• “first extension member”
• “second extension member having an arcuate shape extending therefrom”
• “arcuate shape”
• “arcuate path”
• “travels along an arcuate path through the first extension member”
• “removably attachable to the finger”
• “curved path”
• “a first arm member for coupling to the first body portion and defining a curved path”
• “movable along the curved path”
• “operatively coupled”
• “drive assembly”

• “lockout element”

The court determined that no further construction was necessary for the following terms:

• “base”
• “gear means”
• “second gear is at least partially disposed in a recess in said base”

• “bending mechanism”

December 21, 2015

Indiana Trademark Litigation: Indiana Botanic Gardens Sues VitalMax Vitamins Alleging Infringing Use of “Accu-Hear”

By Overhauser Law Offices, LLC

Hammond, Indiana – Plaintiff Indiana Botanic Gardens, Inc. of Hobart, Indiana filed a trademark infringement lawsuit in the Northern District of Indiana alleging that Almark Products, Inc. d/b/a VitalMax Vitamins (“VitalMax”) of Delray Beach, Florida infringed its trademarked “ACCU HEAR”, U.S. Trademark No. 3,010,289, which has been registered with the U.S. Patent and Trademark Office.

Indiana Botanic allege that it has been in the business of processing, packaging and otherwise selling variety of herbal products for many years. It contends that it has done so under the ACCU HEAR trademark, which has been registered for use in connection with dietary supplements.

In this trademark litigation, Indiana Botanic accuses Defendant VitalMax of production, labeling, sale and offering for sale of a nutritional supplement offered under the name ACCU-HEAR. This term, Indiana Botanic states, is confusingly similar to Plaintiff’s ACCU HEAR trademark and will irreparably harm Plaintiff by diminishing the reputation and goodwill of that trademark. Indiana Botanic asserts that VitalMax infringed the ACCU HEAR trademark willfully and deliberately.

In this federal complaint, filed by a trademark attorney for Indiana Botanic, the following is alleged:

• Count I: Federal Trademark Infringement

• Count II: Unfair Competition Under Federal Law

The “Jurisdiction and Venue” section of this federal complaint lists additional claims – “state trademark infringement, injury to business reputation and dilution, deceptive trade practices, deceptive business practices and unfair competition under the laws of the State of Indiana” – but those claims were not included as separate counts.

Indiana Botanic seeks equitable relief along with damages, including punitive damages, costs and attorneys’ fees.

December 4, 2015

Federal Circuit Patent Law: Quality Control Testing Is Not Patent Infringement; Does Not “Make” a Product as Contemplated Under § 271(g)

By Overhauser Law Offices, LLC

Washington, D.C. – The United States Court of Appeals for the Federal Circuit heard a patent infringement lawsuit styled Momenta Pharms., Inc. v. Teva Pharms. USA Inc. on the issue of whether Defendants’ quality control procedures infringed the patent-in-suit. This appeal included a companion case, Momenta Pharms., Inc. v. Amphastar et al. Both cases were heard at the trial court level in the United States District Court for the District of Massachusetts by Judge Nathaniel M. Gorton.

Momenta was the first to market enoxaparin, an anticoagulant drug, in generic form. Momenta also owns U.S. Patent No. 7,575,886 (“the ‘886 patent”), which includes claimed methods designed to ensure that every batch of enoxaparin was of sufficient quality. Momenta asserted the ‘886 patent against other manufacturers, including Teva and Amphastar, which also wanted to bring a generic version of enoxaparin to market. It contended that Defendants’ quality-control measures infringed the ‘886 patent.

In this litigation, the United States District Court for the District of Massachusetts determined that patent infringement had not taken place, listing two separate grounds. First, the asserted claims were directed towards analyzing enoxaparin for the purpose of quality control, not manufacture of the drug, which did not amount to patent infringement. Second, the district court found that use of the analytical methods of the ‘886 patent were protected under the safe harbor provisions of 35 U.S.C § 271(e)(1). Momenta appealed.

Circuit Judges Dyk, Moore and Wallach of the Federal Circuit ruled on this appeal in November. Writing for the court, Judge Wallach affirmed the trial court’s ruling that Defendants Teva and Amphastar had not infringed the ‘886 patent, holding that infringement under 35 U.S.C. § 271(g) occurs when “making” a product and that quality-control testing, thus, did not constitute patent infringement.

The Federal Circuit vacated the district court’s judgment that the activities were also protected under the “safe harbor” provisions within § 271(e)(1) and remanded this issue to the district court for further inquiry.

November 12, 2015

Indiana Patent Litigation: USITC Begins Investigation at Request of Indianapolis-Based Plaintiff

By Overhauser Law Offices, LLC

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Washington, D.C. – The U.S. International Trade Commission (“USITC”) began an investigation under section 337 of the Tariff Act of 1930 regarding the importation and sale of blood cholesterol test strips that allegedly infringe a U.S. patent. The respondents are Jant Pharmacal Corp. of Encino, California; Infopia America LLC of Titusville, Florida and Infopia Co., Ltd. of the Republic of Korea.

In August 2014, Indiana patent attorneys for Plaintiff Polymer Technology Systems (“PTS”) of Indianapolis, Indiana sued respondents in the Southern District of Indiana alleging infringement of U.S. Patent No. 7,087,397, “Method for determining HDL concentration from whole blood or plasma,” which was granted by the United States Patent and Trademark Office. In the lawsuit filed in Indiana federal court, PTS also asserted that Defendants had violated the Lanham Act.

In October 2015, PTS filed a complaint with the USITC involving its point-of-care blood cholesterol testing meters, test strips, and systems containing the same naming the same three parties. PTS asks that the USITC issue an exclusion order and a cease and desist order.

No decision has yet been made on the merits of the USITC action. The matter will be assigned to an administrative law judge (“ALJ”), who will hold an evidentiary hearing. The ALJ will make an initial determination regarding whether there is a violation of section 337. That decision, in turn, is subject to review by the USITC, which then makes a final determination.

October 27, 2015

Indiana Intellectual Property Litigation: Roche Seeks Declaration of Non-Infringement of Meso’s Rights to ECL Technology

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Indiana intellectual property attorneys for Plaintiff Roche Diagnostics Corporation of Indianapolis, Indiana filed a lawsuit in the Southern District of Indiana asking for a declaration of non-infringement of rights to patented technology licensed to Defendant Meso Scale Diagnostics, LLC of Rockville, Maryland.

At issue in this patent-related lawsuit is the right to use patented Electrochemiluminescence (“ECL”) technology owned by BioVeris Corporation. ECL is a detection technology that uses electricity, chemistry and light to detect and measure the presence of specific molecules in a test sample. It is used to detect, monitor, and guide the treatment of disease and other conditions.

In 1995, BioVeris licensed its ECL technology to Defendant Meso. Under this license, Meso was granted an exclusive license to use ECL technology for certain limited purposes. BioVeris later entered licensing agreements granting Roche Diagnostics use of ECL technology. Meso contends that Roche Diagnostics’ use of BioVeris’ ECL technology constitutes a violation of the exclusive rights granted to Meso. Roche Diagnostics asserts that its use does not violate Meso’s rights under the Meso license and that, while Meso was not a party to the first agreement licensing the ECL technology to Roche Diagnostics, executed in 2003, Meso expressly consented to that entire agreement. A second agreement licensing the technology was executed between BioVeris and Roche Diagnostics in 2007.

In 2013, a related dispute between Miso and Roche Diagnostics in Delaware state court was resolved in favor of Roche Diagnostics after a five-day bench trial. That judgment was affirmed by the Delaware Supreme Court in June 2015. Roche Diagnostics claims that, this concluded lawsuit notwithstanding, Meso continues to assert that Roche Diagnostics’ activities infringe Meso’s rights and continues to threaten litigation.

Indiana patent lawyers for Roche Diagnostics filed this action for declaratory judgment seeking a judgment declaring that it has not infringed Meso’s license rights in the ECL technology. Roche also seeks an award of attorney’s fees and costs.

Practice Tip: Because the validity of the BioVeris’ patents is not in dispute, and because Roche Diagnostics concedes that some of its products include BioVeris’ patented ECL technology, BioVeris was not included as a party in this lawsuit.

October 12, 2015

Federal Circuit Law: Laches Preserved as a Defense to Patent Infringement

By Overhauser Law Offices, LLC

Washington, D.C. – The Court of Appeals for the Federal Circuit decided the matter of SCA Hygiene v. First Quality Baby Products, a case about adult incontinence products.

At issue in the case was the legal doctrine of “laches.” The laches doctrine penalizes a plaintiff who “sleeps on” his or her rights by waiting a long time to file a lawsuit after learning of a violation of those rights. Laches, an equitable defense, protects those who would be harmed by the assertion of those rights after a plaintiff’s delay. For example, in the case of a lawsuit asserting patent infringement, laches could work against a patent owner who saw an infringing product emerge in 2000 but waited until 2015 to sue, after a significant investment of time and resources had been put into the product.

The Federal Circuit had long recognized laches as a limitation on patent owners’ rights. But a recent Supreme Court case, Petrella v. MGM, called the doctrine into question. In Petrella, the Supreme Court held that laches was not a defense in copyright cases. Given the ruling in Petrella, the Federal Circuit opted to hear this litigation en banc to determine whether laches should still be a defense in patent cases.

The court held that the defense should be preserved. Proponents of laches in the patent-infringement context (see, e.g., Electronic Frontier Foundation‘s friend-of-the-court brief), contend that patent defendants and copyright defendants are in very different positions when it comes to defending against stale claims. Patent defendants, unlike their copyright counterparts, often defend themselves by showing that the patent owner’s claimed invention was obvious at the time of filing (thus making the patent invalid). But, by delaying a lawsuit, a patent owner can make it difficult for the defendant to find evidence of what people in the field knew about or would have found obvious back when the application was filed. This is especially true in the Internet age, those proponents argue. Websites are constantly rewritten. Software code gets lost or is not documented. In sum, without the defense of laches, patent owners can sit and wait for time to destroy the evidence that an alleged infringer needs to defend herself.

The decision came out 6-5, meaning five judges of the Federal Circuit think Petrella changed the availability of the doctrine of laches in both copyright infringement and patent infringement lawsuits. Given the closeness of the decision, this case may go to the Supreme Court.

This edited article was provided by the Electronic Frontier Foundation, a nonprofit group which advocates for innovators and users of technology. The article has been licensed under the Creative Commons Attribution License.

August 26, 2015

Indiana Patent Litigation: Court Permits Bonutti to Withdraw Counterclaim, Denies Attorneys’ Fees to Biomet

By Overhauser Law Offices, LLC

Hammond, Indiana – In the matter of Biomet, Inc. v. Bonutti Skeletal Innovations, LLC, the Northern District of Indiana, Hammond Division granted Defendant Bonutti’s motion to dismiss with prejudice its counterclaim. Bonutti’s counterclaim alleged that Biomet had infringed U.S. Patent No. 7,806,897 (the “‘897 patent”). Patent attorneys for Biomet Inc. asked the court to impose attorneys’ fees as a condition of the dismissal but this motion was denied.

On March 8, 2013, patent lawyers for Plaintiff Biomet filed an action for declaratory judgment against Bonutti Skeletal Innovations LLC. At issue were contentions of patent infringement of fifteen patents. Bonutti counterclaimed against Biomet and several other counterclaim Defendants. This multi-faceted dispute had been resolved with respect to some of the patents prior to this order. Other allegations of patent infringement remained.

Among the assertions by Bonutti that had remained was a counterclaim that Biomet had infringed the ‘897 patent. In this order, the court granted Bonutti’s request under Rule 41(a)(2) to dismiss this counterclaim with prejudice. The court also addressed Biomet’s contention that it should be awarded attorneys’ fees as a “prevailing party” in this portion of the patent litigation.

The court denied attorneys’ fees to Biomet on several grounds. First, it noted that, while attorney’s fees are available as part of a Rule 41(a)(2) dismissal without prejudice, this is justified as compensation for requiring a defendant to incur unnecessary litigation expenses. That same rationale does not apply where, as in this case, the dismissal is with prejudice.

Additionally, the court noted that any request for attorneys’ fees was premature. Such fees are only available to the “prevailing party” and Biomet had not established itself as such a prevailing party. Biomet may yet be able to recover attorneys’ fees if, at the conclusion of the patent lawsuit, Biomet is held to be the prevailing party.

August 10, 2015

Indiana Patent Litigation: Lilly Files New Lawsuit Alleging Patent Infringement of Alimta

By Overhauser Law Offices, LLC

Indianapolis, Indiana – An Indiana patent attorney for Eli Lilly and Company of Indianapolis,

Indiana, in conjunction with Washington, D.C. co-counsel, sued for patent infringement in the Southern District of Indiana. Lilly claims that Emcure Pharmaceuticals Ltd. of Pune, India; Heritage Pharma Labs, Inc. of East Brunswick, New Jersey; and Heritage Pharmaceuticals, Inc. of Eatontown, New Jersey, will infringe and/or have infringed Lilly’s patented “Novel Antifolate Combination Therapies,” U.S. Patent Number 7,772,209 (the “‘209 patent”), which has been issued by the U.S. Patent Office.

Plaintiff Lilly is in the business of, among other things, the manufacture and sale of various pharmaceuticals. Emcure Pharmaceuticals Ltd. is a generic pharmaceutical company engaged in developing, manufacturing and marketing a broad range of pharmaceutical products. Heritage Labs is believed to perform functions relating to Emcure’s active pharmaceutical ingredient as well as formulation research and development. Heritage Pharmaceuticals is thought to be engaged in the acquisition, licensing, development, marketing, sale, and distribution of generic pharmaceutical products for the U.S. prescription drug market on behalf of Emcure.

Alimta®, which is licensed to Lilly, is a chemotherapy agent used for the treatment of various types of cancer. The drug is composed of the pharmaceutical chemical pemetrexed disodium. It is indicated, in combination with cisplatin, (a) for the treatment of patients with malignant pleural mesothelioma, or (b) for the initial treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer.

Alimta is also indicated as a single-agent treatment for patients with locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy. Additionally, Alimta is used for maintenance treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. One or more claims of the ‘209 patent cover a method of administering pemetrexed disodium to a patient in need thereof that also involves administration of folic acid and vitamin B12.

This Indiana lawsuit for patent infringement, submitted to the court by an Indiana patent lawyer, was triggered by the filing by defendant Emcure Pharmaceuticals of an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration. In that ANDA, Emcure Pharmaceuticals seeks approval to manufacture and sell its pemetrexed for injection, 500 mg/vial product prior to the expiration of the ‘209 patent.

This patent litigation asserts a single count: infringement of U.S. Patent No. 7,772,209. Lilly asks for a judgment that Emcure has infringed the ‘209 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of the ‘209 patent; a judgment that use of the intellectual property currently covered by the ‘209 patent shall be protected until its expiration date; injunctive relief; attorneys’ fees and expenses; as well as other relief.