Media Mentions
2011
“Movers & Shakers: October 3, 2011”
The Deal Pipeline, October 3, 2011
Glenn Engelmann and Susan Lee were noted for recently joining McDermott Will & Emery’s Life Sciences Practice Group.
Glenn Engelmann, Susan S. Lee, Health, Life Sciences & Medical Products
“New Hires: Firm Adds to Life Sciences Practice”
Washington Post’s Capital Business, October 3, 2011
Glenn Engelmann and Susan Lee were recognized for joining McDermott Will & Emery’s Life Science Practice Group. Both lawyers' photos were included with the story.
Glenn Engelmann, Susan S. Lee, Health, Life Sciences & Medical Products
“Power Circuit”
Washingtonian, September 28, 2011
Glenn Engelmann (former general counsel at AstraZeneca Pharmaceuticals) and Susan Lee were noted as new Washington office members of McDermott’s Life Sciences practice.
Glenn Engelmann, Susan S. Lee, Health, Life Sciences & Medical Products
“AstraZeneca GC Engelmann Jumps to McDermott Will”
Blog of Legal Times, September 27, 2011
Glenn Engelmann, now Life Sciences senior counsel with McDermott in Washington, formerly was the top counsel for leading pharmaceutical company AstraZeneca, where he advised company leadership on a variety of legal and regulatory matters. Associate Susan Lee, who joins him in the Life Sciences practice, has a strong background in matters involving the Food & Drug Administration and clinical trials.
Glenn Engelmann, Health, Life Sciences & Medical Products
“AstraZeneca GC Joins McDermott’s Life Sciences Group”
Law360, September 27, 2011
Glenn Engelmann, former general counsel at AstraZeneca Pharmaceuticals, joined the Life Sciences practice in McDermott’s Washington office. Mr. Engelmann said he was “drawn to McDermott’s multidisciplinary and coordinated approach to life sciences.” His experience handling regulatory investigations and patent litigation was praised by Stephen Bernstein, who said that Englemann knows “firsthand the concerns and motivations that drive our clients.” Also joining the Washington Life Sciences practice was associate Susan Lee, who will focus on regulatory compliance and public policy matters.
Stephen W. Bernstein, Glenn Engelmann, Susan S. Lee, Health, Life Sciences & Medical Products
“Seed Capital: Beyond Angels And VC”
Life Science Leader, January 2011
Paul DeStefano said about the trend of venture funding that “the United States is seeing more tranches than in the past.” Mr. DeStafano noted that “foundations are applying their [venture] funds differently than in the past,” making larger, but fewer, grants. He added that one of his life science clients just received a family foundation grant that funds all clinical trials up to $50 million.
Paul R. DeStefano, Life Sciences & Medical Products, Life Sciences - Corporate
2010
“Expanding Practice to Provide Integrated Cancer Care”
Journal of Oncology Practice, November 2010
Daniel Gottlieb discussed a federal commission that is preparing recommendations regarding referrals for radiation therapy within a multi-specialty group practice. He stated that an outright prohibition of such referrals would be unlikely, because “many of the country’s leading physician groups would be forced to reorganize into separate single-specialty practices or disband.” Other options could involve greater clinical integration, or adjusted Medicare reimbursement. Mr. Gottlieb said the complexity of the issue could mean that the commission’s recommendations could be delayed until 2011.
Daniel F. Gottlieb, Health, Health Care Law Reform, Life Sciences & Medical Products
Christopher Jedrey was quoted by The Wall Street Journal (August 16) in a story on increased private equity investments in the health care sector. Citing the fragmentation among health care providers when compared to insurers, Mr. Jedrey said acquisitions and other forms of consolidation show that the “provider side is bulking up to catch up with the payer side.” He added that private equity mergers and investments will help providers make technology investments and other performance enhancements required by the health reform law, such that the recent increase in consolidation is an “intensification of an existing pattern” toward cost saving.
Christopher M. Jedrey, Health, Hospital and Health System Transactions, Life Sciences & Medical Products
Eric Gordon’s appointment as new head of McDermott’s Los Angeles office was covered by The Recorder on June 2. He will be the fourth lawyer to lead the office since it opened in 1987, and he adds his new responsibilities to those as partner-in-charge of the Firm’s California health law practice and national co-chair of McDermott’s Academic Medical Center practice. “I’ll still have a full-time practice,” Mr. Gordon also noted, one that focuses on fraud, abuse and compliance issues and on health care transactions.
Eric B. Gordon M.D., Health, Life Sciences & Medical Products
Daniel Melvin and Christopher Jedrey discussed in Healthcare Finance News (May 11) how the new health care reform law could impact consolidation in the provider sector. Mr. Melvin noted that “all of the costs and [provider] pay cuts” in the law "are going to change the rules of the game. Health reform is likely to mean the acceleration of consolidation." Mr. Jedrey stated that the law’s extension of coverage to millions more people means that "cost control will follow." This will spur consolidation, he said, because "the healthcare provider market is currently fragmented, causing duplications of overhead and services, creating more costly and sometimes sub-optimal care." Mr. Jedrey expects that physician groups and solo practices are less likely to be able to handle consolidation, to which Mr. Melvin added, "[W]e’re going to see clinical integration in healthcare, rather than full integration."
Christopher M. Jedrey, Daniel H. Melvin, Health, Life Sciences & Medical Products
Eric Zimmerman commented for Modern Healthcare (May 3) on the health care reform law’s provision that enables hospitals to purchase discounted outpatient drugs through a government program, but that does not include an inpatient drug provision. “It’s not a hassle-free program,” he said, because “hospitals will need to take steps to ensure compliance,” such as separating outpatient and inpatient drug purchases. “This brings administrative challenges and complications,” he noted. However, Mr. Zimmerman added, because the program as a whole benefits hospitals, “there continues to be a great deal of interest in expanding inpatient drugs to the program. It’s appealing to large numbers of members in the House. It will certainly get another hearing.”
Eric Zimmerman, Health, Life Sciences & Medical Products
Paul Radensky and T. Reed Stephens were interviewed on April 16 by BNA’s Daily Health Care Report concerning the impact of the health reform law on the life sciences industry. Mr. Radensky discussed the greater opportunities for drug and medical device makers through the bill’s national long-term care insurance program and its mandated coverage for routine care in clinical trials. However, he also cited cost pressures that the industry will face both from health care providers and from an independent advisory board that will set Medicare reimbursement rates. Mr. Stephens noted that fees and taxes in the bill also will have a negative impact on life sciences companies. He singled out as examples the pharmacy benefit manager provision on the pricing of generic drugs, the required annual fee on dispensing brand-name drugs, and the new tax on medical device manufacturers.
Paul W. Radensky M.D., T. Reed Stephens, Health, Life Sciences & Medical Products, Life Sciences - Health
Eric Zimmerman spoke to BNA Health Care Daily Report on April 1 regarding a new Centers for Medicare and Medicaid Services (CMS) rule for reimbursement of ambulatory surgery centers (ASCs). The rule was intended to raise ASC reimbursement closer to that of hospital outpatient procedures, but Mr. Zimmerman said ASCs will still be paid only 62 percent of the hospital rate for the same procedure. In addition, some 350 procedures are subject to an ASC payments cap, which Mr. Zimmerman says means “there’s not a lot of payment incentive” to perform the procedures in an ASC. He that the new health care reform law requires CMS to work with ASCs on how to incorporate value-based purchasing (VBP) into ASC procedures, but “there’s no telling” if VBP will become a requirement for ASCs. “Congress is taking it one step closer,” he added.
Eric Zimmerman, Health, Life Sciences & Medical Products
William Gaede was quoted in a March 30 Law360 story about the potential negative impact on the biotechnology industry of a federal judge’s ruling that invalidated patents on two genes linked to breast and ovarian cancer because they involve DNA as it is found in nature. Mr. Gaede, who filed an amicus brief in the case for a coalition of diagnostic companies, expressed concern about the ruling’s impact on life sciences investors. “The incentive to invest in diagnostic and biologic companies rests on certainty in patent law,” he said. “This decision will create uncertainty in investors’ minds as to whether the business models of certain companies are sustainable under the patent laws.”
William Gaede, Intellectual Property, Life Sciences & Medical Products, Life Sciences - IP
Eric Zimmerman told Modern Healthcare on January 25 that he is “still confident that healthcare reform will be enacted. It’s too much of a priority for the administration, and Congress hasn’t sunk this much time into it” for it to fail. Mr. Zimmerman said he believes that House consideration of the Senate’s reform bill “remains the only possible pathway to getting reform done,” adding that he expects President Obama’s State of the Union address will give House members an incentive to vote for the Senate bill. “I think that the Democrats will realize that it is less desirable to do nothing, even if enacting health reform is not universally popular,” Mr. Zimmerman stated. Click here to view the full article.
Eric Zimmerman, Health, Life Sciences & Medical Products
AmLaw Daily interviewed Eric Zimmerman (January 21) regarding the prospects for passage of health reform legislation. "I'm very confident that health care reform will be enacted," he declared. "The question is what will it look like, and when will it be enacted." He based his belief on the effort expended on the legislation to date: "Health care reform...has consumed a great deal of time, attention and resources from Congress and the administration for the past year...at the expense of other issues, like the economy and jobs." Saying he did not "think it's likely" that reform will have bipartisan approval, Mr. Zimmerman stated that Democratic leadership will "figure out its strategy and pursue one." He added that McDermott will "help businesses navigate these shoals" once reform is passed.
Eric Zimmerman, Health, Life Sciences & Medical Products
Paul DeStefano discussed the current initial public offering (IPO) environment for biotech and life sciences companies in a January 18 Boston Business Journal story. He noted that the industry has become more stratified and that more individualized criteria are being used to evaluate the IPO opportunities for medical device, therapeutics and other life science companies. By contrast, Mr. DeStefano said, “There used to be literally a checklist. If you had validation from one corporate partnership and, let’s say, a license to Japanese rights for the lead drug, you could count on an IPO of at least $90 million to $120 million.”
Paul R. DeStefano, Life Sciences & Medical Products
Paul DeStefano was mentioned in a January 4 National Law Journal feature on significant new law firm lateral hires. Mr. Stefano joined McDermott’s Menlo Park office as a member of the Health Industry Advisory and the Life Sciences & Medical Devices Practice Groups. He will counsel companies in the biotech-pharmaceutical sector on strategic planning, company formation, financing and operations.
Paul R. DeStefano, Health, Life Sciences & Medical Products
Reed Stephens told Law360 on January 1 that Bates and Patrick v. Unnamed Defendant will be a particularly important health law case in 2010. The case involves a nationwide Department of Justice investigation into false Medicare claims for kyphoplasty spinal surgery, and Mr. Stephens said that it “highlights the real risk associated with the relationship between pharmaceutical and device manufacturers and hospitals and doctors.” He added that providers must be able to prove that the procedures they bill for are medically necessary. Mr. Stephens represents a provider client in a similar case, which he sees either moving toward a “reasonable” resolution or to trial if the government is too aggressive.
T. Reed Stephens, Health, Health Care Litigation, Life Sciences & Medical Products, Trial
2009
Paul DeStefano was cited by Biotech Business Week on December 14 for joining McDermott’s Silicon Valley office as a partner. Calling Mr. De Stefano “one of the nation’s elite attorneys in the biotech industry,” the article noted that he will provide guidance on the formation, financing and operations of companies in the biotech-pharmaceutical sector.
Paul R. DeStefano, Health, Life Sciences & Medical Products
Paul De Stefano was mentioned in numerous media outlets on December 2 and 3 as he joined the Health Industry Practice Group and Life Sciences & Medical Devices practice at McDermott’s Silicon Valley office. Mr. De Stefano will focus on strategic planning and legal representation in the formation, financing and operation of biotech and pharmaceutical companies. Coverage appeared in (among others) Intellectual Property Today, BusinessWeek.com, Bizz.Yahoo.com, Law360, National Law Journal, Law.com, USA Today, The Recorder, LawFuel.com and Biovalley.
Paul R. DeStefano, Health, Life Sciences & Medical Products
Shelia Walcoff is quoted in a September 30 Genomeweb.com story concerning a California bill seeking to legally set apart consumer genomics firms from clinical laboratories. Ms. Walcoff believes that the language in SB 420 could have implications for the bioinformatics field. As she noted, consumer genomics “is a new industry, and should California statutorily define and regulate it in a new or different manner, it could, at least at the state level, have an unanticipated impact on the regulatory requirements for the broader bioinformatics industry.”
, Government Strategies, Life Sciences & Medical Products
Robert Nicholas analyzed the Seventh Circuit's decision in U.S. v. Farinella in a May 8 Washington Legal Foundation Legal Opinion Letter. The decision held that the Food & Drug Administration cannot merely rely on its own assertion and opinion when claiming that food or drug labeling is misleading and in violation of the law. Mr. Nicholas concluded that "one can make a compelling argument based on Farinella that . . . both the [Food & Drug] Act and the Constitution demand more than an assertion by the FDA about what something means . . . without any authoritative support whatsoever."
, Health, Life Sciences & Medical Products, Life Sciences - Health
Robert Nicholas analyzed the U.S. Seventh Circuit's decision in United States v. Farinella for Health Lawyers Weekly (April 24). The decision rejected the Food & Drug Administration's assertion that "misleading" product labeling violates the "misbranding" provisions of federal law. Although the case related to a food product, Robert noted that it has "significant potential applications" for prescription drug and medical device advertising and promotion, where "the FDA often relies only on its own expertise in deciding what meaning to ascribe to otherwise ambiguous and undefined representations."
, Health, Life Sciences & Medical Products, Life Sciences - Health, Life Sciences - Medical Products & Technology
Kate Feola was quoted in ePharmaceuticals (April 2009) about the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct regulations. Pharmaceutical and medical device companies must annually disclose to the Massachusetts Department of Public Health any payment or economic benefit with a value of at least $50 made for sales or marketing. Ms. Feola said that the disclosure requirements are not new to pharmaceutical companies. However, Ms. Feola said that Massachusetts is the first state to require financial disclosure by medical device companies which will increase compliance challenges facing the manufacturers. "Device manufactures have never had to think through what systems, whether manual or electronic, are necessary to ensure the company is accounting for all of the expenses that must be reported to the state, what accounts are those expenses coming from, and to whom they are being paid."
, Health, Life Sciences & Medical Products, Life Sciences - Health, Life Sciences - Medical Products & Technology
Robert Nicolas was quoted April 3 in Dickinson's FDA Webview concerning the Seventh Circuit Court of Appeals reversal in a jury conviction of a food manufacturer for misbranding food. The conviction had hinged on the FDA's unfounded assertion that a "best when purchased by" date was the same as an "expiration date" that could raise freshness or safety concerns for consumers. The attorney said that the FDA's interpretation lacked empirical support about the term's meaning, and added: "Surely the First Amendment demands at least some reliable extrinsic evidence . . . before FDA can simply assert, in the absence of any otherwise controlling authority, that consumers comprehend ambiguous advertising and labeling claims in the way the agency alleges."
, Health, Health - Product Regulation, Life Sciences & Medical Products
T. Reed Stephens was quoted in a March 30 story in The National Law Journal concerning letters about marketing practices sent by the Food & Drug Administration (FDA) to pharmaceutical companies. State attorneys general increasingly use the letters to sue those companies for false advertising. Mr. Stephens urged companies who receive such letters to assess their marketing practices for compliance problems, adding that "[w]hen you get this type of regulatory action from the FDA that's public, you do need to take proactive measures to better understand what's going on under the hood of your car."
T. Reed Stephens, Government Strategies, Health, Life Sciences & Medical Products, Life Sciences - Health
Eric Zimmerman was extensively quoted in BNA's Daily Health Care Reporter on March 30 regarding final rules for the Centers for Medicare and Medicaid Services (CMS) to reimburse ambulatory service centers (ASCs). Mr. Zimmerman said the new rules "are really shaking up the industry" by more closely aligning ASC reimbursement with hospital outpatient surgical services. However, because of statutory budget constraints, CMS pays ACSs considerably less than hospitals. "It's outrageous to think that ACSs can furnish procedures for that little money," Mr. Zimmerman stated. ACSs seeking reimbursement must also submit quality and performance data, but Mr. Zimmerman noted that "there is no indication" that CMS will adopt industry suggestions for what this data should contain.
Eric Zimmerman, Health, Life Sciences & Medical Products, Reimbursement/Fraud & Abuse
William Gaede was quoted in a detailed BNA Life Sciences Law and Industry March 27 report on the impact that bills introduced in Congress to "reform" the patent law system could have on life science/medical device companies. He focused specifically on the reasonable royalty measure of damage provisions for infringement in the pending S. 515, saying that they "put a level of rigidity into the analysis that ultimately may fail to capture the value of patent contributions to the overall value of infringing product or process." He noted that a patented composition or process "may be a small component of a product, but without that composition or process the product may not be operable, have sufficient value, or even be able to be produced," and that by not giving them due weight S. 515 may “potentially encourage infringement."
William Gaede, Intellectual Property, Life Sciences & Medical Products, Life Sciences - IP
William Gaede was quoted in the March 27 BNA Life Sciences Law and Industry regarding the Federal Circuit Court of Appeals decision in Tafas v. Doll. The decision upheld several new Patent & Trademark Office rules intended to limit the number of an applicant's requests for continued examinations and the number of independent claims. Mr. Gaede observed that Tafas struck down Rule 78, which limited continuations to two, but upheld Rule 75, which limits independent claims and total claims to five and 25 respectively. "The limits on the number of claims and the practical effect that subject matter will have to be pursued in continuations to obtain comprehensive coverage will delay the ability of an entity to obtain comprehensive coverage," he said, and because of that delay "a cloud could be put on the financing efforts" to monetize or license patents, since investors cannot be confident a patent will be granted.
William Gaede, Intellectual Property, Life Sciences & Medical Products, Life Sciences - IP, Life Sciences - Medical Products & Technology
Robert Nicholas and Sheila Walcoff's article, "President Obama Announces FDA Commissioner and Deputy Commissioner Appointments" was mentioned in a March 17 story by Dickinson's FDA Webview.
, Health, Life Sciences & Medical Products, Life Sciences - Health
Stephen Bernstein was quoted in the February 10 issue of Health Law360 in an authored article discussing IMS Health Inc. v. Ayotte.
Stephen W. Bernstein, Health, Life Sciences & Medical Products, Life Sciences - Health
Stephen Bernstein was quoted in the January 30 issue of the Washington Legal Backgrounder in an authored article discussing IMS Health Inc. v. Ayotte.
Health, Life Sciences & Medical Products, Life Sciences - Health
2008
Robert Nicholas and Paul Radensky’s article "FDA and Drug Advertising: No Attention Deficit On Nooed For 'Substantial Evidence'" appeared in the November 7 issue of the Washington Legal Foundations' Legal Backgrounder.
Paul W. Radensky M.D., Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott's On the Subject "FDA Challenges Implied Outcomes Claims For Several ADHD Products: An Analysis" was featured in the October 17 issue of Health Lawyers Weekly.
, Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott's On the Subject "FDA Confirms Its View on Generic Drug Label Carve-Outs" was featured on October 9 in Health Law360.
, Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott Will & Emery's White Paper entitled "FDA Challenges Implied Outcomes Claims for Several ADHD Products: An Analysis" was featured in the Guest Column on October 3 in Health Law360.
Paul W. Radensky M.D., Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott was mentioned in the October 2 issue of FDA's Webview in an article regarding the Firm's On the Subject discussing the letters issued by the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing, Advertising, and Communications alleging that promotional material for certain products intended for use in treating attention deficit hyperactivity disorder (ADHD) made implied claims about an effect on ADHD "outcomes" that were not supported by "substantial evidence." FDA Webview notes, "Attorneys at McDermott...say FDA's Warning Letters and notices of violation to several manufacturers of ADHD drugs mean that drug companies wanting to avoid a challenge from CDER's Division of Drug Marketing, Advertising, and Communications (DDMAC) should review ad and promotional materials in all therapeutic categories to determine whether they make implied outcomes claims of the kind alleged by DDMAC in the ADHD letters."
Paul W. Radensky M.D., Conflicts of Interest - Health, Health, Life Sciences & Medical Products, Life Sciences - Health
Robert H. Underwood was mentioned in the September issue of Intellectual Property Today in an article regarding his move to McDermott. Mr. Underwood joins the Firm as a partner in the Intellectual Property, Media & Technology Department and the Life Sciences & Medical Devices Practice Group.
Robert H. Underwood Ph.D., Intellectual Property, Life Sciences & Medical Products
Robert Nicholas was mentioned in the September 2008 issue of Innsight Industry Newsletter in an article discussing the FDA's view on generic drug-label carve outs.
, Health, Life Sciences & Medical Products, Life Sciences - Health
Mark J. Mihanovic was quoted on September 18 by the San Francisco Chronicle in an article regarding Bay Area leaders' financial forecasts for the nation's economy. "Certainly it's my perspective that the current crisis is quite significant. That, ultimately, to the extent it doesn't resolve quickly, will have an impact on life sciences companies. Up until now, I think the life sciences industry, particularly in Northern California, has been somewhat insulated from some of the credit crunch troubles that have been problematic for other parts of the economy," said Mr. Mihanovic.
Mark J. Mihanovic, Life Sciences & Medical Products, Markets Restructuring
Robert H. Underwood was mentioned in the September 8 issue of The National Law Journal in an article regarding his recent move to McDermott. Mr. Underwood is a partner in the Boston office and a member of the Firm's Intellectual Property, Media & Technology Department and Life Sciences Practice Group.
Robert H. Underwood Ph.D., Intellectual Property, Life Sciences & Medical Products
Bernadette Broccolo was quoted in the September 8 issue of The National Law Journal regarding McDermott's relationship with the medical device trade group, Advanced Medical Technology Association (AdvaMed). "The seminars are technically AdvaMed's, but the relationship gives the firm exposure to the hundreds of device companies, large, medium and small, that are members of AdvaMed," said Ms. Broccolo.
Bernadette M. Broccolo, Health, Life Sciences & Medical Products, Life Sciences - Health
Robert H. Underwood was mentioned in the August 11 issue of the Boston Business Journal in an article regarding his move to McDermott. Mr. Underwood is a member of the Firm's Intellectual Property, Media & Technology Department and the Life Sciences & Medical Devices Practice Group.
Robert H. Underwood Ph.D., Intellectual Property, Life Sciences & Medical Products
John M. Callahan was mentioned in the June 23 issue of PR-inside.com regarding McDermott’s legal counsel to EyeCyte, Inc. in the company’s Series A funding through an agreement with Pfizer. Under the terms of the deal, Pfizer has invested $3 million in Series A Preferred shares of EyeCyte, a company that believes to have developed a way to isolate and use stem cells to cure macular degeneration, retinopathy and other leading causes of blindness in the world. Mr. Callahan provided legal services to EyeCyte supporting this arrangement.
John M. Callahan, Health, Life Sciences & Medical Products, Life Sciences - Health
John M. Callahan was mentioned in the June 23 issue of Forbes.com regarding McDermott’s legal counsel to EyeCyte, Inc. in the company’s Series A funding through an agreement with Pfizer. Under the terms of the deal, Pfizer has invested $3 million in Series A Preferred shares of EyeCyte, a company that believes to have developed a way to isolate and use stem cells to cure macular degeneration, retinopathy and other leading causes of blindness in the world. Mr. Callahan provided legal services to EyeCyte supporting this arrangement.
John M. Callahan, Health, Life Sciences & Medical Products, Life Sciences - Health
Robert Nicholas was quoted in the April 2008 issue of Medical Marketing and Media regarding scientific 'free speech' being threatened. "Calls for an investigation into support for the American Heart Association (AHA) and American College of Cardiology stating are likely to convince other scientific groups not to speak out on issues of public concern," Mr. Nicholas said.
, Health, Life Sciences & Medical Products, Life Sciences - Health
Mark J. Mihanovic was quoted on April 22 by the San Francisco Chronicle in an article regarding the fall in venture investment in start-ups in the first quarter of 2008. The article specifically discusses the impact in Silicon Valley despite its unique market. "The dynamics of Silicon Valley are different from elsewhere in the country because it has so many life sciences and technology companies that can merge with each other for strategic gain and wait out tough times," said Mr. Mihanovic. He continues, "If we had a more vibrant market, even an average market, I'd be doing two or three (life sciences) IPOs right now."
Mark J. Mihanovic, Corporate, Emerging Companies/Venture Financing, Life Sciences & Medical Products
Stephen W. Bernstein and Jennifer S. Geetter were quoted in the February 1 issue of Mass High Tech in an article regarding the state of Massachusetts funding stem cell research. "States see it as a hot new thing, and that's debatable. But in Massachusetts we have all the raw expertise and can use legislation to springboard what's already here," Mr. Bernstein said. "State programs can clarify legal aspects. It's an opportunity for states to clear up any state regulations which may impede stem cell research. State privacy laws are a patchwork, and you can get tangled in ways the legislation didn't intend," Ms. Geetter said.
Stephen W. Bernstein, Jennifer S. Geetter, Health, Life Sciences & Medical Products, Life Sciences - Health
2007
William Gaede was quoted in an October 23 article published by IP Law360 regarding a federal jury's ruling that Amgen Inc.'s patents were infringed by Roche Holding AG's generic drug Mircera. Mr. Gaede represented Amgen in the case along with others from McDermott. "We're thrilled with it…It's a terrific victory for Amgen," Mr. Gaede commented.
William Gaede, Intellectual Property, IP Litigation, Life Sciences & Medical Products, Life Sciences & Medical Products Litigation, Life Sciences - IP
Stephen Bernstein was quoted in the April 30 issue of The National Law Journal on law firms' involvement in the BIO conference in Boston. Mr. Bernstein mentioned the Firm's involvement in the conference as chairs of panel discussions, "We have gone for the substance of what the conference is about," and he also mentioned the Firm's evening reception.
Stephen W. Bernstein, Health, Life Sciences & Medical Products
2006
Stephen Bernstein was quoted by the Boston Business Journal on December 4 in an article regarding the growth of Boston's top five venture capital-backed pharmaceutical start-up companies. "In Massachusetts, part of the reason this sector is hot is that there is good clustering of companies, academia and capital," Mr. Bernstein said. "The markets are doing quite well and there's a lot of capital chasing a number of companies positioned in that three-to-five-year window when return is expected."
Stephen W. Bernstein, Health, Life Sciences & Medical Products
Joan Griffin was quoted in The Boston Globe on December 4 in regard to a trademark dispute between Lunesta and Tharos Laboratories, Inc. "In the old days, you'd say a logo didn’t really matter, because these things are prescribed by doctors," commented Ms. Griffin. "But if they're advertising it on TV, they're aiming it at consumers, and the logo matters." She continued and said Tharos could face a tough road proving that a big green moth is causing confusion with its blue butterfly.
, Intellectual Property, Life Sciences & Medical Products
William Gaede was recognized in American Lawyer's (February 2006) "Star Laterals of the Year" as one of the 10 most significant lateral moves in the United States in 2005.
William Gaede, Intellectual Property, Life Sciences & Medical Products
2005
Mauricio Flores was quoted in The Wall Street Journal on June 14 in regard to the U.S. Supreme Court's decision, vacated and remanded, in Merck KGaA v. Integra LifeSciences (03-1237), in which Mauricio argued before the Court on behalf of Integra. Mauricio was also quoted in the Associated Press, Law.com, Washington Post,Los Angeles Times, The New York Times, San Diego Union-Tribune and San Francisco Daily Journal.
, Intellectual Property, IP Litigation, Life Sciences & Medical Products, Life Sciences - IP, Trial
Mauricio Flores was quoted in the June issue of Corporate Legal Times in an article reporting on Merck KGaA v. Integra LifeSciences, et al. which was argued before the U.S. Supreme Court this spring. Integra argued that Scripps was conducting research for a lot of commercial reasons unrelated to a FDA application. "We think that the evidence show that what was going on at Scripps was not FDA related, that they were just trying to come up with some FDA justification after the fact," commented Mr. Flores, who argued the case before the Supreme Court on behalf of Integra. "They were doing it to generally strengthen the scientific premise of Merck's drug program. The premise is that if you inhibit a particular receptor with anything, whether its' an RGD peptide or something completely different, you can inhibit the growth of blood vessels. So that's a non-FDA related purpose."
, Intellectual Property, IP Litigation, Life Sciences & Medical Products, Life Sciences - IP
Mauricio Flores was quoted in the April 21 issue of the San Diego Union-Tribune in regard to representing Integra LifeSciences before the U.S. Supreme Court.
, Intellectual Property, IP Litigation, Life Sciences & Medical Products, Life Sciences - IP
Cathryn Campbell was quoted in the New York Times on April 19 and the Boston Globe and Los Angeles Times on April 20 regarding our representation of Integra LifeSciences in Merck RGaA v. Integra Life Sciences before the U.S. Supreme Court.
, Intellectual Property, IP Litigation, Life Sciences & Medical Products, Life Sciences - IP
Mauricio Flores was quoted, "Justices to Review Patent Safe Harbor," an article that appeared in the April 11 issue of The National Law Journal regarding Merck KGaA v. Integra LifeSciences. Mr. Flores commented on the case which is scheduled to be argued before the U.S. Supreme Court on April 20. The article examined the Merck case and questioned "how far down the chain of research and experimentation into new drugs does a federal safe harbor statute reach to protect drug manufacturers from liability for patent infringement."
, Intellectual Property, IP Litigation, Life Sciences & Medical Products, Life Sciences - IP
Cathryn Campbell and Mauricio Flores were quoted in the April 1 issue of San Diego's The Daily Transcript in the article, "Patent disputed leads local law firm to the U.S. Supreme Court." Mr. Flores will present the case for Integra LifeSciences, which is charging Merck KGaA with patent infringement. Mr. Flores states, "it's always exciting to argue something in front of the highest court in the land, especially something this important." Dr. Campbell notes that "this is a very important case and it's been recognized as such," and "everyone from big pharmaceutical companies and biotech firms to bar associations and law professors will be watching the proceedings."
, Intellectual Property, IP Litigation, Life Sciences & Medical Products, Life Sciences - IP
2004
Judith Toffenetti was quoted in the December 10 issue of The Miami Herald regarding ways a company might stretch the life of patent or created new patents for older drugs. Ms. Toffenetti said different crystal forms, different dosage forms, molecular variations on the drugs and combinations of drugs are among the ways to extend the life of a drug.
Judith L. Toffenetti Ph.D., Intellectual Property, Life Sciences & Medical Products, Life Sciences - IP
Cathryn Campbell was quoted in the November 2004 issue of California Lawyer in regard to the success of the biotech industry, now exceeding $39 billion and the success is due in large part to the amount of litigation. Cathryn Campbell states, "[V]irtually every product that's come out of biotech has been the subject of a lawsuit." "Those lawsuits have included everything from infringement to inventorship to licensing to whether royalties have been sufficient." Cathryn Campbell explains how much of the litigation stems from the early licensing agreements and how the royalty base is effected. She concludes that "[E]ven though we're getting more sophisticated, there will be a lot of disputes, because of the amount of money at stake and the difficulty of writing prospective licenses...."
, Intellectual Property, Life Sciences & Medical Products, Life Sciences - IP
Global Counsel 3000 (Practical Law), a law-related resource site, recently recommended MWE's Miami office as a top firm for Company and Corporate Transactions, where the office is a leader in health care transactions. In addition, Paul Radensky was recommended nationally for his work in the Life Sciences/Regulatory area.
Paul W. Radensky M.D., Corporate, Life Sciences & Medical Products
2003
McDermott Will & Emery was mentioned in the August 2003 issue of Intellectual Property Today for successfully representing Burnham Institute and Integra LifeSciences, by obtaining a significant victory related to patent infringement in the context of biomedical research.
Intellectual Property, IP Litigation, Life Sciences & Medical Products, Life Sciences - IP
Peter Resnik was quoted in Mass High Tech on June 16 in regard to life sciences companies that have been threatened as plaintiff attorneys are winning huge settlements against these pharmaceutical and biotech companies. "The tort system seems out of control. The amount that some juries are awarding is totally out of proportion," commented Mr. Resnik.
Peter L. Resnik, Life Sciences & Medical Products, Trial
Cathryn Campbell was quoted in the April 11 issue of the Boston Business Journal regarding how companies merge their intellectual property during a corporate merger or acquisition. "Often, firms merge to get the intellectual property, particularly in the biotech and pharmaceutical industry." Ms. Campbell continued, "Before the merger, they were in essence competitors; now they own the competing technologies. You have two companies working in the same field, or they're working to find treatments for the same disease, and they'll realize by combining technologies and approaches they're in a better position to tackle that."
, Intellectual Property, Life Sciences & Medical Products, Life Sciences - IP
McDermott Will & Emery was mentioned in the April 1 issue of Managing Intellectual Property regarding the addition of the 10-strong biotech IP boutique Campbell & Flores.
, Intellectual Property, Life Sciences & Medical Products
McDermott Will & Emery was mentioned in the April issue of Intellectual Property Today regarding the acquisition of Campbell & Flores, a San Diego-based biotechnology intellectual property law firm.
, Intellectual Property, Life Sciences & Medical Products
McDermott Will & Emery was mentioned in the March 4 issue of San Diego Daily Transcript in regard to adding 10 lawyers and professionals from Campbell & Flores, a San Diego-based biotechnology intellectual property law firm.
, Intellectual Property, Life Sciences & Medical Products, Life Sciences - IP
McDermott Will & Emery was mentioned in the February 10 issue of the Global Competition Review in regard to advising Centerpulse on the sale of its heart valve entity, Carbomedics, to Snia S.p.A.
Antitrust & Competition, Life Sciences & Medical Products, Mergers & Acquisitions
Thomas Weinberger, Todd Garvelink, Toby Kusmer, Daphne Trotter, Robert Nicholas, Felise Feingold, Jason Ment, Michael Serafini, Eric Halverson and Nathan Beaver were mentioned as the McDermott legal team advising Centerpulse's Carbomedics in its acquisition by Snia S.p.A. in the January 6 issue of the New Jersey Law Journal.
Life Sciences & Medical Products, Mergers & Acquisitions
McDermott Will & Emery was mentioned as counsel for Centerpulse in its sale of Carbomedics to Snia S.p.A. in the January 5 issues of Medical Devices & Surgical Technology Week and Heart Disease Weekly.
Life Sciences & Medical Products, Mergers & Acquisitions
McDermott Will & Emery was mentioned as counsel for Centerpulse in its sale of Carbomedics to Snia S.p.A. in the January 1 issue of Biotech Week.
Life Sciences & Medical Products, Mergers & Acquisitions
2002
Peter Resnik and McDermott Will, and Emery's Life Science Litigation Practice was profiled in "Biotech's Warrior," a feature article that appeared in the Boston Globe on Wednesday, October 16, 2002. The article, which appeared on the front page of the Business Section profiled Peter's biotech litigation work, including Fen-Phen and StarLink.
Peter L. Resnik, Life Sciences & Medical Products, Trial
McDermott Will & Emery was mentioned in the July 8 issue of Crain's Chicago Business in regard to adding professional staff to advise on specific issues. It was mentioned that McDermott has hired nurses for pharmaceutical clients and a canon lawyer/nun for Catholic hospital clients.
Catholic Organizations, Health, Life Sciences & Medical Products
Stephen Bernstein was quoted in the May 7 issue of InfoWorld Daily News in regard to how biotechnology companies are preparing for the HIPAA deadline. According to Mr. Bernstein HIPAA has not been a top priority. "For the most part, biotechnology companies are not covered entities, but there area number of hidden traps and pitfalls, where some companies may be covered entities or hybrids," he commented.
Stephen W. Bernstein, Health, HIPAA, Life Sciences & Medical Products
Cathryn Campbell was honored by UCSD Athena, an organization that unites women executives in high tech and life sciences companies and the firms that support them, receiving the organization's Individual Pinnacle Award in the service category in April 2002. Click here to reed the USCD Athena press release.
, Intellectual Property, Life Sciences & Medical Products, Life Sciences - IP
Toby Kusmer was quoted in the March 29 issue of the Boston Business Journal in regard to the lawsuits arising in the biotech industry. The article mentions that biotech lawsuits sometimes get emotional because the executives involved invented the technology or product in dispute.
Toby H. Kusmer PC, Intellectual Property, Life Sciences & Medical Products
2001
McDermott's U.S. partners were included in a list of biotech M&A deals in the second half of 2000 in the January 25 issue of Legal Week.
